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Sample records for trial supportive behandlung

  1. Psychosocial distress and need for supportive counselling in patients during radiotherapy; Subjektiv erlebte Belastung und Bedarf an psychosozialer Unterstuetzung bei Tumorpatienten in strahlentherapeutischer Behandlung

    Energy Technology Data Exchange (ETDEWEB)

    Vries, A. de; Steixner, E.; Stzankay, A.; Iglseder, W. [Universitaetsklinik fuer Strahlentherapie und Radioonkologie, Innsbruck (Austria); Soellner, W.; Auer, V.; Schiessling, G. [Universitaetsklinik fuer Medizinische Psychologie und Psychotherapie, Innsbruck (Austria); Lukas, P.

    1998-08-01

    Purpose: Psychosocial distress and patient attitude towards psychosocial support as well as the correlations with clinical and sociodemographic characteristics should be assessed. Methods: The stress due to cancer was measured in a consecutive sample of tumor patients at the start of radiotherapy (n=117) by use of the Hornheide Questionnaire. In addition, the interest of these patients in professional psychosocial support was assesed with the help of the Questionnaire for Psychosocial Support. Results: Patients in the course of radiotherapy and patients with a poor prognosis and advanced disease were more strongly distressed. 32.7% of patients wished professional psychosocial support from the oncologist treating them, 40.6% of the patients wished support from the oncologist and additionally from a psychotherapist or social worker. Interest in professional psychosocial support correlated with the amount of distress, but not with sociodemographic variables. Conclusions: Results stress the importance of training programs for oncologists in order to improve their ability to detect psychosocial distress in cancer patients and to offer adequate emotional support to them. (orig.) [Deutsch] Hintergrund: Tumorpatienten fuehlen sich vor allem am Beginn einer strahlentherapeutischen Behandlung belastet. Der Mangel an ausreichendem Wissen ueber die Art und das Ausmass der Belastung sowie ueber die Einstellung der Patienten gegenueber psychosozialer Unterstuetzung erschwert die Ausarbeitung adaequater Unterstuetzungsangebote. Patienten und Methoden: Bei einer konsekutiven Stichprobe von Krebspatienten am Beginn der strahlentherapeutischen Behandlung (n=117) wurde die Belastung durch die Tumorerkrankung mit der Kurzform des Hornheider Fragebogens untersucht. Das Interesse an professioneller psychosozialer Unterstuetzung wurde mit Hilfe des Fragebogens zur psychosozialen Unterstuetzung erhoben. Letztere wurde in einen an den behandelnden Onkologen sowie an einen Psychotherapeuten

  2. Endovascular therapy of high-degree stenoses of the neck vessels-stent-supported percutaneous angioplasty of the carotid artery without cerebral protection; Endovaskulaere Behandlung hochgradiger Halsgefaessstenosen - Stentgestuetzte perkutane Angioplastie der Arteria Carotis ohne Protektion

    Energy Technology Data Exchange (ETDEWEB)

    Koch, C.; Kucinski, T.; Eckert, B.; Wittkugel, O.; Zeumer, H. [Abt. fuer Neuroradiologie, Universitaetsklinikum Hamburg Eppendorf (Germany); Roether, J. [Klinik fuer Neurologie, Universitaetsklinikum Hamburg Eppendorf (Germany)

    2002-12-01

    Purpose: Technical essentials and therapeutic results of carotid stenting without cerebral protection are presented. Materials and methods: In 161 patients, 167 high grade carotid stenoses were stented, followed by percutaneous transluminal angioplasty, with subsequent evaluation of the clinical and angiographic results. Diffusion-weighted MRI was carried out in 108 patients to detect cerebral sequelae. Results: Endovascular therapy was successful (residual stenosis <25%) in 166 stenoses (99.4%). Twelve patients (7.5%) had cerebrovascular complications within the 30-day perioperative period, seven of which occurred during the procedure. After treatment, diffusion-weighted MRI disclosed at least one new cerebral lesion in 40 patients (37%), which were symptomatic in six patients. Conclusion: Even without cerebral protection, high grade carotid stenosis can be safely treated with stent-protected percutaneous angioplasty. Microemboli detected by postoperative MRI are infrequently symptomatic. (orig.) [German] Ziel: Es werden die Durchfuehrung der direkten Stentangioplastie der A.ccarotis ohne zerebrale Protektion und die Ergebnisse dieses Behandlungsverfahrens beschrieben. Methoden: Bei 161 Patienten wurden 167 hochgradige Karotisstenosen durch Platzieren eines Stents mit anschliessender perkutaner transluminaler Angioplastie behandelt. Die Behandlungsergebnisse wurden klinisch und angiographisch bewertet. 108 Patienten wurden mit diffusionsgewichteter MRT zum Nachweis klinisch stummer Infarkte untersucht. Ergebnisse: 166 Stenosen (99,4%) wurden erfolgreich behandelt (Reststenose <25%). Im perioperativen Zeitraum von 30 Tagen trat bei insgesamt 12 Patienten eine zerebrovaskulaere Komplikation auf (7,5%), 7 Patienten erlitten die Komplikation waehrend des Eingriffs. Nach der Behandlung hatten 40 Patienten (37%) mindestens eine neue zerebrale Diffusionsstoerung, 6 davon mit klinischen Symptomen. Schlussfolgerungen: Mit der stentgestuetzten perkutanen Angioplastie

  3. Harnröhrenstriktur: Ursachen, Klassifikation, Diagnostik und Behandlung

    Directory of Open Access Journals (Sweden)

    Klevecka V

    2010-01-01

    Full Text Available Die operative Behandlung von langstreckigen Harnröhrenstrikturen (HRS ist auch heute noch eine Herausforderung. Santucci et al. berichten, dass in den USA ca. 0,6 % der Bevölkerung an einer HRS leiden. Meistens sind HRS erworben und nur sehr selten angeboren. Die Behandlung der symptomatischen HRS kann entweder durch endoskopische Verfahren oder aber durch verschiedene offen-chirurgische Techniken erfolgen. Die Harnröhrenbougierung ist die älteste Form der Behandlung, bei der die definitive Heilung nur bei kurzstreckigen, epithelialen Strikturen ohne begleitende Spongiofibrose zu erwarten ist. Die Urethrotomia interna nach Sachse ist noch heute das am meisten verbreitete endoskopische Behandlungsverfahren der HRS. Der Therapieerfolg dieses Verfahrens hängt von der Länge und der Lokalisation der Striktur sowie vom Ausmaß der Spongiofibrose ab. Deshalb führen die endoskopischen Operationsverfahren bei langstreckigen HRS nur sehr selten zu einem dauerhaften Erfolg. In den meisten Fällen ist schließlich eine offene Rekonstruktion der Harnröhre (HR notwendig. Es besteht die Möglichkeit, die langstreckige HRS mittels primärer End-zu-End-Anastomose nach Exzision des vernarbten Bereichs oder mittels Substitutionsurethroplastik, entweder mit einem vaskularisierten Hautlappen oder mit Mundschleimhaut- (MSH- Transplantat, zu rekonstruieren. Die besten Ergebnisse aller offenen operativen Verfahren der HRRekonstruktion weist die primäre End-zu-End- Anastomose auf. Allerdings ist diese Form der Behandlung durch die Lokalisation und Länge der HRS limitiert. Bei der Anwendung von freien Transplantaten im Rahmen der HR-Rekonstruktion erscheint die MSH zurzeit aufgrund ihrer spezifischen Eigenschaften als bestgeeignetes Gewebe. Daher ist in den meisten urologischen Kliniken dieses Operationsverfahren die Therapie der Wahl. Die Behandlung einer hinteren HRS gehört nur in die Hände von sehr erfahrenen Operateuren, die über das gesamte Repertoire

  4. Radiotherapy of calcaneal spur; Strahlentherapeutische Behandlung des schmerzhaften Fersenbeinsporns

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    Schaefer, U. [Muenster Univ. (Germany). Klinik und Poliklinik fuer Strahlentherapie und Radioonkologie; Micke, O. [Muenster Univ. (Germany). Klinik und Poliklinik fuer Strahlentherapie und Radioonkologie; Glashoerster, M. [Muenster Univ. (Germany). Klinik und Poliklinik fuer Strahlentherapie und Radioonkologie; Ruebe, C. [Muenster Univ. (Germany). Klinik und Poliklinik fuer Strahlentherapie und Radioonkologie; Prott, F.J. [Muenster Univ. (Germany). Klinik und Poliklinik fuer Strahlentherapie und Radioonkologie; Willich, N. [Muenster Univ. (Germany). Klinik und Poliklinik fuer Strahlentherapie und Radioonkologie

    1995-04-01

    From April 1981 through December 1991, 18 patients with painful heel were irradiated mostly with the caesium or telecobalt unit, usually with a dose of 4 times 0.5 Gy. Among these patients, 12 could be followed up during a prolonged period on the basis of questionnaires. According to the categories of v. Pannewitz 17% of the patients were pain-free by the end of the treatment course, 22% showed marked improvement, 33% showed improvement and in 28% the pain was not influenced. Over an average of 41.5 months 58% of the patients reported freedom from pain. (orig./MG) [Deutsch] Von April 1981 bis Dezember 1991 wurden 18 Patienten mit einem schmerzhaften Fersenbeinsporn am Caesium- oder Telekobaltbestrahlungsgeraet behandelt, in der Regel mit einer Einstrahldosis von viermal 0,5 Gy. Von diesen Patienten konnten zwoelf mit Hilfe von Frageboegen ueber einen laengeren Zeitraum nachbeobachtet werden. Entsprechend der Einteilung nach von Pannewitz waren 17% der Patienten sofort nach der Behandlung schmerzfrei, 22% wesentlich gebessert, 33% gebessert und 28% unbeeinflusst. Nach im Median 41,5 Monaten berichteten 58% der Patienten von Schmerzfreiheit. (orig./MG)

  5. Surgical treatment of inflammatory bowel diseases; Chirurgische Behandlung entzuendlicher Darmerkrankungen

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    Fuerst, H.; Schildberg, F.W. [Chirurgische Klinik und Poliklinik, Ludwig Maximilians Univ. Muenchen, Klinikum Grosshadern (Germany)

    1998-01-01

    Purpose: To summarize current knowledge on surgical therapy in patients with inflammatory bowel disease (Crohn`s disease, ulcerative colitis and diverticulitis). Material and methods: To discuss surgical indications and strategies, we reviewed major peer review publications of the last 10 years, and we also analysed data from patients with Crohn`s disease who were treated in our institution between 1978 and 1994. Results: With Crohn`s disease (305 patients), emergency surgery should be avoided as much as possible, since morbidity (50% vs 8.8%) and mortality (11% vs 0.6%) rise significantly in comparison to elective procedures. With ulcerative colitis, operative therapy is indicated in patients with secondary malignoma, and urgent surgery is requested in cases with associated perforation, toxic megacolon or massive bleeding. With diverticulitis, the first episode should be managed conservatively. Surgery is indicated in patients with recurrent episodes or with secondary complications. (orig.) [Deutsch] In dieser Uebersichtsarbeit wird die operative Behandlung der entzuendlichen Darmerkrankungen M. Crohn, Colitis ulcerosa und Divertikulitis dargestellt. Anhand einer Literaturuebersicht wird sowohl die Operationsindikation als auch das operative Vorgehen besprochen, wobei beim M. Crohn auch Daten des eigenen Patientengutes zwischen 1978-1994 eingehen. Anhand der Daten von 305 Patienten wird deutlich, dass eine Notfalloperation bei M. Crohn vermieden werden muss, da darunter die Komplikationsrate (50% vs. 8,8%) und die Letalitaet (11% vs. 0,6%) deutlich steigen. Absolute Operationsindikationen bei Colitis ulcerosa sind die Perforation, das toxische Megakolon, Blutungen und das Auftreten eines Karzinoms. Der erste Schub einer Divertikulitis wird konservativ behandelt, bei Rezidivschueben sowie bei Kompliktionen besteht eine Operationsindikation. Wesentlich ist die rechtzeitige Operationsindikation bei M. Crohn und Divertikulitis, um Notfallsituationen zu vermeiden. Ziel

  6. SPARC-System zur Behandlung der weiblichen Belastungsinkontinenz

    Directory of Open Access Journals (Sweden)

    Primus G

    2004-01-01

    nach 6 Monaten und auf 0,5; 2,38 g; 16,6 nach 12 Monaten. Die objektive komplette Heilrate entsprechend der Definition – keine Verwendung von Vorlagen, Vorlagentest 0–1 g, negativer Hustentest und keine urodynamisch nachweisbare Belastungsinkontinenz – nach 3, 6 und 12 Monaten beträgt 81,9 %, 82,8 % und 80 %. Subjektiv beurteilten sich 79,3 % nach 6 Monaten bzw. 74 % nach 12 Monaten als vollständig kontinent. Die Ergebnisse unserer prospektiven Studie untermauern die Sicherheit und Effektivität des SPARC-Verfahrens zur operativen Behandlung der weiblichen Belastungsinkontinenz.

  7. Thermal processing of conditioned waste and fuel substitutes; Thermische Behandlung vorbehandelter Abfaelle und Ersatzbrennstoffe

    Energy Technology Data Exchange (ETDEWEB)

    Velden, F. van der; Engweiler, J. [Von Roll Umwelttechnik AG, Zurich (Switzerland)

    1998-12-31

    Different technologies for the thermal processing of mechanical-biologically conditioned waste are described and compared in terms of cost and flexibility. (orig.) [Deutsch] Es werden verschiedene Technologien der thermischen Behandlung mechanisch-biologisch vorbehandelter Abfaelle vorgestellt und im Hinblick auf Kosten und Flexibilitaet verglichen. (orig.)

  8. [COPD und Klangtherapie: Pilotstudie zur Wirksamkeit einer Behandlung mit Körpertambura bei COPD-Patienten].

    Science.gov (United States)

    Hartwig, Bernhard; Schmidt, Stefan; Hartwig, Isabella

    2016-01-01

    Hintergrund: Erkrankungen der Atemorgane treten mit steigendem Alter öfter auf, nehmen weltweit zu und sind häufige Ursachen für Morbidität und Mortalität. In dieser Pilotstudie wurde der Frage nachgegangen, ob eine einmalige 10-minütige Behandlung mit einer Körpertambura eine signifikante und effektive Verbesserung der Lungenfunktion von Patienten mit chronisch-obstruktiver Lungenerkrankung (COPD; GOLD-Stadium A oder B) erbringen kann. Patienten und Methoden: 54 Probanden konnten je zur Hälfte in eine Behandlungsgruppe (Körpertambura) und eine aktive Kontrollgruppe (Atemtherapie) randomisiert werden. Eine Bestimmung der Lungenfunktionsmessparameter «Einsekundenkapazität» (FEV1) und «inspiratorische Vitalkapazität» (IVC) zu den Zeitpunkten T1 (Baseline), T2 (direkt nach Behandlung) und als Follow-up etwa 3 Wochen nach T1 (T3). Ergebnisse: Die Behandlungsgruppe zeigte sich der Kontrollgruppe in beiden Werten signifikant überlegen. Die Zeit-×-Gruppe-Interaktion (Varianzanalyse) ergab p = 0,001 (FEV1) bzw. p = 0,04 (IVC). Die Behandlungsgruppe zeigte bei beiden Werten eine Verbesserung von klinischer Relevanz. Schlussfolgerung: Diese Ergebnisse zeigen, dass die Klangbehandlung mittels einer Körpertambura - neben den schulmedizinischen, leitliniengerechten Therapien - eine zusätzliche, nebenwirkungsarme, aber durchaus klinisch wirksame Option für die Behandlung von COPD-Patienten darstellen kann, um deren Lebensqualität zu stabilisieren und zu verbessern. © 2016 S. Karger GmbH, Freiburg.

  9. [Homöopathisch-phytotherapeutische Behandlung des Reizdarmsyndroms mit Magen-Darm-Entoxin N®: Eine Anwendungsbeobachtung].

    Science.gov (United States)

    Märtens, Diane; Range, Natasha; Günnewich, Nils; Gruber, Nicola; Schmidt, Stefan

    Hintergrund: In dieser Anwendungsbeobachtung wird zum ersten Mal die Behandlung des Reizdarmsyndroms (RDS) mit einem homöopathisch-phytotherapeutischen Komplexpräparat beschrieben. Methodik: Ziel der 6-wöchigen Therapie mit dem Magen-Darm-Entoxin N® war die Reduzierung der RDS-Symptomatik sowie die Verbesserung der Lebensqualität. Zielkriterien waren die Veränderungen in der Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS) und der Irritable Bowel Syndrome - Quality-of-Life Scale (IBS-QoL). Die Patient/innen (N = 41; Alter 44,0 ± 15,74 Jahre) wurden zu gleichen Teilen in einer Hausarztpraxis (N = 20) und einer Heilpraktikerpraxis (N = 21) rekrutiert. Ergebnisse: Der IBS-QoL-Score verringerte sich signifikant (prä: 35,9 ± 16,3; post: 20,1 ± 13,4; t = 8,504; p mit einer Effektstärke von d = 1,24. Die Neben- und Wechselwirkungen waren minimal und signifikante Unterschiede zwischen beiden Praxen wurden nicht gefunden. Schlussfolgerungen: Magen-Darm-Entoxin N® ist eine sichere und sinnvolle Therapieoption bei der Behandlung des RDS. Allerdings sollten randomisierte kontrollierte Studien folgen, um die Spezifizität der Ergebnisse dieser Anwendungsbeobachtung zu stützen. © 2017 S. Karger GmbH, Freiburg.

  10. The STRIPES Trial - Support to Rural India's Public Education System

    Science.gov (United States)

    2010-01-01

    Background Performance of primary school students in India lags far below government expectations, and major disparity exists between rural and urban areas. The Naandi Foundation has designed and implemented a programme using community members to deliver after-school academic support for children in over 1,100 schools in five Indian states. Assessments to date suggest that it might have a substantial effect. This trial aims to evaluate the impact of this programme in villages of rural Andhra Pradesh and will compare test scores for children in three arms: a control and two intervention arms. In both intervention arms additional after-school instruction and learning materials will be offered to all eligible children and in one arm girls will also receive an additional 'kit' with a uniform and clothes. Methods/Design The trial is a cluster-randomised controlled trial conducted in conjunction with the CHAMPION trial. In the CHAMPION trial 464 villages were randomised so that half receive health interventions aiming to reduce neonatal mortality. STRIPES will be introduced in those CHAMPION villages which have a public primary school attended by at least 15 students at the time of a baseline test in 2008. 214 villages of the 464 were found to fulfil above criteria, 107 belonging to the control and 107 to the intervention arm of the CHAMPION trial. These latter 107 villages will serve as control villages in the STRIPES trial. A further randomisation will be carried out within the 107 STRIPES intervention villages allocating half to receive an additional kit for girls on the top of the instruction and learning materials. The primary outcome of the trial is a composite maths and language test score. Discussion The study is designed to measure (i) whether the educational intervention affects the exam score of children compared to the control arm, (ii) if the exam scores of girls who receive the additional kit are different from those of girls living in the other STRIPES

  11. Job maintenance by supported employment: an overview of the Supported Employment plus trial

    Directory of Open Access Journals (Sweden)

    Wolfram eKawohl

    2015-05-01

    Full Text Available The number of days of absence from work associated with mental illness has risen dramatically in the past ten years in Germany. Companies are challenged by this issue and seek help for the physical and mental health of their employees. Supported Employment concepts such as the Individual Placement and Support (IPS model have been designed to bring jobless persons with mental disorders back to work. In the randomized, controlled SEplus-trial a modified IPS-approach is tested concerning its ability to shorten times of sick leave of persons with mental distress or a mental disorder and to prevent them from losing their job. The trial is outlined in this study protocol.

  12. Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis.

    Science.gov (United States)

    Iglesias, Cynthia; Nixon, Jane; Cranny, Gillian; Nelson, E Andrea; Hawkins, Kim; Phillips, Angela; Torgerson, David; Mason, Su; Cullum, Nicky

    2006-06-17

    To assess the cost effectiveness of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers in patients admitted to hospital. Cost effectiveness analysis carried out alongside the pressure relieving support surfaces (PRESSURE) trial; a multicentre UK based pragmatic randomised controlled trial. 11 hospitals in six UK NHS trusts. Intention to treat population comprising 1971 participants. Kaplan Meier estimates of restricted mean time to development of pressure ulcers and total costs for treatment in hospital. Alternating pressure mattresses were associated with lower overall costs (283.6 pounds sterling per patient on average, 95% confidence interval--377.59 pounds sterling to 976.79 pounds sterling) mainly due to reduced length of stay in hospital, and greater benefits (a delay in time to ulceration of 10.64 days on average,--24.40 to 3.09). The differences in health benefits and total costs for hospital stay between alternating pressure mattresses and alternating pressure overlays were not statistically significant; however, a cost effectiveness acceptability curve indicated that on average alternating pressure mattresses compared with alternating pressure overlays were associated with an 80% probability of being cost saving. Alternating pressure mattresses for the prevention of pressure ulcers are more likely to be cost effective and are more acceptable to patients than alternating pressure overlays.

  13. Support from hospital to home for elders: a randomized trial.

    Science.gov (United States)

    Goldman, L Elizabeth; Sarkar, Urmimala; Kessell, Eric; Guzman, David; Schneidermann, Michelle; Pierluissi, Edgar; Walter, Barbara; Vittinghoff, Eric; Critchfield, Jeff; Kushel, Margot

    2014-10-07

    Hospitals are implementing discharge support programs to reduce readmissions, and these programs have had mixed success. To examine whether a peridischarge, nurse-led intervention decreased emergency department (ED) visits or readmissions among ethnically and linguistically diverse older patients admitted to a safety-net hospital. Randomized, controlled trial using computer-generated randomization with 1:1 allocation, stratified by language. (Clinical Trials.gov: NCT01221532). Publicly funded urban hospital in Northern California. Hospitalized adults aged 55 years or older with anticipated discharge to the community who spoke English, Spanish, or Chinese (Mandarin or Cantonese). Usual care versus in-hospital, one-on-one, self-management education given by a dedicated language-concordant registered nurse combined with a telephone follow-up after discharge from a nurse practitioner. Staff blinded to the study groups determined ED visits or readmissions to any facility at 30, 90, and 180 days after initial hospital discharge using administrative data from several hospitals. There were 700 low-income, ethnically and linguistically diverse patients with a mean age of 66.2 years (SD, 9.0). The primary outcome of ED visits or readmissions did not differ between the intervention and usual care groups (hazard ratio, 1.26 [95% CI, 0.89 to 1.78] at 30 days, 1.21 [CI, 0.91 to 1.62] at 90 days, and 1.11 [CI, 0.86 to 1.43] at 180 days). This study was done at a single acute-care hospital. There were fewer outcomes than expected, which may have caused the study to be underpowered. A nurse-led, in-hospital discharge support intervention did not show a reduction in readmissions or ED visits among diverse, low-income older adults at a safety-net hospital. Although wide CIs preclude firm conclusions, the intervention may have increased ED visits. Alternative readmission prevention strategies should be tested in this population. Gordon and Betty Moore Foundation.

  14. Online psychoeducational support for infertile women: a randomized controlled trial

    Science.gov (United States)

    Cousineau, Tara M.; Green, Traci C.; Corsini, Evelyn; Seibring, A; Showstack, Marianne T.; Applegarth, Linda; Davidson, Marie; Perloe, Mark

    2008-01-01

    BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress (P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices. PMID:18089552

  15. The Clinical Trials Transformation Initiative: Methodology supporting the mission.

    Science.gov (United States)

    Corneli, Amy; Hallinan, Zachary; Hamre, Gerrit; Perry, Brian; Goldsack, Jennifer C; Calvert, Sara B; Forrest, Annemarie

    2018-02-01

    The mission of the Clinical Trials Transformation Initiative, a public-private partnership co-founded by the U.S. Food and Drug Administration and Duke University, is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. The Clinical Trials Transformation Initiative works collaboratively with key stakeholders, implements "fit-for-purpose" evidence-gathering projects, and develops actionable recommendations and tools to address the challenges faced by the clinical trials enterprise. In pursuit of its mission, The Clinical Trials Transformation Initiative follows an innovative and collaborative, five-step methodology: (1) state the problem and identify impediments to research, (2) gather evidence to identify gaps and barriers, (3) explore results by analyzing and interpreting findings, (4) finalize solutions by developing recommendations and tools, and (5) drive adoption through disseminating and implementing recommendations and tools. This article describes each step of the Clinical Trials Transformation Initiative's methodology, with a specific focus on describing the evidence-gathering activities.

  16. Siebenjährige Follow-up-Studie zur Anwendung des spannungsfreien Vaginalbandes (TVT zur Behandlung der Stressharninkontinenz

    Directory of Open Access Journals (Sweden)

    Nilsson CG

    2005-01-01

    Full Text Available Studienzweck: Evaluierung der langfristigen Heilungs- und Spätkomplikationsraten bei Stressharninkontinenz der Frau bei Behandlung mit dem spannungsfreien Vaginalband (TVT, das anhand einer minimal-invasiven Operation eingesetzt wird. Methodik: In drei Studienzentren durchgeführte prospektive Beobachtungs- und Kohortenstudie mit ursprünglich 90 Frauen, deren primäre Stressharninkontinenz einen operativen Eingriff erforderlich machte. Zu den Bewertungsvariablen gehörten ein Vorlagentest (Pad-Test zur Messung des Uringewichts je 24 Stunden, ein Stresstest, eine visuelle Analogskala (VAS zur Beurteilung des Beschwerdegrads sowie ein Fragebogen zur Beurteilung der subjektiven Wahrnehmung des Kontinenzstatus durch die Frauen. Ergebnisse: Als Follow-up-Zeitraum wurde ein durchschnittlicher Zeitraum von 91 Monaten (78–100 Monate festgelegt. Sowohl die objektive als auch die subjektive Heilungsrate lag bei den an der Follow-up-Studie teilnehmenden 80 Frauen bei 81,3 %. Bei 7,8 % der Frauen wurde ein asymptomatischer Prolaps der Organe des kleinen Beckens, bei 6,3 % De-novo-Drangsymptome und bei 7,5 % eine rezidivierende Harnwegsinfektion festgestellt. Weitere unerwünschte Nebenwirkungen des Verfahrens wurden nicht festgestellt. Schlussfolgerung: Die Wirkung der TVT-Operation zur Behandlung der Stressharninkontinenz der Frau bleibt über einen Zeitraum von 7 Jahren erhalten.

  17. Tools in a clinical information system supporting clinical trials at a Swiss University Hospital.

    Science.gov (United States)

    Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg

    2014-12-01

    Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient-trial-assignment-tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of

  18. Protocol for the saMS trial (supportive adjustment for multiple sclerosis: a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2009-08-01

    Full Text Available Abstract Background Multiple Sclerosis (MS is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS. Methods/Design This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks, mid-therapy (week 5 of therapy, post-therapy (15 weeks and at six months (26 weeks and twelve months (52 weeks follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. Discussion This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the

  19. Cluster randomized controlled trial of a peer support program for people with diabetes

    DEFF Research Database (Denmark)

    Riddell, Michaela A; Renwick, Carla; Wolfe, Rory

    2012-01-01

    and social support, assist and encourage clinical care and be available when needed. METHODS: A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self...... to the participants. (1) Trained supporters lead 12 monthly group meetings. Participants are assisted to set goals to improve diabetes self-management, discuss with and encourage each other to strengthen linkages with local clinical services (including allied health services) as well as provide social and emotional......-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN...

  20. Verbesserung der Lebensqualität bei Kinderwunsch-Behandlung durch den Gebrauch patientenfreundlicher Follitropin-Fertigpens

    Directory of Open Access Journals (Sweden)

    Bitzer J

    2011-01-01

    Full Text Available Zur Behandlung des unerfüllten Kinderwunsches unterziehen sich viele Frauen einer assistierten Reproduktionstherapie mit ovarieller Stimulation. Dazu erfolgen tägliche subkutane Injektionen mit Gonadotropinen, welche die Patientinnen eigenständig durchführen können. Häufig haben Patientinnen dabei Angst vor Spritzen und injektionsbedingten Schmerzen. Die vorliegende Beobachtungsstudie zum Einfluss der Anwendung des Follitropin alfa-Fertigpens (Gonal-f®-Pen auf die Lebensqualität der Patientinnen zeigt die Ergebnisse einer Befragung von 170 Frauen zu Angst und Zufriedenheit mit diesem Applikationssystem. Die Erfahrungen wurden vor und nach den Behandlungszyklen auf numerischen Analogskalen quantifiziert und nachfolgend verglichen. Die Studie ergab, dass durch die Verwendung des Gonal-f®-Pens die Angst vor der Injektion und vor Schmerzen signifikant abnahm. Zudem waren die Patientinnen mit dem Applikationssystem äußerst zufrieden.

  1. Job maintenance through Supported Employment PLUS: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nils-Torge Telle

    2016-09-01

    Full Text Available Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58 received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41 received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention and at a 3-month follow up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  2. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial.

    Science.gov (United States)

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N  = 99 employees who reported mental distress due to work-related problems. The intervention group ( n  = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group ( n  = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  3. Clinical Trial Designs to Support Clinical Utility of Pharmacogenomic Testing.

    Science.gov (United States)

    Drozda, Katarzyna; Pacanowski, Michael A

    2017-09-01

    Advancing the use of biomarkers and pharmacogenomics has been a key priority area for the U.S. Food and Drug Administration (FDA). The FDA offers prescribing recommendations to manage ~100 gene-drug interactions, and multiple institutions around the United States and abroad have incorporated genomic testing into patient care. However, the penetration of pharmacogenomic testing remains incomplete. In this perspective, we summarize the evidence streams to support the clinical utility of pharmacogenomic testing and its transition into clinical practice. © 2017 Pharmacotherapy Publications, Inc.

  4. Regenerierung fester Katalysatoren für die Isobutan-Buten-Alkylierung durch hydrierende Behandlung in flüssiger Phase

    OpenAIRE

    Klingmann, Raoul

    2005-01-01

    In der vorliegenden Arbeit wurde die Regenerierung fester Katalysatoren für die Isobutan/Buten-Alkylierung durch hydrierende Behandlung in flüssiger Phase untersucht. Als Katalysatoren dienten edelmetallhaltige Zeolithe des Typs La-X (FAU). Die Alkylierungs- und Regenerierungsexperimente wurden in einer Apparatur mit kontinuierlich betriebenem Rührkesselreaktor und Analytikeinheit mit On-line-Probenahmevorrichtung durchgeführt. Zunächst wurde der Aufbau der Koksdeposite in Abhängigkeit von...

  5. [Kombinierte Anwendung von Strahlentherapie und adjuvanter Therapie mit einem Mistelextrakt (Viscum album L.) zur Behandlung des oralen malignen Melanoms beim Hund: Eine retrospektive Studie].

    Science.gov (United States)

    von Bodungen, Uta; Ruess, Katja; Reif, Marcus; Biegel, Ulrike

    2017-01-01

    Hintergrund: Orale maligne Melanome (OMM) des Hundes zeichnen sich durch schnelles Wachstum, lokale Invasion und hohe Metastasierungsraten aus. Extrakte auf Basis von Viscum album L. (VAE) werden zunehmend in der Krebstherapie sowohl in der Human- als auch in der Veterinärmedizin eingesetzt. Ziel unserer Studie war es zu untersuchen, inwieweit die adjuvante Therapie mit VAE eine therapeutische Option zur Behandlung von OMM ist. Besonderes Augenmerk galt dabei der Überlebenszeit und möglichen Nebenwirkungen. Tiere und Methoden: 26 Hunde mit OMM, die in einem der größten veterinäronkologischen Zentren der Schweiz allesamt eine Strahlentherapie erhielten (teilweise nach operativer Tumorresektion) wurden in die retrospektive Studie eingeschlossen: 18 Hunde wurden mit VAE behandelt (1 ml VAE (Iscador®) in ansteigenden Konzentrationen von 0,1 bis 20 mg/ml subkutan 3-mal pro Woche (VAE-Gruppe), 8 erhielten keine adjuvante Behandlung (Vergleichsgruppe). Wir verglichen die Größenentwicklung der OMM sowie die Überlebenszeit. Ergebnisse: Patienten mit Bestrahlung und adjuvanter VAE-Therapie zeigten mit 236 Tagen eine signifikant längere mediane Überlebenszeit im Vergleich zu Patienten mit Bestrahlung, aber ohne adjuvante VAE-Therapie (49 Tage; Log-Rank-Test: p = 0,0047). Die VAE-Therapie verlängerte die Überlebenszeit um mehr als zwei Drittel (Hazard Ratio (HR) = 0,30, 95%-Konfidenzintervall (KI) 0,11-0,86; p = 0,024), während ein höheres Tumorstadium gemäß UICC (Union internationale contre le cancer) einen statistischen Trend zur Verdopplung des Sterberisikos zeigte (UICC-Stadium III/IV vs. I/II: HR = 2,12, 95%-KI 0,88-5,12; p = 0,095). Zwei Patienten zeigten milde Nebenwirkungen während der VAE-Behandlung. Einer der beiden zeigte 1 Tag lang ein selbstlimitiertes Fieber, bei dem anderen Patienten reduzierten wir die Dosis von einem konzentrierteren zu einem weniger konzentrierten VAE (Serie 0) aufgrund von Müdigkeit, die daraufhin verschwand

  6. Spirometry expert support in family practice: a cluster-randomised trial.

    NARCIS (Netherlands)

    Poels, P.J.P.; Schermer, T.R.J.; Thoonen, B.P.A.; Jacobs, J.E.; Akkermans, R.P.; Vries Robbe, P.F. de; Quanjer, P.H.; Bottema, B.J.A.M.; Weel, C. van

    2009-01-01

    AIM: To assess the impact of two modes of spirometry expert support on Family physicians' (FPs') diagnoses and planned management in patients with apparent respiratory disease. METHOD: A cluster-randomised trial was performed with family practices as the unit of randomisation. FPs from 44 family

  7. Evidence-Based Literacy Support: The "Literacy Octopus" Trial. Evaluation Report and Executive Summary

    Science.gov (United States)

    Lord, Pippa; Rabiasz, Adam; Roy, Palak; Harland, Jennie; Styles, Ben; Fowler, Katherine

    2017-01-01

    The Evidence-based Literacy Support-"Literacy Octopus" Trial tested a range of dissemination interventions and resources, all of which aimed to engage schools in using evidence-based materials to improve teaching and learning in Key Stage 2 literacy. Four delivery partners provided interventions. These included light-touch,…

  8. Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Golant Mitch

    2011-08-01

    Full Text Available Abstract Background The Internet can increase access to psychosocial care for breast cancer survivors through online support groups. This study will test a novel prosocial online group that emphasizes both opportunities for getting and giving help. Based on the helper therapy principle, it is hypothesized that the addition of structured helping opportunities and coaching on how to help others online will increase the psychological benefits of a standard online group. Methods/Design A two-armed randomized controlled trial with pretest and posttest. Non-metastatic breast cancer survivors with elevated psychological distress will be randomized to either a standard facilitated online group or to a prosocial facilitated online group, which combines online exchanges of support with structured helping opportunities (blogging, breast cancer outreach and coaching on how best to give support to others. Validated and reliable measures will be administered to women approximately one month before and after the interventions. Self-esteem, positive affect, and sense of belonging will be tested as potential mediators of the primary outcomes of depressive/anxious symptoms and sense of purpose in life. Discussion This study will test an innovative approach to maximizing the psychological benefits of cancer online support groups. The theory-based prosocial online support group intervention model is sustainable, because it can be implemented by private non-profit or other organizations, such as cancer centers, which mostly offer face-to-face support groups with limited patient reach. Trial Registration ClinicalTrials.gov: NCT01396174

  9. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    Directory of Open Access Journals (Sweden)

    Clancy Richard

    2011-07-01

    Full Text Available Abstract Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic. Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT; referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide, will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration

  10. The STRIPES trial--support to rural India's public education system.

    Science.gov (United States)

    Eble, Alex; Mann, Vera; Bhakta, Preetha; Lakshminarayana, Rashmi; Frost, Chris; Elbourne, Diana; Boone, Peter

    2010-02-01

    Performance of primary school students in India lags far below government expectations, and major disparity exists between rural and urban areas. The Naandi Foundation has designed and implemented a programme using community members to deliver after-school academic support for children in over 1,100 schools in five Indian states. Assessments to date suggest that it might have a substantial effect. This trial aims to evaluate the impact of this programme in villages of rural Andhra Pradesh and will compare test scores for children in three arms: a control and two intervention arms. In both intervention arms additional after-school instruction and learning materials will be offered to all eligible children and in one arm girls will also receive an additional 'kit' with a uniform and clothes. The trial is a cluster-randomised controlled trial conducted in conjunction with the CHAMPION trial. In the CHAMPION trial 464 villages were randomised so that half receive health interventions aiming to reduce neonatal mortality. STRIPES will be introduced in those CHAMPION villages which have a public primary school attended by at least 15 students at the time of a baseline test in 2008. 214 villages of the 464 were found to fulfil above criteria, 107 belonging to the control and 107 to the intervention arm of the CHAMPION trial. These latter 107 villages will serve as control villages in the STRIPES trial. A further randomisation will be carried out within the 107 STRIPES intervention villages allocating half to receive an additional kit for girls on the top of the instruction and learning materials. The primary outcome of the trial is a composite maths and language test score. The study is designed to measure (i) whether the educational intervention affects the exam score of children compared to the control arm, (ii) if the exam scores of girls who receive the additional kit are different from those of girls living in the other STRIPES intervention arm. One of the goals of

  11. Power function arguments in support of an alternative approach for analyzing management trials.

    Science.gov (United States)

    Willan, A R

    1994-06-01

    Power function arguments are used in support of an alternative approach for analyzing management trials. Central to the arguments is the recognition that, based on interpreting the smallest clinically important difference as a point of indifference, management trials require different power functions than explanatory trials. This interpretation of the smallest clinically important difference implies a specific ideal power function, and the alternative approach, by testing a nonzero null hypothesis at the appropriate level, is designed to achieve a power function with intuitive appeal and some optimal properties with respect to this ideal function. The alternative approach, by moving away from the traditional null hypothesis, better reflects clinical considerations, and eliminates the conflict between statistical and clinical significance. In addition, with adequate sample size, a decision in favor of the superior treatment will be made with a predetermined high level of confidence, if the therapies differ significantly.

  12. Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cabassa, Leopoldo J; Stefancic, Ana; O'Hara, Kathleen; El-Bassel, Nabila; Lewis-Fernández, Roberto; Luchsinger, José A; Gates, Lauren; Younge, Richard; Wall, Melanie; Weinstein, Lara; Palinkas, Lawrence A

    2015-09-02

    The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese. The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial. This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI. www

  13. Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder

    Directory of Open Access Journals (Sweden)

    Roberts Christopher

    2011-07-01

    Full Text Available Abstract Background Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years, and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. Methods/design Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. Discussion The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement. Trial Registration ISRCTN62761948 Funding National Institute for Health Research, England.

  14. Leitlinie für die Diagnose, Prävention und Behandlung des Handekzems

    DEFF Research Database (Denmark)

    Diepgen, Thomas L.; Andersen, Klaus E.; Chosidow, Oliver

    2015-01-01

    -searching). In addition to the evidence- and consensus-based recommendation on the treatment of HE, the guidelines cover mainly consensus-based diagnostic aspects and preventive measures (primary and secondary prevention). Treatment recommendations include non-pharmacological interventions, topical, physical and systemic...... treatments. Topical corticosteroids are recommended as first line treatment in the management of HE, however continuous long-term treatment beyond six weeks only when necessary and under careful medical supervision. Alitretinoin is recommended as a second line treatment (relative to topical corticosteroids......) for patients with severe chronic HE. Randomized control trials (RCT) are missing for other used systemic treatments and comparison of systemic drugs in “head-to-head” RCTs are needed. The guidelines development group is a working group of the European Society of Contact Dermatitis (ESCD) and has carefully...

  15. Predictors of treatment response for depression and inadequate social support--the ENRICHD randomized clinical trial.

    Science.gov (United States)

    Cowan, Marie J; Freedland, Kenneth E; Burg, Matthew M; Saab, Patrice G; Youngblood, Marston E; Cornell, Carol E; Powell, Lynda H; Czajkowski, Susan M

    2008-01-01

    To determine whether the 'dose' of treatment exposure, delivery of specific components of cognitive behavior therapy (CBT), patient adherence and/or use of antidepressants predict favorable depression and social support outcomes after 6 months of cognitive behavioral treatment. Secondary analyses of the intervention arm of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial involving persons with acute myocardial infarction (MI): n = 641 for the depression outcomes and n = 523 for the social support outcomes. The outcome measures were, for depression: the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HAM-D); for social support: the ENRICHD Social Support Instrument (ESSI) and Perceived Social Support Scale (PSSS). Better depression outcomes (measured by the BDI) were receiving a high number of depression-specific intervention components, p depression outcomes (measured by the HAM-D) were receiving a high number of the social communication and assertiveness components of the intervention, p social support outcomes (measured by the ESSI and PSSS) were predicted by membership in a racial or ethnic minority group, p social communication and assertiveness components of the intervention was an independent predictor of a worse social support outcome, p depression are useful in treating comorbid depression in post-MI patients. Working on communication skills may help to improve depression but not necessarily social support outcomes in this patient population, while adherence to cognitive-behavioral homework assignments is important for both outcomes. Other components of the ENRICHD intervention that were designed to improve social support had no discernible effects on outcomes. Intervention refinements may be needed in order to achieve better results in future post-MI clinical trials. A greater emphasis on CBT homework adherence could improve both depression and social support outcomes. 2008 S. Karger AG, Basel

  16. Feasibility trial of GP and case-managed support for workplace sickness absence.

    Science.gov (United States)

    Rannard, Anne; Gabbay, Mark; Sen, Dil; Riley, Richard; Britt, David

    2014-07-01

    Aim Our aim was to compare the return-to-work rates between individuals supported by their GP plus workplace health advisers (intervention group) and those supported by their GP alone. Workplace sickness absence places a significant cost burden on individuals and the wider economy. Previous research shows better outcomes for individuals if they are supported while still in employment, or have been on sick leave for four weeks or less. Those helped back to work at an early stage are more likely to remain at work. A non-medicalised case-managed approach appears to have the best outcomes and can prevent or reduce the slide onto out-of-work benefits, but UK literature on its effectiveness is sparse. The design was a feasibility-controlled trial in which participants were sickness absentees, or presentees in employment with work-related health problems. Individuals completed health status measures (SF-36; EQ-5D) and a Job Content Questionnaire at baseline and again at four-month follow-up. Findings In the intervention group, 29/60 participants completed both phases of the trial. GP practices referred two control patients, and, despite various attempts by the research team, GPs failed to engage with the trial. This finding is of concern, although not unique in primary care research. In earlier studies, GPs reported a lack of knowledge and confidence in dealing with workplace health issues. Despite this, we report interesting findings from the case-managed group, the majority of whom returned to work within a month. Age and length of sickness absence at recruitment were better predictors of return-to-work rates than the number of case-managed contacts. The traditional randomised controlled trial approach was unsuitable for this study. GPs showed low interest in workplace sickness absence, despite their pivotal role in the process. This study informed a larger Department for Work and Pensions study of case-managed support.

  17. A Trial of Telephone Support Services to Prevent Further Intimate Partner Violence.

    Science.gov (United States)

    Stevens, Jack; Scribano, Philip V; Marshall, Jessica; Nadkarni, Radha; Hayes, John; Kelleher, Kelly J

    2015-12-01

    We conducted a randomized-controlled trial of telephone support services (TSS) versus enhanced usual care (EUC) for women who had reported intimate partner violence (IPV) within the past year during a visit to a pediatric emergency department. TSS nurse interventionists identified appropriate referrals to community programs, helped participants by problem-solving barriers to obtaining these local services, and provided social support. Three hundred women, ages 18 years and above were recruited. The TSS and EUC groups did not differ on any outcome variable, including IPV victimization, feelings of chronic vulnerability to a perpetrator, depressive symptoms, and posttraumatic stress disorder symptoms. © The Author(s) 2015.

  18. Extubation after breathing trials with automatic tube compensation, T-tube, or pressure support ventilation.

    Science.gov (United States)

    Haberthür, C; Mols, G; Elsasser, S; Bingisser, R; Stocker, R; Guttmann, J

    2002-09-01

    Automatic tube compensation (ATC) is a new option to compensate for the pressure drop across the endotracheal or tracheostomy tube (ETT), especially during ventilator-assisted spontaneous breathing. While several benefits of this mode have so far been documented, ATC has not yet been used to predict whether the ETT could be safely removed at the end of weaning, from mechanical ventilation. We undertook a systematic trial using a randomized block design. During a 2-year period, all eligible patients of a medical intensive care unit were treated with ATC, conventional pressure support ventilation (PSV, 5 cmH2O), or T-tube for 2-h. Tolerance of the breathing trial served as a basis for the decision to remove the endotracheal tube. Extubation failure was considered if reintubation was necessary or if the patient required non-invasive ventilatory assistance (both within 48 h). After the inclusion of 90 patients (30 per group) we did not observe significant differences between the modes. Twelve patients failed the initial weaning trial. However, half of the patients who appeared to fail the spontaneous breathing trial on the T-tube, PSV, or both, were successfully extubated after a succeeding trial with ATC. Extubation was thus withheld from four and three of these patients while breathing with PSV or the T-tube, respectively, but to any patient breathing with ATC. It seems that ATC can be used as an alternative mode during the final phase of weaning from mechanical ventilation. Furthermore, this study may promote a larger multicenter trial on weaning with ATC compared with standard modes.

  19. Teaching school children basic life support improves teaching and basic life support skills of medical students: A randomised, controlled trial.

    Science.gov (United States)

    Beck, Stefanie; Meier-Klages, Vivian; Michaelis, Maria; Sehner, Susanne; Harendza, Sigrid; Zöllner, Christian; Kubitz, Jens Christian

    2016-11-01

    The "kids save lives" joint-statement highlights the effectiveness of training all school children worldwide in cardiopulmonary resuscitation (CPR) to improve survival after cardiac arrest. The personnel requirement to implement this statement is high. Until now, no randomised controlled trial investigated if medical students benefit from their engagement in the BLS-education of school children regarding their later roles as physicians. The objective of the present study is to evaluate if medical students improve their teaching behaviour and CPR-skills by teaching school children in basic life support. The study is a randomised, single blind, controlled trial carried out with medical students during their final year. In total, 80 participants were allocated alternately to either the intervention or the control group. The intervention group participated in a CPR-instructor-course consisting of a 4h-preparatory seminar and a teaching-session in BLS for school children. The primary endpoints were effectiveness of teaching in an objective teaching examination and pass-rates in a simulated BLS-scenario. The 28 students who completed the CPR-instructor-course had significantly higher scores for effective teaching in five of eight dimensions and passed the BLS-assessment significantly more often than the 25 students of the control group (Odds Ratio (OR): 10.0; 95%-CI: 1.9-54.0; p=0.007). Active teaching of BLS improves teaching behaviour and resuscitation skills of students. Teaching school children in BLS may prepare medical students for their future role as a clinical teacher and support the implementation of the "kids save lives" statement on training all school children worldwide in BLS at the same time. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  20. Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

    Science.gov (United States)

    Sawyer, Michael G; Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

    2017-07-24

    Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List-Short Form, Maternal Support Scale, Ages and Stages Questionnaire-Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of

  1. A cluster randomized trial to evaluate external support for the implementation of positive behavioral interventions and supports by school personnel.

    Science.gov (United States)

    Eiraldi, Ricardo; McCurdy, Barry; Khanna, Muniya; Mautone, Jennifer; Jawad, Abbas F; Power, Thomas; Cidav, Zuleyha; Cacia, Jaclyn; Sugai, George

    2014-01-15

    Urban schools lag behind non-urban schools in attending to the behavioral health needs of their students. This is especially evident with regard to the level of use of evidence-based interventions with school children. Increased used of evidence-based interventions in urban schools would contribute to reducing mental health services disparities in low-income communities. School-wide positive behavioral interventions and supports (SWPBIS) is a service delivery framework that can be used to deliver universal preventive interventions and evidence-based behavioral health treatments, such as group cognitive behavioral therapy. In this article, we describe our ongoing research on creating internal capacity for program implementation. We also examine the cost-effectiveness and resulting school climate when two different levels of external support are provided to personnel as they implement a two-tier SWPBIS program. The study follows six K - 8 schools in the School District of Philadelphia randomly assigned to consultation support or consultation-plus-coaching support. Participants are: approximately 48 leadership team members, 180 school staff and 3,900 students in Tier 1, and 12 counselors, and 306 child participants in Tier 2. Children who meet inclusion criteria for Tier 2 will participate in group cognitive behavioral therapy for externalizing or anxiety disorders. The study has three phases, baseline/training, implementation, and sustainability. We will measure implementation outcomes, service outcomes, child outcomes, and cost. Findings from this study will provide evidence as to the appropriateness of school-wide prevention and treatment service delivery models for addressing services disparities in schools. The effectiveness and cost-effectiveness analyses of the two levels of training and consultation should help urban school districts and policymakers with the planning and deployment of cost-effective strategies for the implementation of evidence

  2. Evaluation of Evidence of Statistical Support and Corroboration of Subgroup Claims in Randomized Clinical Trials.

    Science.gov (United States)

    Wallach, Joshua D; Sullivan, Patrick G; Trepanowski, John F; Sainani, Kristin L; Steyerberg, Ewout W; Ioannidis, John P A

    2017-04-01

    Many published randomized clinical trials (RCTs) make claims for subgroup differences. To evaluate how often subgroup claims reported in the abstracts of RCTs are actually supported by statistical evidence (P SATIRE) articles and Discontinuation of Randomized Trials (DISCO) articles. We used Scopus (updated July 2016) to search for English-language articles citing each of the eligible index articles with at least 1 subgroup finding in the abstract. Articles with a subgroup claim in the abstract with or without evidence of statistical heterogeneity (P < .05 from an interaction test) in the text and articles attempting to corroborate the subgroup findings. Study characteristics of trials with at least 1 subgroup claim in the abstract were recorded. Two reviewers extracted the data necessary to calculate subgroup-level effect sizes, standard errors, and the P values for interaction. For individual RCTs and meta-analyses that attempted to corroborate the subgroup findings from the index articles, trial characteristics were extracted. Cochran Q test was used to reevaluate heterogeneity with the data from all available trials. The number of subgroup claims in the abstracts of RCTs, the number of subgroup claims in the abstracts of RCTs with statistical support (subgroup findings), and the number of subgroup findings corroborated by subsequent RCTs and meta-analyses. Sixty-four eligible RCTs made a total of 117 subgroup claims in their abstracts. Of these 117 claims, only 46 (39.3%) in 33 articles had evidence of statistically significant heterogeneity from a test for interaction. In addition, out of these 46 subgroup findings, only 16 (34.8%) ensured balance between randomization groups within the subgroups (eg, through stratified randomization), 13 (28.3%) entailed a prespecified subgroup analysis, and 1 (2.2%) was adjusted for multiple testing. Only 5 (10.9%) of the 46 subgroup findings had at least 1 subsequent pure corroboration attempt by a meta-analysis or an

  3. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial.

    Science.gov (United States)

    Bucknall, C E; Miller, G; Lloyd, S M; Cleland, J; McCluskey, S; Cotton, M; Stevenson, R D; Cotton, P; McConnachie, A

    2012-03-06

    To determine whether supported self management in chronic obstructive pulmonary disease (COPD) can reduce hospital readmissions in the United Kingdom. Randomised controlled trial. Community based intervention in the west of Scotland. Patients admitted to hospital with acute exacerbation of COPD. Participants in the intervention group were trained to detect and treat exacerbations promptly, with ongoing support for 12 months. The primary outcome was hospital readmissions and deaths due to COPD assessed by record linkage of Scottish Morbidity Records; health related quality of life measures were secondary outcomes. 464 patients were randomised, stratified by age, sex, per cent predicted forced expiratory volume in 1 second, recent pulmonary rehabilitation attendance, smoking status, deprivation category of area of residence, and previous COPD admissions. No difference was found in COPD admissions or death (111/232 (48%) v 108/232 (47%); hazard ratio 1.05, 95% confidence interval 0.80 to 1.38). Return of health related quality of life questionnaires was poor (n=265; 57%), so that no useful conclusions could be made from these data. Pre-planned subgroup analysis showed no differential benefit in the primary outcome relating to disease severity or demographic variables. In an exploratory analysis, 42% (75/150) of patients in the intervention group were classified as successful self managers at study exit, from review of appropriateness of use of self management therapy. Predictors of successful self management on stepwise regression were younger age (P=0.012) and living with others (P=0.010). COPD readmissions/deaths were reduced in successful self managers compared with unsuccessful self managers (20/75 (27%) v 51/105 (49%); hazard ratio 0.44, 0.25 to 0.76; P=0.003). Supported self management had no effect on time to first readmission or death with COPD. Exploratory subgroup analysis identified a minority of participants who learnt to self manage; this group had a

  4. Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers.

    Science.gov (United States)

    Wahid, Rahnuma; Holt, Renee; Hjorth, Richard; Berlanda Scorza, Francesco

    2016-10-26

    With the support of the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, PATH has contributed to the World Health Organization's (WHO's) Global Action Plan for Influenza Vaccines (GAP) by providing technical and clinical assistance to several developing country vaccine manufacturers (DCVMs). GAP builds regionally based independent and sustainable influenza vaccine production capacity to mitigate the overall global shortage of influenza vaccines. The program also ensures adequate influenza vaccine manufacturing capacity in the event of an influenza pandemic. Since 2009, PATH has worked closely with two DCVMs in Vietnam: the Institute of Vaccines and Medical Biologicals (IVAC) and VABIOTECH. Beginning in 2013, PATH also began working with Torlak Institute in Serbia; Instituto Butantan in Brazil; Serum Institute of India Private Ltd. in India; and Changchun BCHT Biotechnology Co. (BCHT) in China. The DCVMs supported under the GAP program all had existing influenza vaccine manufacturing capability and required technical support from PATH to improve vaccine yield, process efficiency, and product formulation. PATH has provided customized technical support for the manufacturing process to each DCVM based on their respective requirements. Additionally, PATH, working with BARDA and WHO, supported several DCVMs in the clinical development of influenza vaccine candidates progressing toward national licensure or WHO prequalification. As a result of the activities outlined in this review, several companies were able to make excellent progress in developing state-of-the-art manufacturing processes and completing early phase clinical trials. Licensure trials are currently ongoing or planned for several DCVMs. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. Comparison of electronic health record system functionalities to support the patient recruitment process in clinical trials.

    Science.gov (United States)

    Schreiweis, Björn; Trinczek, Benjamin; Köpcke, Felix; Leusch, Thomas; Majeed, Raphael W; Wenk, Joachim; Bergh, Björn; Ohmann, Christian; Röhrig, Rainer; Dugas, Martin; Prokosch, Hans-Ulrich

    2014-11-01

    Reusing data from electronic health records for clinical and translational research and especially for patient recruitment has been tackled in a broader manner since about a decade. Most projects found in the literature however focus on standalone systems and proprietary implementations at one particular institution often for only one singular trial and no generic evaluation of EHR systems for their applicability to support the patient recruitment process does yet exist. Thus we sought to assess whether the current generation of EHR systems in Germany provides modules/tools, which can readily be applied for IT-supported patient recruitment scenarios. We first analysed the EHR portfolio implemented at German University Hospitals and then selected 5 sites with five different EHR implementations covering all major commercial systems applied in German University Hospitals. Further, major functionalities required for patient recruitment support have been defined and the five sample EHRs and their standard tools have been compared to the major functionalities. In our analysis of the site's hospital information system environments (with four commercial EHR systems and one self-developed system) we found that - even though no dedicated module for patient recruitment has been provided - most EHR products comprise generic tools such as workflow engines, querying capabilities, report generators and direct SQL-based database access which can be applied as query modules, screening lists and notification components for patient recruitment support. A major limitation of all current EHR products however is that they provide no dedicated data structures and functionalities for implementing and maintaining a local trial registry. At the five sites with standard EHR tools the typical functionalities of the patient recruitment process could be mostly implemented. However, no EHR component is yet directly dedicated to support research requirements such as patient recruitment. We

  6. Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

    Science.gov (United States)

    Pencina, Michael J; Louzao, Darcy M; McCourt, Brian J; Adams, Monique R; Tayyabkhan, Rehbar H; Ronco, Peter; Peterson, Eric D

    2016-02-01

    There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Development and delivery of a physiotherapist-led exercise intervention in a randomised controlled trial for subacromial impingement syndrome (the SUPPORT trial).

    Science.gov (United States)

    Stevenson, Kay; Jackson, Sue; Shufflebotham, Julie; Roddy, Edward; Foster, Nadine E

    2017-12-01

    This paper describes the development, content and delivery of a physiotherapist- led individualised, supervised and progressed exercise programme for use in a factorial randomised controlled trial testing treatments for subacromial impingement syndrome. To develop the intervention, a survey of community physiotherapists and national guidelines provided the basis for a consensus workshop through which a protocol was developed for the SUPPORT trial physiotherapist-led exercise programme (SUPPORT: SUbacromial impingement syndrome and Pain: a randomised controlled trial Of exeRcise and injection). The protocol included three stages of exercise progression: (1) scapular stability and active exercise with no resistance (2) range of motion exercise with scapular control, isometrics and stretches, and (3) through range resistance exercise. A two day training programme was developed for physiotherapists which included the trial background, current evidence and strategies to improve exercise adherence. Twenty physiotherapists were trained to deliver the exercise intervention. In the SUPPORT trial, 128 participants were randomised to physiotherapist-led exercise. Ninety nine (81%) participants had their first physiotherapy session within 2 to 3 weeks and 71 (56%) received six to eight treatment sessions. Frequently-used exercises were: stage 1 scapular setting with glenohumeral joint (GHJ) flexion to 90°, stage 2 GHJ medial rotation stretch, stage 3 scapular setting through lateral rotation, with resistance bands. We combined clinical and research expertise with national guidance in order to develop a physiotherapist-led, individualised, progressed and supervised exercise intervention for use within a randomised trial. The effectiveness of the intervention is being evaluated within the SUPPORT trial. Trial registration number ISRCTN 42399123. Copyright © 2017 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  8. Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials.

    Science.gov (United States)

    Moore, Theresa Helen Mazzarello; King, Anna Jyoti Louise; Evans, Maggie; Sharp, Debbie; Persad, Raj; Huntley, Alyson Louise

    2015-08-01

    Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception--July 2013 for randomized controlled trials and controlled trials. Two authors independently assessed risk of bias and extracted data. Twenty-six studies were included (2740 participants). Interventions were delivered pre and during (n = 12), short-term (n = 8), and longer term (18 months) (n = 5) after primary treatment. No interventions were delivered beyond this time. Few trials recruited ethnic minorities and none recruited men in same sex relationships. Intervention components included information, education, health professional discussion, homework, peer discussion, buddy support, cognitive behavioral therapy, cognitive restructuring, psychoeducation, Reiki and relaxation. Most interventions were delivered for 5-10 weeks. Risk of bias of trials was assessed as unclear for most domains due to lack of information. The majority of trials measuring quality of life and depression found no effect. Relatively few trials measured anxiety, coping skills and self-efficacy, and the majority found no effect. No cost data were available. Trials of supportive care for men with prostate cancer cover a range of interventions but are limited by population diversity, inconsistent measurement and reporting of outcomes, and inability to assess risk of bias. Recommendations on design and conduct of future trials are presented. © 2015 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  9. Breastfeeding Support in the Early Postpartum: Content of Home Visits in the SILC Trial.

    Science.gov (United States)

    Ridgway, Lael; Cramer, Rhian; McLachlan, Helen L; Forster, Della A; Cullinane, Méabh; Shafiei, Touran; Amir, Lisa H

    2016-12-01

    The Supporting breastfeeding In Local Communities (SILC) cluster randomized controlled trial evaluated whether a home visit focussed on infant feeding early in the postpartum period increased the percentage of infants breastfeeding at 4 months in low socioeconomic areas of Victoria, Australia. The visits were offered to women identified as at risk of early breastfeeding cessation after discharge home with a new baby. This paper describes the content of the home visits. SILC visited 1,043 women from September 2012 to March 2013, and completed a data sheet for each visit documenting topics discussed, as well as what support and resources were offered. Frequencies and percentages are presented. Home visits most commonly included the provision of reassurance to women (91%). Topics discussed included general breastfeeding information (83%), supply and demand (83%), positioning (79%), and feeding frequency (78%). Newborn feeding/behavior (57%), expression of breastmilk (54%), nipple pain (41%), low breastmilk supply (41%), and the use of nipple shields (18%) were also prominent topics. The issues and support needs of women were similar across locations (rural, regional or metropolitan) and regardless of maternal parity or age. There was some variation in the resources suggested in different localities. New mothers require help and reassurance independent of whether this is their first or subsequent child, reinforcing the need for support, breastfeeding information, and education about normal neonatal behavior. Key aspects of support are reassurance, normalization of infant behavior, and education. © 2016 Wiley Periodicals, Inc.

  10. Framing the role of Decision Support in the case of Stockholm Congestion Charging Trial

    DEFF Research Database (Denmark)

    Gudmundsson, Henrik; Ericsson, Eva; Hugosson, Muriel Besser

    2009-01-01

    the way for investigating the use and role of ‘Decision Support’ in the Stockholm Congestion Charging experiment. We adopt a definition of Decision Support as the systematic application of externally produced knowledge in transport planning and policy making processes. We then derive an analytical...... evaluation programme during the Trial, extensive stakeholder consultations throughout, and various information and communication strategies. But what difference did this information input make, and what was its role in the process from initiating the system, to its final adoption? In this paper we pave...... framework from the research literature on ‘knowledge utilization’ in policy making. This research has generally found that both ‘technical’, ‘communicative’, and ‘institutional’ aspects of the Decision Support matter for its influence on actual policy making processes and results. In our analysis we find...

  11. Support and Assessment for Fall Emergency Referrals (SAFER 1): cluster randomised trial of computerised clinical decision support for paramedics.

    Science.gov (United States)

    Snooks, Helen Anne; Carter, Ben; Dale, Jeremy; Foster, Theresa; Humphreys, Ioan; Logan, Philippa Anne; Lyons, Ronan Anthony; Mason, Suzanne Margaret; Phillips, Ceri James; Sanchez, Antonio; Wani, Mushtaq; Watkins, Alan; Wells, Bridget Elizabeth; Whitfield, Richard; Russell, Ian Trevor

    2014-01-01

    To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS) for paramedics attending older people who fall. Cluster trial randomised by paramedic; modelling. 13 ambulance stations in two UK emergency ambulance services. 42 of 409 eligible paramedics, who attended 779 older patients for a reported fall. Intervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture. Effectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care. Further emergency contacts or death within one month. Costs and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness. 17 intervention paramedics used CCDS for 54 (12.4%) of 436 participants. They referred 42 (9.6%) to falls services, compared with 17 (5.0%) of 343 participants seen by 19 control paramedics [Odds ratio (OR) 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72); quality of life (mean SF12 differences: MCS -0.74, 95% CI -2.83 to +1.28; PCS -0.13, 95% CI -1.65 to +1.39) and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52). However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3). Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without. Intervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture. ISRCTN Register ISRCTN

  12. Support and Assessment for Fall Emergency Referrals (SAFER 1: cluster randomised trial of computerised clinical decision support for paramedics.

    Directory of Open Access Journals (Sweden)

    Helen Anne Snooks

    Full Text Available To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS for paramedics attending older people who fall.Cluster trial randomised by paramedic; modelling.13 ambulance stations in two UK emergency ambulance services.42 of 409 eligible paramedics, who attended 779 older patients for a reported fall.Intervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture.Effectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care.Further emergency contacts or death within one month.Costs and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness.17 intervention paramedics used CCDS for 54 (12.4% of 436 participants. They referred 42 (9.6% to falls services, compared with 17 (5.0% of 343 participants seen by 19 control paramedics [Odds ratio (OR 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72; quality of life (mean SF12 differences: MCS -0.74, 95% CI -2.83 to +1.28; PCS -0.13, 95% CI -1.65 to +1.39 and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52. However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3. Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without.Intervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture.ISRCTN Register ISRCTN

  13. Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kenyon Sara

    2012-02-01

    Full Text Available Abstract Background Maternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK. Method/Design The aim of this study is to evaluate a lay Pregnancy Outreach Worker (POW service for nulliparous women identified as having social risk within a maternity service that is systematically assessing social risks alongside the usual obstetric and medical risks. The study design is a randomised controlled trial (RCT in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service. The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care from randomisation (before 28 weeks gestation until 6 weeks after birth. The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. The two primary outcomes are engagement with antenatal care, assessed by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy and mother-to-infant bonding will also be collected using validated tools. A sample size of 1316 will provide 90% power (at the 5% significance level to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will

  14. Developing a Framework of Innovative Trials to Support Water Companies Strategic Response to WFD

    Science.gov (United States)

    Whitehead, Jodie; Cherry, Katherine; Revens, Neasa; O'Hanlon, Thomas

    2014-05-01

    Slug control in high risk fields and catchments can have serious implications for water companies, threatening compliance with drinking water standards and challenging the Water Framework Directive's requirement that additional water treatment is avoided. Severn Trent Water has established a framework of innovative trails at a range of scales and locations to help shape the company's strategic, sustainable response to elevated metaldehyde concentrations at drinking water abstractions. Currently four contrasting trials are underway, two at the catchment scale, one at the field scale and one at the 'operational site' scale at locations across the English Midlands. This presentation provides an overview of the different approaches, their effectiveness to date and lessons learnt to aid strategy development. The first trial entitled Farmer's as Producers of Clean Water adopts a 'results orientated' approach, rewarding farmers for improvements in water quality at the catchment scale and allowing farmers to decide how best to manage the issue on their land with no prescribed measures. It acknowledges that co-ordinated action is needed across the catchment to see improvements in water quality, and that by incentivising outcomes rather than actions, land owners and farmers may take greater ownership of water quality issues. The second project explores the potential for a 'zero metaldehyde' catchment with all farmers throughout the catchment being financial supported to use a water friendly alternative to metaldehyde. This project is being compared to more voluntary approaches adopted elsewhere. The third project is a field scale trial to test the efficacy of alternative products to metaldehyde and different pellet formulations. Field drains are being sampled following heavy rain and crop damaged assessed to review the benefits to water quality and crops. The final project considers what Severn Trent Water can do from an operational perspective, investigating the size and

  15. Lay support for pregnant women with social risk: a randomised controlled trial

    Science.gov (United States)

    Kenyon, Sara; Jolly, Kate; Hemming, Karla; Hope, Lucy; Blissett, Jackie; Dann, Sophie-Anna; Lilford, Richard; MacArthur, Christine

    2016-01-01

    Objectives We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families. Design Prospective, pragmatic, individually randomised controlled trial. Setting 3 Maternity Trusts in West Midlands, UK. Participants Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded. Interventions POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms. Main outcome measures Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8–12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8–12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems. Results Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) −0.00, 95% CI (95% CI −0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD −0.79 (95% CI −1.56 to −0.02) was significantly better, although for all women recruited, no significant differences were seen (MD −0.59 (95% CI −1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group

  16. Effect of Telephone-Based Support on Postpartum Depression: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hourieh Shamshiri Milani

    2015-07-01

    Full Text Available Background: Postpartum depression (PPD is one public health issue that affects both maternal and child health. This research studies the effect of health volunteers’ telephonebased support on decreasing PPD. Materials and Methods: This randomized controlled trial evaluated 203 women who had uncomplicated deliveries. The women completed the Edinburg Postnatal Depression Scale (EPDS, 10 to 15 days after childbirth in order to be assessed for pre-trial depression scores. The cut-off point for depression was considered to be a score of >10. We randomly assigned 54 eligible mothers (n=27 per group with mild and moderate depression to the intervention and control groups. In both groups, mothers received routine postpartum care. The intervention group additionally received telephone support from health volunteers. A questionnaire was used to gather demographic and obstetric information. By the end of the 6th week, mothers completed the EPDS to be reassessed for depression after intervention. Data were analyzed using the chi-square, Fisher’s exact, t- and paired t tests. Results: The mean depression scores before intervention (10 to 15 days after childbirth in the intervention and control groups did not significantly differ (P=0.682. Depression scores of the intervention and control groups showed a significant difference after 6 weeks (P=0.035. In addition, there was a significant decrease in depression for the intervention and control groups (P=0.045. Conclusion: Health volunteer telephone-based support effectively decreased PPD and may be beneficial to women with symptoms of mild and moderate PPD (Registration number: IRCT201202159027N1.

  17. Effect of Telephone-Based Support on Postpartum Depression: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hourieh Shamshiri Milani

    2015-08-01

    Full Text Available Background: Postpartum depression (PPD is one public health issue that affects both maternal and child health. This research studies the effect of health volunteers’ telephonebased support on decreasing PPD. Materials and Methods: This randomized controlled trial evaluated 203 women who had uncomplicated deliveries. The women completed the Edinburg Postnatal Depression Scale (EPDS, 10 to 15 days after childbirth in order to be assessed for pre-trial depression scores. The cut-off point for depression was considered to be a score of >10. We randomly assigned 54 eligible mothers (n=27 per group with mild and moderate depression to the intervention and control groups. In both groups, mothers received routine postpartum care. The intervention group additionally received telephone support from health volunteers. A questionnaire was used to gather demographic and obstetric information. By the end of the 6th week, mothers completed the EPDS to be reassessed for depression after intervention. Data were analyzed using the chi-square, Fisher’s exact, t- and paired t tests. Results: The mean depression scores before intervention (10 to 15 days after childbirth in the intervention and control groups did not significantly differ (P=0.682. Depression scores of the intervention and control groups showed a significant difference after 6 weeks (P=0.035. In addition, there was a significant decrease in depression for the intervention and control groups (P=0.045. Conclusion: Health volunteer telephone-based support effectively decreased PPD and may be beneficial to women with symptoms of mild and moderate PPD (Registration number: IRCT201202159027N1.

  18. Improving Social Support for Older Adults Through Technology: Findings From the PRISM Randomized Controlled Trial.

    Science.gov (United States)

    Czaja, Sara J; Boot, Walter R; Charness, Neil; Rogers, Wendy A; Sharit, Joseph

    2017-02-15

    Information and communication technology holds promise in terms of providing support and reducing isolation among older adults. We evaluated the impact of a specially designed computer system for older adults, the Personal Reminder Information and Social Management (PRISM) system. The trial was a multisite randomized field trial conducted at 3 sites. PRISM was compared to a Binder condition wherein participants received a notebook that contained paper content similar to that contained in PRISM. The sample included 300 older adults at risk for social isolation who lived independently in the community (Mage = 76.15 years). Primary outcome measures included indices of social isolation, social support, loneliness, and well-being. Secondary outcome measures included indices of computer proficiency and attitudes toward technology. Data were collected at baseline and at 6 and 12 months post-randomization. The PRISM group reported significantly less loneliness and increased perceived social support and well-being at 6 months. There was a trend indicating a decline in social isolation. Group differences were not maintained at 12 months, but those in the PRISM condition still showed improvements from baseline. There was also an increase in computer self-efficacy, proficiency, and comfort with computers for PRISM participants at 6 and 12 months. The findings suggest that access to technology applications such as PRISM may enhance social connectivity and reduce loneliness among older adults and has the potential to change attitudes toward technology and increase technology self-efficacy. © The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  19. Support or competition? How online social networks increase physical activity: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jingwen Zhang, PhD

    2016-12-01

    Full Text Available To identify what features of online social networks can increase physical activity, we conducted a 4-arm randomized controlled trial in 2014 in Philadelphia, PA. Students (n = 790, mean age = 25.2 at an university were randomly assigned to one of four conditions composed of either supportive or competitive relationships and either with individual or team incentives for attending exercise classes. The social comparison condition placed participants into 6-person competitive networks with individual incentives. The social support condition placed participants into 6-person teams with team incentives. The combined condition with both supportive and competitive relationships placed participants into 6-person teams, where participants could compare their team's performance to 5 other teams' performances. The control condition only allowed participants to attend classes with individual incentives. Rewards were based on the total number of classes attended by an individual, or the average number of classes attended by the members of a team. The outcome was the number of classes that participants attended. Data were analyzed using multilevel models in 2014. The mean attendance numbers per week were 35.7, 38.5, 20.3, and 16.8 in the social comparison, the combined, the control, and the social support conditions. Attendance numbers were 90% higher in the social comparison and the combined conditions (mean = 1.9, SE = 0.2 in contrast to the two conditions without comparison (mean = 1.0, SE = 0.2 (p = 0.003. Social comparison was more effective for increasing physical activity than social support and its effects did not depend on individual or team incentives.

  20. Supportive supervision for volunteers to deliver reproductive health education: a cluster randomized trial.

    Science.gov (United States)

    Singh, Debra; Negin, Joel; Orach, Christopher Garimoi; Cumming, Robert

    2016-10-03

    Community Health Volunteers (CHVs) can be effective in improving pregnancy and newborn outcomes through community education. Inadequate supervision of CHVs, whether due to poor planning, irregular visits, or ineffective supervisory methods, is, however, recognized as a weakness in many programs. There has been little research on best practice supervisory or accompaniment models. From March 2014 to February 2015 a proof of concept study was conducted to compare training alone versus training and supportive supervision by paid CHWs (n = 4) on the effectiveness of CHVs (n = 82) to deliver education about pregnancy, newborn care, family planning and hygiene. The pair-matched cluster randomized trial was conducted in eight villages (four intervention and four control) in Budondo sub-county in Jinja, Uganda. Increases in desired behaviors were seen in both the intervention and control arms over the study period. Both arms showed high retention rates of CHVs (95 %). At 1 year follow-up there was a significantly higher prevalence of installed and functioning tippy taps for hand washing (p services. Supportive supervision involves creating a non-threatening, empowering environment in which both the CHV and the supervising CHW learn together and overcome obstacles that might otherwise demotivate the CHV. While the results seem promising for added value with supportive supervision for CHVs undertaking reproductive health activities, further research on a larger scale will be needed to substantiate the effect.

  1. Music-supported therapy in the rehabilitation of subacute stroke patients: a randomized controlled trial.

    Science.gov (United States)

    Grau-Sánchez, Jennifer; Duarte, Esther; Ramos-Escobar, Neus; Sierpowska, Joanna; Rueda, Nohora; Redón, Susana; Veciana de Las Heras, Misericordia; Pedro, Jordi; Särkämö, Teppo; Rodríguez-Fornells, Antoni

    2018-04-01

    The effect of music-supported therapy (MST) as a tool to restore hemiparesis of the upper extremity after a stroke has not been appropriately contrasted with conventional therapy. The aim of this trial was to test the effectiveness of adding MST to a standard rehabilitation program in subacute stroke patients. A randomized controlled trial was conducted in which patients were randomized to MST or conventional therapy in addition to the rehabilitation program. The intensity and duration of the interventions were equated in both groups. Before and after 4 weeks of treatment, motor and cognitive functions, mood, and quality of life (QoL) of participants were evaluated. A follow-up at 3 months was conducted to examine the retention of motor gains. Both groups significantly improved their motor function, and no differences between groups were found. The only difference between groups was observed in the language domain for QoL. Importantly, an association was encountered between the capacity to experience pleasure from music activities and the motor improvement in the MST group. MST as an add-on treatment showed no superiority to conventional therapies for motor recovery. Importantly, patient's intrinsic motivation to engage in musical activities was associated with better motor improvement. © 2018 New York Academy of Sciences.

  2. A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pellegrini Christine A

    2012-11-01

    Full Text Available Abstract Background Obesity remains a major public health challenge, demanding cost-effective and scalable weight management programs. Delivering key treatment components via mobile technology offers a potential way to reduce expensive in-person contact, thereby lowering the cost and burden of intensive weight loss programs. The ENGAGED study is a theory-guided, randomized controlled trial designed to examine the feasibility and efficacy of an abbreviated smartphone-supported weight loss program. Methods/design Ninety-six obese adults (BMI 30–39.9 kg/m2 will be randomized to one of three treatment conditions: (1 standard behavioral weight loss (STND, (2 technology-supported behavioral weight loss (TECH; or (3 self-guided behavioral weight loss (SELF. All groups will aim to achieve a 7% weight loss goal by reducing calorie and fat intake and progressively increasing moderate intensity physical activity to 175 minutes/week. STND and TECH will attend 8 group sessions and receive regular coaching calls during the first 6 months of the intervention; SELF will receive the Group Lifestyle Balance Program DVD’s and will not receive coaching calls. During months 1–6, TECH will use a specially designed smartphone application to monitor dietary intake, body weight, and objectively measured physical activity (obtained from a Blue-tooth enabled accelerometer. STND and SELF will self-monitor on paper diaries. Linear mixed modeling will be used to examine group differences on weight loss at months 3, 6, and 12. Self-monitoring adherence and diet and activity goal attainment will be tested as mediators. Discussion ENGAGED is an innovative weight loss intervention that integrates theory with emerging mobile technologies. We hypothesize that TECH, as compared to STND and SELF, will result in greater weight loss by virtue of improved behavioral adherence and goal achievement. Trial registration NCT01051713

  3. Supporting breastfeeding In Local Communities (SILC) in Victoria, Australia: a cluster randomised controlled trial

    Science.gov (United States)

    McLachlan, Helen L; Forster, Della A; Amir, Lisa H; Cullinane, Meabh; Shafiei, Touran; Watson, Lyndsey F; Ridgway, Lael; Cramer, Rhian L; Small, Rhonda

    2016-01-01

    Objectives Breastfeeding has significant health benefits for mothers and infants. Despite recommendations from the WHO, by 6 months of age 40% of Australian infants are receiving no breast milk. Increased early postpartum breastfeeding support may improve breastfeeding maintenance. 2 community-based interventions to increase breastfeeding duration in local government areas (LGAs) in Victoria, Australia, were implemented and evaluated. Design 3-arm cluster randomised trial. Setting LGAs in Victoria, Australia. Participants LGAs across Victoria with breastfeeding initiation rates below the state average and > 450 births/year were eligible for inclusion. The LGA was the unit of randomisation, and maternal and child health centres in the LGAs comprised the clusters. Interventions Early home-based breastfeeding support by a maternal and child health nurse (home visit, HV) with or without access to a community-based breastfeeding drop-in centre (HV+drop-in). Main outcome measures The proportion of infants receiving ‘any’ breast milk at 3, 4 and 6 months (women's self-report). Findings 4 LGAs were randomised to the comparison arm and provided usual care (n=41 clusters; n=2414 women); 3 to HV (n=32 clusters; n=2281 women); and 3 to HV+drop-in (n=26 clusters; 2344 women). There was no difference in breastfeeding at 4 months in either HV (adjusted OR 1.04; 95% CI 0.84 to 1.29) or HV+drop-in (adjusted OR 0.92; 95% CI 0.78 to 1.08) compared with the comparison arm, no difference at 3 or 6 months, nor in any LGA in breastfeeding before and after the intervention. Some issues were experienced with intervention protocol fidelity. Conclusions Early home-based and community-based support proved difficult to implement. Interventions to increase breastfeeding in complex community settings require sufficient time and partnership building for successful implementation. We cannot conclude that additional community-based support is ineffective in improving breastfeeding

  4. Randomized controlled effectiveness trial of reciprocal peer support in heart failure.

    Science.gov (United States)

    Heisler, Michele; Halasyamani, Lakshmi; Cowen, Mark E; Davis, Matthew D; Resnicow, Ken; Strawderman, Robert L; Choi, Hwajung; Mase, Rebecca; Piette, John D

    2013-03-01

    Although disease management programs for patients hospitalized with heart failure (HF) are effective, they are, however, often resource intensive, limiting their uptake. Peer support programs have led to improved outcomes among patients with other chronic conditions and may result in similar improvements for patients with HF. In this randomized controlled trial, reciprocal peer support (RPS) arm patients participated in a HF nurse practitioner-led goal setting group session, received brief training in peer communication skills, and were paired with another participant in their cohort with whom they were encouraged to talk weekly using a telephone platform. Participants were also encouraged to attend 3 nurse practitioner-facilitated peer support group sessions. Patients in the nurse care management arm attended a nurse practitioner-led session to address their HF care questions and receive HF educational materials and information on how to access care management services. The median age of the patients was 69 years; 51% were female and 26% were racial/ethnic minorities. Only 55% of RPS patients participated in peer calls or group sessions. In intention-to-treat analyses, the RPS and nurse care management groups did not differ in time-to-first all-cause rehospitalization or death or in mean numbers of rehospitalizations or deaths. There were no differences in improvements in 6-month measures of HF-specific quality of life or social support. Conclusions- Among patients recently hospitalized for HF, more than half of RPS participants had no or minimal engagement with the RPS program, and the program did not improve outcomes compared with usual HF nurse care management. URL: http://www.clinicaltrials.gov. UNIQUE IDENTIFIER: NCT00508508.

  5. Clinical Trials

    Medline Plus

    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

  6. The Effect of Peers Support on Postpartum Depression: A Single-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mahin Kamalifard

    2013-08-01

    Full Text Available Introduction: Postpartum depression and its consequences not only involve mothers and their children but it will also affect their families. Therefore, this study aimed to investigate the effect of mothers receiving peer support on postpartum depression. Methods: 100 eligible primiparous women participated in a randomized clinical trial. The intervention group received phone calls by their peers from the last three months of pregnancy until two months after delivery. The control group only had access to routine care. Both groups in the second month after delivery were checked regarding depression using Edinburgh Postnatal Depression Scale. Data analysis was performed using independent t-test, chi-square test and covariance analysis. Results: Mean depression score before intervention was 13.92 (3.23 in the control group and 14.06 (3.12 in the intervention group. In week 8 after delivery, mean score of depression in control group was 13.29 (4.08 but in the intervention group it was reduced to 10.25 (4.18. Difference in the reduction of mean postpartum depression score between the two groups showed statistically significant difference (p < 0.001. Conclusion: This study showed that peer support was effective in the prevention of postpartum depression, therefore, it is recommended to be used in the reduction of postpartum depression.

  7. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial.

    Science.gov (United States)

    Kangovi, Shreya; Mitra, Nandita; Grande, David; Huo, Hairong; Smith, Robyn A; Long, Judith A

    2017-10-01

    To determine whether a community health worker (CHW) intervention improved outcomes in a low-income population with multiple chronic conditions. We conducted a single-blind, randomized clinical trial in Philadelphia, Pennsylvania (2013-2014). Participants (n = 302) were high-poverty neighborhood residents, uninsured or publicly insured, and diagnosed with 2 or more chronic diseases (diabetes, obesity, tobacco dependence, hypertension). All patients set a disease-management goal. Patients randomly assigned to CHWs also received 6 months of support tailored to their goals and preferences. Support from CHWs (vs goal-setting alone) led to improvements in several chronic diseases (changes in glycosylated hemoglobin: -0.4 vs 0.0; body mass index: -0.3 vs -0.1; cigarettes per day: -5.5 vs -1.3; systolic blood pressure: -1.8 vs -11.2; overall P = .08), self-rated mental health (12-item Short Form survey; 2.3 vs -0.2; P = .008), and quality of care (Consumer Assessment of Healthcare Providers and Systems; 62.9% vs 38%; P health. A standardized CHW intervention improved chronic disease control, mental health, quality of care, and hospitalizations and could be a useful population health management tool for health care systems. clinicaltrials.gov identifier: NCT01900470.

  8. Attentional and affective consequences of technology supported mindfulness training: a randomised, active control, efficacy trial.

    Science.gov (United States)

    Bhayee, Sheffy; Tomaszewski, Patricia; Lee, Daniel H; Moffat, Graeme; Pino, Lou; Moreno, Sylvain; Farb, Norman A S

    2016-11-29

    Mindfulness training (MT) programs represent an approach to attention training with well-validated mental health benefits. However, research supporting MT efficacy is based predominantly on weekly-meeting, facilitator-led, group-intervention formats. It is unknown whether participants might benefit from neurofeedback-assisted, technology-supported MT (N-tsMT), in which meditation is delivered individually, without the need for a facilitator, travel to a training site, or the presence of a supportive group environment. Mirroring the validation of group MT interventions, the first step in addressing this question requires identifying whether N-tsMT promotes measurable benefits. Here, we report on an initial investigation of a commercial N-tsMT system. In a randomized, active control trial, community-dwelling healthy adult participants carried out 6 weeks of daily practice, receiving either N-tsMT (n = 13), or a control condition of daily online math training (n = 13). Training effects were assessed on target measures of attention and well-being. Participants also completed daily post-training surveys assessing effects on mood, body awareness, calm, effort, and stress. Analysis revealed training effects specific to N-tsMT, with attentional improvements in overall reaction time on a Stroop task, and well-being improvements via reduced somatic symptoms on the Brief Symptom Inventory. Attention and well-being improvements were correlated, and effects were greatest for the most neurotic participants. However, secondary, exploratory measures of attention and well-being did not show training-specific effects. N-tsMT was associated with greater body awareness and calm, and initially greater effort that later converged with effort in the control condition. Preliminary findings indicate that N-tsMT promotes modest benefits for attention and subjective well-being in a healthy community sample relative to an active control condition. However, the findings would benefit

  9. Organized Self-Management Support Services for Chronic Depressive Symptoms: A Randomized Controlled Trial.

    Science.gov (United States)

    Ludman, Evette J; Simon, Gregory E; Grothaus, Louis C; Richards, Julie Elissa; Whiteside, Ursula; Stewart, Christine

    2016-01-01

    This study aimed to determine whether a self-management support service was more effective than treatment as usual in reducing depressive symptoms and major depressive episodes and increasing personal recovery among individuals with chronic or recurrent depressive symptoms. The study was a randomized controlled trial of a self-management support service consisting of depression self-management training, recovery coaching, and care coordination. The 18-month intervention included regular telephone or in-person contacts with a care manager and a structured group program co-led by a professional therapist and a trained peer specialist. Intervention (N=150) and control (N=152) participants ages ≥ 18 with chronic or recurrent depressive symptoms were recruited from five clinics in Seattle, Washington. Outcome measures included the Hopkins Symptom Checklist depression scale, the Recovery Assessment Scale, the Patient-Rated Global Improvement scale, and the percentage of participants with a major depressive episode. Interviewers were masked to treatment condition. Repeated-measures estimates of the long-term effect of the intervention versus usual care (average of the six-, 12-, and 18-month outcomes adjusted for age, gender, and site) indicated that intervention participants had less severe symptoms (p=.002) and higher recovery scores (p=.03), were less likely to be depressed (odds ratio [OR]=.52, p=.001), and were more likely to be much improved (OR=1.96, p=.001). These findings support providing regular outreach care management and a self-care group offering a combined behavioral and recovery-oriented approach for people with chronic or recurrent depressive symptoms.

  10. Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial.

    Science.gov (United States)

    Agyapong, Vincent I O; Ahern, Sinead; McLoughlin, Declan M; Farren, Conor K

    2012-12-10

    Mobile phone text message technology has the potential to improve outcomes for patients with depression and co-morbid Alcohol Use Disorder (AUD). To perform a randomised rater-blinded trial to explore the effects of supportive text messages on mood and abstinence outcomes for patients with depression and co-morbid AUD. Participants (n=54) with a DSM IV diagnosis of unipolar depression and AUD who completed an in-patient dual diagnosis treatment programme were randomised to receive twice daily supportive text messages (n=26) or a fortnightly thank you text message (n=28) for three months. Primary outcome measures were Beck's Depression Inventory (BDI-II) scores and Cumulative Abstinence Duration (CAD) in days at three months. NCT0137868. There was a statistically significant difference in three month BDI-II scores between the intervention and control groups; 8.5 (SD=8.0) vs. 16.7 (SD=10.3) respectively after adjusting for the baseline scores, F (1, 49)=9.54, p=0.003, η(p)(2)=0.17. The mean difference in change BDI-II scores was -7.9 (95% CI -13.06 to -2.76, Cohen'sd=0.85). There was a trend for a greater CAD in the text message group than the control group: 88.3 (SD=6.2) vs. 79.3 (SD=24.1), t=1.78, df=48, p=0.08. Limitations of the study include the small sample size, the potential for loss of rater blinding and the lack of long term follow-up to determine the longer term effects of the intervention. Supportive text messages have the potential to improve outcomes for patients with comorbid depression and alcohol dependency syndrome. Copyright © 2012 Elsevier B.V. All rights reserved.

  11. Patterns of Attendance at Mother Support Groups in Zimbabwe. The EPAZ Trial (2014-2016).

    Science.gov (United States)

    Orne-Gliemann, Joanna; Font, Hélène; Maphosa, Talent; Kangwende, Abigail; Rusakaniko, Simba; Magezi, Vhumani; Sengai, Tonderai; Shumba, Bridget; Zambezi, Pemberai; Foster, Geoff

    2017-06-01

    In Southern Africa, groups of mothers living with HIV successfully provide peer psychosocial support during pregnancy and early childhood. We report patterns of attendance at Mother Support Groups (MSGs) sessions among women and mothers living with HIV in rural Zimbabwe. In the Elimination of Pediatric AIDS cluster-randomized trial, MSGs were established in 14 health facilities in Mutare and Makoni districts. Patterns of attendance at MSG sessions were categorized by calendar attendance from delivery to 6-month postpartum using a Dynamic Time Warping clustering method. Baseline characteristics of women and postpartum MSG attendance patterns were described. Linkages between these patterns and 12-month postpartum retention in care were explored using mixed-effects models. Most women (88%) attended at least 1 MSG session between enrollment and 6-month postpartum. Two patterns of postpartum MSG attendance, "Regular Attendance" and "Non-Regular Attendance," were readily identified. Being older than 32 (P = 0.01), booking for antenatal care before 22 weeks gestational age (P = 0.02), and being on antiretroviral therapy at first antenatal care booking (P = 0.01) were significantly associated with "Regular Attendance." "Regular Attendance" at MSG sessions during the 6-month postpartum period was significantly associated with better retention in care at 12 months, compared with "Non-Regular Attendance" (P attended MSG sessions. However, few attended regularly. Younger and newly diagnosed women were less likely to attend postpartum MSG sessions or remain in care at 12 months postpartum. Peer support models should consider specific needs of these women, especially in rural areas, in order for MSGs to contribute to improve maternal and child health outcomes.

  12. Improving the quality of hospital care for children by supportive supervision: a cluster randomized trial, Kyrgyzstan.

    Science.gov (United States)

    Lazzerini, Marzia; Shukurova, Venera; Davletbaeva, Marina; Monolbaev, Kubanychbek; Kulichenko, Tatiana; Akoev, Yuri; Bakradze, Maya; Margieva, Tea; Mityushino, Ilya; Namazova-Baranova, Leyla; Boronbayeva, Elnura; Kuttumuratova, Aigul; Weber, Martin Willy; Tamburlini, Giorgio

    2017-06-01

    To determine whether periodic supportive supervision after a training course improved the quality of paediatric hospital care in Kyrgyzstan, where inappropriate care was common but in-hospital postnatal mortality was low. In a cluster, randomized, parallel-group trial, 10 public hospitals were allocated to a 4-day World Health Organization (WHO) course on hospital care for children followed by periodic supportive supervision by paediatricians for 1 year, while 10 hospitals had no intervention. We assessed prospectively 10 key indicators of inappropriate paediatric case management, as indicated by WHO guidelines. The primary indicator was the combination of the three indicators: unnecessary hospitalization, increased iatrogenic risk and unnecessary painful procedures. An independent team evaluated the overall quality of care. We prospectively reviewed the medical records of 4626 hospitalized children aged 2 to 60 months. In the intervention hospitals, the mean proportion of the primary indicator decreased from 46.9% (95% confidence interval, CI: 24.2 to 68.9) at baseline to 6.8% (95% CI: 1.1 to 12.1) at 1 year, but was unchanged in the control group (45.5%, 95% CI: 25.2 to 67.9, to 64.7%, 95% CI: 43.3 to 86.1). At 1 year, the risk ratio for the primary indicator in the intervention versus the control group was 0.09 (95% CI: 0.06 to 0.13). The proportions of the other nine indicators also decreased in the intervention group ( P  < 0.0001 for all). Overall quality of care improved significantly in intervention hospitals. Periodic supportive supervision for 1 year after a training course improved both adherence to WHO guidelines on hospital care for children and the overall quality of paediatric care.

  13. The impact of supportive counselling on women's psychological wellbeing after miscarriage--a randomised controlled trial.

    Science.gov (United States)

    Kong, G W S; Chung, T K H; Lok, I H

    2014-09-01

    To assess the effectiveness of supportive counselling after miscarriage. Randomised controlled trial. University hospital. Two hundred and eighty women with miscarriage. Women were randomised to receive supportive counselling from a nurse (at diagnosis and 2 weeks later) or routine care. Psychological wellbeing was measured with the General Health Questionnaire (GHQ-12) and Beck Depression Inventory (BDI). Primary outcome measured the proportion of women suffering psychological distress (GHQ-12 score ≥4) at 3 months after miscarriage. Secondary outcomes were GHQ-12 and BDI scores at 6 weeks, 3 and 6 months. There was no difference in the proportion of women suffering psychological distress at 3 months after miscarriage (17.1% in counselling group versus 24.4% in control group; 95% CI -0.034 to 0.177; P = 0.19). However, for the subgroup of women (n = 152) with high baseline GHQ-12 scores, the median GHQ-12 score in the counselling group was significantly lower than the control group at 6 weeks (median score 3 versus 4.5 in counselling and control groups; P = 0.04) and 3 months (median score 1 versus 2.5 in counselling and control groups; P = 0.03). Similarly, for women with high baseline BDI scores (BDI > 12), the proportion for women continuing to score high was significantly lower in the counselling group 6 weeks after miscarriage (33.3 versus 61.1% in counselling group and control group; P = 0.03). Although the results of current study do not justify routine counselling of all women following miscarriage, a supportive counselling programme for selected women with high levels of psychological distress is promising and merits further investigation. © 2014 Royal College of Obstetricians and Gynaecologists.

  14. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Kien Hoa Ly

    Full Text Available There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment--including four face-to-face sessions and a smartphone application--was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression.This was a randomised controlled non-inferiority trial (NCT01819025 comparing a blended treatment (n=46 against a full ten-session treatment (n=47 for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment.Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen's d=1.35; CI [-0.82, 3.52] to d=1.47; CI [-0.41, 3.35]; between group d=-0.13 CI [-2.37, 2.09] and d=-0.10 CI [-2.53, 2.33]. At the same time, the blended treatment reduced the therapist time with an average of 47%.We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone application as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression.Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025.

  15. The Support to Rural India's Public Education System (STRIPES) trial: a cluster randomised controlled trial of supplementary teaching, learning material and material support.

    Science.gov (United States)

    Lakshminarayana, Rashmi; Eble, Alex; Bhakta, Preetha; Frost, Chris; Boone, Peter; Elbourne, Diana; Mann, Vera

    2013-01-01

    The aim of the STRIPES trial was to assess the effectiveness of providing supplementary, remedial teaching and learning materials (and an additional 'kit' of materials for girls) on a composite of language and mathematics test scores for children in classes two, three and four in public primary schools in villages in the Nagarkurnool division of Andhra Pradesh, India. STRIPES was a cluster randomised trial in which 214 villages were allocated either to the supplementary teaching intervention (n = 107) or to serve as controls (n = 107). 54 of the intervention villages were further randomly allocated to receive additional kit for girls. The study was not blinded. Analysis was conducted on the intention to treat principle, allowing for clustering. Composite test scores were significantly higher in the intervention group (107 villages; 2364 children) than in the control group (106 villages; 2014 children) at the end of the trial (mean difference on a percentage scale 15.8; 95% CI 13.1 to 18.6; p<0.001; 0.75 Standard Deviation (SD) difference). Composite test scores were not significantly different in the 54 villages (614 girls) with the additional kits for girls compared to the 53 villages (636 girls) without these kits at the end of the trial (mean difference on a percentage scale 0.5; 95% CI -4.34 to 5.4; p = 0.84). The cost per 0.1 SD increase in composite test score for intervention without kits is Rs. 382.97 (£4.45, $7.13), and Rs.480.59 (£5.58, $8.94) for the intervention with kits. A 18 month programme of supplementary remedial teaching and learning materials had a substantial impact on language and mathematics scores of primary school students in rural Andhra Pradesh, yet providing a 'kit' of materials to girls in these villages did not lead to any measured additional benefit. Controlled-Trials.com ISRCTN69951502.

  16. Protocol for SAMS (Support and Advice for Medication Study: A randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medication

    Directory of Open Access Journals (Sweden)

    Sutton Stephen

    2008-04-01

    Full Text Available Abstract Background Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design. Methods and Design The SAMS (Supported Adherence to Medication Study trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation

  17. Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial.

    Science.gov (United States)

    Lamb, S E; Marsh, J L; Hutton, J L; Nakash, R; Cooke, M W

    2009-02-14

    Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (Aircast brace, Bledsoe boot, or 10-day below-knee cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. Patients who received the below-knee cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the cast compared with tubular compression bandage (mean difference 9%; 95% CI 2.4-15.0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between Aircast brace and tubular compression bandage was 8%; 95% CI 1.8-14.2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and

  18. A Randomized, Wait-List Controlled Effectiveness Trial Assessing School-Wide Positive Behavior Support in Elementary Schools

    Science.gov (United States)

    Horner, Robert H.; Sugai, George; Smolkowski, Keith; Eber, Lucille; Nakasato, Jean; Todd, Anne W.; Esperanza, Jody

    2009-01-01

    We report a randomized, wait-list controlled trial assessing the effects of school-wide positive behavior support (SWPBS). An effectiveness analysis was conducted with elementary schools in Hawaii and Illinois where training and technical assistance in SWPBS was provided by regular state personnel over a 3-year period. Results document that the…

  19. [Telephone support for breastfeeding by primary care: a randomised multicentre trial].

    Science.gov (United States)

    Balaguer Martínez, Josep Vicent; Valcarce Pérez, Inmaculada; Esquivel Ojeda, Jessica Noelia; Hernández Gil, Alicia; Martín Jiménez, María Del Pilar; Bernad Albareda, Mercè

    2018-03-22

    To evaluate a telephone support programme for mothers who breastfeed for the first 6 months. A randomised unmasked clinical trial was conducted in 5 urban Primary Care centres that included mothers with healthy newborns who were breastfeeding exclusively (EBF) or partially (PBF). The control group received the usual care. The intervention group also received telephone support for breastfeeding on a weekly basis for the first 2months and then every 2weeks until the sixth month. The type of breastfeeding was recorded in the usual check-up visit (1, 2, 4 and 6 months). The study included 193 patients in the intervention group, and 187 in a control group. The greatest increase in the percentage of EBF was observed at 6 months: 21.4% in the control group compared to 30.1% in the intervention group. However, in the adjusted odds ratios analysis, confidence intervals did not show statistical significance. The odds ratio at 1 month, 2 months, 4 months, and 6 months for EBF were 1.45 (0.91-2.31), 1.35 (0.87-2.08), 1.21 (0.80-1.81), and 1.58 (0.99-2.53), respectively. The odds ratio in the same age groups for any type of breastfeeding (EBF + PBF) were 1.65 (0.39-7.00), 2.08 (0.94-4.61), 1.37 (0.79-2.38), and 1.60 (0.98-2.61), respectively. Telephone intervention was not effective enough to generalise it. Copyright © 2018. Publicado por Elsevier España, S.L.U.

  20. Evaluation of a transdiagnostic psychodynamic online intervention to support return to work: A randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Rüdiger Zwerenz

    Full Text Available Given their flexibility, online interventions may be useful as an outpatient treatment option to support vocational reintegration after inpatient rehabilitation. To that purpose we devised a transdiagnostic psychodynamic online intervention to facilitate return to work, focusing on interpersonal conflicts at the workplace often responsible for work-related stress.In a randomized controlled trial, we included employed patients from cardiologic, psychosomatic and orthopedic rehabilitation with work-related stress or need for support at intake to inpatient rehabilitation after they had given written consent to take part in the study. Following discharge, maladaptive interpersonal interactions at the workplace were identified via weekly blogs and processed by written therapeutic comments over 12 weeks in the intervention group (IG. The control group (CG received an augmented treatment as usual condition. The main outcome, subjective prognosis of gainful employment (SPE, and secondary outcomes (psychological complaints were assessed by means of online questionnaires before, at the end of aftercare (3 months and at follow-up (12 months. We used ITT analyses controlling for baseline scores and medical group.N = 319 patients were enrolled into IG and N = 345 into CG. 77% of the IG logged in to the webpage (CG 74% and 65% of the IG wrote blogs. Compared to the CG, the IG reported a significantly more positive SPE at follow-up. Measures of depression, anxiety and psychosocial stressors decreased from baseline to follow-up, whereas the corresponding scores increased in the CG. Correspondingly, somatization and psychological quality of life improved in the IG.Psychodynamic online aftercare was effective to enhance subjective prognosis of future employment and improved psychological complaints across a variety of chronic physical and psychological conditions, albeit with small effect sizes.

  1. Couple-focused support to improve HIV medication adherence: a randomized controlled trial.

    Science.gov (United States)

    Remien, Robert H; Stirratt, Michael J; Dolezal, Curtis; Dognin, Joanna S; Wagner, Glenn J; Carballo-Dieguez, Alex; El-Bassel, Nabila; Jung, Tiffany M

    2005-05-20

    To assess the efficacy of a couple-based intervention to improve medication-taking behavior in a clinic population with demonstrated adherence problems. A randomized controlled trial (SMART Couples Study) conducted between August 2000 and January 2004. Two HIV/AIDS outpatient clinics in New York City. Heterosexual and homosexual HIV-serodiscordant couples (n = 215) in which the HIV-seropositive partner had education about treatment and adherence, identifying adherence barriers, developing communication and problem-solving strategies, optimizing partner support, and building confidence for optimal adherence. Medication adherence at week 8 (2 weeks after the intervention) compared with baseline, assessed with a Medication Event Monitoring System cap. Intervention participants showed higher mean medication adherence at post-intervention when compared with controls whether adherence was defined as proportion of prescribed doses taken (76% versus 60%) or doses taken within specified time parameters (58% versus 35%). Also, participants in the intervention arm were significantly more likely to achieve high levels of adherence (> 80%, > 90%, or > 95%) when compared with controls. However, in most cases, effects diminished with time, as seen at follow-up at 3 and 6 months. The SMART Couples program significantly improved medication adherence over usual care, although the level of improved adherence, for many participants, was still suboptimal and the effect was attenuated over time.

  2. A randomized trial of interpersonal therapy versus supportive therapy for social anxiety disorder.

    Science.gov (United States)

    Lipsitz, Joshua D; Gur, Merav; Vermes, Donna; Petkova, Eva; Cheng, Jianfeng; Miller, Nina; Laino, Joseph; Liebowitz, Michael R; Fyer, Abby J

    2008-01-01

    Seventy patients seeking treatment for social anxiety disorder (SAD) were randomly assigned to 14 weekly individual sessions of interpersonal therapy (IPT) or supportive therapy (ST). We hypothesized that IPT, a psychotherapy with established efficacy for depression and other psychiatric disorders, would lead to greater improvement than ST. Patients in both groups experienced significant improvement from pretreatment to posttreatment. However, improvement with IPT was not superior to improvement with ST. Mean scores on the Liebowitz Social Anxiety Scale decreased from 67.7 to 46.9 in the IPT group and 64.5 to 49.8 in the ST group. There were also no differences in proportion of responders between IPT and ST. Only for a scale measuring concern about negative evaluation (Brief Fear of Negative Evaluation Scale) was IPT superior. Limitations of this initial controlled trial of IPT include a nonsequential recruitment strategy and overlap in the administration of the two therapies. It is recommended that future studies of IPT for SAD include a more carefully defined control therapy condition, different therapists administering each therapy, a larger sample, and a more rigorous strategy for long-term follow-up assessments.

  3. An interdisciplinary framework for measuring and supporting adherence in HIV prevention trials of ARV-based vaginal rings.

    Science.gov (United States)

    MacQueen, Kathleen M; Tolley, Elizabeth E; Owen, Derek H; Amico, K Rivet; Morrow, Kathleen M; Moench, Thomas; Friend, David R; Friedland, Barbara

    2014-01-01

    Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline. Participant motivations, counselling support and measurement challenges during ring trials must still be addressed. In previous HIV prevention trials, this has been done largely using descriptive and post-hoc methods that are highly variable and minimally evaluated. We outline an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence, and to measure adherence in the context of randomized, blinded clinical trials. The interdisciplinary framework highlights the dual use of adherence measurement (i.e. to provide feedback during trial implementation and to inform interpretation of trial findings) and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour. Three inter-related approaches are highlighted: 1) adherence support - sequential efforts to define motivators of study product adherence and to develop, test, refine and evaluate adherence support messages; 2) self-reported psychometric measures - creation of valid and generalizable measures based in easily administered scales that capture vaginal ring use with improved predictive ability at screening, baseline and follow-up that better engage participants in reporting adherence; and 3) more objective measurement of adherence - real-time adherence monitoring and cumulative measurement to correlate adherence with overall product effectiveness through innovative designs, models and prototypes using electronic and biometric technologies to detect ring insertion and/or removal or expulsion. Coordinating research along these three pathways will

  4. 75 FR 39950 - Proposed Collection; Comment Request; Cancer Trials Support Unit (CTSU) Public Use Forms and...

    Science.gov (United States)

    2010-07-13

    ... regulatory information, changes to membership, patient enrollment data, and routing information for case... grant and contract holders, thereby reducing overall cost of maintaining a robust treatment trials...

  5. Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR

    Directory of Open Access Journals (Sweden)

    Colin McCowan

    2015-01-01

    Full Text Available Background. The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Methods. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. Results. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. Conclusions. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.

  6. Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.

    Science.gov (United States)

    McCowan, Colin; Thomson, Elizabeth; Szmigielski, Cezary A; Kalra, Dipak; Sullivan, Frank M; Prokosch, Hans-Ulrich; Dugas, Martin; Ford, Ian

    2015-01-01

    The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.

  7. Web-Based Cognitive Remediation Improves Supported Employment Outcomes in Severe Mental Illness: Randomized Controlled Trial.

    Science.gov (United States)

    Harris, Anthony Wf; Kosic, Tanya; Xu, Jean; Walker, Chris; Gye, William; Redoblado Hodge, Antoinette

    2017-09-20

    Finding work is a top priority for most people; however, this goal remains out of reach for the majority of individuals with a severe mental illness (SMI) who remain on benefits or are unemployed. Supported employment (SE) programs aimed at returning people with a severe mental illness to work are successful; however, they still leave a significant number of people with severe mental illness unemployed. Cognitive deficits are commonly found in SMI and are a powerful predictor of poor outcome. Fortunately, these deficits are amenable to treatment with cognitive remediation therapy (CRT) that significantly improves cognition in SMI. CRT combined with SE significantly increases the likelihood of individuals with severe mental illness obtaining and staying in work. However, the availability of CRT is limited in many settings. The aim of this study was to examine whether Web-based CRT combined with a SE program can improve the rate return to work of people with severe mental illness. A total of 86 people with severe mental illness (mean age 39.6 years; male: n=55) who were unemployed and who had joined a SE program were randomized to either a Web-based CRT program (CogRem) or an Internet-based control condition (WebInfo). Primary outcome measured was hours worked over 6 months post treatment. At 6 months, those participants randomized to CogRem had worked significantly more hours (P=.01) and had earned significantly more money (P=.03) than those participants randomized to the WebInfo control condition. No change was observed in cognition. This study corroborates other work that has found a synergistic effect of combining CRT with a SE program and extends this to the use of Web-based CRT. The lack of any improvement in cognition obscures the mechanism by which an improved wage outcome for participants randomized to the active treatment was achieved. However, the study substantially lowers the barrier to the deployment of CRT with other psychosocial interventions for

  8. Bone graft substitutes for the treatment of traumatic fractures of the extremities [Knochenersatzmaterialien zur Behandlung von traumatischen Frakturen der Extremitäten

    Directory of Open Access Journals (Sweden)

    Hagen, Anja

    2012-06-01

    Full Text Available [english] Bone graft substitutes are increasingly being used as supplements to standard care or as alternative to bone grafts in the treatment of traumatic fractures.The efficacy and cost-effectiveness of bone graft substitutes for the treatment of traumatic fractures as well as the ethical, social and legal implications of their use are the main research questions addressed.A systematic literature search was conducted in electronic medical databases (MEDLINE, EMBASE etc. in December 2009. Randomised controlled trials (RCT, where applicable also containing relevant health economic evaluations and publications addressing the ethical, social and legal aspects of using bone graft substitutes for fracture treatment were included in the analysis. After assessment of study quality the information synthesis of the medical data was performed using metaanalysis, the synthesis of the health economic data was performed descriptively. 14 RCT were included in the medical analysis, and two in the heath economic evaluation. No relevant publications on the ethical, social and legal implications of the bone graft substitute use were found. In the RCT on fracture treatment with bone morphogenetic protein-2 (BMP-2 versus standard care without bone grafting (RCT with an elevd high risk of bias there was a significant difference in favour of BMP-2 for several outcome measures. The RCT of calcium phosphate (CaP cement and bone marrow-based composite materials versus autogenous bone grafts (RCT with a high risk of bias revealed significant differences in favour of bone graft substitutes for some outcome measures. Regarding the other bone graft substitutes, almost all comparisons demonstrated no significant difference.The use of BMP-2 in addition to standard care without bone grafting led in the study to increased treatment costs considering all patients with traumatic open fractures. However, cost savings through the additional use of BMP-2 were calculated in a

  9. Remedial after-school support classes offered in rural Gambia (The SCORE trial): study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Boone, Peter; Camara, Alpha; Eble, Alex; Elbourne, Diana; Fernandes, Samory; Frost, Chris; Jayanty, Chitra; Lenin, Maitri; Silva, Ana Filipa

    2015-12-16

    Low education levels are endemic in much of the developing world, particularly in rural areas where traditional government-provided public services often have difficulty reaching beneficiaries. Providing trained para-teachers to teach regular after-school remedial education classes has been shown to improve literacy and numeracy in children of primary school age residing in such areas in India. This trial investigates whether such an intervention can also be effective in a West African setting with similarly low learning levels and difficult geographic access. cluster-randomized controlled trial. Clusters: villages or groups of villages with 15-300 households and at least 15 eligible children in the Lower River and North Bank Regions of The Gambia. children born between 1 September 2007 and 31 August 2009 planning to enter the first grade, for the first time, in the 2015-2016 school year in eligible villages. We anticipate enrolling approximately 150 clusters of villages with approximately 6000 children as participants. a program providing remedial after-school lessons, focusing on literacy and numeracy, 5 to 6 days a week for 3 years to eligible children, based on the intervention evaluated in the Support To Rural India's Public Education System (STRIPES) trial (PLoS ONE 8(7):e65775). both the intervention and control groups will receive small bundles of useful materials during annual data collection as recompense for their time. If the education intervention is shown to be cost-effective at raising learning levels, it is expected that the control group villages will receive the intervention for several years after the trial results are available. the primary outcome of the trial is a composite mathematics and language test score. Secondary outcomes include school attendance, enrollment, performance on nationally administered exams, parents' spending on education, spillover learning to siblings and family members, and school-related time use of parents and

  10. Retrievability of implant-supported crowns when using three different cements: a controlled clinical trial.

    Science.gov (United States)

    Worni, Andreas; Gholami, Hadi; Marchand, Laurent; Katsoulis, Joannis; Mericske-Stern, Regina; Enkling, Norbert

    2015-01-01

    The purpose of this study was to analyze the removal of implant-supported crowns retained by three different cements using an air-accelerated crown remover and to evaluate the patients' response to the procedure. This controlled clinical trial was conducted with 21 patients (10 women, 11 men; mean age: 51 ± 10.2 years) who had received a total of 74 implants (all placed in the posterior zone of the mandible). Four months after implant surgery, the crowns were cemented on standard titanium abutments of different heights. Three different cements (two temporary: Harvard TEMP and Improv; and one definitive: Durelon) were used and randomly assigned to the patients. Eight months later, one blinded investigator removed all crowns. The number of activations of the instrument (CORONAflex, KaVo) required for crown removal was recorded. The patients completed a questionnaire retrospectively to determine the impact of the procedure and to gauge their subjective perception. A linear regression model and descriptive statistics were used for data analysis. All crowns could be retrieved without any technical complications or damage. Both abutment height (P = .019) and cement type (P = .004) had a significant effect on the number of activations, but the type of cement was more important. An increased total number of activations had no or only a weak correlation to the patients' perception of concussion, noise, pain, and unwillingness to use the device. Cemented implant crowns can be removed, and the application of an air-accelerated device is a practicable method. A type of cement with appropriate retention force has to be selected. The impact on the patients' subjective perception should be taken into account.

  11. Pet ownership, social support, and one-year survival after acute myocardial infarction in the Cardiac Arrhythmia Suppression Trial (CAST).

    Science.gov (United States)

    Friedmann, E; Thomas, S A

    1995-12-15

    Social support and pet ownership, a nonhuman form of social support, have both been associated with increased coronary artery disease survival. The independent effects of pet ownership, social support, disease severity, and other psychosocial factors on 1-year survival after acute myocardial infarction are examined prospectively. The Cardiac Arrhythmia Suppression Trial provided physiologic data on a group of post-myocardial infarction patients with asymptomatic ventricular arrhythmias. An ancillary study provided psychosocial data, including pet ownership, social support, recent life events, future life events, anxiety, depression, coronary prone behavior, and expression of anger. Subjects (n = 424) were randomly selected from patients attending participating Cardiac Arrhythmia Suppression Trial sites and completed baseline psychosocial questionnaires. One year survival data were obtained from 369 patients (87%), of whom 112 (30.4%) owned pets and 20 (5.4%) died. Logistic regression indicates that high social support (p owning a pet (p = 0.085) tend to predict survival independent of physiologic severity and demographic and other psychosocial factors. Dog owners (n = 87, 1 died) are significantly less likely to die within 1 year than those who did not own dogs (n = 282, 19 died; p pet ownership and social support are significant predictors of survival, independent of the effects of the other psychosocial factors and physiologic status. These data confirm and extend previous findings relating pet ownership and social support to survival among patients with coronary artery disease.

  12. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study

    DEFF Research Database (Denmark)

    Lundh, Andreas; Barbateskovic, Marija; Hróbjartsson, Asbjørn

    2010-01-01

    transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals....... We investigated industry-supported trials' influence on journal impact factors and revenue....

  13. Optimised utilisation of existing incinerators by installation of upstream reactors for treatment of waste with high calorifica value - HYBRID waste treatment plants; Optimierte Nutzung bestehender Abfallverbrennungsanlagen durch Errichtung vorgeschalteter Reaktoren zur Behandlung heizwertreicher Abfaelle - HYBRID-Abfallbehandlungsanlagen

    Energy Technology Data Exchange (ETDEWEB)

    El Labani, M.

    2000-07-01

    Waste incineration plants are based on the process of thermal waste treatment, i.e. the generation of power from the controlled conversion of organic reactive residue waste. Statutory requirements forced operators to install powerful flue gas cleaning systems into their existing waste incineration plants. This led to a tremendous increase in cost and treatment prices generating pressure to optimize the process. Currently, markets demand additional capacities for the treatment of waste of elevated heating value ({proportional_to}5,0 MWh/Mg). It is possible to treat this type of waste in a conventional waste incineration plant. However, the elevated heating value dictates a reduction in throughput with ever increasing pressure on costs. This is why current concepts consider the treatment of waste of elevated heating value in specific, so called de-centralized plants. These plants are usually of low throughput with accordingly high specific cost of developing the infrastructure. The capacity of existing waste incineration plants has been investigated in order to assess the potential for optimization. Extensive test runs at the Municipal Solid Waste Incineration Plant (MSW) Darmstadt revealed a capacity gap in the flue gas cleaning system even with the incineration unit running at full capacity. This gap could be filled with an additional incineration plant for waste of elevated heating value, whose capacity is matched accordingly. Such additional incineration plant defines in conjunction with the existing waste incineration plant a so called HYBRID Waste Treatment Plant. It is the aim of this treatise to develop an instrument to support the decision making process related to the planning of such plants. (orig.) [German] Abfallverbrennungsanlagen basieren auf dem Verfahren der thermischen Abfallbehandlung; das ist die Energieerzeugung aus der kontrollierten Umwandlung organischer, reaktionsfaehiger Restabfaelle. Aufgrund gesetzlicher Vorgaben mussten bestehende

  14. Incorporating a Static Versus Supportive Mobile Phone App Into a Partial Meal Replacement Program With Face-to-Face Support: Randomized Controlled Trial.

    Science.gov (United States)

    Brindal, Emily; Hendrie, Gilly A; Freyne, Jill; Noakes, Manny

    2018-04-18

    Mobile phone apps may be acceptable to users and could improve retention and adherence over more traditional methods, but there is mixed literature supporting their efficacy. In the weight management space, very little is known about how a mobile phone app integrating features beyond text messaging (short message service) can affect behavior, particularly when combined with face-to-face support. The objective of this study was to examine the effectiveness of a mobile phone app when combined with a partial meal replacement program including face-to-face support. This paper compares a static versus supportive app over a 6-month randomized trial for effects on weight loss, weight-related biomarkers, and psychological outcomes. Overweight and obese adults (71.2% female, 104/146; mean 48.11, SD 11.75 years) were recruited to participate in the weight loss study, and they were randomized on a 1:1 basis using a computer algorithm. The supportive app (n=75) provided information, food intake recording, rewards, prompts for regular interaction through reminders, and the opportunity to review personal compliance with the dietary program. The static app (n=71) included only recipes and weight loss information. Both groups recieved equal amounts of face-to-face support in addition to app. The overall reduction in app usage over 24 weeks was lower for the supportive app in comparison with the static app; approximately 39.0% (57/146) of the users were still using the app at week 24. Despite the promising results for app usage, there were no differences in weight loss between groups (F1,128.12=0.83, P=.36). However, it should be noted that almost 60% (49/84) of all participants lost 5% or more of body weight during the trial. No weight-related biomarkers were significantly different between groups. Both groups experienced an increase in positive mood, but this was significantly higher for those who received the static app (F1,118.12=4.93, P=.03). Although the supportive app was

  15. Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer

    Directory of Open Access Journals (Sweden)

    Lepore Stephen

    2011-07-01

    Full Text Available Abstract Background Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity. Methods/design A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention "Living with Prostate Cancer" that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and health-related quality of life (QoL; psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial. Discussion This study will address a critical but as yet unanswered research question: to identify a population-based way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention. Trial Registration ACTRN12611000392965

  16. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial.

    Science.gov (United States)

    Bobrow, Kirsten; Farmer, Andrew J; Springer, David; Shanyinde, Milensu; Yu, Ly-Mee; Brennan, Thomas; Rayner, Brian; Namane, Mosedi; Steyn, Krisela; Tarassenko, Lionel; Levitt, Naomi

    2016-02-09

    We assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure. In this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141. © 2016 American Heart Association, Inc.

  17. Supporting carers to manage pain medication in cancer patients at the end of life: A feasibility trial.

    Science.gov (United States)

    Latter, Sue; Hopkinson, Jane B; Lowson, Elizabeth; Hughes, Jane A; Hughes, Jacki; Duke, Sue; Anstey, Sally; Bennett, Michael I; May, Carl; Smith, Peter; Richardson, Alison

    2018-01-01

    Carers of people with advanced cancer play a significant role in managing pain medication, yet they report insufficient information and support to do so confidently and competently. There is limited research evidence on the best ways for clinicians to help carers with medication management. To develop a pain medicines management intervention (Cancer Carers Medicines Management) for cancer patients' carers near the end of life and evaluate feasibility and acceptability to nurses and carers. To test the feasibility of trial research procedures and to inform decisions concerning a full-scale randomised controlled trial. Phase I-II clinical trial. A systematic, evidence-informed participatory method was used to develop CCMM: a nurse-delivered structured conversational process. A two-arm, cluster randomised controlled feasibility trial of Cancer Carers Medicines Management was conducted, with an embedded qualitative study to evaluate participants' experiences of Cancer Carers Medicines Management and trial procedures. Community settings in two study sites. Phase I comprises 57 carers, patients and healthcare professionals and Phase II comprises 12 nurses and 15 carers. A novel intervention was developed. Nurses were recruited and randomised. Carer recruitment to the trial was problematic with fewer than predicted eligible participants, and nurses judged a high proportion unsuitable to recruit into the study. Attrition rates following recruitment were typical for the study population. Cancer Carers Medicines Management was acceptable to carers and nurses who took part, and some benefits were identified. Cancer Carers Medicines Management is a robustly developed medicines management intervention which merits further research to test its effectiveness to improve carers' management of pain medicines with patients at the end of life. The study highlighted aspects of trial design that need to be considered in future research.

  18. Sodium Restriction in Patients With CKD : A Randomized Controlled Trial of Self-management Support

    NARCIS (Netherlands)

    Meuleman, Yvette; Hoekstra, Tiny; Dekker, Friedo W.; Navis, Gerjan; Vogt, Liffert; van der Boog, Paul J. M.; Bos, Willem Jan W.; van Montfrans, Gert A.; van Dijk, Sandra

    Background: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. Study Design: Open randomized controlled trial. Setting & Participants: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.

  19. Trial participants' experiences of early enhanced speech and language therapy after stroke compared with employed visitor support: a qualitative study nested within a randomized controlled trial.

    Science.gov (United States)

    Young, Alys; Gomersall, Timothy; Bowen, Audrey

    2013-02-01

    To explore trial participants' experiences of the process and outcomes of early, enhanced speech and language therapy after stroke with support from an employed visitor. Qualitative study nested within a randomized controlled trial. Twney-two people who, after stroke, had a diagnosis of aphasia (12), dysarthria (5) or both (5) and who participated in the ACT NoW study. Eight English NHS usual care settings. Individual interviews. Thematic content analysis assisted by a bespoke data transformation protocol for incorporating non-verbal and semantically ambiguous data. Participants highly regarded regular and sustained contact with someone outside of immediate family/friends who engaged them in deliberate activities/communication in the early months after stroke. Participants identified differences in the process of intervention between speech and language therapists and employed visitors. But no major discriminations were made between the impact or value of this contact according to whether provided by a speech and language therapist or employed visitor. Participant-defined criteria for effectiveness of contact included: impact on mood and confidence, self-recognition of progress and the meeting of individual needs. As in the randomized controlled trial, participants reported no evidence of added benefit of early communication therapy beyond that from attention control. The findings do not imply that regular contact with any non-professional can have beneficial effects for someone with aphasia or dysarthria in the early weeks following a stroke. The study points to specific conditions that would have to be met for contact to have a positive effect.

  20. Comparison of body weight-supported treadmill training versus body weight-supported overground training in people with incomplete tetraplegia: a pilot randomized trial.

    Science.gov (United States)

    Senthilvelkumar, Thangavelu; Magimairaj, Henry; Fletcher, Jebaraj; Tharion, George; George, Jacob

    2015-01-01

    To compare the effectiveness of body weight-supported treadmill training and body weight-supported overground training for improving gait and strength in people with traumatic incomplete tetraplegia. Assessor blinded randomized trial. Rehabilitation institute of a tertiary care teaching hospital in India. Sixteen participants with traumatic motor incomplete tetraplegia and within two years of injury. Participants were randomised to one of two groups: body weight-supported overground training on level ground and body weight-supported treadmill training. Both groups received 30 minutes of gait training per day, five days a week for eight weeks. In addition, both groups received regular rehabilitation which included flexibility, strength, balance, self care and functional training. The primary outcome measure was the Walking Index for Spinal Cord Injury (/20 points) and the secondary outcome was the Lower Extremity Muscle Score (/50 points). There was no statistically significant between group differences in the Walking Index for Spinal Cord Injury [mean difference=0.3points; 95% CI (-4.8 to 5.4); p=0.748] or the Lower Extremity Muscle Score [mean difference=0.2 points; 95% CI (-3.8 to 5.1); p=0.749]. Gait training with body weight-supported overground training is comparable to treadmill training for improving locomotion in people with traumatic incomplete tetraplegia. © The Author(s) 2014.

  1. The Relaxation Exercise and Social Support Trial (RESST: a community-based randomized controlled trial to alleviate medically unexplained vaginal discharge symptoms

    Directory of Open Access Journals (Sweden)

    Kobeissi Loulou

    2012-11-01

    no evidence of mediation of the effect on MUVD through measures of common mental disorders. Conclusion This study confirms that MUVD is an important public health problem. While the benefits of this intervention may appear modest, the intervention offers an opportunity for women to enhance their problem-solving skills as well as use physical relaxation techniques that can help them deal with stressful in their lives. Further research is needed in a variety of contexts, for different populations and preferably involving larger randomized trials of such an intervention. Trial registration * Title of trial: The Relaxation Exercise and Social Support Trial ISRCTN assigned: ISRCTN98441241 Date of assignation: 10/09/2010 Link: http://www.controlled-trials.com/ISRCTN98441241 * Also registered at the Wellcome Trust register: http://www.controlled-trials.com/mrct/trial/469943/98441241

  2. Gothenburg very early supported discharge study (GOTVED) NCT01622205: a block randomized trial with superiority design of very early supported discharge for patients with stroke.

    Science.gov (United States)

    Sunnerhagen, Katharina S; Danielsson, Anna; Rafsten, Lena; Björkdahl, Ann; Axelsson, Åsa B; Nordin, Åsa; Petersson, Cathrine A; Lundgren-Nilsson, Åsa; Fröjd, Karin

    2013-06-24

    Stroke is the disease with the highest costs for hospital care and also after discharge. Early supported discharge (ESD) has shown to be efficient and safe and the best results with well-organised discharge teams and patients with less severe strokes. The aim is to investigate if very early supported discharge (VESD) for stroke patients in need for on-going individualised rehabilitation at home is useful for the patient and cost effective. A randomized controlled trial comparing VESD with ordinary discharge. confirmed stroke, >18 years of age, living within 30 min from the stroke unit, on day 2 0-16 points on the National institute of health stroke scale (NIHSS) and 50-100 points on the Barthel Index (BI), with BI 100 then the patient can be included if the Montreal Cognitive Assessment is 16, BI block randomization of 20 and with blinded assessor. levels of anxiety and depression. independence, security, level of function, quality of health, needs of support in activities of daily living and caregiver burden. Power calculation is based on the level of anxiety and with a power of 80%, p-value 0.05 (2 sided test) 44 persons per group are needed. Data is gathered on co-morbidity, re-entry to hospital, mortality and a health economic analysis. Interviews will be accomplished with a strategic sample of 15 patients in the intervention group before discharge, within two weeks after homecoming and 3 months later. Interviews are also planned with 15 relatives in the intervention group 3 months after discharge. The ESD studies in the Cochrane review present hospital stays of a length that no longer exist in Sweden. There is not yet, to our knowledge, any study of early supported discharge with present length of hospital stay. Thus it is not clear if home rehabilitation nowadays without risks, is cost effective, or with the same patient usefulness as earlier studies. ClinicalTrials.gov NCT01622205.

  3. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Brown, Sarah; Smith, Isabelle L; Brown, Julia M; Hulme, Claire; McGinnis, Elizabeth; Stubbs, Nikki; Nelson, E Andrea; Muir, Delia; Rutherford, Claudia; Walker, Kay; Henderson, Valerie; Wilson, Lyn; Gilberts, Rachael; Collier, Howard; Fernandez, Catherine; Hartley, Suzanne; Bhogal, Moninder; Coleman, Susanne; Nixon, Jane E

    2016-12-20

    Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual's functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the NHS: high-specification foam and alternating pressure mattresses, in the prevention of pressure ulcers. PRESSURE 2 is a multicentre, open-label, randomised, double triangular, group sequential, parallel group trial. A maximum of 2954 'high-risk' patients with evidence of acute illness will be randomised on a 1:1 basis to receive either a high-specification foam mattress or alternating-pressure mattress in conjunction with an electric profiling bed frame. The primary objective of the trial is to compare mattresses in terms of the time to developing a new Category 2 or above pressure ulcer by 30 days post end of treatment phase. Secondary endpoints include time to developing new Category 1 and 3 or above pressure ulcers, time to healing of pre-existing Category 2 pressure ulcers, health-related quality of life, cost-effectiveness, incidence of mattress change and safety. Validation objectives are to determine the responsiveness of the Pressure Ulcer Quality of Life-Prevention instrument and the feasibility of having a blinded endpoint assessment using photography. The trial will have a maximum of three planned analyses with unequally spaced reviews at event-driven coherent cut-points. The futility boundaries are constructed as non-binding to allow a decision for stopping early to be overruled by the Data Monitoring and Ethics Committee. The double triangular, group sequential design of the PRESSURE 2 trial will provide an efficient design through the possibility of early stopping for

  4. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Harvey, Allison G; Dong, Lu; Lee, Jason Y; Gumport, Nicole B; Hollon, Steven D; Rabe-Hesketh, Sophia; Hein, Kerrie; Haman, Kirsten; McNamara, Mary E; Weaver, Claire; Martinez, Armando; Notsu, Haruka; Zieve, Garret; Armstrong, Courtney C

    2017-11-14

    The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.

  5. A nurse-led randomised trial of pressure-relieving support surfaces.

    Science.gov (United States)

    Nelson, E Andrea; Nixon, Jane; Mason, Su; Barrow, Helen; Phillips, Angela; Cullum, Nicky

    2003-05-01

    A nurse-led trial is currently collecting data comparing interventions for the prevention and treatment of pressure ulcers. The aim is to provide reliable guidance on the relative merits of alternating-pressure mattresses and overlays for people at moderate to high risk of pressure ulceration. This paper outlines the main objectives, methodology and progress of the study.

  6. Leidos Biomed Supports Clinical Trials for Vaccine Against Mosquito-borne Chikungunya | FNLCR Staging

    Science.gov (United States)

    An experimental vaccine for mosquito-borne chikungunya is being tested at sites in the Caribbean as part of a phase II clinical trial being managed by the Frederick National Lab. No vaccine or treatment currently exists for the viral disease, which c

  7. NCI-supported facility to conduct cancer trials breaks ground in Puerto Rico

    Science.gov (United States)

    The Puerto Rican government has allocated $196 million dollars to build a 287,000 sq. ft., 96-bed, cancer hospital in San Juan. The new hospital, which will provide cancer treatment and conduct clinical trials, is the first of its kind in the Caribbean.

  8. Frederick National Lab Supports Clinical Trials for Vaccine Against Mosquito-borne Chikungunya | FNLCR

    Science.gov (United States)

    An experimental vaccine for mosquito-borne chikungunya is being tested at sites in the Caribbean as part of a phase II clinical trial being managed by the Frederick National Lab. No vaccine or treatment currently exists for the viral disease, which c

  9. Data-driven decision support for radiologists: re-using the National Lung Screening Trial dataset for pulmonary nodule management.

    Science.gov (United States)

    Morrison, James J; Hostetter, Jason; Wang, Kenneth; Siegel, Eliot L

    2015-02-01

    Real-time mining of large research trial datasets enables development of case-based clinical decision support tools. Several applicable research datasets exist including the National Lung Screening Trial (NLST), a dataset unparalleled in size and scope for studying population-based lung cancer screening. Using these data, a clinical decision support tool was developed which matches patient demographics and lung nodule characteristics to a cohort of similar patients. The NLST dataset was converted into Structured Query Language (SQL) tables hosted on a web server, and a web-based JavaScript application was developed which performs real-time queries. JavaScript is used for both the server-side and client-side language, allowing for rapid development of a robust client interface and server-side data layer. Real-time data mining of user-specified patient cohorts achieved a rapid return of cohort cancer statistics and lung nodule distribution information. This system demonstrates the potential of individualized real-time data mining using large high-quality clinical trial datasets to drive evidence-based clinical decision-making.

  10. Treatment of lumbar facet joint syndrome by CT-guided intraarticular infiltration of fact joints; Behandlung des lumbalen Facettensyndroms durch CT-gesteuerte Infiltration der Zwischenwirbelgelenke

    Energy Technology Data Exchange (ETDEWEB)

    Schleifer, J. [Knappschaftsklinik Puettlingen/Saar (Germany). Orthopaedische Abteilung; Fenzl, G. [Knappschaftsklinik Puettlingen/Saar (Germany). Orthopaedische Abteilung; Wolf, A. [Knappschaftsklinik Puettlingen/Saar (Germany). Radiologische Abteilung; Diehl, K. [Knappschaftsklinik Puettlingen/Saar (Germany). Radiologische Abteilung

    1994-11-01

    In 62 patients with facet syndrome a total of 205 joints were infiltrated, CT monitoring being used in all cases. Each facet joint was infiltrated with 0.3 ml bupivacaine and 0.8 ml methylprednisolone. The patients were divided into three groups. Group 1 consisted of 24 persons who had undergone lumbar disc surgery, group 2 of 23 patients with spondylarthrosis of the facet joints, and group 3 of 15 patients who had undergone lumbar disc surgery but hat additional spondylarthrosis. Very good results were defined as pain relief for longer than 4 weeks, good results as pain relief for up to 4 weeks and poor results as brief pain relief or none at all. In 27 patients facet infiltration was performed for the purpose of diagnosis. Results were significantly in group 2 than in group 1. In group 3 results were better than in group 1, but worse than in group 2. These differences were not statistical by significant. Seven patients in the diagnostic group had no pain relief, and facet syndrome was excluded. (orig.) [Deutsch] Bei 62 Patienten mit lumbalem Facettensyndrom wurden insgesamt 205 Zwischenwirbelgelenke (Facettengelenke) perkutan CT-gesteuert infiltriert. Je Gelenk wurden 0,3 ml Bupivacain und 0,8 ml Methylprednisolon intraartikulaer infiziert. Die Patienten wurden in 3 Gruppen unterteilt. Die 1. Gruppe umfasste 24 Patienten mit Postnukleotomiesyndrom, die 2. Gruppe 23 Patienten mit spondylarthrotischen Veraenderungen, die 3. Gruppe 15 bandscheibenoperierte Patienten mit zusaetzlicher Spondylarthrose. In Gruppe 2 fanden sich signifikant bessere Ergebnisse als in Gruppe 1. Gute Resultate ergab auch die dritte Gruppe, sie waren jedoch nicht signifikant besser als die der Gruppe 1. Die sorgfaeltige Auswahl der Patienten ist fuer den Erfolg der Behandlung entscheidend. Die Infiltrationsbehandlung der Zwischenwirbelgelenke hat nahezu keine Nebenwirkungen. Ausser zur Therapie wird das Verfahren diagnostisch zum Ausschluss eines Facettensyndromes im Rahmen der Abklaerung

  11. Radiological findings, evaluation and treatment of patellofemoral pain after total knee arthroplasty; Radiologische Diagnostik, Beurteilung und Behandlung des patellofemoralen Schmerzes nach primaerer Knieendoprothetik

    Energy Technology Data Exchange (ETDEWEB)

    Springorum, H.R.; Keshmiri, A.; Heers, G.; Renkawitz, T.; Grifka, J.; Baier, C. [Asklepios Klinikum Bad Abbach, Orthopaedische Klinik fuer die Universitaet Regensburg, Bad Abbach (Germany)

    2012-11-15

    Total knee arthroplasty (TKA) is one of the most successful operative procedures over the last decades in orthopedic surgery; however, some patients suffer from pain, limited range of motion, instability, infections or other complications postoperatively. Patellofemoral pain (PFP) in particular is a common problem after TKA and often necessitates revision surgery. Mainly increasing and localized contact pressure and patella maltracking are held responsible for PFP but the reasons vary. Diagnostics and therapy of PFP is not easy to manage and should be treated following a clinical pathway. The authors suggest that patients with PFP should be categorized after basic diagnostic measures according to the suspected diagnosis: (1) tendinosis, (2) mechanical reasons, (3) intra-articular non-mechanical reasons and (4) neurogenic/psychiatric reasons. Efficient application of special diagnostic measures and further therapy is facilitated by this classification. (orig.) [German] Die endoprothetische Versorgung des Kniegelenks ist eine Operation mit hohem Zugewinn an Lebensqualitaet. Dennoch sind je nach Literaturstelle bis zu 50% der Patienten von Schmerzen, Bewegungseinschraenkung, Instabilitaet, Infektion oder anderen Komplikationen betroffen. Insbesondere der patellofemorale Schmerz (PFS) ist eine haeufige Komplikation nach primaerer Knieendoprothetik und wird je nach Literatur mit 1-50% der Faelle angegeben. Insbesondere der erhoehte retropatellare Anpressdruck und eine schlechte Fuehrung der Patella werden fuer den PFS verantwortlich gemacht, doch die Ursachen sind vielfaeltig. Diagnostik und Behandlung sind komplex und sollten strukturiert durchgefuehrt werden. Nach der Basisdiagnostik schlagen die Autoren daher eine Einteilung in eine der 4 Gruppen vor: (1) Tendinosen, (2) mechanische Probleme, (3) intraartikulaere nichtmechanische Probleme, (4) neurogene/psychische Probleme. Durch die Einteilung in diese verschiedenen Gruppen werden eine effiziente spezielle

  12. Pragmatic cluster randomised trial of a free telephone-based health coaching program to support women in managing weight gain during pregnancy: the Get Healthy in Pregnancy Trial.

    Science.gov (United States)

    Clements, Vanessa; Leung, Kit; Khanal, Santosh; Raymond, Jane; Maxwell, Michelle; Rissel, Chris

    2016-08-30

    Excessive gestational weight gain can result in poor maternal and child health outcomes. Estimates from single studies indicate the prevalence of excessive gestational weight gain in Australia could lie between 38 and 67 %. The risk of excessive weight gain can be reduced through healthy eating and exercise. We describe the rationale and methods of the Get Healthy in Pregnancy Service, a trial service which aims to support women in achieving appropriate gestational weight gain through an existing telephone-based health coaching service. This study aims to compare the effectiveness of a telephone-based health coaching program versus provision of information only in supporting pregnant women to achieve appropriate gestational weight gain. A pragmatic stratified clustered randomised controlled trial will be conducted with 710 women who present to 5 hospitals for their first antenatal appointment during the recruitment period (6-8 months), have a pre-pregnancy body mass index (BMI) ≥ 18.50 (healthy weight or above), are 18 years and over, singleton gestation, English speaking, have no pre-existing medical conditions that may limit their ability to exercise or require a restricted diet and are 18 weeks or less gestation. Hospitals will be randomised into one of two intervention models: a) information only; or b) information plus 10 telephone-based health coaching sessions with a university qualified coach. Both interventions will set a weight-range target with pregnant women. The women attending antenatal clinics at participating hospitals will be screened at their initial hospital appointment to assess their eligibility. Women recruited to the trial will have a number of measures recorded including anthropometrics (self-reported height and weight) and dietary and physical activity scores during and following pregnancy. These measurements will be collected at baseline (prior to 18 weeks gestation), 36 weeks gestation and 12 months post-birth. This study

  13. Clinical Efficacy of Jump Training Augmented With Body Weight Support After ACL Reconstruction: A Randomized Controlled Trial.

    Science.gov (United States)

    Elias, Audrey R C; Harris, Kari J; LaStayo, Paul C; Mizner, Ryan L

    2018-03-01

    Limited knee flexion and increased muscle co-contraction during jump landing are believed to diminish outcomes after anterior cruciate ligament (ACL) reconstruction. The efficacy of jump training to improve patients' mechanical and neuromuscular deficits is understudied. Jump training will improve functional, mechanical, and neuromuscular outcomes and higher repetition training augmented by body weight support will result in better retention of gains. Randomized controlled trial; Level of evidence, 1. Thirty athletes (18 months after surgery) were screened, and 19 with mechanical deficits and limited clinical outcomes were enrolled in the trial. Testing included the International Knee Documentation Committee (IKDC) questionnaire, leg landing mechanics via motion analysis, knee joint effusion using a stroke test, and a surface electromyography-generated co-contraction index during a single-legged landing. Participants were randomly assigned to 1 of 2 groups: jump training with normal body weight (JTBW) and high-repetition jump training with body weight support (JTBWS). Knee effusion grading throughout training was used to assess joint tolerance. Changes in outcomes over time were analyzed with mixed-effects modeling. Immediate outcomes were compared with retention testing at 8 weeks after training by use of 2-way analyses of variance with effects of time and group. Significant effects of time were found during the training phase for all outcome measures, but no effects of group or sex were found. IKDC score (pooled; mean ± SD) increased from 76 ± 12 to 87 ± 8 ( P training mitigated some risk factors for second injury and osteoarthritis in patients after ACL reconstruction. Training made lasting improvements in physical function measures as well as mechanical and neuromuscular coordination deficits. Higher repetitions used with body weight support did not improve retention but substantially reduced risk for effusion. Jump training is an efficacious intervention

  14. The effect of flexible acrylic resin on masticatory muscle activity in implant-supported mandibular overdentures: a controlled clinical trial.

    Science.gov (United States)

    Ibraheem, Eman Mostafa Ahmed; Nassani, Mohammad Zakaria

    2016-01-01

    It is not yet clear from the current literature to what extent masticatory muscle activity is affected by the use of flexible acrylic resin in the construction of implant-supported mandibular overdentures. To compare masticatory muscle activity between patients who were provided with implant-supported mandibular overdentures constructed from flexible acrylic resin and those who were provided with implant-supported mandibular overdentures constructed from heat-cured conventional acrylic resin. In this clinical trial, 12 completely edentulous patients were selected and randomly allocated into two equal treatment groups. Each patient in Group 1 received two implants to support a mandibular overdenture made of conventional acrylic resin. In Group 2, the patients received two implants to support mandibular overdentures constructed from "Versacryl" flexible acrylic resin. The maxillary edentulous arch for patients in both groups was restored by conventional complete dentures. For all patients, masseter and temporalis muscle activity was evaluated using surface electromyography (sEMG). The results showed a significant decrease in masticatory muscle activity among patients with implant-supported mandibular overdentures constructed from flexible acrylic resin. The use of "Versacryl" flexible acrylic resin in the construction of implant-supported mandibular overdentures resulted in decreased masticatory muscle activity.

  15. The effect of flexible acrylic resin on masticatory muscle activity in implant-supported mandibular overdentures: a controlled clinical trial

    Science.gov (United States)

    Ibraheem, Eman Mostafa Ahmed; Nassani, Mohammad Zakaria

    2016-01-01

    Background It is not yet clear from the current literature to what extent masticatory muscle activity is affected by the use of flexible acrylic resin in the construction of implant-supported mandibular overdentures. Objective To compare masticatory muscle activity between patients who were provided with implant-supported mandibular overdentures constructed from flexible acrylic resin and those who were provided with implant-supported mandibular overdentures constructed from heat-cured conventional acrylic resin. Methods In this clinical trial, 12 completely edentulous patients were selected and randomly allocated into two equal treatment groups. Each patient in Group 1 received two implants to support a mandibular overdenture made of conventional acrylic resin. In Group 2, the patients received two implants to support mandibular overdentures constructed from “Versacryl” flexible acrylic resin. The maxillary edentulous arch for patients in both groups was restored by conventional complete dentures. For all patients, masseter and temporalis muscle activity was evaluated using surface electromyography (sEMG). Results The results showed a significant decrease in masticatory muscle activity among patients with implant-supported mandibular overdentures constructed from flexible acrylic resin. Conclusion The use of “Versacryl” flexible acrylic resin in the construction of implant-supported mandibular overdentures resulted in decreased masticatory muscle activity. PMID:26955445

  16. Randomized clinical trial comparing affect regulation and supportive group therapies for victimization-related PTSD with incarcerated women.

    Science.gov (United States)

    Ford, Julian D; Chang, Rocío; Levine, Joan; Zhang, Wanli

    2013-06-01

    Traumatic victimization and associated problems with posttraumatic stress disorder (PTSD) and affect dysregulation are prevalent among incarcerated women, but there is limited evidence to support psychotherapeutic interventions for these problems in this underserved population. A group psychotherapy designed to enhance affect regulation without trauma memory processing-Trauma Affect Regulation: Guide for Education and Therapy (TARGET)-was compared to a supportive group therapy (SGT) in a randomized clinical trial with 72 incarcerated women with full or partial PTSD. Both interventions achieved statistically significant reductions in PTSD and associated symptom severity and increased self-efficacy. Dropout rates for both interventions were low (women's ability to achieve affective resolution (forgiveness) while also reducing their victimization-related PTSD and associated symptoms. Experiential-focused supportive group therapy also may reduce victimization-related PTSD and associated symptoms. Both group therapy approaches warrant further study with this vulnerable population. Copyright © 2012. Published by Elsevier Ltd.

  17. Comparison of global versus Asian clinical trial strategies supportive of registration of drugs in Japan.

    Science.gov (United States)

    Shirotani, Mari; Kurokawa, Tatsuo; Chiba, Koji

    2014-07-01

    The number of worldwide and Asian multiregional clinical trials (MRCTs) submitted for Japanese New Drug Applications increased markedly between 2009 and 2013, with an increasing number performed for simultaneously submission in the USA, EU, and Japan. Asian studies accounted for 32% of MRCTs (14/44 studies) and had comparatively small sample sizes (phase 3 clinical trials were not be planned in the USA/EU, when there was insufficient knowledge of ethnic differences in drug efficacy and safety, or when Caucasian data could not be extrapolated to the Japanese population. New strategies with Asian studies including the Japanese population could be conducted instead of Japanese domestic development strategy. © 2014, The American College of Clinical Pharmacology.

  18. Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial.

    Science.gov (United States)

    El Shafie, Rami A; Bougatf, Nina; Sprave, Tanja; Weber, Dorothea; Oetzel, Dieter; Machmer, Timo; Huber, Peter E; Debus, Jürgen; Nicolay, Nils H

    2018-03-06

    The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App - A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication

  19. Doula support during first-trimester surgical abortion: a randomized controlled trial.

    Science.gov (United States)

    Chor, Julie; Hill, Brandon; Martins, Summer; Mistretta, Stephanie; Patel, Ashlesha; Gilliam, Melissa

    2015-01-01

    The objective of the study was to evaluate the impact of doula support on first-trimester abortion care. Women were randomized to receive doula support or routine care during first-trimester surgical abortion. We examined the effect of doula support on pain during abortion using a 100 mm visual analog scale. The study had the statistical power to detect a 20% difference in mean pain scores. Secondary measures included satisfaction, procedure duration, and patient recommendations regarding doula support. Two hundred fourteen women completed the study: 106 received doula support, and 108 received routine care. The groups did not differ regarding demographics, gestational age, or medical history. Pain scores in the doula and control groups did not differ at speculum insertion (38.6 [±26.3 mm] vs 43.6 mm [±25.9 mm], P = .18) or procedure completion (68.2 [±28.0 mm] vs 70.6 mm [±23.5 mm], P = .52). Procedure duration (3.39 [±2.83 min] vs 3.18 min [±2.36 min], P = .55) and patient satisfaction (75.2 [±28.6 mm] vs 74.6 mm [±27.4 mm], P = .89) did not differ between the doula and control groups. Among women who received doula support, 96.2% recommended routine doula support for abortion and 60.4% indicated interest in training as doulas. Among women who did not receive doula support, 71.6% of women would have wanted it. Additional clinical staff was needed to provide support for 2.9% of women in the doula group and 14.7% of controls (P effect on pain or satisfaction, women overwhelmingly recommended it for routine care. Women receiving doula support were less likely to require additional clinic support resources. Doula support therefore may address patient psychosocial needs. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Education improves bra knowledge and fit, and level of breast support in adolescent female athletes: a cluster-randomised trial.

    Science.gov (United States)

    McGhee, Deirdre E; Steele, Julie R; Munro, Bridget J

    2010-01-01

    Can an education booklet handed out by a physiotherapist improve bra knowledge and fit, and level of breast support, of bras worn by adolescent female athletes? Cluster-randomised trial with intention-to-treat analysis. 115 adolescent females from four regional sporting academies aged 16 yr (SD 1) and with an average Australian bra size of 12B. The experimental group received an education booklet on bra fit and breast support from a sports physiotherapist. The control group received no intervention. The primary outcome was bra knowledge measured by a questionnaire. Secondary outcomes were a pass on the Bra Fit Assessment and the Level of Breast Support tests, and breast discomfort during exercise rated on a 10-cm visual analogue scale. Four months after receiving the education booklet, the experimental group had improved their bra knowledge 19% (95% CI 14 to 25) more than the control group. In addition, 39% (95% CI 19 to 54) more of the experimental group passed the Bra Fit Assessment test and 30% (95% CI 11 to 47) more passed the Level of Breast Support test than the control group at 4 months. There was no difference in the level of breast discomfort during exercise. Bra knowledge, bra fit, and level of breast support in adolescent female athletes were all poor but improved significantly after receiving an education booklet about breast support designed specifically for them. ACTRN12609000607279.

  1. The effectiveness of peer support groups in psychosis : a randomized controlled trial

    NARCIS (Netherlands)

    Castelein, S.; Bruggeman, R.; van Busschbach, J. T.; van der Gaag, M.; Stant, A. D.; Knegtering, H.; Wiersma, D.

    Objective: To investigate the effect of a (minimally) guided peer support group (GPSG) for people with psychosis on social network, social support, self-efficacy, self-esteem, and quality of life, and to evaluate the intervention and its economic consequences. Method: In a multi-center randomized

  2. Lumbar supports to prevent recurrent low back pain among home care workers: a randomized trial

    NARCIS (Netherlands)

    Roelofs, Pepijn D. D. M.; Bierma-Zeinstra, Sita M. A.; van Poppel, Mireille N. M.; Jellema, Petra; Willemsen, Sten P.; van Tulder, Maurits W.; van Mechelen, Willem; Koes, Bart W.

    2007-01-01

    People use lumbar supports to prevent low back pain. Secondary analyses from primary preventive studies suggest benefit among workers with previous low back pain, but definitive studies on the effectiveness of supports for the secondary prevention of low back pain are lacking. To determine the

  3. The impact of the carer support needs assessment tool (CSNAT in community palliative care using a stepped wedge cluster trial.

    Directory of Open Access Journals (Sweden)

    Samar M Aoun

    Full Text Available Family caregiving towards the end-of-life entails considerable emotional, social, financial and physical costs for caregivers. Evidence suggests that good support can improve caregiver psychological outcomes. The primary aim of this study was to investigate the impact of using the carer support needs assessment tool (CSNAT, as an intervention to identify and address support needs in end of life home care, on family caregiver outcomes. A stepped wedge design was used to trial the CSNAT intervention in three bases of Silver Chain Hospice Care in Western Australia, 2012-14. The intervention consisted of at least two visits from nurses (2-3 weeks apart to identify, review and address caregivers' needs. The outcome measures for the intervention and control groups were caregiver strain and distress as measured by the Family Appraisal of Caregiving Questionnaire (FACQ-PC, caregiver mental and physical health as measured by SF-12v2, and caregiver workload as measured by extent of caregiver assistance with activities of daily living, at baseline and follow up. Total recruitment was 620. There was 45% attrition for each group between baseline and follow-up mainly due to patient deaths resulting in 322 caregivers completing the study (233 in the intervention group and 89 in the control group. At follow-up, the intervention group showed significant reduction in caregiver strain relative to controls, p=0.018, d=0.348 (95% CI 0.25 to 0.41. Priority support needs identified by caregivers included knowing what to expect in the future, having time for yourself in the day and dealing with your feelings and worries. Despite the challenges at the clinician, organisational and trial levels, the CSNAT intervention led to an improvement in caregiver strain. Effective implementation of an evidence-informed and caregiver-led tool represents a necessary step towards helping palliative care providers better assess and address caregiver needs, ensuring adequate family

  4. A pilot study assessing social support among cancer patients enrolled on clinical trials: a comparison of younger versus older adults

    Directory of Open Access Journals (Sweden)

    Paul J Novotny

    2010-05-01

    Full Text Available Paul J Novotny1, Denise J Smith1, Lorna Guse2, Teresa A Rummans3, Lynn Hartmann4, Steven Alberts4, Richard Goldberg5, David Gregory6, Mary Johnson7, Jeff A Sloan11Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2Faculty of Nursing, University of Manitoba, Winnipeg, Manitoba, Canada; 3Psychiatry, Mayo Clinic, Rochester, MN, USA; 4Medical Oncology, Mayo Clinic, Rochester, MN, USA; 5Oncology Services, University of North Carolina, Chapel Hill, NC, USA; 6Faculty of Health Sciences Nursing, University of Lethbridge, Lethbridge, Alberta, Canada; 7Chaplain Services, Mayo Clinic, Rochester, MN, USAPurpose: This study tested the logistical feasibility of obtaining data on social support systems from cancer patients enrolled on clinical trials and compared the social support of older adults (age ≥65 and younger adults (<50 years of age with cancer.Methods: Patients had to be eligible for a phase II or phase III oncology clinical trial and enter the study prior to treatment. Patients filled out the Lubben Social Network Scale (LSNS at baseline. The Symptom Distress Scale (SDS and single-item overall quality of life (QOL Uniscale were assessed at baseline and weekly for 4 weeks.Results: There was no significant difference in overall mean Lubben social support levels by age. Older patients had more relatives they felt close to (85% versus 53% with 5 or more relatives, P = 0.02, heard from more friends monthly (84% versus 53% with 3 or more friends, P = 0.02, less overall symptom distress (P = 0.03, less insomnia (P = 0.003, better concentration (P = 0.005, better outlook (P = 0.01, and less depression (P = 0.005 than younger patients.Conclusions: Younger subjects reported worse symptoms, a smaller social support network, and fewer close friends and relatives than older subjects. Having someone to discuss decisions and seeing friends or relatives often was associated with longer survival. Keywords: social support, Lubben scale, QOL, elderly

  5. Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration.

    Science.gov (United States)

    Khin, Ni A; Chen, Yeh-Fong; Yang, Yang; Yang, Peiling; Laughren, Thomas P

    2012-06-01

    There has been concern about a high rate of placebo response and a decline in treatment effect over time in schizophrenia trials as well as the implications of increasing conduct of such trials outside North America. This report explores differences in efficacy data over an 18-year period from randomized placebo-controlled trials submitted in support of new drug applications (NDAs) for the treatment of schizophrenia and differences in results between trials conducted in North America and elsewhere. Clinical trial data that were submitted to the US Food and Drug Administration (FDA) as part of NDAs for the indication of schizophrenia between 1991 and 2009. Efficacy data were compiled from 32 clinical trials with 11,567 evaluable patients with schizophrenia. Data from completed, randomized, multicenter, double-blind, placebo-controlled, 4- to 8-week clinical trials in adult patients diagnosed with schizophrenia according to DSM-III or DSM-IV criteria were included. Baseline demographic and disease characteristics, including mean Positive and Negative Syndrome Scale (PANSS) total scores, were summarized and compared between North American and multiregional trials. Mean change from baseline to endpoint in PANSS total scores was utilized as the primary outcome of interest. We explored differences in treatment effect and success rate of these trials based on when and where the studies were conducted, sample size, trial duration, and baseline patient characteristics. Twenty-one of the 32 trials were conducted solely in North America, and 11 were carried out in multiple regions. Of those 11 multiregional trials, 2 were conducted exclusively in foreign countries. Although the observed responses (change from baseline) in placebo and drug-treated groups in multiregional trials tended to be larger than in North American trials, the treatment effects (drug-placebo difference) were -9 and -8 PANSS units for North American and multiregional trials, respectively. When time of

  6. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study.

    Science.gov (United States)

    Lundh, Andreas; Barbateskovic, Marija; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

    2010-10-26

    transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue. we sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006. publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.

  7. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study.

    Directory of Open Access Journals (Sweden)

    Andreas Lundh

    2010-10-01

    Full Text Available BACKGROUND: transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials' influence on journal impact factors and revenue. METHODS AND FINDINGS: we sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]. For each journal, we identified randomised trials published in 1996-1997 and 2005-2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005-2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005-2006. CONCLUSIONS: publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals' revenue and impact.

  8. Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II.

    Directory of Open Access Journals (Sweden)

    Annie LeBlanc

    Full Text Available Osteoporosis Choice, an encounter decision aid, can engage patients and clinicians in shared decision making about osteoporosis treatment. Its effectiveness compared to the routine provision to clinicians of the patient's estimated risk of fracture using the FRAX calculator is unknown.Patient-level, randomized, three-arm trial enrolling women over 50 with osteopenia or osteoporosis eligible for treatment with bisphosphonates, where the use of Osteoporosis Choice was compared to FRAX only and to usual care to determine impact on patient knowledge, decisional conflict, involvement in the decision-making process, decision to start and adherence to bisphosphonates.We enrolled 79 women in the three arms. Because FRAX estimation alone and usual care produced similar results, we grouped them for analysis. Compared to these, use of Osteoporosis Choice increased patient knowledge (median score 6 vs. 4, p = .01, improved understanding of fracture risk and risk reduction with bisphosphonates (p = .01 and p<.0001, respectively, had no effect on decision conflict, and increased patient engagement in the decision making process (OPTION scores 57% vs. 43%, p = .001. Encounters with the decision aid were 0.8 minutes longer (range: 33 minutes shorter to 3.0 minutes longer. There were twice as many patients receiving and filling prescriptions in the decision aid arm (83% vs. 40%, p = .07; medication adherence at 6 months was no different across arms.Supporting both patients and clinicians during the clinical encounter with the Osteoporosis Choice decision aid efficiently improves treatment decision making when compared to usual care with or without clinical decision support with FRAX results.clinical trials.gov NCT00949611.

  9. Single-Trial Classification of Bistable Perception by Integrating Empirical Mode Decomposition, Clustering, and Support Vector Machine

    Directory of Open Access Journals (Sweden)

    Hualou Liang

    2008-04-01

    Full Text Available We propose an empirical mode decomposition (EMD- based method to extract features from the multichannel recordings of local field potential (LFP, collected from the middle temporal (MT visual cortex in a macaque monkey, for decoding its bistable structure-from-motion (SFM perception. The feature extraction approach consists of three stages. First, we employ EMD to decompose nonstationary single-trial time series into narrowband components called intrinsic mode functions (IMFs with time scales dependent on the data. Second, we adopt unsupervised K-means clustering to group the IMFs and residues into several clusters across all trials and channels. Third, we use the supervised common spatial patterns (CSP approach to design spatial filters for the clustered spatiotemporal signals. We exploit the support vector machine (SVM classifier on the extracted features to decode the reported perception on a single-trial basis. We demonstrate that the CSP feature of the cluster in the gamma frequency band outperforms the features in other frequency bands and leads to the best decoding performance. We also show that the EMD-based feature extraction can be useful for evoked potential estimation. Our proposed feature extraction approach may have potential for many applications involving nonstationary multivariable time series such as brain-computer interfaces (BCI.

  10. The Impact of Psychological Support on Weight Loss Post Weight Loss Surgery: a Randomised Control Trial

    OpenAIRE

    Ogden, J; Hollywood, A; Pring, C

    2015-01-01

    BACKGROUND: The purpose of the present study is to evaluate the impact of a health psychology-led bariatric rehabilitation service (BRS) on patient weight loss following bariatric surgery at 1 year. METHODS: A single-site open-randomised parallel group control trial based at St. Richard's Hospital in Chichester in the UK. Patients (n = 162) were recruited immediately prior to Roux-en-Y gastric bypass and randomly allocated to receive either treatment as usual (n = 80) or the BRS (n = 82). The...

  11. Preclinical safety of human embryonic stem cell-derived oligodendrocyte progenitors supporting clinical trials in spinal cord injury.

    Science.gov (United States)

    Priest, Catherine A; Manley, Nathan C; Denham, Jerrod; Wirth, Edward D; Lebkowski, Jane S

    2015-11-01

    To characterize the preclinical safety profile of a human embryonic stem cell-derived oligodendrocyte progenitor cell therapy product (AST-OPC1) in support of its use as a treatment for spinal cord injury (SCI). The phenotype and functional capacity of AST-OPC1 was characterized in vitro and in vivo. Safety and toxicology of AST-OPC1 administration was assessed in rodent models of thoracic SCI. These results identify AST-OPC1 as an early-stage oligodendrocyte progenitor population capable of promoting neurite outgrowth in vitro and myelination in vivo. AST-OPC1 administration did not cause any adverse clinical observations, toxicities, allodynia or tumors. These results supported initiation of a Phase I clinical trial in patients with sensorimotor complete thoracic SCI.

  12. Moving the Self-Esteem of People with Epilepsy by Supportive Group: A Clinical Trial

    OpenAIRE

    Kritaya Sawangchareon; Sineenard Pranboon; Somsak Tiamkao; Kittisak Sawanyawisuth

    2013-01-01

    Introduction: People with epilepsy (PWE) face physical and mental illness, and social stigma, which affect their self-esteem and quality of life. The purpose of this study was to examine the effects of a support group on the self-esteem of PWE. Methods: A Quasi-experimental study was performed on 120 PWE in the Epilepsy Clinic at Srinagarind Hospital.  The experimental group (N=60) attended the support group before receiving regular health care services. The control group (N...

  13. ProsCan for Men: Randomised controlled trial of a decision support intervention for men with localised prostate cancer

    Directory of Open Access Journals (Sweden)

    Gardiner RA

    2008-07-01

    Full Text Available Abstract Background Prostate cancer is the most common male cancer in the Western world but is highly heterogeneous in disease progression and outcomes. Consequently, the most substantial morbidity may actually arise from the adverse psychosocial impact of distress in decision-making and long term quality of life effects such as impotence. This paper presents the design of a randomised controlled trial of a decision support/psychosocial intervention for men newly diagnosed with localised prostate cancer. Methods/Design 350 men per condition (700 men in total have been recruited after diagnosis and before treatment through urology private practices and hospital outpatient clinics and randomised to 1 a tele-based nurse delivered five session decision support/psychosocial intervention or 2 a usual care control group. Two intervention sessions are delivered before treatment that address decision support, stress management and preparation for treatment. Three further sessions are provided three weeks, seven weeks and five months after treatment that focus on adjustment to cancer, problem solving and coping with treatment side effects. Participants are assessed at baseline (before treatment and 2, 6, 12, 24 and 36 months post-treatment. Outcome measures include: cancer threat appraisal; decision-related distress and bother from treatment side effects; involvement in decision making; satisfaction with health care; heath care utilisation; use of health care resources; and a return to previous activities. Discussion The study will provide recommendations about the efficacy of early decision support to facilitate adjustment after prostate cancer. As well the study will identify men diagnosed with localised prostate cancer at risk of poorer long term psychosocial adjustment. Trial Registration ACTRN012607000233426.

  14. Prospective, multicenter, randomized trial of a new organizational modality for providing information and support to cancer patients.

    Science.gov (United States)

    Passalacqua, Rodolfo; Caminiti, Caterina; Campione, Francesco; Diodati, Francesca; Todeschini, Renata; Bisagni, Giancarlo; Labianca, Roberto; Dalla Chiesa, Matteo; Bracci, Raffaella; Aragona, Marcello; Artioli, Fabrizio; Cavanna, Luigi; Masina, Alceste; De Falco, Francesco; Marzocchini, Barbara; Iacono, Carmelo; Contu, Antonio; Di Costanzo, Francesco; Bertetto, Oscar; Annunziata, Maria A

    2009-04-10

    No structured modality for providing information and support to patients in oncology wards has been validated in clinical trials. This is a pragmatic, two-arm, cluster randomized trial, with the oncology ward as random assignment unit. Centers were allocated to implement a Point of Information and Support (PIS) or to a control group. The PIS included a library for cancer patients and a specifically trained oncology nurse. End points, measured at patient level, were psychological distress and satisfaction with received information. Both intent-to-treat and per-protocol analyses considering clustering were performed. Thirty-eight Italian cancer centers were randomly assigned, and 6 months after PIS creation, 3,286 unselected, consecutive cancer patients were surveyed (1,654 in the experimental group and 1,632 in the control group). Three thousand one hundred ninety-seven (97%) questionnaires were collected and deemed valid. Fifty-two percent of centers (11 of 21 centers) in the experimental arm did not implement the PIS in accordance with the protocol. Overall, 34% of patients showed moderate to severe psychological distress, and only 9% declared dissatisfaction. Intent-to-treat analysis did not yield significant differences. Although the per-protocol analysis did show a reduction in psychological distress (28.9% for functioning PIS v 33.3% for no PIS) and dissatisfaction (6.4% for functioning PIS v 9.3% for no PIS), differences did not reach significance. This is the first cluster randomized trial aiming to demonstrate that a structured modality of providing information reduces psychological distress. We did not find this, but we believe results should be interpreted cautiously, particularly because of the low compliance with PIS implementation. Context analysis preceding such interventions is essential.

  15. A short-term clinical trial on selected outcomes for immediately loaded implant-supported mandibular overdentures.

    Science.gov (United States)

    Turkyilmaz, Ilser; Tumer, Celal; Avci, Mehmet; Hersek, Nur; Celik-Bagci, Emine

    2006-01-01

    This clinical trial aimed to evaluate the outcomes of implant-supported mandibular overdentures (ISMOs) using 2 different loading protocols. Two groups of 10 edentulous patients each were selected for the study. Each patient received 2 implants placed in the mandibular canine sites. After 1 week, ISMOs were delivered to the 10 patients in the test group, while conventional mandibular dentures were delivered to the 10 patients in the control group. The conventional prostheses were converted to ISMOs after 3 months. Treatment outcomes for the ISMOs were evaluated 1 year after implant surgery. The number of appointments and time needed for fabrication of ISMOs revealed statistically significant differences between the patient groups. The requirements for prosthodontic maintenance of ISMOs in the test group were higher than those in the control group; however, these differences were not statistically significant. The mean marginal bone resorption for each group was 0.3 mm after 1 year. The results of this clinical trial suggest that early loading of a specific length of implants used to support mandibular overdentures does not jeopardize treatment outcomes during the first year of service.

  16. The effectiveness of an online support group for members of the community with depression: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Kathleen M Griffiths

    Full Text Available BACKGROUND: Internet support groups (ISGs are popular, particularly among people with depression, but there is little high quality evidence concerning their effectiveness. AIM: The study aimed to evaluate the efficacy of an ISG for reducing depressive symptoms among community members when used alone and in combination with an automated Internet-based psychotherapy training program. METHOD: Volunteers with elevated psychological distress were identified using a community-based screening postal survey. Participants were randomised to one of four 12-week conditions: depression Internet Support Group (ISG, automated depression Internet Training Program (ITP, combination of the two (ITP+ISG, or a control website with delayed access to e-couch at 6 months. Assessments were conducted at baseline, post-intervention, 6 and 12 months. RESULTS: There was no change in depressive symptoms relative to control after 3 months of exposure to the ISG. However, both the ISG alone and the combined ISG+ITP group showed significantly greater reduction in depressive symptoms at 6 and 12 months follow-up than the control group. The ITP program was effective relative to control at post-intervention but not at 6 months. CONCLUSIONS: ISGs for depression are promising and warrant further empirical investigation. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN65657330.

  17. A single blind randomized control trial on support groups for Chinese persons with mild dementia

    Directory of Open Access Journals (Sweden)

    Young DKW

    2014-12-01

    Full Text Available Daniel KW Young,1 Timothy CY Kwok,2 Petrus YN Ng1 1Department of Social Work, Hong Kong Baptist University, Kowloon Tong, Hong Kong; 2Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong Purpose: Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Research methods: Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. Results: At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59% of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48 to 7.35 (standard deviation =2.18, which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05, while the control group’s participants did not show any significant change. Conclusion: This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants. Keywords: support group, mild dementia, Chinese, depression

  18. Supporting Family Carers of Community-Dwelling Elder with Cognitive Decline: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Birgitte Schoenmakers

    2010-01-01

    Full Text Available Objective. Caring for a patient with cognitive decline has an important impact on the general well-being of family caregivers. Although highly appreciated, interventions in dementia home care remain mainly ineffective in terms of well-being. Consequently, in spite of an extensive support system, abrupt ending of home care remains more rule than exception. Method. The hypothesis was that the intervention of a care counselor, coordinating care in quasi-unstructured way during one year, will alleviate caregivers' feelings of depression. The study population was composed of community-dwelling patients with cognitive decline. A care counselor was at the exclusive disposal of the intervention group. Primary outcome measure was caregiver depression. Results. Finally, depression was 6.25 times less frequent in the intervention group. The actual intervention appeared minimal with only ten applications for more support followed by only three interventions effectively carried out. Although caregivers felt burdened and depressed, formal support remained stable. On the other hand, the availability of the care counselor made caregivers feel less depressed with the same amount of support. Conclusion. Carers do not always need to be surrounded with more professionals, but they want to feel more supported. In terms of policy, this could have some important implications.

  19. Prevention of pressure ulcers in the intensive care unit: a randomized trial of 2 viscoelastic foam support surfaces.

    Science.gov (United States)

    Ozyurek, Pakize; Yavuz, Meryem

    2015-01-01

    The aim of this study is to compare whether differences exist between 2 viscoelastic foam support surfaces in the development of new pressure ulcers. There is evidence to support the use of viscoelastic foam over standard hospital foam to reduce pressure. A comparative effectiveness study was done to compare 2 viscoelastic foam support surfaces. A randomized controlled trial was carried out. The study was performed in 2 intensive care units between October 1, 2008, and January 4, 2010. Patients (n = 105) admitted to intensive care unit were randomly assigned to viscoelastic foam 1 (n = 53) or viscoelastic foam 2 support surface (n = 52). In total, 42.8% of all patients developed a new pressure ulcer of stage 1 or worse. By stages, pressure ulcer incidence was 28.6%, 13.3%, and 1.0% for stages 1, 2, and 3, respectively. There was no significant difference in pressure ulcer incidence between the viscoelastic foam 1 and 2 groups (X2 = 0.07, df = 1, P > .05). No difference was found between 2 different viscoelastic foam surfaces in the prevention of pressure ulcers in patients treated in intensive care. Pressure ulcer incidence in critically ill patients remains high. Nurses must compare current products for effectiveness and develop innovative systems, processes, or devices to deliver best practices.

  20. Multimedia support for improving preoperative patient education: a randomized controlled trial using the example of radical prostatectomy.

    Science.gov (United States)

    Huber, Johannes; Ihrig, Andreas; Yass, Mohammed; Bruckner, Tom; Peters, Tim; Huber, Christian G; Konyango, Beryl; Lozankovski, Novica; Stredele, Regina J F; Moll, Peter; Schneider, Meike; Pahernik, Sascha; Hohenfellner, Markus

    2013-01-01

    Growing evidence supports the use of multimedia presentations for informing patients. Therefore, we supported preoperative education by adding a multimedia tool and examined the effects in a randomized controlled trial. We randomized German-speaking patients scheduled for radical prostatectomy at our center to receive either a multimedia-supported (MME) or a standard education (SE). Outcomes were measured in a structured interview. Primary outcome was patient satisfaction. In addition, we applied validated instruments to determine anxiety and measures of decision-making. Results were given by mean and standard deviation. For comparison of groups we used t test and chi-square test. For an explorative analysis we applied multivariate logistic regression. We randomized 203 patients to receive MME (n=102) or SE (n=101). Complete satisfaction with preoperative education was more frequent in the MME group (69 vs 52%, p=.016) and patients after MME reported more questions (5.7 vs 4.2, p=.018). There was no difference concerning the duration of talks and the number of recalled risks. However, perceived knowledge was higher after MME (1.3 vs 1.6, p=.037). Anxiety and measures of decision-making were comparable. Patients judged the multimedia tool very positive, and 74% of the MME group thought that their preoperative education had been superior to SE. Multimedia support should be considered worthwhile for improving the informed consent process before surgery (www.germanctr.de; DRKS00000096).

  1. The effectiveness of supported employment for people with severe mental illness : a randomised controlled trial

    NARCIS (Netherlands)

    Burns, Tom; Catty, Jocelyn; Becker, Thomas; Drake, Robert E.; Fioritti, Angelo; Knapp, Martin; Lauber, Christoph; Rossler, Wulf; Tomov, Toma; van Busschbach, Jooske; White, Sarah; Wiersma, Durk

    2007-01-01

    Background The value of the individual placement and support (IPS) programme in helping people with severe mental illness gain open employment is unknown in Europe. Our aim was to assess the effectiveness of IPS, and to examine whether its effect is modified by local labour markets and welfare

  2. Moving the Self-Esteem of People with Epilepsy by Supportive Group: A Clinical Trial

    Directory of Open Access Journals (Sweden)

    Kritaya Sawangchareon

    2013-11-01

    Full Text Available Introduction: People with epilepsy (PWE face physical and mental illness, and social stigma, which affect their self-esteem and quality of life. The purpose of this study was to examine the effects of a support group on the self-esteem of PWE. Methods: A Quasi-experimental study was performed on 120 PWE in the Epilepsy Clinic at Srinagarind Hospital. The experimental group (N=60 attended the support group before receiving regular health care services. The control group (N=60 received only regular healthcare services. Data was collected by using the Rosenberg self-esteem scale scoring before and after the experiment. The score was analyzed by using a paired t-test and an independent t-test. Results: The study showed that before the experiment, the self–esteem score of the control group was significantly higher than the experimental group. After the experiment, the scores of the control group and the experimental group showed a significant statistical difference. The score in the control group was significantly lower than the experimental group, while the score in the experimental group was significantly higher than before the experiment. Conclusion: The support group improves the self-esteem of PWE. Medical personnel should set up a support group for PWE to enhance their self-esteem.

  3. Investigating a training supporting shared decision making (IT'S SDM 2011: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Geiger Friedemann

    2011-10-01

    Full Text Available Background Shared Decision Making (SDM is regarded as the best practice model for the communicative challenge of decision making about treatment or diagnostic options. However, randomized controlled trials focusing the effectiveness of SDM trainings are rare and existing measures of SDM are increasingly challenged by the latest research findings. This study will 1 evaluate a new physicians' communication training regarding patient involvement in terms of SDM, 2 validate SDMMASS, a new compound measure of SDM, and 3 evaluate the effects of SDM on the perceived quality of the decision process and on the elaboration of the decision. Methods In a multi-center randomized controlled trial with a waiting control group, 40 physicians from 7 medical fields are enrolled. Each physician contributes a sequence of four medical consultations including a diagnostic or treatment decision. The intervention consists of two condensed video-based individual coaching sessions (15min. supported by a manual and a DVD. The interventions alternate with three measurement points plus follow up (6 months. Realized patient involvement is measured using the coefficient SDMMASS drawn from the Multifocal Approach to the Sharing in SDM (MAPPIN'SDM which includes objective involvement, involvement as perceived by the patient, and the doctor-patient concordance regarding their judges of the involvement. For validation purposes, all three components of SDMMASS are supplemented by similar measures, the OPTION observer scale, the Shared Decision Making Questionnaire (SDM-Q and the dyadic application of the Decisional Conflict Scale (DCS. Training effects are analyzed using t-tests. Spearman correlation coefficients are used to determine convergent validities, the influence of involvement (SDMMASS on the perceived decision quality (DCS and on the elaboration of the decision. The latter is operationalised by the ELAB coefficient from the UP24 (Uncertainty Profile, 24 items version

  4. Robot-supported upper limb training in a virtual learning environment : a pilot randomized controlled trial in persons with MS.

    Science.gov (United States)

    Feys, Peter; Coninx, Karin; Kerkhofs, Lore; De Weyer, Tom; Truyens, Veronik; Maris, Anneleen; Lamers, Ilse

    2015-07-23

    limb dysfunction may benefit most from additional robot-supported training, but larger studies are needed. This trial is registered within the registry Clinical Trials GOV ( NCT02257606 ).

  5. The Latin American trial of psychosocial support during pregnancy: a social intervention evaluated through an experimental design.

    Science.gov (United States)

    Langer, A; Victora, C; Victora, M; Barros, F; Farnot, U; Belizan, J; Villar, J

    1993-02-01

    Perinatal health problems are a public health priority in Latin America. Among the identified risk factors, psychological and social conditions play a crucial role. However, care during pregnancy and delivery in the region is usually hospital-centered and does not address women's psychological and social conditions. The preeminence of research on perinatal health, along with the necessity for testing interventions that represent alternative models to improve women's health, gave the Latin American Network for Perinatal and Reproductive Research grounds to develop a multicenter randomized controlled trial to evaluate a program of social support and health education during pregnancy. The conceptual framework for this study was based on an ecological model of social support, i.e. a model in which social support and health education play a synergistic role and are meant to modify stressful situations and negative health-related behaviors. The target population consisted of women attending obstetric hospitals before the 22nd gestational week, at high psychological and social risk (n = 2236). The intervention consisted of four to six home visits, carried out by social workers, and had four main components: the reinforcement of pregnant women's social support network, emotional support, health education, and the improvement of health services utilization. The main foci of the intervention were determined after an ethnographic study was carried out to identify stress-producing situations and needs for support during pregnancy. Besides the home visits, the program also offered a hot-line, an office in the hospital, a specially designed poster and booklet, and a 'guided tour' of the health institution. Since this was a multicenter trial, the program's standardization was a crucial methodological aspect that was achieved through the training course for the home-visitors team. Biological and psychosocial outcomes were measured in both experimental and control groups at the 36

  6. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  7. A multisite randomized controlled trial on time to self-support among sickness absence beneficiaries

    DEFF Research Database (Denmark)

    Nielsen, Maj Britt D.; Vinsløv Hansen, Jørgen; Aust, Birgit

    2015-01-01

    BACKGROUND: In 2010, the Danish Government launched the Danish national return-to-work (RTW) programme to reduce sickness absence and promote labour market attainment. Multidisciplinary teams delivered the RTW programme, which comprised a coordinated, tailored and multidisciplinary effort (CTM...... randomly assigned beneficiaries to CTM (M1: n = 598; M2: n = 459; M3: n = 331) or to ordinary sickness absence management (OSM) (M1: n = 393; M2: n = 324; M3: n = 95). We used the Cox proportional hazards model to estimate hazard ratios (HR) comparing rates of becoming self-supporting between beneficiaries.......54-0.95). In M1, we found no difference between the two groups (HR = 0.99, 95% CI: 0.84-1.17). CONCLUSION: The effect of the CTM programme on return to self-support differed substantially across the three participating municipalities. Thus, generalizing the study results to other Danish municipalities...

  8. Two-year outcomes of the Early Risers prevention trial with formerly homeless families residing in supportive housing.

    Science.gov (United States)

    Gewirtz, Abigail H; DeGarmo, David S; Lee, Susanne; Morrell, Nicole; August, Gerald

    2015-04-01

    This article reports 2-year outcomes from a cluster randomized, controlled trial of the Early Risers (ER) program implemented as a selective preventive intervention in supportive housing settings for homeless families. Based on the goals of this comprehensive prevention program, we predicted that intervention participants receiving ER services would show improvement in parenting and child outcomes relative to families in treatment-as-usual sites. The sample included 270 children in 161 families, residing in 15 supportive housing sites; multimethod, multi-informant assessments conducted at baseline and yearly thereafter included parent and teacher report of child adjustment, parent report of parenting self-efficacy, and parent-child observations that yielded scores of effective parenting practices. Data were modeled in HLM7 (4-level model accounting for nesting of children within families and families within housing sites). Two years' postbaseline, intent-to-treat (ITT) analyses indicated that parents in the ER group showed significantly improved parenting self-efficacy, and parent report indicated significant reductions in ER group children's depression. No main effects of ITT were shown for observed parenting effectiveness. However, over time, average levels of parenting self-efficacy predicted observed effective parenting practices, and observed effective parenting practices predicted improvements in both teacher- and parent-report of child adjustment. This is the first study to our knowledge to demonstrate prevention effects of a program for homeless families residing in family supportive housing. (c) 2015 APA, all rights reserved).

  9. A School Support Intervention and Educational Outcomes Among Orphaned Adolescents: Results of a Cluster Randomized Controlled Trial in Kenya.

    Science.gov (United States)

    Cho, Hyunsan; Catherine Ryberg, Renee; Hwang, Karam; Pearce, Lisa D; Iritani, Bonita J

    2017-11-01

    Globally, significant progress has been made in primary school enrollment. However, there are millions of adolescents-including orphans in sub-Saharan Africa-who still experience barriers to remaining in school. We conducted a 4-year cluster randomized controlled trial (cRCT) (N = 835) in a high HIV prevalence area in western Kenya to test whether providing orphaned adolescents with a school support intervention improves their educational outcomes. The school support intervention consisted of directly paying tuition, exam fees, and uniform costs to primary and secondary schools for those students who remained enrolled. In addition, research staff monitored intervention participants' school attendance and helped to address barriers to staying in school. This school support intervention had significant positive impacts on educational outcomes for orphaned adolescents. Over the course of the study, school absence remained stable for intervention group participants but increased in frequency for control group participants. Intervention group participants were less likely to drop out of school compared to the control group. Furthermore, the intervention participants were more likely to make age-appropriate progression in grade, matriculate into secondary school, and achieve higher levels of education by the end of the study. The intervention also increased students' expectations of graduating from college in the future. However, we found no significant intervention impact on primary and secondary school test scores. Results from this cRCT suggest that directly covering school-related expenses for male and female orphaned adolescents in western Kenya can improve their educational outcomes.

  10. The effects of intervention based on supportive leadership behaviour on Iranian nursing leadership performance: a randomized controlled trial.

    Science.gov (United States)

    Shirazi, Mandana; Emami, Amir Hossein; Mirmoosavi, Seyed Jamal; Alavinia, Seyed Mohammad; Zamanian, Hadi; Fathollahbeigi, Faezeh; Masiello, Italo

    2016-04-01

    To assess the effects of a workshop on supportive leadership behaviour (SLB) on the performance of head nurses, using a randomized controlled trial design. The effect of transformational leadership on SLB in nursing management is emphasised. A total of 110 head nurses working at university hospitals were included randomly in two control and intervention groups. The head nurses in the intervention group participated in supportive leadership training, but the control group did not. Performance in supportive leadership was assessed with a validated instrument, which six subordinates used to assess their head nurse (n = 731). There was a significant difference in SLB scores from baseline to the 3 month follow-up (P leadership behaviour, particularly the interactive multifaceted training, improved the leadership performance of the head nurses who participated in this study. Health policy decision makers should apply SLB, which is a significant leadership style, to improve the outcomes in other groups of health-care management, such as physicians. Future studies are needed to investigate the effects of such workshops in longer periods of follow up. © 2015 John Wiley & Sons Ltd.

  11. Examining Contextual Influences on Classroom-Based Implementation of Positive Behavior Support Strategies: Findings from a Randomized Controlled Effectiveness Trial.

    Science.gov (United States)

    Pas, Elise T; Waasdorp, Tracy E; Bradshaw, Catherine P

    2015-11-01

    Although it is widely recognized that variation in implementation fidelity influences the impact of preventive interventions, little is known about how specific contextual factors may affect the implementation of social and behavioral interventions in classrooms. Theoretical research highlights the importance of multiple contextual influences on implementation, including factors at the classroom and school level (Domitrovich et al., Advances in School Mental Health Promotion, 1, 6-28, 2008). The current study used multi-level modeling to empirically examine the influence of teacher, classroom, and school characteristics on the implementation of classroom-based positive behavior support strategies over the course of 4 years. Data were collected in the context of a 37-school randomized controlled trial examining the effectiveness of school-wide Positive Behavioral Interventions and Supports. Multi-level results identified several school-level contextual factors (e.g., school size, behavioral disruptions) and teacher-level factors (perceptions of school organizational health and grade level taught) associated with variability in the implementation of classroom-based positive behavior supports. Implications for prevention research and practice are discussed.

  12. Effect of Supportive Nursing Care on Self Esteem of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Hossein Ebrahimi

    2014-06-01

    Full Text Available Introduction: Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. Methods: This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35 and intervention (n=35 groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES. Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ2, t-test and ANCOVA. Results: Results showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention.Conclusion: The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients.

  13. Peer characteristics associated with improved glycemic control in a randomized controlled trial of a reciprocal peer support program for diabetes.

    Science.gov (United States)

    Kaselitz, Elizabeth; Shah, Megha; Choi, Hwajung; Heisler, Michele

    2018-01-01

    Objective In a secondary analysis of a randomized controlled trial of diabetes reciprocal peer support, we examined characteristics of peers associated with improvements in their partner's glycemic control. Methods A total of 102 adults with diabetes were randomized to the reciprocal peer support arm (vs. a nurse care management arm). The primary outcome was change in A1c over six months. Intermediate outcomes were insulin initiation and peer engagement. A number of baseline characteristics of peers were hypothesized to influence outcomes for their peer, and concordant characteristics of peer dyads were hypothesized that would influence outcomes for both peer partners. Results Improvement in A1c was associated with having a peer older than oneself ( P peers who reported poorer health at baseline had worse glycemic control at follow-up ( P peers had a more controlled self-regulation style were more likely to initiate insulin ( P peers whose partners were older and reported more diabetes distress at baseline supports the need for further research into the peer characteristics that lead to improved outcomes. This could allow for better matching and more effective partnerships.

  14. Effect of supportive nursing care on self esteem of patients receiving electroconvulsive therapy: a randomized controlled clinical trial.

    Science.gov (United States)

    Ebrahimi, Hossein; Navidian, Ali; Keykha, Roghaieh

    2014-06-01

    Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35) and intervention (n=35) groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES). Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ(2), t-test and ANCOVA. RESULTS showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention. The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients.

  15. Altering school climate through school-wide Positive Behavioral Interventions and Supports: findings from a group-randomized effectiveness trial.

    Science.gov (United States)

    Bradshaw, Catherine P; Koth, Christine W; Thornton, Leslie A; Leaf, Philip J

    2009-06-01

    Positive Behavioral Interventions and Supports (PBIS) is a universal, school-wide prevention strategy that is currently implemented in over 7,500 schools to reduce disruptive behavior problems. The present study examines the impact of PBIS on staff reports of school organizational health using data from a group-randomized controlled effectiveness trial of PBIS conducted in 37 elementary schools. Longitudinal multilevel analyses on data from 2,596 staff revealed a significant effect of PBIS on the schools' overall organizational health, resource influence, staff affiliation, and academic emphasis over the 5-year trial; the effects on collegial leadership and institutional integrity were significant when implementation fidelity was included in the model. Trained schools that adopted PBIS the fastest tended to have higher levels of organizational health at baseline, but the later-implementing schools tended to experience the greatest improvements in organizational health after implementing PBIS. This study indicated that changes in school organizational health are important consequences of the PBIS whole-school prevention model, and may in turn be a potential contextual mediator of the effect of PBIS on student performance.

  16. Rationale, design and baseline data for the Activating Consumers to Exercise through Peer Support (ACE trial): A randomized controlled trial to increase fitness among adults with mental illness

    Science.gov (United States)

    Jerome, Gerald J.; Dalcin, Arlene T.; Young, Deborah Rohm; Stewart, Kerry J.; Crum, Rosa M.; Latkin, Carl; Cullen, Bernadette A.; Charleston, Jeanne; Leatherman, Elisabeth; Appel, Lawrence J.; Daumit, Gail L.

    2012-01-01

    Background The benefits of regular physical activity are particularly salient to persons with serious mental illness (SMI) who have increased prevalence of obesity, diabetes, and earlier mortality from cardiovascular disease. Methods The Activating Consumers to Exercise through Peer Support (ACE) trial will examine the effectiveness of peer support on adherence to a 4-month pilot exercise program for adults with SMI. Design, rationale and baseline data are reported. Baseline measures included: graded treadmill test; six-minute walk; height, weight and blood pressure; body composition; fasting blood; and self-reported psychiatric symptoms. Fitness levels were compared with national data and relationships among fitness parameters, psychological factors and cardiovascular disease risk factors were examined. Results There were 93 participants and 18 peer leaders recruited from community psychiatry programs with an average age of 47 years (SD 10). There were no differences in demographics (76% female, 72% African American) or mental health symptoms between participants and peer leaders. Ninety-five percent of the sample had below average fitness levels for their age and sex with average MET levels of 5.9(SD 2.2) for participants and 6.2(SD 2.3) for peer leaders. Fitness evaluated during the treadmill test and the six-minute-walk were associated (rs = 0.36, p<.001). Lower MET levels were associated with a higher BMI (rs = −0.35, p<.001) and percent body fat (rs = −0.36, p <.001). Conclusion The uniformly low baseline cardiovascular fitness and the association of fitness with BMI and adiposity underscore the importance of suitably tailored programs to increase physical activity among adults with SMI. PMID:23471190

  17. Safety and Health Support for Home Care Workers: The COMPASS Randomized Controlled Trial.

    Science.gov (United States)

    Olson, Ryan; Thompson, Sharon V; Elliot, Diane L; Hess, Jennifer A; Rhoten, Kristy Luther; Parker, Kelsey N; Wright, Robert R; Wipfli, Brad; Bettencourt, Katrina M; Buckmaster, Annie; Marino, Miguel

    2016-10-01

    To determine the effectiveness of the COMmunity of Practice And Safety Support (COMPASS) Total Worker Health intervention for home care workers. We randomized 16 clusters of workers (n = 149) to intervention or usual-practice control conditions. The 12-month intervention was scripted and peer-led, and involved education on safety, health, and well-being; goal setting and self-monitoring; and structured social support. We collected measures at baseline, 6 months, and 12 months, which included workers' experienced community of practice (i.e., people engaged in a common activity who interact regularly for shared learning and improvement). Implementation occurred during 2013 and 2014 in Oregon. In an intent-to-treat analysis, relative to control, the intervention produced significant and sustained improvements in workers' experienced community of practice. Additional significant improvements included the use of ergonomic tools or techniques for physical work, safety communication with consumer-employers, hazard correction in homes, fruit and vegetable consumption, lost work days because of injury, high-density lipoprotein cholesterol, and grip strength. Consumer-employers' reports of caregiver safety behaviors also significantly improved. COMPASS was effective for improving home care workers' social resources and simultaneously impacted both safety and health factors.

  18. Mobile Sensing and Support for People With Depression: A Pilot Trial in the Wild.

    Science.gov (United States)

    Wahle, Fabian; Kowatsch, Tobias; Fleisch, Elgar; Rufer, Michael; Weidt, Steffi

    2016-09-21

    Depression is a burdensome, recurring mental health disorder with high prevalence. Even in developed countries, patients have to wait for several months to receive treatment. In many parts of the world there is only one mental health professional for over 200 people. Smartphones are ubiquitous and have a large complement of sensors that can potentially be useful in monitoring behavioral patterns that might be indicative of depressive symptoms and providing context-sensitive intervention support. The objective of this study is 2-fold, first to explore the detection of daily-life behavior based on sensor information to identify subjects with a clinically meaningful depression level, second to explore the potential of context sensitive intervention delivery to provide in-situ support for people with depressive symptoms. A total of 126 adults (age 20-57) were recruited to use the smartphone app Mobile Sensing and Support (MOSS), collecting context-sensitive sensor information and providing just-in-time interventions derived from cognitive behavior therapy. Real-time learning-systems were deployed to adapt to each subject's preferences to optimize recommendations with respect to time, location, and personal preference. Biweekly, participants were asked to complete a self-reported depression survey (PHQ-9) to track symptom progression. Wilcoxon tests were conducted to compare scores before and after intervention. Correlation analysis was used to test the relationship between adherence and change in PHQ-9. One hundred twenty features were constructed based on smartphone usage and sensors including accelerometer, Wifi, and global positioning systems (GPS). Machine-learning models used these features to infer behavior and context for PHQ-9 level prediction and tailored intervention delivery. A total of 36 subjects used MOSS for ≥2 weeks. For subjects with clinical depression (PHQ-9≥11) at baseline and adherence ≥8 weeks (n=12), a significant drop in PHQ-9 was observed

  19. A tailored, supportive care intervention using systematic assessment designed for people with inoperable lung cancer: a randomised controlled trial.

    Science.gov (United States)

    Schofield, Penelope; Ugalde, Anna; Gough, Karla; Reece, John; Krishnasamy, Meinir; Carey, Mariko; Ball, David; Aranda, Sanchia

    2013-11-01

    People with inoperable lung cancer experience higher levels of distress, more unmet needs and symptoms than other cancer patients. There is an urgent need to test innovative approaches to improve psychosocial and symptom outcomes in this group. This study tested the hypothesis that a tailored, multidisciplinary supportive care programme based on systematic needs assessment would reduce perceived unmet needs and distress and improve quality of life. A randomised controlled trial design was used. The tailored intervention comprised two sessions at treatment commencement and completion. Sessions included a self-completed needs assessment, active listening, self-care education and communication of unmet psychosocial and symptom needs to the multidisciplinary team for management and referral. Outcomes were assessed with the Needs Assessment for Advanced Lung Cancer Patients, Hospital Anxiety and Depression Scale, Distress Thermometer and European Organization of Research and Treatment of Cancer Quality of Life Q-C30 V2.0. One hundred and eight patients with a diagnosis of inoperable lung or pleural cancer (including mesothelioma) were recruited from a specialist facility before the trial closed prematurely (original target 200). None of the primary contrasts of interest were significant (all p > 0.10), although change score analysis indicated a relative benefit from the intervention for unmet symptom needs at 8 and 12 weeks post-assessment (effect size = 0.55 and 0.40, respectively). Although a novel approach, the hypothesis that the intervention would benefit perceived unmet needs, psychological morbidity, distress and health-related quality of life was not supported overall. Copyright © 2013 John Wiley & Sons, Ltd.

  20. Randomized clinical trial comparing 2 support surfaces: results of the Prevention of Pressure Ulcers Study.

    Science.gov (United States)

    Russell, Linda J; Reynolds, Tim M; Park, Carol; Rithalia, Shyam; Gonsalkorale, M; Birch, Jan; Torgerson, David; Iglesias, Cynthia

    2003-11-01

    To determine whether a viscoelastic polymer (energy absorbing) foam mattress was superior to a standard hospital mattress for pressure ulcer prevention and to analyze the cost-effectiveness in comparison with standard hospital mattresses. Unblinded, randomized, prospective trial. Elderly acute care, rehabilitation, and orthopedic wards at 3 hospitals in the United Kingdom. 1168 patients at risk of developing pressure ulcers (Waterlow score, 15 to 20), with a median age of 83 years (25th to 75th percentile range, 79-87). Participants were allocated to either the experimental equipment (CONFOR-Med mattress/cushion combination) or a standard mattress/cushion combination; all were given standard nursing care. Pressure areas were observed daily. Development of nonblanching erythema. A significant decrease in the incidence of blanching erythema (26.3% to 19.9%; P =.004) and a nonsignificant decrease in the incidence of nonblanching erythema occurred in participants allocated to the experimental equipment. However, when the survival curve plots were analyzed at 7 days, both categories showed statistically significant decreases (P =.0015 and P =.042, respectively). Participants on standard equipment had a relative odds ratio of 1.36 (95% confidence interval [CI], 1.10-1.69) for developing blanching erythema or worse and 1.46 (95% CI, 0.90-1.82) for developing nonblanching erythema or worse. To prevent nonblanching erythema, the number needed to treat (NNT) was 41.9 (95% CI, -82.6-15.3). To prevent any erythema (blanching or nonblanching), the NNT was 11.5 (95% CI, 41.6-9.3). Participants with blanching or nonblanching erythema were significantly less mobile than participants with normal skin and more likely to have worsening mobility (P pressure ulcer status, mattress type was not associated with difference in mobility. Regardless of prevention routine, pressure ulcers occur. In this study, the experimental equipment showed statistical significance to standard equipment

  1. Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Broadbent, Elizabeth; Garrett, Jeff; Jepsen, Nicola; Li Ogilvie, Vickie; Ahn, Ho Seok; Robinson, Hayley; Peri, Kathryn; Kerse, Ngaire; Rouse, Paul; Pillai, Avinesh; MacDonald, Bruce

    2018-02-13

    especially useful for patients struggling with adherence. Australian New Zealand Clinical Trials Registry ACTRN12615000259549; http://www.anzctr.org.au (Archived by WebCite at  http://www.webcitation.org/6whIjptLS). ©Elizabeth Broadbent, Jeff Garrett, Nicola Jepsen, Vickie Li Ogilvie, Ho Seok Ahn, Hayley Robinson, Kathryn Peri, Ngaire Kerse, Paul Rouse, Avinesh Pillai, Bruce MacDonald. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 13.02.2018.

  2. Metronomic Chemotherapy vs Best Supportive Care in Progressive Pediatric Solid Malignant Tumors: A Randomized Clinical Trial.

    Science.gov (United States)

    Pramanik, Raja; Agarwala, Sandeep; Gupta, Yogendra Kumar; Thulkar, Sanjay; Vishnubhatla, Sreenivas; Batra, Atul; Dhawan, Deepa; Bakhshi, Sameer

    2017-09-01

    Although oral metronomic chemotherapy is often used in progressive pediatric solid malignant tumors, a literature review reveals that only small single-arm retrospective or phase 1 and 2 studies have been performed. Skepticism abounds because of the lack of level 1 evidence. To compare the effect of metronomic chemotherapy on progression-free survival (PFS) with that of placebo in pediatric patients with primary extracranial, nonhematopoietic solid malignant tumors that progress after at least 2 lines of chemotherapy. A double-blinded, placebo-controlled randomized clinical trial was conducted from October 1, 2013, through December 31, 2015, at the cancer center at All India Institute of Medical Sciences in children aged 5 to 18 years with primary extracranial, nonhematopoietic solid malignant tumors that progressed after at least 2 lines of chemotherapy and had no further curative options. One arm received a 4-drug oral metronomic regimen of daily celecoxib and thalidomide with alternating periods of etoposide and cyclophosphamide, whereas the other arm received placebo. Disease status was assessed at baseline, 9 weeks, 18 weeks, and 27 weeks or at clinical progression. The primary end point was PFS as defined by the proportion of patients without disease progression at 6 months, and PFS duration and overall survival (OS) were secondary end points. A total of 108 of the 123 patients screened were enrolled, with 52 randomized to the placebo group (median age, 15 years; 40 male [76.9%]) and 56 to the metronomic chemotherapy group (median age, 13 years; 42 male [75.0%]). At a median follow-up of 2.9 months, 100% of the patients had disease progression by 6 months in the placebo group vs 96.4% in the metronomic chemotherapy group (P = .24). Median PFS and OS in the 2 groups was similar (hazard ratio [HR], 0.69; 95% CI, 0.47-1.03 [P = .07] for PFS; and HR, 0.74; 95% CI, 0.50-1.09 [P = .13] for OS). In post hoc subgroup analysis, cohorts receiving more than

  3. Effectiveness of a hospital-based work support intervention for female cancer patients - a multi-centre randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sietske J Tamminga

    Full Text Available OBJECTIVE: One key aspect of cancer survivorship is return-to-work. Unfortunately, many cancer survivors face problems upon their return-to-work. For that reason, we developed a hospital-based work support intervention aimed at enhancing return-to-work. We studied effectiveness of the intervention compared to usual care for female cancer patients in a multi-centre randomised controlled trial. METHODS: Breast and gynaecological cancer patients who were treated with curative intent and had paid work were randomised to the intervention group (n = 65 or control group (n = 68. The intervention involved patient education and support at the hospital and improvement of communication between treating and occupational physicians. In addition, we asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. Outcomes at 12 months of follow-up included rate and time until return-to-work (full or partial, quality of life, work ability, work functioning, and lost productivity costs. Time until return-to-work was analyzed with Kaplan-Meier survival analysis. RESULTS: Return-to-work rates were 86% and 83% (p = 0.6 for the intervention group and control group when excluding 8 patients who died or with a life expectancy of months at follow-up. Median time from initial sick leave to partial return-to-work was 194 days (range 14-435 versus 192 days (range 82-465 (p = 0.90 with a hazard ratio of 1.03 (95% CI 0.64-1.6. Quality of life and work ability improved statistically over time but did not differ statistically between groups. Work functioning and costs did not differ statistically between groups. CONCLUSION: The intervention was easily implemented into usual psycho-oncological care and showed high return-to-work rates. We failed to show any differences between groups on return-to-work outcomes and quality of life scores. Further research is needed to study which

  4. Body weight-supported treadmill training vs. overground walking training for persons with chronic stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Combs-Miller, Stephanie A; Kalpathi Parameswaran, Anu; Colburn, Dawn; Ertel, Tara; Harmeyer, Amanda; Tucker, Lindsay; Schmid, Arlene A

    2014-09-01

    To compare the effects of body weight-supported treadmill training and overground walking training when matched for task and dose (duration/frequency/intensity) on improving walking function, activity, and participation after stroke. Single-blind, pilot randomized controlled trial with three-month follow-up. University and community settings. A convenience sample of participants (N = 20) at least six months post-stroke and able to walk independently were recruited. Thirty-minute walking interventions (body weight-supported treadmill training or overground walking training) were administered five times a week for two weeks. Intensity was monitored with the Borg Rating of Perceived Exertion Scale at five-minute increments to maintain a moderate training intensity. Walking speed (comfortable/fast 10-meter walk), walking endurance (6-minute walk), spatiotemporal symmetry, and the ICF Measure of Participation and ACTivity were assessed before, immediately after, and three months following the intervention. The overground walking training group demonstrated significantly greater improvements in comfortable walking speed compared with the body weight-supported treadmill training group immediately (change of 0.11 m/s vs. 0.06 m/s, respectively; p = 0.047) and three months (change of 0.14 m/s vs. 0.08 m/s, respectively; p = 0.029) after training. Only the overground walking training group significantly improved comfortable walking speed (p = 0.001), aspects of gait symmetry (p = 0.032), and activity (p = 0.003) immediately after training. Gains were maintained at the three-month follow-up (p training was more beneficial than body weight-supported treadmill training at improving self-selected walking speed for the participants in this study. © The Author(s) 2014.

  5. Impact of clinical decision support on radiography for acute ankle injuries: a randomized trial

    Directory of Open Access Journals (Sweden)

    Shahein Tajmir

    2017-04-01

    Full Text Available Introduction: While only 15-20% of patients with foot and ankle injuries presenting to urgent care centers have clinically significant fractures, most undergo radiography. We examined the impact of electronic point-of-care clinical decision support (CDS on adherence to the Ottawa Ankle Rules (OAR, as well as use and yield of foot and ankle radiographs in patients with acute ankle injury. Methods: We obtained institutional review board approval for this randomized controlled study performed April 18, 2012—December 15, 2013. All ordering providers credentialed at an urgent care affiliated with a quaternary care academic hospital were randomized to either receive or not receive CDS, based on the OAR and integrated into the physician order-entry system, with feedback at the time of imaging order. If the patient met OAR low-risk criteria, providers were advised against imaging and could either cancel the order or ignore the alert. We identified patients with foot and ankle complaints via ICD-9 billing codes and electronic health records and radiology reports reviewed for those who were eligible. Chi-square was used to compare adherence to the OAR (primary outcome, radiography utilization rate and radiography yield of foot and ankle imaging (secondary outcomes between the intervention and control groups. Results: Of 14,642 patients seen at urgent care during the study period, 613 (4.2%, representing 632 visits presented with acute ankle injury and were eligible for application of the OAR; 374 (59.2% of these were seen by control-group providers. In the intervention group, CDS adherence was higher for both ankle (239/258=92.6% vs. 231/374=61.8%, p=0.02 and foot radiography (209/258=81.0% vs. 238/374=63.6%; p<0.01. However, ankle radiography use was higher in the intervention group (166/258=64.3% vs. 183/374=48.9%; p<0.01, while foot radiography use (141/258=54.6% vs. 202/374=54.0%; p=0.95 was not. Radiography yield was also higher in the intervention

  6. Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial

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    Wenborn Jennifer

    2011-09-01

    Full Text Available Abstract Background Peer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design. Design A 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness. Discussion The methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches. Trial Registration ISRCTN37956201

  7. Total integrated performance excellence system (TIPES: A true north direction for a clinical trial support center

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    Mike R. Sather

    2018-03-01

    Full Text Available This paper presents the quality journey taken by a Federal organization over more than 20 years. These efforts have resulted in the implementation of a Total Integrated Performance Excellence System (TIPES that combines key principles and practices of established quality systems. The Center has progressively integrated quality system frameworks including the Malcom Baldrige National Quality Award (MBNQA Framework and Criteria for Performance Excellence, ISO 9001, and the Organizational Project Management Maturity Model (OPM3, as well as supplemental quality systems of ISO 15378 (packaging for medicinal products and ISO 21500 (guide to project management to systematically improve all areas of operations. These frameworks were selected for applicability to Center processes and systems, consistency and reinforcement of complimentary approaches, and international acceptance. External validations include the MBNQA, the highest quality award in the US, continued registration and conformance to ISO standards and guidelines, and multiple VA and state awards. With a focus on a holistic approach to quality involving processes, systems and personnel, this paper presents activities and lessons that were critical to building TIPES and establishing the quality environment for conducting clinical research in support of Veterans and national health care.

  8. Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center.

    Science.gov (United States)

    Sather, Mike R; Parsons, Sherry; Boardman, Kathy D; Warren, Stuart R; Davis-Karim, Anne; Griffin, Kevin; Betterton, Jane A; Jones, Mark S; Johnson, Stanley H; Vertrees, Julia E; Hickey, Jan H; Salazar, Thelma P; Huang, Grant D

    2018-03-01

    This paper presents the quality journey taken by a Federal organization over more than 20 years. These efforts have resulted in the implementation of a Total Integrated Performance Excellence System (TIPES) that combines key principles and practices of established quality systems. The Center has progressively integrated quality system frameworks including the Malcom Baldrige National Quality Award (MBNQA) Framework and Criteria for Performance Excellence, ISO 9001, and the Organizational Project Management Maturity Model (OPM3), as well as supplemental quality systems of ISO 15378 (packaging for medicinal products) and ISO 21500 (guide to project management) to systematically improve all areas of operations. These frameworks were selected for applicability to Center processes and systems, consistency and reinforcement of complimentary approaches, and international acceptance. External validations include the MBNQA, the highest quality award in the US, continued registration and conformance to ISO standards and guidelines, and multiple VA and state awards. With a focus on a holistic approach to quality involving processes, systems and personnel, this paper presents activities and lessons that were critical to building TIPES and establishing the quality environment for conducting clinical research in support of Veterans and national health care.

  9. The Effect of a Breastfeeding Motivation Program Maintained During Pregnancy on Supporting Breastfeeding: A Randomized Controlled Trial.

    Science.gov (United States)

    Cangöl, Eda; Şahin, Nevin Hotun

    2017-05-01

    Exclusive breastfeeding is the recommended breastfeeding method for infants during the first 6 postnatal months. This study aimed to increase breastfeeding duration and frequency using a breastfeeding motivation program (BMP), which was structurally based on Pender's Health Promotion Model (HPM) and administered during pregnancy and the postnatal period. The study was also designed to determine the BMP effectiveness in supporting exclusive breastfeeding. The sample of this randomized controlled trial included 100 pregnant women (50 in the BMP, 50 in the control group) who applied to the pregnancy preparation course in a state hospital located in Usak, western Turkey. Participants in the study were allocated into either the BMP group or control group through systematic sampling and randomization. The BMP was structured based on the HPM and was carried out with the BMP study group four times: during the antenatal period, on the first postnatal day, between the fourth and sixth postnatal weeks, and during the fourth postnatal month. Data were analyzed using the descriptive statistical test, Pearson's chi-square test, independent samples t test, and ANOVA. The mothers in the BMP group started breastfeeding earlier than the mothers in the control group (97.1%) and had fewer problems with their first breastfeeding experience. The average score of perceived self-efficacy in breastfeeding and the rate of first breastfeeding experience (70.6%) were higher in the BMP group by a statistically significant amount. BMP for breastfeeding, structurally based on Pender's HPM, can help in supporting and maintaining exclusive breastfeeding.

  10. Randomized Controlled Trial of Nurse-Delivered Cognitive Behavioral Therapy Versus Supportive Psychotherapy Telehealth Interventions for Chronic Back Pain.

    Science.gov (United States)

    Rutledge, Thomas; Atkinson, J Hampton; Holloway, Rachael; Chircop-Rollick, Tatiana; D'Andrea, John; Garfin, Steven R; Patel, Shetal; Penzien, Donald B; Wallace, Mark; Weickgenant, Anne L; Slater, Mark

    2018-04-16

    This study evaluated a nurse-delivered, telehealth intervention of cognitive behavioral therapy versus supportive psychotherapy for chronic back pain. Participants (N=61) had chronic back pain (pain "daily" ≥ 6 months at an intensity ≥4/10 scale) and were randomized to an 8-week, 12-session, Cognitive Behavioral Therapy (CBT) or to Supportive Care (SC) matched for frequency, format, and time, with each treatment delivered by a primary care nurse. The primary outcome was the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included the Numerical Rating Scale (NRS) and the Patient Global Impressions Scale (CGI). CBT participants (n=30) showed significant improvements on the RMDQ (means=11.4[5.9] vs. 9.4[6.1] at baseline and post-treatment, respectively, p.10). The results suggest that telehealth, nurse-delivered CBT and SC treatments for chronic back pain can offer significant and relatively comparable benefits. ClinicalTrials.gov: NCT00608530. This article describes the benefits of training primary care nurses to deliver evidence-based behavioral therapies for low back pain. Due to the high prevalence of chronic pain and the growing emphasis on non-opioid therapies, training nurses to provide behavior therapies could be a cost-effective way to improve pain management. Copyright © 2018. Published by Elsevier Inc.

  11. Self-learning basic life support: A randomised controlled trial on learning conditions.

    Science.gov (United States)

    Pedersen, Tina Heidi; Kasper, Nina; Roman, Hari; Egloff, Mike; Marx, David; Abegglen, Sandra; Greif, Robert

    2018-03-06

    To investigate whether pure self-learning without instructor support, resulted in the same BLS-competencies as facilitator-led learning, when using the same commercially available video BLS teaching kit. First-year medical students were randomised to either BLS self-learning without supervision or facilitator-led BLS-teaching. Both groups used the MiniAnne kit (Laerdal Medical, Stavanger, Norway) in the students' local language. Directly after the teaching and three months later, all participants were tested on their BLS-competencies in a simulated scenario, using the Resusci Anne SkillReporter™ (Laerdal Medical, Stavanger, Norway). The primary outcome was percentage of correct cardiac compressions three months after the teaching. Secondary outcomes were all other BLS parameters recorded by the SkillReporter and parameters from a BLS-competence rating form. 240 students were assessed at baseline and 152 students participated in the 3-month follow-up. For our primary outcome, the percentage of correct compressions, we found a median of 48% (interquartile range (IQR) 10-83) for facilitator-led learning vs. 42% (IQR 14-81) for self-learning (p = 0.770) directly after the teaching. In the 3-month follow-up, the rate of correct compressions dropped to 28% (IQR 6-59) for facilitator-led learning (p = 0.043) and did not change significantly in the self-learning group (47% (IQR 12-78), p = 0.729). Self-learning is not inferior to facilitator-led learning in the short term. Self-learning resulted in a better retention of BLS-skills three months after training compared to facilitator-led training. Copyright © 2018 Elsevier B.V. All rights reserved.

  12. The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments: what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Witjes Suzanne

    2012-02-01

    Full Text Available Abstract Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180 with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales, number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR: NTR2151

  13. The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments): what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180) with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales), number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR): NTR2151 PMID:22340371

  14. Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial.

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    Sarah H Wild

    2016-07-01

    Full Text Available Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD HbA1c at follow-up was 63.0 (15.5 mmol/mol in the intervention group and 67.8 (14.7 mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007. For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56-5.56 mmHg, p = 0.017 and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62-3.72, p = 0.006 among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified

  15. Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Capozzi Lauren C

    2012-10-01

    Full Text Available Abstract Background Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck (HN cancer populations. This translates into a lack of clinical programming available for these patient populations. HN cancer patients deal with severe weight loss, with more than 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL, and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Our pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Methods/Design Therefore, the purpose of the present study is to examine the impact and timing of a 12-week PA and nutrition intervention (either during or following treatment for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, we will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects, as well as return to work. Discussion This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical-activity and wellness-education model that can be implemented in other cancer centers. Trial registration Current Controlled Trials NCT01681654

  16. Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

    Science.gov (United States)

    Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike

    2014-01-01

    To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Process evaluation nested within a cluster randomised controlled trial (RCT). 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. 14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention. The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research

  17. Weaning by gradual pressure support (PS reduction without an initial spontaneous breathing trial (SBT versus PS-supported SBT: A pilot study

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    K. Gnanapandithan

    2011-11-01

    Full Text Available Background and aim: Studies on weaning strategies have yielded conflicting results regarding the superiority of different methods. The aim of this RCT was to compare the efficacy of gradual pressure support (PS reduction without an initial spontaneous breathing trial (SBT with PS-supported SBT. Methods: Patients mechanically ventilated for >24 h were randomized to weaning by gradual reduction of PS without an initial SBT versus once daily SBT (PS 7 cm H2O. The primary outcomes were the rates of successful weaning trial and time to successful extubation. The secondary outcomes were the ICU and hospital length of stay, hospital mortality and the occurrence of ventilator-associated pneumonia (VAP. Results: Of the 120 patients (61 males, median age 35 years, 58 were assigned to PS and 62 to the SBT group. The median (IQR duration of ventilation prior to weaning was 80.2 (50.5–175.6 h. The baseline characteristics were similar in the two groups except the PaO2/FiO2 ratio, which was significantly higher in SBT group. The rates of successful weaning trial (89.7% versus 69.4% were significantly higher in the PS group. The median duration of weaning (66 h versus 81.5 h, P = 0.05 and the median duration of ICU stay (8 days versus 9.4 days, P = 0.027 were lower in the PS group. There was no difference in hospital stay, mortality rates or occurrence of VAP in the two arms. On multivariate analysis, the duration of ventilation prior to weaning, baseline SOFA score and the weaning method were predictors of successful extubation. Conclusions: Gradual reduction of PS without an initial SBT was found to be associated with better outcomes compared to once daily PS-supported SBT. Resumo: Antecedentes e objetivo: Os estudos sobre estratégias de desmame tiveram resultados controversos em relação à superioridade de métodos diferentes. O objetivo deste RCT foi comparar a eficácia da redução gradual da press

  18. Rationale and study design of ViPS - variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial.

    Science.gov (United States)

    Kiss, Thomas; Güldner, Andreas; Bluth, Thomas; Uhlig, Christopher; Spieth, Peter Markus; Markstaller, Klaus; Ullrich, Roman; Jaber, Samir; Santos, Jose Alberto; Mancebo, Jordi; Camporota, Luigi; Beale, Richard; Schettino, Guilherme; Saddy, Felipe; Vallverdú, Immaculada; Wiedemann, Bärbel; Koch, Thea; Schultz, Marcus Josephus; Pelosi, Paolo; de Abreu, Marcelo Gama

    2013-10-31

    In pressure support ventilation (PSV), a non-variable level of pressure support is delivered by the ventilator when triggered by the patient. In contrast, variable PSV delivers a level of pressure support that varies in a random fashion, introducing more physiological variability to the respiratory pattern. Experimental studies show that variable PSV improves gas exchange, reduces lung inflammation and the mean pressure support, compared to non-variable PSV. Thus, it can theoretically shorten weaning from the mechanical ventilator. The ViPS (variable pressure support) trial is an international investigator-initiated multicenter randomized controlled open trial comparing variable vs. non-variable PSV. Adult patients on controlled mechanical ventilation for more than 24 hours who are ready to be weaned are eligible for the study. The randomization sequence is blocked per center and performed using a web-based platform. Patients are randomly assigned to one of the two groups: variable PSV or non-variable PSV. In non-variable PSV, breath-by-breath pressure support is kept constant and targeted to achieve a tidal volume of 6 to 8 ml/kg. In variable PSV, the mean pressure support level over a specific time period is targeted at the same mean tidal volume as non-variable PSV, but individual levels vary randomly breath-by-breath. The primary endpoint of the trial is the time to successful weaning, defined as the time from randomization to successful extubation. ViPS is the first randomized controlled trial investigating whether variable, compared to non-variable PSV, shortens the duration of weaning from mechanical ventilation in a mixed population of critically ill patients. This trial aims to determine the role of variable PSV in the intensive care unit. clinicaltrials.gov NCT01769053.

  19. Standards for reporting randomized controlled trials in medical informatics: a systematic review of CONSORT adherence in RCTs on clinical decision support.

    Science.gov (United States)

    Augestad, K M; Berntsen, G; Lassen, K; Bellika, J G; Wootton, R; Lindsetmo, R O

    2012-01-01

    The Consolidated Standards for Reporting Trials (CONSORT) were published to standardize reporting and improve the quality of clinical trials. The objective of this study is to assess CONSORT adherence in randomized clinical trials (RCT) of disease specific clinical decision support (CDS). A systematic search was conducted of the Medline, EMBASE, and Cochrane databases. RCTs on CDS were assessed against CONSORT guidelines and the Jadad score. 32 of 3784 papers identified in the primary search were included in the final review. 181 702 patients and 7315 physicians participated in the selected trials. Most trials were performed in primary care (22), including 897 general practitioner offices. RCTs assessing CDS for asthma (4), diabetes (4), and hyperlipidemia (3) were the most common. Thirteen CDS systems (40%) were implemented in electronic medical records, and 14 (43%) provided automatic alerts. CONSORT and Jadad scores were generally low; the mean CONSORT score was 30.75 (95% CI 27.0 to 34.5), median score 32, range 21-38. Fourteen trials (43%) did not clearly define the study objective, and 11 studies (34%) did not include a sample size calculation. Outcome measures were adequately identified and defined in 23 (71%) trials; adverse events or side effects were not reported in 20 trials (62%). Thirteen trials (40%) were of superior quality according to the Jadad score (≥3 points). Six trials (18%) reported on long-term implementation of CDS. The overall quality of reporting RCTs was low. There is a need to develop standards for reporting RCTs in medical informatics.

  20. Associations among environmental supports, physical activity, and blood pressure in African-American adults in the PATH trial.

    Science.gov (United States)

    Coulon, Sandra M; Wilson, Dawn K; Egan, Brent M

    2013-06-01

    High blood pressure disproportionately affects African-American adults and is a leading cause of stroke and heart attack. Engaging in recommended levels of physical activity reduces blood pressure, and social and physical environmental supports for physical activity may increase engagement in physical activity. Based on social cognitive theory within a bioecological framework, the present study tested hypotheses that perceived peer social support for physical activity and neighborhood walkability would be positively associated with physical activity, and that physical activity would mediate their relation with blood pressure. Baseline data were collected with 434 African-American adults in underserved communities (low income, high crime) participating in the Positive Action for Today's Health (PATH) trial. Perceived peer social support for physical activity and neighborhood walkability were measured with validated surveys. Physical activity was assessed with 7-day accelerometry (moderate-to-vigorous physical activity, min/day) and with a 4-week recall of walking. Three blood pressure assessments were taken by trained staff using standard protocols, with values from the second and third assessments averaged. The sample was predominantly female (63%), overweight (mean body mass index = 30.9, SD = 8.4), and had slightly elevated blood pressures with a mean systolic blood pressure of 132.4 (SD = 17.9) and a mean diastolic blood pressure of 81.4 (SD = 11.0). Results demonstrated that peer social support for physical activity (B = 2.43, p = .02) and neighborhood walkability (B = 2.40, p = .046) were significantly related to average daily moderate-to-vigorous physical activity. Neighborhood walkability was also significantly associated with self-reported average daily walking (B = 8.86, p = .02). Physical activity did not mediate their relation with blood pressure and no significant direct effects of these variables on blood pressure were found. The positive influence of

  1. Effectiveness of web-based self-disclosure peer-to-peer support for weight loss: randomized controlled trial.

    Science.gov (United States)

    Imanaka, Mie; Ando, Masahiko; Kitamura, Tetsuhisa; Kawamura, Takashi

    2013-07-09

    Obesity is one of the most common public health problems in the industrialized world as a cause of noncommunicable diseases. Although primarily used for one-on-one communication, email is available for uninterrupted support for weight loss, but little is known about the effects of dietitian group counseling for weight control via the Internet. We developed a Web-based self-disclosure health support (WSHS) system for weight loss. This study aims to compare the effect of weight change between those using the WSHS and those using the email health support (EHS). This study was designed as an open prospective individual randomized controlled trial. Eligible participants were aged 35 to 65 years with a body mass index (BMI) of ≥25.0 in their latest health examination. Participants were randomly assigned to either the WSHS group or the EHS group. Thirteen registered dietitians under the direction of a principal dietitian each instructed 6 to 8 participants from the respective groups. All participants in the WSHS group could receive nutritional advice and calculate their nutritive intake from a photograph of a meal on their computer screen from the Internet sent to them by their dietitian, receive supervision from the registered dietitian, and view fellow participants' weight changes and lifestyle modifications. In the EHS group, a participant could receive one-on-one nutritional advice and calculate his/her nutritive intake from the photograph of a meal on computer screen sent by email from his/her dietitian, without being able to view fellow participants' status. The follow-up period was 12 weeks for both groups. The primary outcome measure was change in body weight. The secondary outcome measure included changes in BMI and waist circumference. The intergroup comparison of the changes before and after intervention was evaluated using analysis of covariance. A total of 193 participants were randomly assigned to either the WSHS group (n=97) or the EHS group (n=96). Ten

  2. Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial.

    Science.gov (United States)

    Svendsen, Mathias Tiedemann; Andersen, Flemming; Andersen, Kirsten Hammond; Andersen, Klaus Ejner

    2018-02-07

    Topical corticosteroid or corticosteroid/calcipotriol preparations are recommended first-line topical treatments of psoriasis, but a main cause for the lack of efficacy of topical treatments is considered low rates of adherence to topical drugs. Patient support by the use of applications (apps) for smartphones is suggested to improve medical adherence. Design: An investigator-initiated, single-center, single-blind, parallel-group, phase-4 clinical superiority randomized controlled trial (RCT). 134 patients 18 to 75 years of age with mild-to-moderate psoriasis, who are capable of reading English language, own a smartphone, and are candidates for the study drug calcipotriol and betamethasone dipropionate (Cal/BD) cutaneous foam once daily prn (pro re nata). A 28-day adherence-supporting app providing compulsory daily treatment reminders that pop-up on the smartphone screen with a short alert sound. The app synchronizes through Bluetooth® to an electronic monitor (EM) attached to the medication canister. The EM contains a chip registering the amount of foam, day and time the patient use the foam dispenser. The information is displayed in a diary that shows the amount of Cal/BD cutaneous foam used and the number of applied treatment sessions. The app has an optional diary with the patient's rating of symptoms. Non-intervention: Use of Cal/BD cutaneous foam and EM without the app. All participants are prescribed Cal/BD cutaneous foam prn for the entire study period. Primary outcome obtained in week 4: rates of adherence measured by patient report, weight of medication canisters, and number of treatment sessions measured by the EM. Secondary outcomes obtained at baseline, weeks 4, 8, and 26: Lattice System Physician's Global Assessment (LS-PGA) and Dermatology Quality of Life Index (DLQI). This trial tests of whether an app can improve rates of adherence to a topical antipsoriatic drug. If the app improves rates of adherence and reduces the burden of psoriasis in a

  3. Effectiveness of a Group Support Lifestyle Modification (GSLiM) Programme among Obese Adults in Workplace: A Randomised Controlled Trial

    Science.gov (United States)

    Azmi Mohamed, Mohd Nahar; Mukhtar, Firdaus

    2016-01-01

    targeted weight loss, improving weight self-efficacy, friend social support, and quality of life compared to dietary counseling. Trial Registration Iranian Registry of Clinical Trials IRCT201104056127N1 PMID:27537687

  4. Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian peers for progress study

    Directory of Open Access Journals (Sweden)

    Riddell Michaela A

    2012-10-01

    measures are collected on all participants at baseline, 6 and 12 months. The primary outcome is change in cardiovascular disease risk using the UKPDS risk equation. Secondary outcomes include biomedical, quality of life, psychosocial functioning, and other lifestyle measures. An economic evaluation will determine whether the program is cost effective. Discussion This manuscript presents the protocol for a cluster randomized controlled trial of group-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes. Trial registration number Australian New Zealand Clinical Trials Registry (ANZCTR; ACTRN12609000469213

  5. Duration of luteal support (DOLS with progesterone pessaries to improve the success rates in assisted conception: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gazvani Rafet

    2012-07-01

    Full Text Available Abstract Background Luteal support with progesterone is necessary for successful implantation of the embryo following egg collection and embryo transfer in an in-vitro fertilization (IVF cycle. Progesterone has been used for as little as 2 weeks and for as long as 12 weeks of gestation. The optimal length of treatment is unresolved at present and it remains unclear how long to treat women receiving luteal supplementation. Design The trial is a prospective, randomized, double-blind, placebo-controlled trial to investigate the effect of the duration of luteal support with progesterone in IVF cycles. Following 2 weeks standard treatment and a positive biochemical pregnancy test, this randomized control trial will allocate women to a supplementary 8 weeks treatment with vaginal progesterone or 8 weeks placebo. Further studies would be required to investigate whether additional supplementation with progesterone is beneficial in early pregnancy. Discussion Currently at the Hewitt Centre, approximately 32.5% of women have a positive biochemical pregnancy test 2 weeks after embryo transfer. It is this population that is eligible for trial entry and randomization. Once the patient has confirmed a positive urinary pregnancy test they will be invited to join the trial. Once the consent form has been completed by the patient a trial prescription sheet will be sent to pharmacy with a stated collection time. The patient can then be randomized and the drugs dispensed according to pharmacy protocol. A blood sample will then be drawn for measurement of baseline hormone levels (progesterone, estradiol, free beta-human chorionic gonadotrophin, pregnancy-associated plasma protein-A, Activin A, Inhibin A and Inhibin B. The primary outcome measure is the proportion of all randomized women that continue successfully to a viable pregnancy (at least one fetus with fetal heart rate >100 beats/minute on transabdominal/transvaginal ultrasound at 10 weeks post embryo

  6. Peer support in type 2 diabetes: a randomised controlled trial in primary care with parallel economic and qualitative analyses: pilot study and protocol

    Directory of Open Access Journals (Sweden)

    O'Kelly Fergus

    2007-07-01

    Full Text Available Abstract Background Diabetes is a chronic illness, which requires the individual to assume responsibility for their own care with the aim of maintaining glucose and blood pressure levels as close to normal as possible. Traditionally self-management training for diabetes has been delivered in a didactic manner. In recent times alternatives to the traditional delivery of diabetes care have been investigated, for example, the concept of peer support which emphasises patient rather than professional domination. This paper describes the pilot study and protocol for a study that aims to evaluate the effectiveness of a peer support intervention for people with type 2 diabetes in a primary care setting. Methods/Design A pilot study was conducted to access the feasibility of a randomized controlled trial of a peer support intervention. We used the MRC Framework for the evaluation of complex interventions. Elements of the intervention were defined and the study protocol was finalized. In this cluster randomised controlled trial twenty general practices are assigned to control and intervention groups. Each practice compiles a diabetes register and randomly selects 21 patients. All practices implement a standardised diabetes care system. In the intervention group all practices recruit three peer supporters. The peer supporters are trained to conduct nine group meetings in their general practice over a period of two years. Each meeting has a structured component. The primary outcomes are blood pressure, total cholesterol, HBA1c and the Diabetes Well-being score. In addition to biophysical, psychosocial, economic and health service utilization data peer supporter activity and qualitative data are collected. Discussion Peer support is a complex intervention and evaluating such an intervention presents challenges to researchers. This study will evaluate whether a peer support programme for patients with type 2 diabetes improves biophysical and psychosocial

  7. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial.

    Science.gov (United States)

    Nelson, Lyndsay A; Wallston, Kenneth A; Kripalani, Sunil; Greevy, Robert A; Elasy, Tom A; Bergner, Erin M; Gentry, Chad K; Mayberry, Lindsay S

    2018-04-10

    Nonadherence to self-care is common among patients with type 2 diabetes (T2D) and often leads to severe complications. Moreover, patients with T2D who have low socioeconomic status and are racial/ethnic minorities disproportionately experience barriers to adherence and poor outcomes. Basic phone technology (text messages and phone calls) provides a practical medium for delivering content to address patients' barriers to adherence; however, trials are needed to explore long-term and sustainable effects of mobile phone interventions among diverse patients. The aim of this study is to evaluate the effects of mobile phone-based diabetes support interventions on self-care and hemoglobin A 1c (HbA 1c ) among adults with T2D using a 3-arm, 15-month randomized controlled trial with a Type 1 hybrid effectiveness-implementation approach. The intervention arms are (1) Rapid Encouragement/Education And Communications for Health (REACH) and (2) REACH + Family-focused Add-on for Motivating Self-care (FAMS). We recruited primary care patients with T2D (N=512) from Federally Qualified Health Centers and an academic medical center, prioritizing recruitment of publicly insured and minority patients from the latter. Eligible patients were prescribed daily diabetes medication and owned a cell phone with text messaging capability. We excluded patients whose most recent HbA 1c result within 12 months was phone coaching with related text message content focused on family and friend barriers to diet and exercise adherence. We collect HbA 1c and self-reported survey data at baseline and at 3, 6, and 12 months, and again at 15 months to assess sustained changes. We will use generalized estimating equation models to test the effects of REACH (either intervention arm) on HbA 1c relative to the control group, the potential additive effects of FAMS, and effects of either intervention on adherence to self-care behaviors and diabetes self-efficacy. The trial is ongoing; recruitment closed

  8. Using smartphones to decrease substance use via self-monitoring and recovery support: study protocol for a randomized control trial.

    Science.gov (United States)

    Scott, Christy K; Dennis, Michael L; Gustafson, David H

    2017-08-10

    Alcohol abuse, other substance use disorders, and risk behaviors associated with the human immunodeficiency virus (HIV) represent three of the top 10 modifiable causes of mortality in the US. Despite evidence that continuing care is effective in sustaining recovery from substance use disorders and associated behaviors, patients rarely receive it. Smartphone applications (apps) have been effective in delivering continuing care to patients almost anywhere and anytime. This study tests the effectiveness of two components of such apps: ongoing self-monitoring through Ecological Momentary Assessments (EMAs) and immediate recovery support through Ecological Momentary Interventions (EMIs). The target population, adults enrolled in substance use disorder treatment (n = 400), are being recruited from treatment centers in Chicago and randomly assigned to one of four conditions upon discharge in a 2 × 2 factorial design. Participants receive (1) EMAs only, (2) EMIs only, (3) combined EMAs + EMIs, or (4) a control condition without EMA or EMI for 6 months. People in the experimental conditions receive smartphones with the apps (EMA and/or EMI) specific to their condition. Phones alert participants in the EMA and EMA + EMI conditions at five random times per day and present participants with questions about people, places, activities, and feelings that they experienced in the past 30 min and whether these factors make them want to use substances, support their recovery, or have no impact. Those in the EMI and EMA + EMI conditions have continual access to a suite of support services. In the EMA + EMI condition, participants are prompted to use the EMI(s) when responses to the EMA(s) indicate risk. All groups have access to recovery support as usual. The primary outcome is days of abstinence from alcohol and other drugs. Secondary outcomes are number of HIV risk behaviors and whether abstinence mediates the effects of EMA, EMI, or EMA + EMI on HIV

  9. The Family Startup Program: study protocol for a randomized controlled trial of a universal group-based parenting support program.

    Science.gov (United States)

    Trillingsgaard, Tea; Maimburg, Rikke Damkjær; Simonsen, Marianne

    2015-04-21

    , utility of primary sector service and child physical health, socio-emotional and cognitive development. The protocol describes an ambitious experimental evaluation of a universal group-based parenting support program; an evaluation that has not yet been made either in Denmark or internationally. ClinicalTrials.gov ID: NCT02294968. Registered November 14 2014.

  10. Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol.

    Science.gov (United States)

    Hochstenbach, Laura M J; Courtens, Annemie M; Zwakhalen, Sandra M G; van Kleef, Maarten; de Witte, Luc P

    2015-05-19

    Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Fragmentation of care, inadequate pain communication, and reluctance towards pain medication contribute to difficulties in optimizing outcomes. Integration of patient self-management and professional care by means of healthcare technology provides new opportunities in the outpatient setting. This study protocol outlines a two-armed multicenter randomized controlled trial that compares a technology based multicomponent self-management support intervention with care as usual and includes an effect, economic and process evaluation. Patients will be recruited consecutively via the outpatient oncology clinics and inpatient oncology wards of one academic hospital and one regional hospital in the south of the Netherlands. Irrespective of the stage of disease, patients are eligible when they are diagnosed with cancer and have uncontrolled moderate to severe cancer (treatment) related pain defined as NRS≥4 for more than two weeks. Randomization (1:1) will assign patients to either the intervention or control group; patients in the intervention group receive self-management support and patients in the control group receive care as usual. The intervention will be delivered by registered nurses specialized in pain and palliative care. Important components include monitoring of pain, adverse effects and medication as well as graphical feedback, education, and nurse support. Effect measurements for both groups will be carried out with questionnaires at baseline (T0), after 4 weeks (T1) and after 12 weeks (T2). Pain intensity and quality of life are the primary outcomes. Secondary outcomes include self-efficacy, knowledge, anxiety, depression and pain medication use. The final questionnaire contains also questions for the economic evaluation that includes both cost-effectiveness and cost-utility analysis. Data for the process evaluation will be

  11. Short psychodynamic supportive psychotherapy, antidepressants, and their combination in the treatment of major depression: A mega-analysis based on three randomized clinical trials

    NARCIS (Netherlands)

    de Maat, S.C.M.; Dekker, J.J.M.; Schoevers, R.A.; van Aalst, G.; Natijk, C.G.; Hendriksen, M.; Kool, S.; Peen, J.; Van, R.; de Jonghe, F.

    2008-01-01

    The efficacy of Short Psychodynamic Supportive Psychotherapy (SPSP) has not yet been compared with pharmacotherapy. A mega-analysis based on three original Randomized Clinical Trials (RCTs) was performed. Patients with (mild to moderate) major depressive disorder were randomized in (24 weeks) SPSP

  12. A randomized controlled trial of a modified wheelchair arm-support to reduce shoulder pain in stroke patients.

    Science.gov (United States)

    Pan, Ruihuan; Zhou, Mingchao; Cai, Hao; Guo, Youhua; Zhan, Lechang; Li, Mei; Yang, Zhijing; Zhu, Leying; Zhan, Jie; Chen, Hongxia

    2018-01-01

    To evaluate the effect of modified wheelchair arm-support to mitigate hemiplegic shoulder pain and reduce pain frequency in stroke patients. A single-blind randomized controlled trial using computer-generated simple randomization. Participants recruited from inpatients at the Guangdong Provincial Hospital of Chinese Medicine. A total of 120 patients with stroke were divided into two groups. All subjects underwent basic rehabilitation training and wheelchair assistance with eight weeks follow-up period. Patients in the treatment group additionally received modified wheelchair arm-support for at least 60 minutes a day, six days a week, for four weeks. Primary outcome was measured by the Visual Analogue Pain Scale or Numeric Pain Rating Scale. Secondary outcome was measured using the Upper Extremity Fugl-Meyer Assessment scale, Modified Barthel Index and Quality of Life Index. Measurements were made at 4 weeks and 12 weeks, following the intervention. Patients age from 21 to 83 years (mean ± SD = 62.41 ± 12.26). The average duration of disease was 1.9 ± 1.3 months. At four weeks, the median of pain intensity was higher in the control group (median, interquartile range = 3, 5.75 vs. 2, 3.75; P = 0.059). At 12 weeks, the median of pain intensity was higher in the control group (median, interquartile range = 3, 5.00 vs. 0, 1.00; P vs. 1; P stroke patients. It may also improve the patients' quality of life.

  13. Randomized Factorial Trial of Phone-Delivered Support Counseling and Daily Text Message Reminders for HIV Treatment Adherence

    Science.gov (United States)

    Kalichman, Seth C.; Kalichman, Moira O.; Cherry, Chauncey; Eaton, Lisa A.; Cruess, Dean; Schinazi, Raymond F.

    2016-01-01

    Background HIV infection is clinically managed with antiretroviral therapy (ART), but only with sustained adherence. Cost-efficient interventions to improve and sustain ART adherence remain a pressing priority for populations challenged by non-adherence. Purpose To test the independent and interactive effects of (a) brief phone-delivered self-regulation counseling and (b) daily phone-delivered text message medication reminders on HIV adherence and HIV viral suppression. Method A randomized 2 (5-sessions of phone-delivered adherence support counseling vs. contact-matched control) × 2 (daily ART text reminders vs. no reminders) trial with primary endpoints of monthly phone-based unannounced pill count-determined ART adherence and HIV viral suppression monitored over 12-months. Results Self-regulation adherence counseling demonstrated significant improvements in achieving 90% ART adherence relative to the control group over the first 6-months of follow-up. Effects remained significant in sensitivity analyses conducted at 85% and 95% adherence. Counseling also demonstrated modest but significant effects on HIV suppression. There were no main effects or interactions for daily text message reminders, with some evidence for adverse effects on adherence self-efficacy. Conclusions Brief adherence support counseling delivered by phone demonstrates clinically meaningful improvements in ART adherence and HIV suppression, although these benefits were not evidenced in all patients or in the long-term. Advancing adherence interventions along with an effective means for sustaining gains in adherence remain priorities if ART is to achieve its potential clinical and public health benefits. PMID:27105048

  14. Effectiveness of an online SUpport PRogramme (SUPR) for older hearing aid users: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Meijerink, Janine Fj; Pronk, Marieke; Paulissen, Bernadette; Witte, Birgit I; Wouden, Bregje van der; Jansen, Vera; Kramer, Sophia E

    2017-06-20

    An educational SUpport PRogramme called SUPR has been developed for hearing aid users (HAUs) and their communication partners (CPs) offering care beyond hearing aid fitting. SUPR teaches its users communication strategies, hearing aid handling skills and personal adjustment to hearing impairment. Using a cluster randomised controlled trial design, 70 Dutch hearing aid dispenser practices were randomised into hearing aid fitting (care as usual, 34 practices) and hearing aid fitting including SUPR (36 practices). The aim was to recruit a total of 569 older (aged 50+ years) first-time (n=258) and experienced (n=311) HAUs and their CPs. SUPR consists of a Practical Support Booklet and online material offered via email over a period of 6-7 months. The booklet provides practical information on hearing aids, advice on communication strategies and home exercises. The online material consists of educational videos on hearing aid functionality and usage, communication strategies and peer testimonials. Finally, noncommittal email contact with the dispenser is offered. Every HAU is asked to assign a CP who is advised to be involved intensively. Effect measurements for HAUs and their CPs will occur at baseline and at 6, 12 and 18 months follow-up via online questionnaires. The primary outcomes for HAUs will be the use of communication strategies as measured by the subscales of the Communication Profile for the Hearing Impaired. A process evaluation will be performed. The study was approved by the Dutch Institutional Review Board of the VU Medical University Center Amsterdam. This intervention could contribute to lowering the hearing impairment burden in our ageing society. The results will be disseminated through peer-reviewed publications and scientific conferences. ISRCTN77340339; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly

  15. The impact of schoolwide positive behavioral interventions and supports on bullying and peer rejection: a randomized controlled effectiveness trial.

    Science.gov (United States)

    Waasdorp, Tracy E; Bradshaw, Catherine P; Leaf, Philip J

    2012-02-01

    To build on prior research documenting the impact of School-wide Positive Behavioral Interventions and Supports (SWPBIS) on school climate and discipline problems to examine the extent to which it affects bullying and peer rejection during the transition into early adolescence. Three-level models were fit using hierarchical linear modeling to determine the effect of SWPBIS on children's involvement in bullying. Thirty-seven Maryland public elementary schools. Data involved 12 344 children (52.9% male, 45.1% African American, 46.1% white) followed up longitudinally across 4 school years. A randomized controlled effectiveness trial of SWPBIS. Reports from teachers on bully-related behaviors were assessed through the Teacher Observation of Classroom Adaptation-Checklist. Analyses indicated that children in schools that implemented SWPBIS displayed lower rates of teacher-reported bullying and peer rejection than those in schools without SWPBIS. A significant interaction also emerged between grade level of first exposure to SWPBIS and intervention status, suggesting that the effects of SWPBIS on rejection were strongest among children who were first exposed to SWPBIS at a younger age. The results indicated that SWPBIS has a significant effect on teachers' reports of children's involvement in bullying as victims and perpetrators. The findings were considered in light of other outcomes for students, staff, and the school environment, and they suggest that SWPBIS may help address the increasing national concerns related to school bullying by improving school climate.

  16. Internet-based information and support program for parents of children with burns: A randomized controlled trial.

    Science.gov (United States)

    Sveen, Josefin; Andersson, Gerhard; Buhrman, Bo; Sjöberg, Folke; Willebrand, Mimmie

    2017-05-01

    The aim of the study was to evaluate the feasibility and effects of an internet-based information and self-help program with therapist contact for parents of children and adolescents with burns. The program aimed to reduce parents' symptoms of general and posttraumatic stress. Participants were parents of children treated for burns between 2009-2013 at either of the two specialized Swedish Burn centers. Sixty-two parents were included in a two-armed, randomized controlled trial with a six-week intervention group and a wait-list control group, including a pre and post-assessment, as well as a 3 and 12-month follow-up. The intervention contained psychoeducation, exercises and homework assignments, and the intervention group received weekly written feedback from a therapist. The main outcome was stress (post-traumatic stress, general stress and parental stress). The program had a beneficial effect on posttraumatic stress in the short term, but did not affect general stress or parental stress. The parents rated the program as being informative and meaningful, but some of them thought it was time-consuming. The program has the potential to support parents of children with burns. The intervention is easily accessible, cost-effective and could be implemented in burn care rehabilitation. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  17. Body weight supported treadmill training versus traditional training in patients dependent on walking assistance after stroke: a randomized controlled trial.

    Science.gov (United States)

    Høyer, Ellen; Jahnsen, Reidun; Stanghelle, Johan Kvalvik; Strand, Liv Inger

    2012-01-01

    Treadmill training with body weight support (TTBWS) for relearning walking ability after brain damage is an approach under current investigation. Efficiency of this method beyond traditional training is lacking evidence, especially in patients needing walking assistance after stroke. The objective of this study was to investigate change in walking and transfer abilities, comparing TTBWS with traditional walking training. A single-blinded, randomized controlled trial was conducted. Sixty patients referred for multi-disciplinary primary rehabilitation were assigned into one of two intervention groups, one received 30 sessions of TTBWS plus traditional training, the other traditional training alone. Daily training was 1 hr. Outcome measures were Functional Ambulation Categories (FAC), Walking, Functional Independence Measure (FIM); shorter transfer and stairs, 10 m and 6-min walk tests. Substantial improvements in walking and transfer were shown within both groups after 5 and 11 weeks of intervention. Overall no statistical significant differences were found between the groups, but 12 of 17 physical measures tended to show improvements in favour of the treadmill approach. Both training strategies provided significant improvements in the tested activities, suggesting that similar outcomes can be obtained in the two modalities by systematic, intensive and goal directed training.

  18. Clinical Trials

    Medline Plus

    Full Text Available ... for health-related questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health of millions of ...

  19. Study protocol of the YOU CALL - WE CALL TRIAL: impact of a multimodal support intervention after a "mild" stroke

    Directory of Open Access Journals (Sweden)

    Bravo Gina

    2010-01-01

    Full Text Available Abstract Background More than 60% of new strokes each year are "mild" in severity and this proportion is expected to rise in the years to come. Within our current health care system those with "mild" stroke are typically discharged home within days, without further referral to health or rehabilitation services other than advice to see their family physician. Those with mild stroke often have limited access to support from health professionals with stroke-specific knowledge who would typically provide critical information on topics such as secondary stroke prevention, community reintegration, medication counselling and problem solving with regard to specific concerns that arise. Isolation and lack of knowledge may lead to a worsening of health problems including stroke recurrence and unnecessary and costly health care utilization. The purpose of this study is to assess the effectiveness, for individuals who experience a first "mild" stroke, of a sustainable, low cost, multimodal support intervention (comprising information, education and telephone support - "WE CALL" compared to a passive intervention (providing the name and phone number of a resource person available if they feel the need to - "YOU CALL", on two primary outcomes: unplanned-use of health services for negative events and quality of life. Method/Design We will recruit 384 adults who meet inclusion criteria for a first mild stroke across six Canadian sites. Baseline measures will be taken within the first month after stroke onset. Participants will be stratified according to comorbidity level and randomised to one of two groups: YOU CALL or WE CALL. Both interventions will be offered over a six months period. Primary outcomes include unplanned use of heath services for negative event (frequency calendar and quality of life (EQ-5D and Quality of Life Index. Secondary outcomes include participation level (LIFE-H, depression (Beck Depression Inventory II and use of health services for

  20. Cemented versus screw-retained implant-supported single-tooth crowns: a 10-year randomised controlled trial.

    Science.gov (United States)

    Vigolo, Paolo; Mutinelli, Sabrina; Givani, Andrea; Stellini, Edoardo

    2012-01-01

    The purpose of this randomised controlled trial was to compare the long-term clinical outcome of cemented and screw-retained implant-supported single-tooth crowns. Eighteen consecutive patients presenting with single-tooth bilateral edentulous sites in the canine/molar region with adequate bone width, similar bone height at the implant sites, and an occlusal scheme that allowed for the establishment of identical occlusal cusp/fossa contacts were treated. Each patient received two identical implants according to a split-mouth design. One side was randomly selected to be restored with a cemented implant-supported single crown, and the other was restored with a screw-retained implant-supported single crown. Outcome measures were implant success, complications, marginal bone levels and peri-implant soft tissue health. Ten years after initial loading, 2 patients moved away and were lost to follow-up. Two implants placed in the same patient failed 5 years after their insertion; the remaining 30 implants survived, resulting in a cumulative implant success rate of 93.7%. No complication occurred. The mean marginal bone resorption at 10 years after implant placement, measured on intraoral radiographs, was 1.1 ± 0.2 mm for both types of restorations. There were no statistically significant differences between the two groups with respect to peri-implant marginal bone level at the 10-year follow-up appointment (T2) (P = 0.58); at the 4-year follow-up appointment (T1) a statistically significant difference was observed (P = 0.01), but this was not considered clinically relevant (mean difference: -0.06 mm). The status of the soft tissue around the implants remained stable over the evaluation period. No statistically significant difference was identified for the facial keratinised gingiva between the two groups at T1 (P = 0.10) or at T2 (P = 0.07). Within the limitations of this study, the results indicate that there was no evidence of a significant difference in the clinical

  1. Interoperability of clinical decision-support systems and electronic health records using archetypes: a case study in clinical trial eligibility.

    Science.gov (United States)

    Marcos, Mar; Maldonado, Jose A; Martínez-Salvador, Begoña; Boscá, Diego; Robles, Montserrat

    2013-08-01

    Clinical decision-support systems (CDSSs) comprise systems as diverse as sophisticated platforms to store and manage clinical data, tools to alert clinicians of problematic situations, or decision-making tools to assist clinicians. Irrespective of the kind of decision-support task CDSSs should be smoothly integrated within the clinical information system, interacting with other components, in particular with the electronic health record (EHR). However, despite decades of developments, most CDSSs lack interoperability features. We deal with the interoperability problem of CDSSs and EHRs by exploiting the dual-model methodology. This methodology distinguishes a reference model and archetypes. A reference model is represented by a stable and small object-oriented model that describes the generic properties of health record information. For their part, archetypes are reusable and domain-specific definitions of clinical concepts in the form of structured and constrained combinations of the entities of the reference model. We rely on archetypes to make the CDSS compatible with EHRs from different institutions. Concretely, we use archetypes for modelling the clinical concepts that the CDSS requires, in conjunction with a series of knowledge-intensive mappings relating the archetypes to the data sources (EHR and/or other archetypes) they depend on. We introduce a comprehensive approach, including a set of tools as well as methodological guidelines, to deal with the interoperability of CDSSs and EHRs based on archetypes. Archetypes are used to build a conceptual layer of the kind of a virtual health record (VHR) over the EHR whose contents need to be integrated and used in the CDSS, associating them with structural and terminology-based semantics. Subsequently, the archetypes are mapped to the EHR by means of an expressive mapping language and specific-purpose tools. We also describe a case study where the tools and methodology have been employed in a CDSS to support

  2. A randomized controlled trial of a modified wheelchair arm-support to reduce shoulder pain in stroke patients

    Science.gov (United States)

    Pan, Ruihuan; Zhou, Mingchao; Cai, Hao; Guo, Youhua; Zhan, Lechang; Li, Mei; Yang, Zhijing; Zhu, Leying; Zhan, Jie; Chen, Hongxia

    2017-01-01

    Objective: To evaluate the effect of modified wheelchair arm-support to mitigate hemiplegic shoulder pain and reduce pain frequency in stroke patients. Design: A single-blind randomized controlled trial using computer-generated simple randomization. Setting: Participants recruited from inpatients at the Guangdong Provincial Hospital of Chinese Medicine. Subjects: A total of 120 patients with stroke were divided into two groups. Interventions: All subjects underwent basic rehabilitation training and wheelchair assistance with eight weeks follow-up period. Patients in the treatment group additionally received modified wheelchair arm-support for at least 60 minutes a day, six days a week, for four weeks. Outcome measures: Primary outcome was measured by the Visual Analogue Pain Scale or Numeric Pain Rating Scale. Secondary outcome was measured using the Upper Extremity Fugl-Meyer Assessment scale, Modified Barthel Index and Quality of Life Index. Measurements were made at 4 weeks and 12 weeks, following the intervention. Results: Patients age from 21 to 83 years (mean ± SD = 62.41 ± 12.26). The average duration of disease was 1.9 ± 1.3 months. At four weeks, the median of pain intensity was higher in the control group (median, interquartile range = 3, 5.75 vs. 2, 3.75; P = 0.059). At 12 weeks, the median of pain intensity was higher in the control group (median, interquartile range = 3, 5.00 vs. 0, 1.00; P < 0.001). At 12 weeks, patients with shoulder pain were higher in the control group (6 vs. 1; P < 0.05). Conclusion: Using the modified wheelchair arm-support could lead to the mitigation of hemiplegic shoulder pain and reduction in pain incidence in stroke patients. It may also improve the patients’ quality of life. PMID:28629270

  3. Randomized Clinical Trial of Implant-Supported Ceramic-Ceramic and Metal-Ceramic Fixed Dental Prostheses: Preliminary Results

    Science.gov (United States)

    Esquivel-Upshaw, Josephine F.; Clark, Arthur E.; Shuster, Jonathan J.; Anusavice, Kenneth J.

    2013-01-01

    Purpose The aim of this study was to determine the survival rates over time of implant-supported ceramic-ceramic and metal-ceramic prostheses as a function of core-veneer thickness ratio, gingival connector embrasure design, and connector height. Materials and Methods An IRB-approved, randomized, controlled clinical trial was conducted as a single-blind pilot study involving 55 patients missing three teeth in either one or two posterior areas. These patients (34 women; 21 men; age range 52–75 years) were recruited for the study to receive a 3-unit implant-supported fixed dental prosthesis (FDP). Two implants were placed for each of the 72 FDPs in the study. The implants (Osseospeed, Astra Tech), which were made of titanium, were grit blasted. A gold-shaded, custom-milled titanium abutment (Atlantis, Astra Tech), was secured to each implant body. Each of the 72 FDPs in 55 patients were randomly assigned based on one of the following options: (1) A. Material: ceramic-ceramic (Yttria-stabilized zirconia core, pressable fluorapatite glass-ceramic, IPS e.max ZirCAD and ZirPress, Ivoclar Vivadent) B. metal-ceramic (palladium-based noble alloy, Capricorn, Ivoclar Vivadent, with press-on leucite-reinforced glass-ceramic veneer, IPS InLine POM, Ivoclar Vivadent); (2) occlusal veneer thickness (0.5, 1.0, and 1.5 mm); (3) curvature of gingival embrasure (0.25, 0.5, and 0.75 mm diameter); and (4) connector height (3, 4, and 5 mm). FDPs were fabricated and cemented with dual-cure resin cement (RelyX, Universal Cement, 3M ESPE). Patients were recalled at 6 months, 1 year, and 2 years. FDPs were examined for cracks, fracture, and general surface quality. Results Recall exams of 72 prostheses revealed 10 chipping fractures. No fractures occurred within the connector or embrasure areas. Two-sided Fisher’s exact tests showed no significant correlation between fractures and type of material system (p = 0.51), veneer thickness (p = 0.75), radius of curvature of gingival embrasure

  4. Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Christensen, Thomas Nordahl; Nielsen, Iben Gammelgaard; Stenager, Elsebeth; Morthorst, Britt Reuter; Lindschou, Jane; Nordentoft, Merete; Eplov, Lene Falgaard

    2015-06-21

    Individual Placement and Support (IPS) appears to be an effective vocational intervention for obtaining competitive employment for people with severe mental illness. However, no IPS studies or trials have been conducted in Denmark, a country characterized by a specialized labor market with a higher minimum wage and fewer entry-level jobs in comparison with other countries such as the US. Furthermore, long-term job retention and economic self-sufficiency have not been clearly demonstrated. Integrating methods such as cognitive remediation and work-related social skills training may be ways to address these issues. The trial design is an investigator-initiated, randomized, assessor-blinded, multi-center trial. A total of 750 patients with severe mental illness will be randomly assigned into three groups: (1) IPS, (2) IPS enhanced with cognitive remediation and work-related social skills training, and (3) service as usual. The primary outcome is number of hours in competitive employment or education at 18-month follow-up. Secondary and exploratory outcomes are money earned, days to first employment, symptoms, functional level, self-esteem, and self-efficacy at 18-month follow-up. Thirty- and 60-month follow-ups will be register-based. This will be one of the largest randomized trials investigating IPS to date. The trial will be conducted with high methodological quality in order to reduce the risk of bias. If the results of this trial show that IPS, or IPS enhanced with cognitive remediation and work-related social skills training, is superior to service as usual, this will support preliminary evidence. Furthermore, it will show that the method is generalizable to a variety of labor markets and welfare systems and provide important knowledge about the effect of adding cognitive remediation and social skills training to the IPS intervention. ClinicalTrials registration number: NCT01722344 (registered 2 Nov. 2012).

  5. Clinical Trials

    Science.gov (United States)

    ... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... by participating in a clinical trial is to science first and to the patient second. More About ...

  6. Randomized Controlled Trial of a Video Decision Support Tool for Cardiopulmonary Resuscitation Decision Making in Advanced Cancer

    Science.gov (United States)

    Volandes, Angelo E.; Paasche-Orlow, Michael K.; Mitchell, Susan L.; El-Jawahri, Areej; Davis, Aretha Delight; Barry, Michael J.; Hartshorn, Kevan L.; Jackson, Vicki Ann; Gillick, Muriel R.; Walker-Corkery, Elizabeth S.; Chang, Yuchiao; López, Lenny; Kemeny, Margaret; Bulone, Linda; Mann, Eileen; Misra, Sumi; Peachey, Matt; Abbo, Elmer D.; Eichler, April F.; Epstein, Andrew S.; Noy, Ariela; Levin, Tomer T.; Temel, Jennifer S.

    2013-01-01

    Purpose Decision making regarding cardiopulmonary resuscitation (CPR) is challenging. This study examined the effect of a video decision support tool on CPR preferences among patients with advanced cancer. Patients and Methods We performed a randomized controlled trial of 150 patients with advanced cancer from four oncology centers. Participants in the control arm (n = 80) listened to a verbal narrative describing CPR and the likelihood of successful resuscitation. Participants in the intervention arm (n = 70) listened to the identical narrative and viewed a 3-minute video depicting a patient on a ventilator and CPR being performed on a simulated patient. The primary outcome was participants' preference for or against CPR measured immediately after exposure to either modality. Secondary outcomes were participants' knowledge of CPR (score range of 0 to 4, with higher score indicating more knowledge) and comfort with video. Results The mean age of participants was 62 years (standard deviation, 11 years); 49% were women, 44% were African American or Latino, and 47% had lung or colon cancer. After the verbal narrative, in the control arm, 38 participants (48%) wanted CPR, 41 (51%) wanted no CPR, and one (1%) was uncertain. In contrast, in the intervention arm, 14 participants (20%) wanted CPR, 55 (79%) wanted no CPR, and 1 (1%) was uncertain (unadjusted odds ratio, 3.5; 95% CI, 1.7 to 7.2; P < .001). Mean knowledge scores were higher in the intervention arm than in the control arm (3.3 ± 1.0 v 2.6 ± 1.3, respectively; P < .001), and 65 participants (93%) in the intervention arm were comfortable watching the video. Conclusion Participants with advanced cancer who viewed a video of CPR were less likely to opt for CPR than those who listened to a verbal narrative. PMID:23233708

  7. Effects of pressure support ventilation mode on emergence time and intra-operative ventilatory function: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Xavier Capdevila

    Full Text Available We tested the hypothesis that pressure-support ventilation (PSV allows a reduction in emergence time and laryngeal mask airway (LMA removal time after general anesthesia compared to volume-controlled mechanical ventilation (CMV. Because spontaneous breathing (SB is often used with LMA under general anesthesia, patients were allocated randomly to three groups (CMV, SB and PSV. Thirty-six consecutive ASA I-II patients scheduled for knee arthroscopic surgery under general anesthesia with a LMA and breathing throughout the ventilator circuit were included. Hemodynamic and ventilatory variables were recorded before and 10-min after general anesthesia-induction, at the surgical incision, at the end of anaesthetic drugs infusion and when the patient was totally awake (which defines emergence time. LMA removal time, drug consumption were recorded at the end of the surgical procedure. Leak fraction around the LMA was also evaluated. LMA removal time was significantly higher in the CMV-group (18 ± 6 min compared to both SB (8 ± 4 min and PSV (7 ± 4 min, P < 0.05 groups as well as for emergence time: CMV-group (32 ± 12 min, SB (17 ± 7 min and PSV (13 ± 6 min, P < 0.05 groups. Total propofol consumption was significantly lower in the PSV-group (610 ± 180 mg than in both CMV (852 ± 330 mg and SB (734 ± 246 mg, P < 0.05 groups. Air leaks around the LMA was significantly higher in the CMV-group than in the SB and PSV groups (16% vs 3% and 7%, all P<0.05. In conclusion, in knee arthroscopic surgery, in comparison to CMV, PSV use during general anesthesia in unparalyzed patients decreases LMA removal time, propofol consumption and leaks around LMA while improving ventilatory variables without adverse effects.Controlled-Trials.com ISRCTN17382426.

  8. Effectiveness of a Group Support Lifestyle Modification (GSLiM Programme among Obese Adults in Workplace: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Siti Noraida Jamal

    weight self-efficacy, friend social support, and quality of life compared to dietary counseling.Iranian Registry of Clinical Trials IRCT201104056127N1.

  9. A randomized controlled clinical trial of edentulous patients treated with immediately loaded implant-supported mandibular fixed prostheses.

    Science.gov (United States)

    Alfadda, Sara Abdulaziz

    2014-12-01

    A 1-year blinded two-arm parallel randomized controlled clinical trial was conducted to test the null hypothesis that immediate loading of four dental implants between the mental foramina with a fixed prosthesis has no benefits compared with the conventional loading technique in terms of implant success and clinical function. Forty-five patients, completely edentulous in the mandibles seeking implant-supported prostheses at the Faculty of Dentistry, University of Toronto, were recruited. Four TiUnite dental implants (NobelBiocare®, Göteborg, Sweden) were placed following the one-stage surgical protocol. Immediately after surgery, the patients were randomly assigned to either study arms by a third independent party. In the experimental arm (EA), existing mandibular denture was converted into an interim implant-supported fixed bridge (ISFB) on the same day of surgery. In the control arm (CA), the mandibular denture was hollowed out and relined with a soft tissue reline. The implants were loaded with the permanent ISFB at least 3 months postsurgery. Patients were assessed by a calibrated independent investigator at 2, 6, and 12 months following completion of treatment. A total of one hundred sixty implants were placed. Due to anatomical limitations, one patient was excluded from the study. Four patients in the EA did not receive intervention as allocated and were transferred to the CA. Implant success rate was comparable between the two arms and exceeded 96%. Marginal bone loss was statistically significantly more in the immediate loading arm, -0.296 mm versus -0.037 mm (intention to treat: p = .002; per protocol: p = .021). The relatively early intervention and insertion of the final prosthesis in the immediate arm, when bone healing and remodeling process had not yet been completed, might explain the difference in the amount of bone loss. Immediate loading of four dental implants with a fixed prosthesis in the edentulous mandible is a feasible treatment option

  10. Effectiveness of personalised feedback alone or combined with peer support to improve physical activity in sedentary older Malays with type 2 diabetes: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Shariff-Ghazali eSazlina

    2015-07-01

    Full Text Available Introduction: Regular physical activity is an important aspect of self management among older people with type 2 diabetes but many remain inactive. Interventions to improve physical activity levels have been studied but few studies have evaluated the effects of personalised feedback or peer support; and there was no study on older people of Asian heritage. Hence, this trial evaluated whether personalised feedback (PF only or combined with peer support (PS improves physical activity among older Malays with type 2 diabetes (T2DM compared to usual care only. Materials and methods: A three arm randomised controlled trial was conducted in a primary healthcare clinic in Malaysia. 69 sedentary Malays aged 60 years and older with T2DM who received usual diabetes care were randomised to PF or PS interventions or as controls for 12 weeks with follow-ups at weeks 24 and 36. Intervention groups performed unsupervised walking activity and received written feedback on physical activity. The PS group also received group and telephone contacts from trained peer mentors. The primary outcome was pedometer steps. Secondary outcomes were self-reported physical activity, cardiovascular risk factors, cardiorespiratory fitness, balance, quality of life and psychosocial wellbeing. Results: 52 (75.4% completed the 36-week study. The PS group showed greater daily pedometer readings than the PF and controls (p=0.001. The PS group also had greater improvement in weekly duration (p<0.001 and frequency (p<0.001 of moderate intensity physical activity, scores on the Physical Activity Scale for Elderly (p=0.003, six minute walk test (p<0.001 and social support from friends (p=0.032 than PF and control groups. Conclusions: The findings suggest personalised feedback combined with peer support in older Malays with T2DM improved their physical activity levels, cardiorespiratory fitness and support from friends. Trial registration: Current Controlled Trials ISRCTN71447000.

  11. TU-G-BRB-01: Topic Introduction: Do We Need Clinical Trials in Particle Therapy and How Can Medical Physics Support Them?

    Energy Technology Data Exchange (ETDEWEB)

    Schulte, R. [Loma Linda Univ. (United States)

    2015-06-15

    Proton therapy, in particular, and ion therapy, just beginning, are becoming an increasing focus of attention in clinical radiation oncology and medical physics. Both modalities have been criticized of lacking convincing evidence from randomized trials proving their efficacy, justifying the higher costs involved in these therapies. This session will provide an overview of the current status of clinical trials in proton therapy, including recent developments in ion therapy. As alluded to in the introductory talk by Dr. Schulte, opinions are diverging widely as to the usefulness and need for clinical trials in particle therapy and the challenge of equipoise. The lectures will highlight some of the challenges that surround clinical trials in particle therapy. One, presented by Dr. Choy from UT Southwestern, is that new technology and even different types of particles such as helium and carbon ions are introduced into this environment, increasing the phase space of clinical variables. The other is the issue of medical physics quality assurance with physical phantoms, presented by Mrs. Taylor from IROC Houston, which is more challenging because 3D and 4D image guidance and active delivery techniques are in relatively early stages of development. The role of digital phantoms in developing clinical treatment planning protocols and as a QA tool will also be highlighted by Dr. Lee from NCI. The symposium will be rounded off by a panel discussion among the Symposium speakers, arguing pro or con the need and readiness for clinical trials in proton and ion therapy. Learning Objectives: To get an update on the current status of clinical trials allowing or mandating proton therapy. Learn about the status of planned clinical trials in the U.S. and worldwide involving ion therapy. Discuss the challenges in the design and QA of clinical trials in particle therapy. Learn about existing and future physical and computational anthropomorphic phantoms for charged particle clinical trial

  12. Measurement of adherence in a randomised controlled trial of a complex intervention: supported self-management for adults with learning disability and type 2 diabetes.

    Science.gov (United States)

    Graham, Liz; Wright, Judy; Walwyn, Rebecca; Russell, Amy M; Bryant, Louise; Farrin, Amanda; House, Allan

    2016-10-06

    Reporting adherence to intervention delivery and uptake is a detailed way of describing what was actually delivered and received, in comparison to what was intended. Measuring and reporting adherence is not routinely done well in complex interventions. The OK Diabetes trial (ISRCTN41897033) aimed to develop and subsequently test the feasibility of implementing a supported self-management intervention in adults with a learning disability and type 2 diabetes. A key study objective was to develop a measure of adherence to the intervention. We conducted a systematic review of published literature, extracting data from included papers using a standardised proforma. We undertook a narrative synthesis of papers to determine the form and content of methods for adherence measurement for self-management interventions in this population that had already been developed. We used the framework and data extraction form developed for the review as the basis for an adherence measurement tool that we applied in the OK Diabetes trial. The literature review found variability in the quality and content of adherence measurement and reporting, with no standardised approach. We were able to develop an adherence measure based upon the review, and populate it with data collected during the OK Diabetes trial. The adherence tool proved satisfactory for recording and measuring adherence in the trial. There remains a need for a standardised approach to adherence measurement in the field of complex interventions. We have shown that it is possible to produce a simple, feasible measure for assessing adherence in the OK Diabetes trial.

  13. Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial

    OpenAIRE

    2006-01-01

    Objective To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in the development of new pressure ulcers, healing of existing pressure ulcers, and patient acceptability. Design Pragmatic, open, multicentre, randomised controlled trial. Setting 11 hospitals in six NHS trusts. Participants 1972 people admitted to hospital as acute or elective patients. Interventions Participants were randomised to an alternating pressure mattress (n = 98...

  14. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  15. Work-focused cognitive-behavioural therapy and individual job support to increase work participation in common mental disorders: a randomised controlled multicentre trial

    OpenAIRE

    Reme, Silje Endresen; Grasdal, Astrid Louise; Løvvik, Camilla; Lie, Stein Atle; Øverland, Simon Nygaard

    2015-01-01

    Objectives Common mental disorders (CMDs) are a major cause of rising disability benefit expenditures. We urgently need evidence on programmes that can increase work participation in CMDs. The aim of this study was to evaluate the effectiveness of work-focused cognitive–behavioural therapy (CBT) and individual job support for people struggling with work participation due to CMDs. Methods A randomised controlled multicentre trial (RCT) including 1193 participants was conducted. Participants we...

  16. Process Evaluation of a Randomized Controlled Trial of Group Support Psychotherapy for Depression Treatment Among People with HIV/AIDS in Northern Uganda

    OpenAIRE

    Nakimuli-Mpungu, Etheldreda; Wamala, Kizito; Okello, James; Ndyanabangi, Sheila; Kanters, Steve; Mojtabai, Ramin; Nachega, Jean B.; Mills, Edward J.; Musisi, Seggane

    2017-01-01

    We describe the process evaluation for a randomized controlled trial that compared group support psychotherapy (GSP) with group HIV education for treatment of depression among people with HIV. Process data were obtained using mixed methods. Variables evaluated were indicators of feasibility and acceptability; causal mediating processes and contextual influences. GSP was feasible and acceptable. Potential mediating variables between GSP and reduction of depression were improved emotional and s...

  17. A review of randomized controlled trials of medical record powered clinical decision support system to improve quality of diabetes care.

    Science.gov (United States)

    Ali, Syed Mustafa; Giordano, Richard; Lakhani, Saima; Walker, Dawn Marie

    2016-03-01

    A gap between current diabetes care practice and recommended diabetes care standards has consistently been reported in the literature. Many IT-based interventions have been developed to improve adherence to the quality of care standards for chronic illness like diabetes. The widespread implementation of electronic medical/health records has catalyzed clinical decision support systems (CDSS) which may improve the quality of diabetes care. Therefore, the objective of the review is to evaluate the effectiveness of CDSS in improving quality of type II diabetes care. Moreover, the review aims to highlight the key indicators of quality improvement to assist policy makers in development of future diabetes care policies through the integration of information technology and system. Setting inclusion criteria, a systematic literature search was conducted using Medline, Web of Science and Science Direct. Critical Appraisal Skills Programme (CASP) tools were used to evaluate the quality of studies. Eight randomized controlled trials (RCTs) were selected for the review. In the selected studies, seventeen clinical markers of diabetes care were discussed. Three quality of care indicators were given more importance in monitoring the progress of diabetes care, which is consistent with National Institute for Health and Care Excellence (NICE) guidelines. The presence of these indicators in the studies helped to determine which studies were selected for review. Clinical- and process-related improvements are compared between intervention group using CDSS and control group with usual care. Glycated hemoglobin (HbA1c), low density lipid cholesterol (LDL-C) and blood pressure (BP) were the quality of care indicators studied at the levels of process of care and clinical outcome. The review has found both inconsistent and variable results for quality of diabetes care measures. A significant improvement has been found in the process of care for all three measures of quality of diabetes care

  18. Publication Speed, Reporting Metrics, and Citation Impact of Cardiovascular Trials Supported by the National Heart, Lung, and Blood Institute

    Science.gov (United States)

    Gordon, David; Cooper-Arnold, Katharine; Lauer, Michael

    2015-01-01

    Background We previously demonstrated that cardiovascular (CV) trials funded by the National Heart, Lung, and Blood Institute (NHLBI) were more likely to be published in a timely manner and receive high raw citation counts if they focused on clinical endpoints. We did not examine the metrics of trial reports, and our citation measures were limited by failure to account for topic-related citation behaviors. Methods and Results Of 244 CV trials completed between 2000 and 2011, we identified 184 whose main results were published by August 20, 2014. One investigator who was blinded to rapidity of publication and citation data read each publication and characterized it according to modified Delphi criteria. There were 46 trials (25%) that had Delphi scores of 8 or 9 (of a possible 9); these trials published faster (median time from trial completion to publication, 12.6 [interquartile range {IQR}, 6.7 to 23.3] vs. 21.8 [IQR, 12.1 to 34.9] months; Pcitation impact (median citation percentile for topic and date of publication, with 0 best and 100 worst, 1.92 [IQR, 0.64 to 7.83] vs. 8.41 [IQR, 1.80 to 24.75]; P=0.002). By random forest regression, we found that the 3 most important predictors of normalized citation percentile values were total costs, intention-to-treat analyses (as a modified Delphi quality measure), and focus on clinical (not surrogate) endpoints. Conclusions NHLBI CV trials were more likely to publish results quickly and yield higher topic-normalized citation impact if they reported results according to well-defined metrics, along with focus on clinical endpoints. PMID:26231845

  19. Publication Speed, Reporting Metrics, and Citation Impact of Cardiovascular Trials Supported by the National Heart, Lung, and Blood Institute.

    Science.gov (United States)

    Gordon, David; Cooper-Arnold, Katharine; Lauer, Michael

    2015-07-31

    We previously demonstrated that cardiovascular (CV) trials funded by the National Heart, Lung, and Blood Institute (NHLBI) were more likely to be published in a timely manner and receive high raw citation counts if they focused on clinical endpoints. We did not examine the metrics of trial reports, and our citation measures were limited by failure to account for topic-related citation behaviors. Of 244 CV trials completed between 2000 and 2011, we identified 184 whose main results were published by August 20, 2014. One investigator who was blinded to rapidity of publication and citation data read each publication and characterized it according to modified Delphi criteria. There were 46 trials (25%) that had Delphi scores of 8 or 9 (of a possible 9); these trials published faster (median time from trial completion to publication, 12.6 [interquartile range {IQR}, 6.7 to 23.3] vs. 21.8 [IQR, 12.1 to 34.9] months; Pcitation impact (median citation percentile for topic and date of publication, with 0 best and 100 worst, 1.92 [IQR, 0.64 to 7.83] vs. 8.41 [IQR, 1.80 to 24.75]; P=0.002). By random forest regression, we found that the 3 most important predictors of normalized citation percentile values were total costs, intention-to-treat analyses (as a modified Delphi quality measure), and focus on clinical (not surrogate) endpoints. NHLBI CV trials were more likely to publish results quickly and yield higher topic-normalized citation impact if they reported results according to well-defined metrics, along with focus on clinical endpoints. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  20. Effects of a standard provision versus an autonomy supportive exercise referral programme on physical activity, quality of life and well-being indicators: a cluster randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background The National Institute for Health and Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the feasibility and impact of a Self Determination Theory-based (SDT) exercise referral consultation. Methods An exploratory cluster randomised controlled trial comparing standard provision exercise referral with an exercise referral intervention grounded in Self Determination Theory. Individuals (N = 347) referred to an exercise referral scheme were recruited into the trial from 13 centres. Outcomes and processes of change measured at baseline, 3 and 6-months: Minutes of self-reported moderate or vigorous physical activity (PA) per week (primary outcome), health status, positive and negative indicators of emotional well-being, anxiety, depression, quality of life (QOL), vitality, and perceptions of autonomy support from the advisor, need satisfaction (3 and 6 months only), intentions to be active, and motivational regulations for exercise. Blood pressure and weight were assessed at baseline and 6 months. Results Perceptions of the autonomy support provided by the health and fitness advisor (HFA) did not differ by arm. Between group changes over the 6-months revealed significant differences for reported anxiety only. Within arm contrasts revealed significant improvements in anxiety and most of the Dartmouth CO-OP domains in the SDT arm at 6 months, which were not seen in the standard exercise referral group. A process model depicting hypothesized relationships between advisor autonomy support, need satisfaction and more autonomous motivation, enhanced well being and PA engagement at follow up was supported. Conclusions Significant gains in physical activity and improvements in quality of life and well-being outcomes emerged

  1. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial).

    Science.gov (United States)

    Anstey, Matthew H; Wibrow, Bradley; Thevathasan, Tharusan; Roberts, Brigit; Chhangani, Khushi; Ng, Pauline Yeung; Levine, Alexander; DiBiasio, Alan; Sarge, Todd; Eikermann, Matthias

    2017-03-21

    Patients admitted to intensive care units (ICU) are often treated with intravenous (IV) vasopressors. Persistent hypotension and dependence on IV vasopressors in otherwise resuscitated patients lead to delay in discharge from ICU. Midodrine is an oral alpha-1 adrenergic agonist approved for treatment of symptomatic orthostatic hypotension. This trial aims to evaluate whether oral administration of midodrine is an effective adjunct to standard therapy to reduce the duration of IV vasopressor treatment, and allow earlier discharge from ICU and hospital. The MIDAS trial is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial being conducted in the USA and Australia. We are targeting 120 patients. Adult patients admitted to the ICU who are resuscitated and otherwise stable on low dose IV vasopressors for at least 24 h will be considered for recruitment. Participants will be randomized to receive midodrine (20 mg) or placebo three times a day, in addition to standard care. The primary outcome is time (hours) from initiation of midodrine or placebo to discontinuation of IV vasopressors. Secondary outcomes include time (hours) from ICU admission to discharge readiness, ICU length of stay (LOS) (days), hospital LOS (days), rates of ICU readmission, and rates of adverse events related to midodrine administration. Midodrine is approved by the Food and Drug Administration (FDA) for the treatment of symptomatic orthostatic hypotension. In August 2010, FDA proposed to withdraw approval of midodrine because of lack of studies that verify the clinical benefit of the drug. We obtained Investigational New Drug (IND 113,330) approval to study its effects in critically ill patients who require IV vasopressors but are otherwise ready for discharge from the ICU. A pilot observational study in a cohort of surgical ICU patients showed that the rate of decline in vasopressor requirements increased after initiation of midodrine treatment. We

  2. Home-based exercise and support programme for people with dementia and their caregivers: study protocol of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Prick Anna-Eva

    2011-11-01

    Full Text Available Abstract Background Dementia affects the mood of people with dementia but also of their caregivers. In the coming years, the number of people with dementia will increase worldwide and most of them will continue to live in the community as long as possible. Home-based psychosocial interventions reducing the depressive symptoms of both people with dementia and their caregivers in their own home are highly needed. Methods/Design This manuscript describes the design of a Randomised Controlled Trial (RCT of the effects of a home-based exercise and support programme for people with dementia and their caregivers. The aim is to randomly assign 156 dyads (caregiver and dementia diagnosed person to an intervention group or a comparison group. The experimental group receives a home programme in which exercise and support for the people with dementia and their caregivers are combined and integrated. The comparison group receives a minimal intervention. Primary outcomes are physical health (people with dementia and mood (people with dementia and caregivers. In addition, to get more insight in the working components of the intervention and the impact of the intervention on the relationship of the dyads a qualitative sub-study is carried out. Discussion This study aims to contribute to an evidence-based treatment to reduce depressive symptoms among people with dementia and their caregivers independently living in the community. Trial Registration The study has been registered at the Netherlands National Trial Register (NTR, which is connected to the International Clinical Trials Registry Platform of the WHO. Trial number: NTR1802.

  3. Effectiveness of a Peer Support Programme versus Usual Care in Disease Management of Diabetes Mellitus Type 2 regarding Improvement of Metabolic Control: A Cluster-Randomised Controlled Trial.

    Science.gov (United States)

    Johansson, Tim; Keller, Sophie; Winkler, Henrike; Ostermann, Thomas; Weitgasser, Raimund; Sönnichsen, Andreas C

    2016-01-01

    Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n = 337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI -0.08 to 0.36%, p = 0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p = 0.046) compared to the intervention group. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077).

  4. Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial.

    Science.gov (United States)

    Hudson, Joanna L; Moss-Morris, Rona; Norton, Sam; Picariello, Federica; Game, David; Carroll, Amy; Spencer, Jonathan; McCrone, Paul; Hotopf, Matthew; Yardley, Lucy; Chilcot, Joseph

    2017-11-01

    Psychological distress is prevalent in haemodialysis (HD) patients yet access to psychotherapy remains limited. This study assessed the feasibility and acceptability of online cognitive-behavioural therapy (CBT) tailored for HD patients, with or without therapist support, for managing psychological distress. This feasibility randomised controlled trial recruited patients from a UK HD centre. Following psychological distress screens, patients with mild-moderate psychological distress (Patient Health Questionnaire PHQ-9; score: 5-19 and/or Generalised Anxiety Disorder; GAD-7 score: 5-14) who met remaining inclusion criteria were approached for consent. Consenters were individually randomised (1:1) to online-CBT or online-CBT plus three therapist support calls. Outcomes included recruitment, retention, and adherence rates. Exploratory change analyses were performed for: psychological distress, quality of life (QoL), illness perceptions, and costs. The statistician was blinded to allocation. 182 (44%) out of 410 patients approached completed psychological distress screens. 26% found screening unacceptable; a further 30% found it unfeasible. Psychological distress was detected in 101 (55%) patients, 60 of these met remaining inclusion criteria. The primary reason for ineligibility was poor computer literacy (N=17, 53%). Twenty-five patients were randomised to the supported (N=18) or unsupported arm (N=7); 92% were retained at follow-up. No differences in psychological distress or cost-effectiveness were observed. No trial adverse events occurred. Online CBT appears feasible but only for computer literate patients who identify with the label psychological distress. A definitive trial using the current methods for psychological distress screening and online care delivery is unfeasible. ClinicalTrials.gov Identifier: NCT02352870. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. The role of perceived social support after psychiatric hospitalisation: Post hoc analysis of a randomised controlled trial testing the effectiveness of a transitional intervention.

    Science.gov (United States)

    Hengartner, Michael P; Passalacqua, Silvia; Andreae, Andreas; Rössler, Wulf; von Wyl, Agnes

    2017-06-01

    The association between social support, readmissions and psychopathology following discharge from psychiatric hospitals is not clear. To examine the prospective effects of perceived social support on rehospitalisation rates and psychopathology and to focus on the moderators of a transitional intervention. This post hoc analysis of a multisite randomised controlled trial included 151 patients with no more than three hospitalisations within the last 3 years, a Global Assessment of Functioning (GAF) score ≤60 and aged 18-64 years, assessed at two psychiatric hospitals from Zurich, Switzerland, between September 2011 and February 2014. Participants received either a transitional intervention aimed at improving social support during the transition from inpatient to outpatient care provided by a social worker or treatment as usual. Lack of perceived social support at discharge significantly predicted subsequent rehospitalisation rates and increased psychopathological impairment across 12-month follow-up. Significant interaction effects between patient characteristics and the intervention on perceived social support comprised living at parent's home, having no children and being of younger age. Perceived social support at discharge from inpatient care may reduce rehospitalisation rates and psychopathological impairment in the long term. A transitional intervention aimed at improving social support may negatively impact on the perceived social support in some patient groups.

  6. A randomized clinical trial of diabetes self-management for Mexican Americans: Are there serendipitous health benefits for supporters of study participants?

    Directory of Open Access Journals (Sweden)

    Sharon A Brown

    2017-01-01

    Full Text Available Objectives: Studies of social support in diabetes have focused on the effects of support on the person with type 2 diabetes. We explored diabetes prevention effects of a culturally tailored diabetes self-management intervention in individuals without diabetes who were supporters of intervention participants. Methods: This is a secondary analysis of data from a randomized clinical trial that involved 256 Mexican Americans with diabetes. Each study participant designated a supporter—spouse, relative, friend—who attended intervention sessions and assisted participants in attaining effective diabetes self-management. Supporter’s glycosylated hemoglobin (A1C data were tracked for 1 year to determine diabetes conversion rates in supporters without diabetes at baseline. Results: Fewer individuals in the intervention group (n = 9 converted to an A1C above the 7% threshold, compared to the 1-year wait-listed control group (n = 16. We found a statistically significant difference (p = .021 at 12 months in the number of individuals whose A1C was ⩽8%, with fewer supporters above threshold in the intervention group (reduction of 48%. Supporters in the intervention group with prediabetes, based on baseline A1C, experienced a slight reduction in A1C, while control group supporters with prediabetes experienced an increase. Discussion: The results suggest that there are potential benefits for family members and other supporters of persons with diabetes who participated in diabetes self-management programs.

  7. HealthMap: a cluster randomised trial of interactive health plans and self-management support to prevent coronary heart disease in people with HIV.

    Science.gov (United States)

    Dodson, Sarity; Klassen, Karen M; McDonald, Karalyn; Millard, Tanya; Osborne, Richard H; Battersby, Malcolm W; Fairley, Christopher K; Simpson, Julie A; Lorgelly, Paula; Tonkin, Andrew; Roney, Janine; Slavin, Sean; Sterjovski, Jasminka; Brereton, Margot; Lewin, Sharon R; Crooks, Levinia; Watson, Jo; Kidd, Michael R; Williams, Irith; Elliott, Julian H

    2016-03-05

    The leading causes of morbidity and mortality for people in high-income countries living with HIV are now non-AIDS malignancies, cardiovascular disease and other non-communicable diseases associated with ageing. This protocol describes the trial of HealthMap, a model of care for people with HIV (PWHIV) that includes use of an interactive shared health record and self-management support. The aims of the HealthMap trial are to evaluate engagement of PWHIV and healthcare providers with the model, and its effectiveness for reducing coronary heart disease risk, enhancing self-management, and improving mental health and quality of life of PWHIV. The study is a two-arm cluster randomised trial involving HIV clinical sites in several states in Australia. Doctors will be randomised to the HealthMap model (immediate arm) or to proceed with usual care (deferred arm). People with HIV whose doctors are randomised to the immediate arm receive 1) new opportunities to discuss their health status and goals with their HIV doctor using a HealthMap shared health record; 2) access to their own health record from home; 3) access to health coaching delivered by telephone and online; and 4) access to a peer moderated online group chat programme. Data will be collected from participating PWHIV (n = 710) at baseline, 6 months, and 12 months and from participating doctors (n = 60) at baseline and 12 months. The control arm will be offered the HealthMap intervention at the end of the trial. The primary study outcomes, measured at 12 months, are 1) 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by a Framingham Heart Study risk equation; and 2) Positive and Active Engagement in Life Scale from the Health Education Impact Questionnaire (heiQ). The study will determine the viability and utility of a novel technology-supported model of care for maintaining the health and wellbeing of people with HIV. If shown to be effective, the HealthMap model

  8. Effectiveness of one-to-one peer support for patients with severe mental illness - a randomised controlled trial.

    Science.gov (United States)

    Mahlke, C I; Priebe, S; Heumann, K; Daubmann, A; Wegscheider, K; Bock, T

    2017-05-01

    One-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments. This is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years' duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations. Patients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses. The findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  9. Randomised controlled trials cited in pharmaceutical advertisements targeting New Zealand health professionals: do they support the advertising claims and what is the risk of bias?

    Science.gov (United States)

    Ma, Alison; Parkin, Lianne

    2015-09-04

    To determine whether pharmaceutical advertisement claims targeting health professionals were supported by the randomised controlled trials (RCTs) cited in the advertisements, and to assess the risk of bias in those trials. Pharmaceutical advertisements were obtained from New Zealand Doctor and Pharmacy Today for the period July 2013 to June 2014. All claims made regarding efficacy, safety, and indications were identified and RCTs cited to substantiate these claims were examined. A claim was defined as supported by an RCT if the conclusions drawn in the paper were consistent with the claim. The quality of the RCT was assessed separately, using the Cochrane Risk of Bias Assessment Tool. In 25 (19%) of the 133 instances in which an RCT was cited, the published paper did not support the promotional claim. Moreover, there were only 10 (8%) instances in which the claim was supported by an RCT with a low risk of bias. Of the 78 cited RCTs, only 14% had a low risk of bias, while 49% had an unclear risk and 37% had a high risk. A high proportion of advertisements failed to meet New Zealand regulatory requirements that claims "are valid and have been substantiated".

  10. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Science.gov (United States)

    2012-12-17

    ... drug applications (NDAs) and biologics license applications (BLAs). This document defines several types... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm... applications (BLAs). Similar approaches could be used in clinical trials in earlier phases of drug development...

  11. A cluster randomized controlled platform trial comparing group MEmory specificity training (MEST) to group psychoeducation and supportive counselling (PSC) in the treatment of recurrent depression.

    Science.gov (United States)

    Werner-Seidler, Aliza; Hitchcock, Caitlin; Bevan, Anna; McKinnon, Anna; Gillard, Julia; Dahm, Theresa; Chadwick, Isobel; Panesar, Inderpal; Breakwell, Lauren; Mueller, Viola; Rodrigues, Evangeline; Rees, Catrin; Gormley, Siobhan; Schweizer, Susanne; Watson, Peter; Raes, Filip; Jobson, Laura; Dalgleish, Tim

    2018-06-01

    Impaired ability to recall specific autobiographical memories is characteristic of depression, which when reversed, may have therapeutic benefits. This cluster-randomized controlled pilot trial investigated efficacy and aspects of acceptability, and feasibility of MEmory Specificity Training (MEST) relative to Psychoeducation and Supportive Counselling (PSC) for Major Depressive Disorder (N = 62). A key aim of this study was to determine a range of effect size estimates to inform a later phase trial. Assessments were completed at baseline, post-treatment and 3-month follow-up. The cognitive process outcome was memory specificity. The primary clinical outcome was symptoms on the Beck Depression Inventory-II at 3-month follow-up. The MEST group demonstrated greater improvement in memory specificity relative to PSC at post-intervention (d = 0.88) and follow-up (d = 0.74), relative to PSC. Both groups experienced a reduction in depressive symptoms at 3-month follow-up (d = 0.67). However, there was no support for a greater improvement in depressive symptoms at 3 months following MEST relative to PSC (d = -0.04). Although MEST generated changes on memory specificity and improved depressive symptoms, results provide no indication that MEST is superior to PSC in the resolution of self-reported depressive symptoms. Implications for later-phase definitive trials of MEST are discussed. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Home-based exercise and support programme for people with dementia and their caregivers: study protocol of a randomised controlled trial.

    Science.gov (United States)

    Prick, Anna-Eva; de Lange, Jacomine; Scherder, Erik; Pot, Anne Margriet

    2011-11-25

    Dementia affects the mood of people with dementia but also of their caregivers. In the coming years, the number of people with dementia will increase worldwide and most of them will continue to live in the community as long as possible. Home-based psychosocial interventions reducing the depressive symptoms of both people with dementia and their caregivers in their own home are highly needed. This manuscript describes the design of a Randomised Controlled Trial (RCT) of the effects of a home-based exercise and support programme for people with dementia and their caregivers. The aim is to randomly assign 156 dyads (caregiver and dementia diagnosed person) to an intervention group or a comparison group. The experimental group receives a home programme in which exercise and support for the people with dementia and their caregivers are combined and integrated. The comparison group receives a minimal intervention. Primary outcomes are physical health (people with dementia) and mood (people with dementia and caregivers). In addition, to get more insight in the working components of the intervention and the impact of the intervention on the relationship of the dyads a qualitative sub-study is carried out. This study aims to contribute to an evidence-based treatment to reduce depressive symptoms among people with dementia and their caregivers independently living in the community. The study has been registered at the Netherlands National Trial Register (NTR), which is connected to the International Clinical Trials Registry Platform of the WHO. NTR1802.

  13. An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks. Subsequent support is available on request from staff in community clinics and from a telephone helpline. The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0–6 months versus a single home-visit together with subsequent standard services (the latter support was available to mothers in both study groups). Methods/Design The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups. Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide. Mothers were excluded if they did not have internet access, required an interpreter, or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse. Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units (this was done by administrative staff who had no involvement in recruiting mothers, delivering the intervention, or analyzing results for the study). Consistent with design and power calculations, 819 mothers were recruited to the trial. The primary outcomes for the trial are parents’ sense of competence and self-efficacy measured using standard self-report questionnaires. Secondary outcomes include the quality of mother-infant relationships, maternal social support, role satisfaction and maternal mental health, infant social-emotional and language development, and patterns of service utilisation. Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged <2 months

  14. Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

    Science.gov (United States)

    Robertson, Jane; McNamee, Phillip; Molloy, Gerry; Hubbard, Gill; McNeill, Alan; Bollina, Prasad; Kelly, Daniel; Forbat, Liz

    2016-08-01

    Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this

  15. High-Flow Nasal Cannula versus Nasal Continuous Positive Airway Pressure for Primary Respiratory Support in Preterm Infants with Respiratory Distress: A Randomized Controlled Trial.

    Science.gov (United States)

    Murki, Srinivas; Singh, Jayesh; Khant, Chiragkumar; Kumar Dash, Swarup; Oleti, Tejo Pratap; Joy, Percy; Kabra, Nandkishor S

    2018-01-23

    Nasal continuous positive airway pressure (nCPAP) is the standard noninvasive respiratory support for newborns with respiratory distress. Evidence for high-flow nasal cannula (HFNC) as an alternative mode of respiratory support is inconclusive. The aim of this work was to evaluate whether HFNC is not inferior to nCPAP in reducing the need for higher respiratory support in the first 72 h of life when applied as a noninvasive respiratory support mode for preterm neonates with respiratory distress. Preterm infants (gestation ≥28 weeks and birth weight ≥1,000 g) with respiratory distress were randomized to either HFNC or nCPAP in a non-inferiority trial. Failure of the support mode in the first 72 h after birth was the primary outcome. Infants failing HFNC were rescued either with nCPAP or mechanical ventilation, and those failing nCPAP received mechanical ventilation. During the study period, 139 and 133 infants were randomized to the nCPAP and HFNC groups, respectively. The study was stopped after an interim analysis showed a significant difference (p respiratory distress (SAS score >5). When comparing HFNC to nCPAP as a primary noninvasive respiratory support in preterm infants with respiratory distress, HFNC is inferior to nCPAP in avoiding the need for a higher mode of respiratory support in the first 72 h of life. © 2018 S. Karger AG, Basel.

  16. The Effect of Participation in Support Groups on Depression, Anxiety and Stress in Family Caregivers of People with Alzheimers: Randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Fahimeh Taati

    2016-07-01

    Full Text Available This study sought to determine the effect of participation in support groups on the depression, anxiety and stress level of caregivers of patients with Alzheimer. This study was a single blind randomized clinical controlled trial (RCT with 80 family caregivers of people with Alzheimer’s (per group=40. The intervention group participated in eight sessions 1.5- 2 hours in support groups. The tool used in this study was the DASS-21 questionnaire for measuring depression, anxiety and stress level of the caregivers, analysis of parametric data, using SPSS version 21. Findings showed, participation in support groups showed no significant difference on depression, anxiety and stress in family caregivers of Alzheimer patients in the control group and the intervention group. Given that caring for these patients by their family members are very sensitive and costly issues for policy makers and health service providers, community and families of these patients.

  17. Remote monitoring field trial. Application to automated air sampling. Report on Task FIN-E935 of the Finnish Support Programme to IAEA Safeguards

    International Nuclear Information System (INIS)

    Poellaenen, R.; Ilander, T.; Lehtinen, J.; Leppaenen, A.; Nikkinen, M.; Toivonen, H.; Ylaetalo, S.; Smartt, H.; Garcia, R.; Martinez, R.; Glidewell, D.; Krantz, K.

    1999-01-01

    An automated air sampling station has recently been developed by Radiation and Nuclear Safety Authority (STUK). The station is furnished with equipment that allows comprehensive remote monitoring of the station and the data. Under the Finnish Support Programme to IAEA Safeguards, STUK and Sandia National Laboratories (SNL) established a field trial to demonstrate the use of remote monitoring technologies. STUK provided means for real-lime radiation monitoring and sample authentication whereas SNL delivered means for authenticated surveillance of the equipment and its location. The field trial showed that remote monitoring can be carried out using simple means although advanced facilities are needed for comprehensive surveillance. Authenticated measurement data could be reliably transferred from the monitoring site to the headquarters without the presence of authorized personnel in the monitoring site. The operation of the station and the remote monitoring system were reliable. (orig.)

  18. Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial.

    Science.gov (United States)

    Bobrow, Kirsty; Brennan, Thomas; Springer, David; Levitt, Naomi S; Rayner, Brian; Namane, Mosedi; Yu, Ly-Mee; Tarassenko, Lionel; Farmer, Andrew

    2014-01-11

    Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care. The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data

  19. Project TEAMS (Talking about Eating, Activity, and Mutual Support: a randomized controlled trial of a theory-based weight loss program for couples

    Directory of Open Access Journals (Sweden)

    Amy A. Gorin

    2017-09-01

    Full Text Available Abstract Background Obesity risk is shared between spouses, yet existing weight loss programs focus on individuals and not the marital dyad. Given the interdependence of weight in couples, weight management outcomes might be improved by targeting joint weight loss and the creation of an interpersonal milieu that supports long-term behavior change. According to Self-Determination Theory (SDT, greater autonomous self-regulation of behaviors, and subsequently better treatment outcomes, are observed in needs supportive environments in which personally meaningful choice is supported and criticism and control are minimized. Correlational analyses confirm these pathways in weight management, with needs support from one’s spouse or partner emerging as a distinct predictor of weight loss success. Research is now needed to establish causal links and to develop and test weight loss interventions designed to facilitate the needs supportive behavior of spouses. Methods Project TEAMS (Talking about Eating, Activity, and Mutual Support is a randomized controlled trial testing a couples-based intervention, grounded in SDT, designed to change the social context of weight loss by training spouses to provide needs support for each other’s eating and physical activity behavior. Sixty-four couples will be randomized to either 6 months of behavioral weight loss treatment informed by SDT (SDT-WL or to 6 months of standard behavioral weight loss treatment (BWL. Couples will attend weekly sessions for 6 months and will be assessed at 0, 3, 6, and 12 months. By bolstering needs support, SDT-WL is predicted to increase autonomous self-regulation and perceived competence and produce greater weight loss and maintenance than standard behavioral treatment. Exploratory analyses will examine the SDT process model prediction that the influence of needs support on treatment outcomes will be mediated by autonomous self-regulation and perceived competence. Discussion This

  20. Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.

    Science.gov (United States)

    Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice

    2014-07-01

    This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of

  1. Can community retail pharmacist and diabetes expert support facilitate insulin initiation by family physicians? Results of the AIM@GP randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Harris Stewart B

    2013-02-01

    Full Text Available Abstract Background Limited evidence exists on the effectiveness of external diabetes support provided by diabetes specialists and community retail pharmacists to facilitate insulin-prescribing in family practice. Methods A stratified, parallel group, randomized control study was conducted in 15 sites across Canada. Family physicians received insulin initiation/titration education, a physician-specific ‘report card’ on the characteristics of their type 2 diabetes (T2DM population, and a registry of insulin-eligible patients at a workshop. Intervention physicians in addition received: (1 diabetes specialist/educator consultation support (active diabetes specialist/educator consultation support for 2 months [the educator initiated contact every 2 weeks] and passive consultation support for 10 months [family physician initiated as needed]; and (2 community retail pharmacist support (option to refer patients to the pharmacist(s for a 1-hour insulin-initiation session. The primary outcome was the insulin prescribing rate (IPR per physician defined as the number of insulin starts of insulin-eligible patients during the 12-month strategy. Results Consenting, eligible physicians (n = 151 participated with 15 specialist sites and 107 community pharmacists providing the intervention. Most physicians were male (74%, and had an average of 81 patients with T2DM. Few (9% routinely initiated patients on insulin. Physicians were randomly allocated to usual care (n = 78 or the intervention (n = 73. Intervention physicians had a mean (SE IPR of 2.28 (0.27 compared to 2.29 (0.25 for control physicians, with an estimated adjusted RR (95% CI of 0.99 (0.80 to 1.24, p = 0.96. Conclusions An insulin support program utilizing diabetes experts and community retail pharmacists to enhance insulin prescribing in family practice was not successful. Too few physicians are appropriately intensifying diabetes management through insulin initiation, and

  2. Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial.

    Science.gov (United States)

    Dam, Alieske E H; de Vugt, Marjolein E; van Boxtel, Martin P J; Verhey, Frans R J

    2017-08-29

    Caregivers of people with dementia (PwD) face burden, feelings of loneliness, and social isolation. Previous studies have shown promising effects of online e-health interventions. Using social media may facilitate support for dementia caregiver networks. In an iterative step-wise approach, a social support tool entitled "Inlife" was developed. This paper describes the design of a study evaluating the effects of Inlife and its process characteristics. A mixed-method, randomised controlled trial with 122 caregivers of PwD will be conducted. Participants will be assigned to either the Inlife social support intervention or a waiting-list control group. After 16 weeks, the control group will obtain access to the Inlife environment. Data will be collected at baseline (T 0 ) and at 8-week (T 1 ), 16-week (T 2 ) and 42-week follow up (T 3 ). The 16-week follow-up assessment (T 2 ) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. The primary outcomes include feelings of caregiver competence and perceived social support. The secondary outcomes include received support, feelings of loneliness, psychological complaints (e.g., anxiety, stress), and quality of life. A process evaluation, including semi-structured interviews, will be conducted to examine the internal and external validity of the intervention. Using a mixed-method design, our study will provide valuable insights into the usability, effectiveness, and factors related to implementation of the Inlife intervention. Our study results will indicate whether Inlife could be a valuable social support resource in future routine dementia care. Dutch trial register, NTR6131 . Registered on 20 October 2016.

  3. Impact of food support on food security and body weight among HIV antiretroviral therapy recipients in Honduras: a pilot intervention trial.

    Science.gov (United States)

    Palar, Kartika; Derose, Kathryn Pitkin; Linnemayr, Sebastian; Smith, Alexandria; Farías, Hugo; Wagner, Glenn; Martinez, Homero

    2015-01-01

    Optimal strategies to improve food security and nutrition for people living with HIV (PLHIV) may differ in settings where overweight and obesity are prevalent and cardiovascular disease risk is a concern. However, no studies among PLHIV have investigated the impact of food support on nutritional outcomes in these settings. We therefore assessed the effect of food support on food insecurity and body weight in a population of PLHIV with high prevalence of overweight and obesity. We implemented a pilot intervention trial in four government-run HIV clinics in Honduras. The trial tested the effect of a monthly household food ration plus nutrition education (n = 203), compared to nutrition education alone (n = 197), over 12 months. Participants were clinic patients receiving antiretroviral therapy (ART). Assessments were obtained at baseline, 6 and 12 months. Primary outcomes for this analysis were food security, using the validated Latin American and Caribbean Food Security Scale and body weight (kg). Thirty-one percent of participants were overweight (22%) or obese (8%) at baseline. At 6 months, the probability of severe food insecurity decreased by 48.3% (p < 0.01) in the food support group, compared to 11.6% in the education-only group (p < 0.01). Among overweight or obese participants, food support led to average weight gain of 1.13 kg (p < 0.01), while nutrition education alone was associated with average weight loss of 0.72 kg (p < 0.10). Nutrition education alone was associated with weight gain among underweight and normal weight participants. Household food support may improve food security but not necessarily nutritional status of ART recipients above and beyond nutrition education. Improving nutritional tailoring of food support and testing the impact of nutrition education should be prioritized for PLHIV in Latin America and similar settings.

  4. The protocol of a randomized controlled trial for playgroup mothers: Reminder on Food, Relaxation, Exercise, and Support for Health (REFRESH Program

    Directory of Open Access Journals (Sweden)

    Monteiro Sarojini MDR

    2011-08-01

    Full Text Available Abstract Background Mother's physical activity levels are relatively low, while their energy consumption is generally high resulting in 58% of Australian women over the age of 18 years being overweight or obese. This study aims to confirm if a low-cost, accessible playgroup based intervention program can improve the dietary and physical activity behaviours of mothers with young children. Methods/Design The current study is a randomized controlled trial lifestyle (nutrition and physical activity intervention for mothers with children aged between 0 to 5 years attending playgroups in Perth, Western Australia. Nine-hundred participants will be recruited and randomly assigned to the intervention (n = 450 and control (n = 450 groups. The study is based on the Social Cognitive Theory (SCT and the Transtheoretical Model (TTM, and the Precede-Proceed Framework incorporating goal setting, motivational interviewing, social support and self-efficacy. The six month intervention will include multiple strategies and resources to ensure the engagement and retention of participants. The main strategy is home based and will include a specially designed booklet with dietary and physical activity information, a muscle strength and flexibility exercise chart, a nutrition label reading shopping list and menu planner. The home based strategy will be supported by face-to-face dietary and physical activity workshops in the playgroup setting, posted and emailed bi-monthly newsletters, and monthly Short Message Service (SMS reminders via mobile phones. Participants in the control group receive no intervention materials. Outcome measures will be assessed using data that will be collected at baseline, six months and 12 months from participants in the control and intervention groups. Discussion This trial will add to the evidence base on the recruitment, retention and the impact of community based dietary and physical activity interventions for mothers with young children

  5. Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot

    Directory of Open Access Journals (Sweden)

    Mountain Gail A

    2011-01-01

    Full Text Available Abstract Background Chronic Obstructive Pulmonary Disease (COPD is a prevalent debilitating long term condition. It is the second most common cause of emergency admission to hospital in the UK and remains one of the most costly conditions to treat through acute care. Tele-health monitoring offers potential to reduce the rates of re-hospitalisation and emergency department visits and improve quality of life for people with COPD. However, the current evidence base to support technology adoption and implementation is limited and the resource implications for implementing tele-health in practice can be very high. This trial will employ tele-health monitoring in a preventative capacity for patients diagnosed with early stage COPD following discharge from hospital to determine whether it reduces their need for additional health service support or hospital admission and improves their quality of life. Methods/Design We describe a pilot study for a two arm, one site randomized controlled trial (RCT to determine the effect of tele-health monitoring on self-management, quality of life and patient satisfaction. Sixty patients who have been discharged from one acute trust with a primary diagnosis of COPD and who have agreed to receive community clinical support following discharge from acute care will be randomly assigned to one of two groups: (a Tele-health supported Community COPD Service; or (b Usual Care. The tele-health supported service involves the patient receiving two home visits with a specialist COPD clinician (nurse or physiotherapist then participating in daily tele-monitoring over an eight week period. Usual care consists of six home visits to the patient by specialist COPD clinicians again over eight successive weeks. Health status and quality of life data for all participants will be measured at baseline, on discharge from the service and at six months post discharge from the service. Discussion The tele-health service under study is a

  6. Supporting adherence for people starting a new medication for a long-term condition through community pharmacies: a pragmatic randomised controlled trial of the New Medicine Service.

    Science.gov (United States)

    Elliott, Rachel Ann; Boyd, Matthew J; Salema, Nde-Eshimuni; Davies, James; Barber, Nicholas; Mehta, Rajnikant Laxmishanker; Tanajewski, Lukasz; Waring, Justin; Latif, Asam; Gkountouras, Georgios; Avery, A J; Chuter, Antony; Craig, Christopher

    2016-10-01

    To examine the effectiveness of the New Medicine Service (NMS), a national community pharmacy service to support medicines-taking in people starting a new medicine for a long-term condition, compared with normal practice. Pragmatic patient-level parallel randomised controlled trial, in 46 community pharmacies in England. Patients 1:1 block randomisation stratified by drug/disease group within each pharmacy. 504 participants (NMS: 251) aged 14 years and over, identified in the pharmacy on presentation of a prescription for asthma/chronic obstructive pulmonary disease, hypertension, type 2 diabetes or an anticoagulant/antiplatelet agent. NMS intervention: One consultation 7-14 days after presentation of prescription followed by another 14-21 days thereafter to identify problems with treatment and provide support if needed. Controls received normal practice. Adherence, defined as missing no doses without the advice of a medical professional in the previous 7 days, was assessed through patient self-report at 10 weeks. Intention-to-treat analysis was employed, with outcome adjusted for recruiting pharmacy, NMS disease category, age, sex and medication count. Cost to the National Health Service (NHS) was collected. At 10 weeks, 53 patients had withdrawn and 443 (85%) patients were contacted successfully by telephone. In the unadjusted analysis of 378 patients still taking the initial medicine, 61% (95% CI 54% to 67%) and 71% (95% CI 64% to 77%) patients were adherent in the normal practice and NMS arms, respectively (p=0.04 for difference). In the adjusted intention-to-treat analysis, the OR for increased adherence was 1.67 (95% CI 1.06 to 2.62; p=0.027) in favour of the NMS arm. There was a general trend to reduced NHS costs, albeit, statistically non-significant, for the NMS intervention: saving £21 (95% CI -£59 to £100, p=0.128) per patient. The NMS significantly increased the proportion of patients adhering to their new medicine by about 10%, compared

  7. The effectiveness of a home care program for supporting caregivers of persons with dementia in developing countries: a randomised controlled trial from Goa, India.

    Directory of Open Access Journals (Sweden)

    Amit Dias

    Full Text Available OBJECTIVES: To develop and evaluate the effectiveness of a home based intervention in reducing caregiver burden, promoting caregiver mental health and reducing behavioural problems in elderly persons with dementia. METHODOLOGY AND PRINCIPAL FINDINGS: This was a randomised controlled trial in which the person with dementia-caregiver dyad was randomly allocated either to receive the intervention immediately or to a waiting list group which received the intervention after 6 months. It was carried out in communities based in two talukas (administrative blocks in Goa, India. Mild to moderate cases with dementia (diagnosed using the DSM IV criteria and graded using the Clinical Dementia Rating scale and their caregivers were included in the trial. Community based intervention provided by a team consisting of Home Care Advisors who were supervised by a counselor and a psychiatrist, focusing on supporting the caregiver through information on dementia, guidance on behaviour management, a single psychiatric assessment and psychotropic medication if needed. We measured caregiver mental health (General Health Questionnaire, caregiver burden (Zarit Burden Score, distress due to behavioural disturbances (NPI-D, behavioural problems in the subject (NPI-S and activities of daily living in the elder with dementia (EASI. Outcome evaluations were masked to the allocation status. We analysed each outcome with a mixed effects model. 81 families enrolled in the trial; 41 were randomly allocated to the intervention. 59 completed the trial and 18 died during the trial. The intervention led to a significant reduction of GHQ (-1.12, 95% CI -2.07 to -0.17 and NPI-D scores (-1.96, 95%CI -3.51 to -0.41 and non-significant reductions in the ZBS, EASI and NPI-S scores. We also observed a non-significant reduction in the total number of deaths in people with dementia in the intervention arm (OR 0.34, 95% CI 0.01 to 1.03. CONCLUSION: Home based support for caregivers of persons

  8. The Effectiveness of a Home Care Program for Supporting Caregivers of Persons with Dementia in Developing Countries: A Randomised Controlled Trial from Goa, India

    Science.gov (United States)

    Dias, Amit; Dewey, Michael E.; D'Souza, Jean; Dhume, Rajesh; Motghare, Dilip D.; Shaji, K. S.; Menon, Rajiv; Prince, Martin; Patel, Vikram

    2008-01-01

    Objectives To develop and evaluate the effectiveness of a home based intervention in reducing caregiver burden, promoting caregiver mental health and reducing behavioural problems in elderly persons with dementia. Methodology and Principal Findings This was a randomised controlled trial in which the person with dementia-caregiver dyad was randomly allocated either to receive the intervention immediately or to a waiting list group which received the intervention after 6 months. It was carried out in communities based in two talukas (administrative blocks) in Goa, India. Mild to moderate cases with dementia (diagnosed using the DSM IV criteria and graded using the Clinical Dementia Rating scale) and their caregivers were included in the trial. Community based intervention provided by a team consisting of Home Care Advisors who were supervised by a counselor and a psychiatrist, focusing on supporting the caregiver through information on dementia, guidance on behaviour management, a single psychiatric assessment and psychotropic medication if needed. We measured caregiver mental health (General Health Questionnaire), caregiver burden (Zarit Burden Score), distress due to behavioural disturbances (NPI-D), behavioural problems in the subject (NPI-S) and activities of daily living in the elder with dementia (EASI). Outcome evaluations were masked to the allocation status. We analysed each outcome with a mixed effects model. 81 families enrolled in the trial; 41 were randomly allocated to the intervention. 59 completed the trial and 18 died during the trial. The intervention led to a significant reduction of GHQ (−1.12, 95% CI −2.07 to −0.17) and NPI-D scores (−1.96, 95%CI −3.51 to −0.41) and non-significant reductions in the ZBS, EASI and NPI-S scores. We also observed a non-significant reduction in the total number of deaths in people with dementia in the intervention arm (OR 0.34, 95% CI 0.01 to 1.03). Conclusion Home based support for caregivers of persons

  9. OpenGeneMed: a portable, flexible and customizable informatics hub for the coordination of next-generation sequencing studies in support of precision medicine trials.

    Science.gov (United States)

    Palmisano, Alida; Zhao, Yingdong; Li, Ming-Chung; Polley, Eric C; Simon, Richard M

    2017-09-01

    Trials involving genomic-driven treatment selection require the coordination of many teams interacting with a great variety of information. The need of better informatics support to manage this complex set of operations motivated the creation of OpenGeneMed. OpenGeneMed is a stand-alone and customizable version of GeneMed (Zhao et al. GeneMed: an informatics hub for the coordination of next-generation sequencing studies that support precision oncology clinical trials. Cancer Inform 2015;14(Suppl 2):45), a web-based interface developed for the National Cancer Institute Molecular Profiling-based Assignment of Cancer Therapy (NCI-MPACT) clinical trial coordinated by the NIH. OpenGeneMed streamlines clinical trial management and it can be used by clinicians, lab personnel, statisticians and researchers as a communication hub. It automates the annotation of genomic variants identified by sequencing tumor DNA, classifies the actionable mutations according to customizable rules and facilitates quality control in reviewing variants. The system generates summarized reports with detected genomic alterations that a treatment review team can use for treatment assignment. OpenGeneMed allows collaboration to happen seamlessly along the clinical pipeline; it helps reduce errors made transferring data between groups and facilitates clear documentation along the pipeline. OpenGeneMed is distributed as a stand-alone virtual machine, ready for deployment and use from a web browser; its code is customizable to address specific needs of different clinical trials and research teams. Examples on how to change the code are provided in the technical documentation distributed with the virtual machine. In summary, OpenGeneMed offers an initial set of features inspired by our experience with GeneMed, a system that has been proven to be efficient and successful for coordinating the application of next-generation sequencing in the NCI-MPACT trial. Published by Oxford University Press 2016. This

  10. Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial.

    Science.gov (United States)

    Nixon, Jane; Cranny, Gillian; Iglesias, Cynthia; Nelson, E Andrea; Hawkins, Kim; Phillips, Angela; Torgerson, David; Mason, Su; Cullum, Nicky

    2006-06-17

    To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in the development of new pressure ulcers, healing of existing pressure ulcers, and patient acceptability. Pragmatic, open, multicentre, randomised controlled trial. 11 hospitals in six NHS trusts. 1972 people admitted to hospital as acute or elective patients. Participants were randomised to an alternating pressure mattress (n = 982) or an alternating pressure overlay (n = 990). The proportion of participants developing a new pressure ulcer of grade 2 or worse; time to development of new pressure ulcers; proportions of participants developing a new ulcer within 30 days; healing of existing pressure ulcers; and patient acceptability. Intention to treat analysis found no difference in the proportions of participants developing a new pressure ulcer of grade 2 or worse (10.7% overlay patients, 10.3% mattress patients; difference 0.4%, 95% confidence interval--2.3% to 3.1%, P = 0.75). More overlay patients requested change owing to dissatisfaction (23.3%) than mattress patients (18.9%, P = 0.02). No difference was found between alternating pressure mattresses and alternating pressure overlays in the proportion of people who develop a pressure ulcer. ISRCTN 78646179.

  11. Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial

    Directory of Open Access Journals (Sweden)

    Paul Jansons

    2017-07-01

    Trial registration: ACTRN12610001035011. [Jansons P, Robins L, O’Brien L, Haines T (2017 Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial. Journal of Physiotherapy 63: 154–160

  12. Technical implementation in support of the IAEA's remote monitoring field trial at the Oak Ridge Y-12 Plant

    International Nuclear Information System (INIS)

    Corbell, B.H.; Moran, B.W.; Pickett, C.A.; Whitaker, J.M.; Resnik, W.; Landreth, D.

    1996-01-01

    A remote monitoring system (RMS) field trial will be conducted for the International Atomic Energy Agency (IAEA) on highly enriched uranium materials in a vault at the Oak Ridge Y-12 Plant. Remote monitoring technologies are being evaluated to verify their capability to enhance the effectiveness and timeliness of IAEA safeguards in storage facilities while reducing the costs of inspections and burdens on the operator. Phase one of the field trial, which involved proving the satellite transmission of sensor data and safeguards images from a video camera activated by seals and motion sensors installed in the vault, was completed in September 1995. Phase two involves formal testing of the RMS as a tool for use by the IAEA during their tasks of monitoring the storage of nuclear material. The field trial to be completed during early 1997 includes access and item monitoring of nuclear materials in two storage trays. The RMS includes a variety of Sandia, Oak Ridge, and Aquila sensor technologies that provide video monitoring, radiation attribute measurements, and container identification to the on-site data acquisition system (DAS) by way of radio-frequency and Echelon LONWorks networks. The accumulated safeguards information will be transmitted to the IAEA via satellite (COMSAT/RSI) and international telephone lines

  13. Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial.

    Science.gov (United States)

    Hartnett, Dan; Murphy, Edel; Kehoe, Elizabeth; Agyapong, Vincent; McLoughlin, Declan M; Farren, Conor

    2017-05-29

    Alcohol use disorders (AUDs) and mood disorders commonly co-occur, and are associated with a range of negative outcomes for patients. Mobile phone technology has the potential to provide personalised support for such patients and potentially improve outcomes in this difficult-to-treat cohort. The aim of this study is to examine whether receiving supporting SMS text messages, following discharge from an inpatient dual diagnosis treatment programme, has a positive impact on mood and alcohol abstinence in patients with an AUD and a comorbid mood disorder. The present study is a single-blind randomised controlled trial. Patients aged 18-70 years who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV Axis I will be randomised to receive twice-daily supportive SMS text messages for 6 months plus treatment as usual, or treatment as usual alone, and will be followed-up at 3, 6, 9 and 12 months postdischarge. Primary outcome measures will include changes from baseline in cumulative abstinence duration, which will be expressed as the proportion of days abstinent from alcohol in the preceding 90 days, and changes from baseline in Beck Depression Inventory scores. The trial has received full ethical approval from the St. Patrick's Hospital Research Ethics Committee (protocol 13/14). Results of the trial will be disseminated through peer-reviewed journal articles and at academic conferences. NCT02404662; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  14. Study protocol: Improving patient choice in treating low back pain (IMPACT - LBP: A randomised controlled trial of a decision support package for use in physical therapy

    Directory of Open Access Journals (Sweden)

    Tysall Colin

    2011-02-01

    Full Text Available Abstract Background Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP, designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient. Methods/Design Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study. Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research. Discussion Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction. Trial registration Current Controlled Trials ISRCTN46035546

  15. An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial.

    Science.gov (United States)

    Sawyer, Alyssa C P; Lynch, John; Bowering, Kerrie; Jeffs, Debra; Clark, Jenny; Mpundu-Kaambwa, Christine; Sawyer, Michael G

    2014-05-06

    All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks. Subsequent support is available on request from staff in community clinics and from a telephone helpline. The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0-6 months versus a single home-visit together with subsequent standard services (the latter support was available to mothers in both study groups). The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups. Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide. Mothers were excluded if they did not have internet access, required an interpreter, or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse. Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units (this was done by administrative staff who had no involvement in recruiting mothers, delivering the intervention, or analyzing results for the study). Consistent with design and power calculations, 819 mothers were recruited to the trial. The primary outcomes for the trial are parents' sense of competence and self-efficacy measured using standard self-report questionnaires. Secondary outcomes include the quality of mother-infant relationships, maternal social support, role satisfaction and maternal mental health, infant social-emotional and language development, and patterns of service utilisation. Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged infants. The knowledge gained from this

  16. Implementation of personalized self-management support using the self-management screening questionnaire SeMaS; a study protocol for a cluster randomized trial.

    Science.gov (United States)

    Eikelenboom, Nathalie; van Lieshout, Jan; Wensing, Michel; Smeele, Ivo; Jacobs, Annelies E

    2013-10-17

    The number of patients with one or more chronic diseases is rising. In several standards of care there is a focus on enhancing self-management. We applied the concept of personalization on self-management support and developed a self-management screening questionnaire (SeMaS). The main research objective is to assess the effectiveness of the SeMaS questionnaire and subsequent personalized self-management on patients' self-management behaviors. A cluster randomized controlled trial will be set up in 15 general practices in the Netherlands. The practices are all group practices, and member of one care group. The practices will be assigned to the control or intervention arms by stratified randomization. The strata are determined by the participation of the practice nurses in a course for behavioral change, and the nurse's workload. Patients can be included if they are over 18 years of age, have at least one chronic condition and have a checkup appointment with the practice nurse in the inclusion period. The intervention consists of screening patients with the SeMaS questionnaire, producing a graphic profile with the abilities or barriers for self-management. Patients will receive tailored feedback. Practice nurses are trained in using the profile to enhance self-management of the patient and provide personalized self-management support. The use of individual care plans and self-management interventions is stimulated. In the control arm patients will receive care as usual. Patients of both trial arms will be asked to fill in the SeMaS questionnaire and additional questionnaires at inclusion and after 6 months. The primary outcome is the difference in the level of patient activation (PAM-13) between baseline and 6 months. Secondary outcomes include patient measures for lifestyle factors (exercise, diet, smoking), and process measures from medical record data analysis. This manuscript presents the protocol for a cluster randomized clinical trial of personalized self

  17. Promoting supportive parenting in new mothers with substance-use problems: a pilot randomized trial of residential treatment plus an attachment-based parenting program.

    Science.gov (United States)

    Berlin, Lisa J; Shanahan, Meghan; Appleyard Carmody, Karen

    2014-01-01

    This pilot randomized trial tested the feasibility and efficacy of supplementing residential substance-abuse treatment for new mothers with a brief, yet rigorous, attachment-based parenting program. Twenty-one predominantly (86%) White mothers and their infants living together in residential substance-abuse treatment were randomly assigned to the program (n = 11) or control (n = 10) group. Program mothers received 10 home-based sessions of Dozier's Attachment and Biobehavioral Catch-up (ABC) intervention. Postintervention observations revealed more supportive parenting behaviors among the randomly assigned ABC mothers. © 2013 Michigan Association for Infant Mental Health.

  18. A randomized controlled trial on the role of support in Internet-based problem solving therapy for depression and anxiety

    NARCIS (Netherlands)

    Kleiboer, A; Donker, T; Seekles, W.; van Straten, A.; Riper, H.; Cuijpers, P.

    2015-01-01

    Internet-based interventions can be effective treatments for anxiety and depression. Meta-analytic evidence suggests that they should be delivered with human support to reach optimal effects. These findings have not consistently been replicated in direct comparisons of supported and unsupported

  19. A 1-year randomised controlled trial comparing zirconia versus metal-ceramic implant supported single-tooth restorations

    DEFF Research Database (Denmark)

    Hosseini, Mandana; Worsaae, Nils; Schiodt, Morten

    2011-01-01

    To compare the biological, technical and aesthetic outcomes of single implant-supported all-ceramic versus metal-ceramic crowns.......To compare the biological, technical and aesthetic outcomes of single implant-supported all-ceramic versus metal-ceramic crowns....

  20. Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial.

    Science.gov (United States)

    Sussman, Jonathan; Bainbridge, Daryl; Whelan, Timothy J; Brazil, Kevin; Parpia, Sameer; Wiernikowski, Jennifer; Schiff, Susan; Rodin, Gary; Sergeant, Myles; Howell, Doris

    2017-11-30

    Better coordination of supportive services during the early phases of cancer care has been proposed to improve the care experience of patients. We conducted a randomized trial to test a community-based nurse-led coordination of care intervention in cancer patients. Surgical practices were cluster randomized to a control group involving usual care practices or a standardized nursing intervention consisting of an in-person supportive care assessment with ongoing support to meet identified needs, including linkage to community services. Newly diagnosed breast and colorectal cancer patients within 7 days of cancer surgery were eligible. The primary outcome was the patient-reported outcome (PRO) of continuity of care (CCCQ) measured at 3 weeks. Secondary outcomes included unmet supportive care needs (SCNS), quality of life (EORTC QLQ-C30), health resource utilization, and level of uncertainty with care trajectory (MUIS) at 3 and/or 8 weeks. A total of 121 breast and 72 colorectal patients were randomized through 28 surgical practices. There was a small improvement in the informational domain of continuity of care (difference 0.29 p = 0.05) and a trend to less emergency room use (15.8 vs 7.1%) (p = 0.07). There were no significant differences between groups on unmet need, quality of life, or uncertainty. We did not find substantial gaps in the PROs measured immediately following surgery for breast and colorectal cancer patients. The results of this study support a more targeted approach based on need and inform future research focused on improving navigation during the initial phases of cancer treatment. ClinicalTrials.gov Identifier: NCT00182234. SONICS-Effectiveness of Specialist Oncology Nursing.

  1. Effectiveness of a Technology-Based Supportive Educational Parenting Program on Parental Outcomes in Singapore: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Shorey, Shefaly; Ng, Yvonne Peng Mei; Siew, An Ling; Yoong, Joanne; Mörelius, Evalotte

    2018-01-10

    Supportive educational programs during the perinatal period are scarce in Singapore. There is no continuity of care available in terms of support from community care nurses in Singapore. Parents are left on their own most of the time, which results in a stressful transition to parenthood. There is a need for easily accessible technology-based educational programs that can support parents during this crucial perinatal period. The aim of this study was to describe the study protocol of a randomized controlled trial on a technology-based supportive educational parenting program. A randomized controlled two-group pretest and repeated posttest experimental design will be used. The study will recruit 118 parents (59 couples) from the antenatal clinics of a tertiary public hospital in Singapore. Eligible parents will be randomly allocated to receive either the supportive educational parenting program or routine perinatal care from the hospital. Outcome measures include parenting self-efficacy, parental bonding, postnatal depression, social support, parenting satisfaction, and cost evaluation. Data will be collected at the antenatal period, immediate postnatal period, and at 1 month and 3 months post childbirth. Recruitment of the study participants commenced in December 2016 and is still ongoing. Data collection is projected to finish within 12 months, by December 2017. This study will identify a potentially clinically useful, effective, and cost-effective supportive educational parenting program to improve parental self-efficacy and bonding in newborn care, which will then improve parents' social support-seeking behaviors, emotional well-being, and satisfaction with parenting. It is hoped that better supported and satisfied parents will consider having more children, which may in turn influence Singapore's ailing birth rate. International Standard Randomized Controlled Trial Number (ISRCTN): 48536064; https://www.isrctn.com/ISRCTN48536064 (Archived by WebCite at http

  2. Supporting Treatment decision making to Optimise the Prevention of STROKE in Atrial Fibrillation: The STOP STROKE in AF study. Protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gattellari Melina

    2012-07-01

    Full Text Available Abstract Background Suboptimal uptake of anticoagulation for stroke prevention in atrial fibrillation has persisted for over 20 years, despite high-level evidence demonstrating its effectiveness in reducing the risk of fatal and disabling stroke. Methods The STOP STROKE in AF study is a national, cluster randomised controlled trial designed to improve the uptake of anticoagulation in primary care. General practitioners from around Australia enrolling in this ‘distance education’ program are mailed written educational materials, followed by an academic detailing session delivered via telephone by a medical peer, during which participants discuss patient de-identified cases. General practitioners are then randomised to receive written specialist feedback about the patient de-identified cases either before or after completing a three-month posttest audit. Specialist feedback is designed to provide participants with support and confidence to prescribe anticoagulation. The primary outcome is the proportion of patients with atrial fibrillation receiving oral anticoagulation at the time of the posttest audit. Discussion The STOP STROKE in AF study aims to evaluate a feasible intervention via distance education to prevent avoidable stroke due to atrial fibrillation. It provides a systematic test of augmenting academic detailing with expert feedback about patient management. Trial registration Australian Clinical Trials Registry Registration Number: ACTRN12611000076976.

  3. Successful closure of persistent oro-cutaneous fistulas by injection of autologous adipose-derived stem cells: a case report [Erfolgreiche Behandlung persistierender oro-kutaner Fisteln durch Injektion mit autologen Fettstammzellen: ein Fallbericht

    Directory of Open Access Journals (Sweden)

    Föll, D. A.

    2013-07-01

    Full Text Available [english] Introduction: Oro-cutaneous fistulas are a possible complication of oro-facial surgery. If recurrent they are difficult to treat and greatly affect the patient's functional and aesthetic integrity besides carrying the risk of infection. Usage of concentrated adipose-derived stem cells for chronic wounds is a new and experimental treatment strategy, so far only applied in a few selected studies. We report the case of two oro-cutaneous fistulas in one patient treated with adipose-derived stem cells leading to closure of the fistulas.Case description: The patient was a 57-year old female immunosuppressed liver and kidney recipient who presented with a large mandibular and soft tissue defect after resection and irradiation of a squamous-cell carcinoma of the tongue base. After radical debridement, hardware removal and soft tissue reconstruction using a second free flap two oro-cutaneous fistulas reoccurred. Conventional surgical methods failed to consolidate the fistulas due to the severe radiation of the oral mucosa. Therefore autologous adipose-derived stem cells were extracted from lipoaspirate and applied in the surrounding fistula tissue in one session using the Cytori Celution system. The fistulas closed spontaneously during the postoperative course within 4 weeks and remain closed after 6 months.Conclusion: To our knowledge this is the first report of successful application of adipose-derived stem cells to two oro-cutaneous fistulas. Innovative stem cell therapy in combination with well established surgical methods can be a useful treatment strategy in certain cases.[german] Einleitung: Oro-kutane Fisteln sind eine mögliche Komplikation eines oro-fazialen Eingriffs. Bei Therapieresistenz können solche Fisteln zu hohem Leidensdruck führen und stellen eine ständige Infektionsgefahr dar. Die Applikation von konzentrierten Stammzellen aus Fettgewebe zur Behandlung chronischer Wunden ist eine neue und experimentelle Therapiestrategie

  4. Investigating the cost-effectiveness of videotelephone based support for newly diagnosed paediatric oncology patients and their families: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Theodoros Deborah

    2007-03-01

    Full Text Available Abstract Background Providing ongoing family centred support is an integral part of childhood cancer care. For families living in regional and remote areas, opportunities to receive specialist support are limited by the availability of health care professionals and accessibility, which is often reduced due to distance, time, cost and transport. The primary aim of this work is to investigate the cost-effectiveness of videotelephony to support regional and remote families returning home for the first time with a child newly diagnosed with cancer Methods/design We will recruit 162 paediatric oncology patients and their families to a single centre randomised controlled trial. Patients from regional and remote areas, classified by Accessibility/Remoteness Index of Australia (ARIA+ greater than 0.2, will be randomised to a videotelephone support intervention or a usual support control group. Metropolitan families (ARIA+ ≤ 0.2 will be recruited as an additional usual support control group. Families allocated to the videotelephone support intervention will have access to usual support plus education, communication, counselling and monitoring with specialist multidisciplinary team members via a videotelephone service for a 12-week period following first discharge home. Families in the usual support control group will receive standard care i.e., specialist multidisciplinary team members provide support either face-to-face during inpatient stays, outpatient clinic visits or home visits, or via telephone for families who live far away from the hospital. The primary outcome measure is parental health related quality of life as measured using the Medical Outcome Survey (MOS Short Form SF-12 measured at baseline, 4 weeks, 8 weeks and 12 weeks. The secondary outcome measures are: parental informational and emotional support; parental perceived stress, parent reported patient quality of life and parent reported sibling quality of life, parental satisfaction

  5. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps in a Medicaid managed care plan: study protocol

    Directory of Open Access Journals (Sweden)

    Ratanawongsa Neda

    2012-01-01

    Full Text Available Abstract Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps. Methods/Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252, primary outcomes will be

  6. Direct to Public Peer Support and e-Therapy Program Versus Information to Aid Self-Management of Depression and Anxiety: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Kaylor-Hughes, Catherine J; Rawsthorne, Mat; Coulson, Neil S; Simpson, Sandra; Simons, Lucy; Guo, Boliang; James, Marilyn; Moran, Paul; Simpson, Jayne; Hollis, Chris; Avery, Anthony J; Tata, Laila J; Williams, Laura; Morriss, Richard K

    2017-12-18

    Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe, anonymized public health-driven Web-based services such as Big White Wall (BWW), which offer immediate peer support at low cost. Using Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) methodology, the aim of this study was to determine the population reach, effectiveness, cost-effectiveness, and barriers and drivers to implementation of BWW compared with Web-based information compiled by UK's National Health Service (NHS, NHS Choices Moodzone) in people with probable mild to moderate depression and anxiety disorder. A pragmatic, parallel-group, single-blind randomized controlled trial (RCT) is being conducted using a fully automated trial website in which eligible participants are randomized to receive either 6 months access to BWW or signposted to the NHS Moodzone site. The recruitment of 2200 people to the study will be facilitated by a public health engagement campaign involving general marketing and social media, primary care clinical champions, health care staff, large employers, and third sector groups. People will refer themselves to the study and will be eligible if they are older than 16 years, have probable mild to moderate depression or anxiety disorders, and have access to the Internet. The primary outcome will be the Warwick-Edinburgh Mental Well-Being Scale at 6 weeks. We will also explore the reach, maintenance, cost-effectiveness, and barriers and drivers to implementation and possible mechanisms of actions using a range of qualitative and quantitative methods. This will be the first fully digital trial of a direct to public online peer support program for common mental disorders. The potential advantages of adding this to current NHS mental health services and the challenges of designing a public health campaign and RCT of

  7. Weight Loss Maintenance for 2 Years after a 6-Month Randomised Controlled Trial Comparing Education-Only and Group-Based Support in Japanese Adults

    Directory of Open Access Journals (Sweden)

    Yoshio Nakata

    2014-11-01

    Full Text Available Objective: Our previous study, a 6-month randomised controlled trial, demonstrated that a group-based support promoted weight loss as compared to an education-only intervention. The purpose of this study was to examine weight loss maintenance for 2 years. Methods: Originally, 188 overweight Japanese adults, aged 40-65 years, were randomly assigned to 3 groups: control, education-only or group-based support. After the 6-month intervention, 125 participants in the education-only and the group-based support groups were followed up for 2 years. The primary outcome was the amount of weight lost. The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses. Results: At the end of follow-up, the amount of weight lost in the education-only and the group-based support groups was the same (3.3 kg. Secondary analyses using data of those who completed the study (n = 100 revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile. No significant differences were observed in the energy intake among the four groups. Conclusion: The effects of group-based support disappear within 2 years. Increasing physical activity may be a crucial factor for successful maintenance of weight loss.

  8. Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial.

    Science.gov (United States)

    Edbrooke, Lara; Aranda, Sanchia; Granger, Catherine L; McDonald, Christine F; Krishnasamy, Mei; Mileshkin, Linda; Irving, Louis; Braat, Sabine; Clark, Ross A; Gordon, Ian; Denehy, Linda

    2017-09-29

    Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference. There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly

  9. First experiences with MR mammography in aftercare following plastic surgery of cancer of the breast; Erste Erfahrungen mit der MR-Mammographie in der Nachsorge bei lappenunterstuetzter operativer Behandlung des Mammakarzinoms

    Energy Technology Data Exchange (ETDEWEB)

    Kurtz, B. [Radiologische Klinik, Evangelisches Krankenhaus Duesseldorf (Germany); Audretsch, W. [Abt. fuer Senologie, Frauenklinik des Krankenhauses Gerresheim, Kliniken der Landeshauptstadt Duesseldorf (Germany); Rezai, M. [Abt. fuer Senologie, Frauenklinik des Krankenhauses Gerresheim, Kliniken der Landeshauptstadt Duesseldorf (Germany); Achten, C. [Radiologische Klinik, Evangelisches Krankenhaus Duesseldorf (Germany); Zocholl, G. [Radiologische Klinik, Evangelisches Krankenhaus Duesseldorf (Germany)

    1996-04-01

    To demonstrate typical MR mammographic findings after plastic surgery of breast cancer. Postoperative (7-38 months, median 13) MR mammographic examinations of 25 patients operated for breast cancer (11 latissimus dorsiflaps (LAT)), 14 rectus abdominis myocutaneous-flaps (TRAM) were reevaluated. The examinations were performed with a breast coil at 1 T. The sequences applied were a fat-suppressed 2-D turbo IR-sequence protonweighted and a T{sub 1}-weighted FLASH 3-D sequence as dynamic series. Scars between the myocutaneous flap and the remaining breast tissue always appeared in form of a ligament or septum. Signal and perfusion characteristics of scar tissue and muscle stalk in this investigation were clearly different from fat necrosis was found and rectified by biopsy. MR mammography is a very valuable diagnostic method for postoperative evaluation of myocutaneous flap-based therapy of breast cancer. (orig.) [Deutsch] Erfassung typischer MR-mammographischer Befunde bei lappenunterstuetzter operativer Behandlung des Mammakarzinoms. Die postoperativen (7-38 Monate, Median 13 Monate) MR-Mammographien von 25 (11 Latissimus-dorsi-Plastiken (LAT)), 14 Rectus-abdominis-Plastiken (TRAM) wegen eines Mammakarzinoms lappenunterstuetzt operierten Patientinnen (Alter 34-67 Jahre, Median 48 Jahre) wurden retrospektiv ausgewertet. Die Untersuchungen erfolgten mit einer bimammaeren Brustspule 1 T. Als Untersuchungssequenz dienten eine Protonen-gewichtete, fettsupprimierte 2-D-Turbo-IR-Sequenz und eine T{sub 1}-gewichtete FLASH-3-D-Sequenz als dynamische Untersuchung. Das Narbengewebe zwischen Lappenplastik und Restdruesengewebe stellte sich immer band- oder septenfoermig dar. Signal- und Anreicherungsverhalten der Narben boten in unserem Kollektiv kein differential-diagnostisches Problem bei der Abgrenzung zum Tumorgewebe. Ein Tumorrezidiv und eine Fettgewebsnekrose wurden durch die MR-Mammographie erfasst und histologisch verifiziert. (orig.)

  10. Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial

    DEFF Research Database (Denmark)

    Beck, Anne Marie; Gøgsig Christensen, Annette; Stenbæk Hansen, Birthe

    2014-01-01

    BACKGROUND: Older adults in nursing home and home-care are a particularly high-risk population for weight loss or poor nutrition. One negative consequence of undernutrition is increased health care costs. Several potentially modifiable nutritional risk factors increase the likelihood of weight loss......-effectiveness of nutritional support among undernourished older adults and none of these have used such a multidisciplinary approach. METHODS: An 11 week cluster randomized trial to assess the cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home.......The primary outcome parameter will be change in quality of life (by means of Euroquol-5D-3L). Secondary outcomes will be: physical performance (chair stand), nutritional status (weight, Body Mass Index and hand-grip strength), oral care, fall incidents, hospital admissions, rehabilitation stay, moving...

  11. Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gega Lina

    2012-08-01

    Full Text Available Abstract Background Computerised cognitive behaviour therapy (cCBT involves standardised, automated, interactive self-help programmes delivered via a computer. Randomised controlled trials (RCTs and observational studies have shown than cCBT reduces depressive symptoms as much as face-to-face therapy and more than waiting lists or treatment as usual. cCBT’s efficacy and acceptability may be influenced by the “human” support offered as an adjunct to it, which can vary in duration and can be offered by people with different levels of training and expertise. Methods/design This is a two-by-two factorial RCT investigating the effectiveness, cost-effectiveness and acceptability of cCBT supplemented with 12 weekly phone support sessions are either brief (5–10 min or extended (20–30 min and are offered by either an expert clinician or an assistant with no clinical training. Adults with non-suicidal depression in primary care can self-refer into the study by completing and posting to the research team a standardised questionnaire. Following an assessment interview, eligible referrals have access to an 8-session cCBT programme called Beating the Blues and are randomised to one of four types of support: brief-assistant, extended-assistant, brief-clinician or extended-clinician. A sample size of 35 per group (total 140 is sufficient to detect a moderate effect size with 90% power on our primary outcome measure (Work and Social Adjustment Scale; assuming a 30% attrition rate, 200 patients will be randomised. Secondary outcome measures include the Beck Depression and Anxiety Inventories and the PHQ-9 and GAD-7. Data on clinical outcomes, treatment usage and patient experiences are collected in three ways: by post via self-report questionnaires at week 0 (randomisation and at weeks 12 and 24 post-randomisation; electronically by the cCBT system every time patients log-in; by phone during assessments, support sessions and exit interviews. Discussion

  12. Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial

    Directory of Open Access Journals (Sweden)

    van Gaalen Johanna L

    2012-11-01

    Full Text Available Abstract Background Internet-based self-management (IBSM support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. Methods/design This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS: dissemination of the IBSM program; intermediate strategy (IS: MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals; and extended strategy (ES: IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions are primarily targeted at general practices, randomisation will occur at practice level. In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations; self-management related outcomes (health education impact, medication adherence, and illness perceptions; and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption

  13. Associations among Environmental Supports, Physical Activity, and Blood Pressure in African American Adults in the PATH Trial

    OpenAIRE

    Coulon, Sandra M.; Wilson, Dawn K.; Egan, Brent M.

    2013-01-01

    High blood pressure disproportionately affects African American adults and is a leading cause of stroke and heart attack. Engaging in recommended levels of physical activity reduces blood pressure, and social and physical environmental supports for physical activity may increase engagement in physical activity. Based on social cognitive theory within a bioecological framework, the present study tested hypotheses that perceived peer social support for physical activity and neighborhood walkabi...

  14. Improving parenting in families referred for child maltreatment: a randomized controlled trial examining effects of Project Support.

    Science.gov (United States)

    Jouriles, Ernest N; McDonald, Renee; Rosenfield, David; Norwood, William D; Spiller, Laura; Stephens, Nanette; Corbitt-Shindler, Deborah; Ehrensaft, Miriam

    2010-06-01

    Project Support is an intervention designed to decrease coercive patterns of aggressive discipline and increase positive parenting. This research evaluates Project Support in a sample of families reported to Children's Protective Services (CPS) for allegations of physical abuse or neglect; 35 families with a child between 3- and 8-years-old participated. In all families, CPS allowed the children to remain in the family home while the family received services. Families were randomly assigned to receive either Project Support or services as usual, which were provided by CPS or CPS-contracted service providers. To evaluate intervention effects, a multimethod, multi-informant assessment strategy was used that included data from mothers' reports, direct observation of parents' behavior, and review of CPS records for re-referrals for child maltreatment. Families who received Project Support services showed greater decreases than families who received services as usual in the following areas: mothers' perceived inability to manage childrearing responsibilities, mothers' reports of harsh parenting, and observations of ineffective parenting practices. Only 5.9% of families in the Project Support condition had a subsequent referral to CPS for child maltreatment, compared with 27.7% of families in the comparison condition. The results suggest that Project Support may be a promising intervention for reducing child maltreatment among families in which it has occurred. (c) 2010 APA, all rights reserved.

  15. Lessons learnt from a cluster-randomised trial evaluating the effectiveness of Self-Management Support (SMS) delivered by practice nurses in routine diabetes care

    Science.gov (United States)

    van Dijk-de Vries, Anneke; van Bokhoven, Marloes A; Winkens, Bjorn; Terluin, Berend; Knottnerus, J André; van der Weijden, Trudy; van Eijk, Jacques Th M

    2015-01-01

    Objective To evaluate the effectiveness of biopsychosocial Self-Management Support (SMS) delivered by practice nurses in routine diabetes care. Design A pragmatic cluster-randomised controlled trial within a hybrid effectiveness-implementation study design. Practice nurses were cluster-randomised. Setting A regional care group in the Netherlands consisting of 77 family practices. The study involved practice nurses (n=40) providing care to approximately 4000 patients with diabetes. Participants Patients with type 2 diabetes (n=264) selected by a self-administered questionnaire aimed at measuring emotional distress and diabetes-related reduced daily functioning. Intervention Practice nurses in the intervention arm (n=19) were trained to integrate SMS into their routine consultations. SMS included detection of patients with emotional distress and reduced daily functioning, and supporting them when needed through problem solving and reattribution techniques. Practice nurses in the control arm (n=21) provided usual care. Main outcome measures The primary outcome measure was a dichotomised score on a Visual Analogue Scale that measured the perceived effect of diabetes on daily functioning. Secondary measures included patients’ diabetes-related distress, quality of life, autonomy and participation, self-efficacy, self-management and glycaemic control. Outcomes were measured at baseline and at 4-month and 12-month follow-ups. Results Only 16 of the 117 patients in the intervention arm (14%) who were found eligible by the posted research-driven screening questionnaire were detected by their practice nurses. Extra consultations for the self-management support were delivered to only 11 study participants. In the control arm, 147 patients received usual care. Multilevel analyses showed no significant differences in outcomes between the intervention and control arms. Conclusions SMS in its present form was not effective. The research-driven screening to select trial

  16. An Internet-based program for depressive symptoms using human and automated support: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mira A

    2017-03-01

    Full Text Available Adriana Mira,1 Juana Bretón-López,1,2 Azucena García-Palacios,1,2 Soledad Quero,1,2 Rosa María Baños,2,3 Cristina Botella1,2 1Department of Basic, Clinical Psychology and Psychobiology, Labpsitec, Universitat Jaume I, Castellón de la Plana, Spain; 2CIBER of Physiopathology of Obesity and Nutrition CIBERobn, CB06/03 Instituto de Salud Carlos III, Santiago de Compostela, Spain; 3Department of Personality, Evaluation and Psychological Treatment, Universidad de Valencia, Valencia, Spain Purpose: The purpose of this study was to analyze the efficacy of an Internet-based program for depressive symptoms using automated support by information and communication technologies (ICTs and human support. Patients and methods: An Internet-based program was used to teach adaptive ways to cope with depressive symptoms and daily problems. A total of 124 participants who were experiencing at least one stressful event that caused interference in their lives, many of whom had clinically significant depressive symptoms, were randomly assigned into either an intervention group with ICT support (automated mobile phone messages, automated emails, and continued feedback through the program; an intervention group with ICT support plus human support (brief weekly support phone call without clinical content; or a waiting-list control. At pre-, post-, and 12-month follow-up, they completed depression, anxiety, positive and negative effect, and perceived stress measures. Results were analyzed using both intention-to-treat and completers data. The majority were women (67.7%, with a mean age of 35.6 years (standard deviation =9.7. Results: The analysis showed that the two intervention groups improved significantly pre- to posttreatment, compared with the control group. Furthermore, improvements were maintained at the 12-month follow-up. Adherence and satisfaction with the program was high in both conditions. Conclusion: The Internet-based program was effective and well

  17. Use of a remote clinical decision support service for a multicenter trial to implement prediction rules for children with minor blunt head trauma.

    Science.gov (United States)

    Goldberg, Howard S; Paterno, Marilyn D; Grundmeier, Robert W; Rocha, Beatriz H; Hoffman, Jeffrey M; Tham, Eric; Swietlik, Marguerite; Schaeffer, Molly H; Pabbathi, Deepika; Deakyne, Sara J; Kuppermann, Nathan; Dayan, Peter S

    2016-03-01

    To evaluate the architecture, integration requirements, and execution characteristics of a remote clinical decision support (CDS) service used in a multicenter clinical trial. The trial tested the efficacy of implementing brain injury prediction rules for children with minor blunt head trauma. We integrated the Epic(®) electronic health record (EHR) with the Enterprise Clinical Rules Service (ECRS), a web-based CDS service, at two emergency departments. Patterns of CDS review included either a delayed, near-real-time review, where the physician viewed CDS recommendations generated by the nursing assessment, or a real-time review, where the physician viewed recommendations generated by their own documentation. A backstopping, vendor-based CDS triggered with zero delay when no recommendation was available in the EHR from the web-service. We assessed the execution characteristics of the integrated system and the source of the generated recommendations viewed by physicians. The ECRS mean execution time was 0.74 ±0.72 s. Overall execution time was substantially different at the two sites, with mean total transaction times of 19.67 and 3.99 s. Of 1930 analyzed transactions from the two sites, 60% (310/521) of all physician documentation-initiated recommendations and 99% (1390/1409) of all nurse documentation-initiated recommendations originated from the remote web service. The remote CDS system was the source of recommendations in more than half of the real-time cases and virtually all the near-real-time cases. Comparisons are limited by allowable variation in user workflow and resolution of the EHR clock. With maturation and adoption of standards for CDS services, remote CDS shows promise to decrease time-to-trial for multicenter evaluations of candidate decision support interventions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  18. The Role of Personalised Choice in Decision Support: A Randomized Controlled Trial of an Online Decision Aid for Prostate Cancer Screening.

    Directory of Open Access Journals (Sweden)

    Glenn Salkeld

    Full Text Available Decision support tools can assist people to apply population-based evidence on benefits and harms to individual health decisions. A key question is whether "personalising" choice within decisions aids leads to better decision quality.To assess the effect of personalising the content of a decision aid for prostate cancer screening using the Prostate Specific Antigen (PSA test.Randomized controlled trial.Australia.1,970 men aged 40-69 years were approached to participate in the trial.1,447 men were randomly allocated to either a standard decision aid with a fixed set of five attributes or a personalised decision aid with choice over the inclusion of up to 10 attributes.To determine whether there was a difference between the two groups in terms of: 1 the emergent opinion (generated by the decision aid to have a PSA test or not; 2 self-rated decision quality after completing the online decision aid; 3 their intention to undergo screening in the next 12 months. We also wanted to determine whether men in the personalised choice group made use of the extra decision attributes.5% of men in the fixed attribute group scored 'Have a PSA test' as the opinion generated by the aid, as compared to 62% of men in the personalised choice group (χ2 = 569.38, 2df, p< 0001. Those men who used the personalised decision aid had slightly higher decision quality (t = 2.157, df = 1444, p = 0.031. The men in the personalised choice group made extensive use of the additional decision attributes. There was no difference between the two groups in terms of their stated intention to undergo screening in the next 12 months.Together, these findings suggest that personalised decision support systems could be an important development in shared decision-making and patient-centered care.Australian New Zealand Clinical Trials Registry (ANZCTR ACTRN12612000723886.

  19. The effect of social support features and gamification on a Web-based intervention for rheumatoid arthritis patients: randomized controlled trial.

    Science.gov (United States)

    Allam, Ahmed; Kostova, Zlatina; Nakamoto, Kent; Schulz, Peter Johannes

    2015-01-09

    Rheumatoid arthritis (RA) is chronic systematic disease that affects people during the most productive period of their lives. Web-based health interventions have been effective in many studies; however, there is little evidence and few studies showing the effectiveness of online social support and especially gamification on patients' behavioral and health outcomes. The aim of this study was to look into the effects of a Web-based intervention that included online social support features and gamification on physical activity, health care utilization, medication overuse, empowerment, and RA knowledge of RA patients. The effect of gamification on website use was also investigated. We conducted a 5-arm parallel randomized controlled trial for RA patients in Ticino (Italian-speaking part of Switzerland). A total of 157 patients were recruited through brochures left with physicians and were randomly allocated to 1 of 4 experimental conditions with different types of access to online social support and gamification features and a control group that had no access to the website. Data were collected at 3 time points through questionnaires at baseline, posttest 2 months later, and at follow-up after another 2 months. Primary outcomes were physical activity, health care utilization, and medication overuse; secondary outcomes included empowerment and RA knowledge. All outcomes were self-reported. Intention-to-treat analysis was followed and multilevel linear mixed models were used to study the change of outcomes over time. The best-fit multilevel models (growth curve models) that described the change in the primary outcomes over the course of the intervention included time and empowerment as time-variant predictors. The growth curve analyses of experimental conditions were compared to the control group. Physical activity increased over time for patients having access to social support sections plus gaming (unstandardized beta coefficient [B]=3.39, P=.02). Health care

  20. Effect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial.

    Science.gov (United States)

    Davis, Lori L; Kyriakides, Tassos C; Suris, Alina M; Ottomanelli, Lisa A; Mueller, Lisa; Parker, Pamela E; Resnick, Sandra G; Toscano, Richard; Scrymgeour, Alexandra A; Drake, Robert E

    2018-04-01

    Posttraumatic stress disorder (PTSD) often interferes with a person's ability to obtain or sustain employment, which leads to premature exit from the labor force and reduced income. To determine whether individual placement and support (IPS)-supported employment is more effective than stepwise vocational rehabilitation involving transitional work assignments at helping veterans with PTSD attain steady, competitive employment. The Veterans Individual Placement and Support Toward Advancing Recovery (VIP-STAR) study was a prospective, multisite, randomized clinical trial that included 541 unemployed veterans with PTSD at 12 Veterans Affairs medical centers. Data were collected from December 23, 2013, to May 3, 2017. Intent-to-treat analysis was performed. Individual placement and support is a supported employment intervention that rapidly engages people with disabilities in community job development to obtain work based on their individual job preferences. Transitional work is a stepwise vocational rehabilitation intervention that assigns people temporarily to noncompetitive jobs as preparation for competitive employment in the community. A priori hypotheses were that, compared with those in transitional work, more participants in the IPS group would become steady workers (primary) and earn more income from competitive jobs (secondary) over 18 months. Steady worker was defined as holding a competitive job for at least 50% of the 18-month follow-up period. A total of 541 participants (n = 271 IPS; n = 270 transitional work) were randomized. Mean (SD) age was 42.2 (11) years; 99 (18.3%) were women, 274 (50.6%) were white, 225 (41.6%) were African American, and 90 (16.6%) were of Hispanic, Spanish, or Latino ethnicity. More participants in the IPS group achieved steady employment than in the transitional work group (105 [38.7%] vs 63 [23.3%]; odds ratio, 2.14; 95% CI, 1.46-3.14). A higher proportion of IPS participants attained any competitive job (186 [68.6%] vs

  1. Staff training and outreach support for Cognitive Stimulation Therapy and its implementation in practice: a cluster randomised trial.

    Science.gov (United States)

    Streater, Amy; Spector, Aimee; Hoare, Zoe; Aguirre, Elisa; Russell, Ian; Orrell, Martin

    2017-12-01

    There is evidence that Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy are effective in mild to moderate dementia. There is, however, little evidence available for its implementation in practice and the impact of outreach support on the sustainability of the programme. Two hundred and forty-one staff members were randomised from 63 dementia care settings between outreach support including an online forum, email, and telephone support, compared to usual Cognitive Stimulation Therapy control group. The primary outcome was average number of attendees to the Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy programmes. There was no difference in average number of attendees between the intervention and usual Cognitive Stimulation Therapy control groups for the Cognitive Stimulation Therapy (p = 0.82) or the maintenance Cognitive Stimulation Therapy programme (p = 0.97). Outreach support does not affect the average number of people with dementia attending the Cognitive Stimulation Therapy or maintenance Cognitive Stimulation Therapy programme. Irrespective of outreach support, the programmes remain widely implemented and yield perceived benefits for people with dementia. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  2. Supporting the improvement and management of prescribing for urinary tract infections (SIMPle): protocol for a cluster randomized trial.

    LENUS (Irish Health Repository)

    Duane, Sinead

    2013-01-01

    The overuse of antimicrobials is recognized as the main selective pressure driving the emergence and spread of antimicrobial resistance in human bacterial pathogens. Urinary tract infections (UTIs) are among the most common infections presented in primary care and empirical antimicrobial treatment is currently recommended. Previous research has identified that a substantial proportion of Irish general practitioners (GPs) prescribe antimicrobials for UTIs that are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland. The aim of this trial is to design, implement and evaluate the effectiveness of a complex intervention on GP antimicrobial prescribing and adult (18 years of age and over) patients\\' antimicrobial consumption when presenting with a suspected UTI.

  3. Japan Diabetes Outcome Intervention Trial-1(J-DOIT1, a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment

    Directory of Open Access Journals (Sweden)

    Sakane Naoki

    2013-01-01

    Full Text Available Abstract Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM. To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach. The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1 is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. Methods For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Results Forty-three groups (clusters, formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups or control arm (21 clusters between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There

  4. Project TEAMS (Talking about Eating, Activity, and Mutual Support): a randomized controlled trial of a theory-based weight loss program for couples.

    Science.gov (United States)

    Gorin, Amy A; Powers, Theodore A; Gettens, Katelyn; Cornelius, Talea; Koestner, Richard; Mobley, Amy R; Pescatello, Linda; Medina, Tania Huedo

    2017-09-29

    Obesity risk is shared between spouses, yet existing weight loss programs focus on individuals and not the marital dyad. Given the interdependence of weight in couples, weight management outcomes might be improved by targeting joint weight loss and the creation of an interpersonal milieu that supports long-term behavior change. According to Self-Determination Theory (SDT), greater autonomous self-regulation of behaviors, and subsequently better treatment outcomes, are observed in needs supportive environments in which personally meaningful choice is supported and criticism and control are minimized. Correlational analyses confirm these pathways in weight management, with needs support from one's spouse or partner emerging as a distinct predictor of weight loss success. Research is now needed to establish causal links and to develop and test weight loss interventions designed to facilitate the needs supportive behavior of spouses. Project TEAMS (Talking about Eating, Activity, and Mutual Support) is a randomized controlled trial testing a couples-based intervention, grounded in SDT, designed to change the social context of weight loss by training spouses to provide needs support for each other's eating and physical activity behavior. Sixty-four couples will be randomized to either 6 months of behavioral weight loss treatment informed by SDT (SDT-WL) or to 6 months of standard behavioral weight loss treatment (BWL). Couples will attend weekly sessions for 6 months and will be assessed at 0, 3, 6, and 12 months. By bolstering needs support, SDT-WL is predicted to increase autonomous self-regulation and perceived competence and produce greater weight loss and maintenance than standard behavioral treatment. Exploratory analyses will examine the SDT process model prediction that the influence of needs support on treatment outcomes will be mediated by autonomous self-regulation and perceived competence. This study addresses the fundamental importance of interpersonal

  5. Effectiveness of Supporting Informal Caregivers of People with Dementia: A Systematic Review of Randomized and Non-Randomized Controlled Trials.

    Science.gov (United States)

    Vandepitte, Sophie; Van Den Noortgate, Nele; Putman, Koen; Verhaeghe, Sofie; Faes, Kristof; Annemans, Lieven

    2016-04-08

    Dementia is known as a major public health problem affecting both patients and caregivers, and placing a high financial strain upon society. In community-dwelling patients, it is important to support informal caregivers in order to help them sustain their demanding role. Previous reviews about effectiveness of such supporting strategies often included a small number of studies, focused only on particular supportive types, particular outcomes, or solely on caregivers. A general systematic review was conducted investigating effectiveness of different supportive strategies on at least the well-being of the caregiver or the care-recipient. A systematic literature search was conducted in Web of Science and PubMed. An adapted version of the Downs and Black (1998) checklist was used to assess methodological quality. A new classification was developed to group different types of caregiver support. Fifty-three papers met the inclusion criteria. Although 87% of the interventions were to some extent effective, methods and findings were rather inconsistent. Psychoeducational interventions generally lead to positive outcomes for caregivers, and delay permanent institutionalization of care-recipients. Cognitive behavioral therapy decreases dysfunctional thoughts among caregivers. Occupational therapy decreases behavioral problems among patients and improves self-efficacy of caregivers. In general, those interventions tailored on individual level generate better outcomes. Comparative research on respite care was very rare. Despite methodological inconsistency, supporting caregivers appears to be an effective strategy often improving well-being of caregiver or care-recipient and resulting in additional benefits for society. However, there is a need for more research on the (cost)-effectiveness of respite care.

  6. The use of support people to improve the weight-related and psychological outcomes of adults with obesity: A randomised controlled trial.

    Science.gov (United States)

    Rieger, Elizabeth; Treasure, Janet; Murray, Kristen; Caterson, Ian

    2017-07-01

    To investigate whether training individuals from the personal networks of adults with obesity in the skills of motivational interviewing enhances the anthropometric and psychological outcomes of a cognitive-behavioural weight loss intervention. Adults with obesity (N = 201) were randomised to participate in 26 sessions of cognitive behaviour therapy (CBT) for weight loss either alone (CBT-A) or with the addition of a support person (CBT-SP). Outcomes were assessed at the end of the 12-month intervention and at a follow-up one year later. Analyses indicated negligible additive effect for the CBT-SP versus the CBT-A condition, although the quality of the patient's relationship with their support person predicted the anthropometric outcomes. Across conditions, significant improvements were observed for all anthropometric (weight, body mass index, and waist circumference) and psychological (self efficacy, weight-related quality of life, weight satisfaction, and binge eating) variables between baseline and post-treatment, and baseline and the follow-up. The benefits of the cognitive-behavioural weight loss program were found to extend to psychological variables. Yet the lack of evidence for the additive benefits of including support people in treatment suggests a need to develop more effective training programs for support people in weight management. anzctr.org.au Trial ID: ACTRN12611000509965. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Randomized Trial of a Clinical Decision Support System: Impact on the Management of Children with Fever without Apparent Source

    NARCIS (Netherlands)

    J. Roukema (Jolt); E.W. Steyerberg (Ewout); J. van der Lei (Johan); H.A. Moll (Henriëtte)

    2008-01-01

    textabstractObjective: To assess compliance with a clinical decision support system (CDSS) for diagnostic management of children with fever without apparent source and to study the effects of application of the CDSS on time spent in the emergency department (ED) and number of laboratory tests.

  8. Structural distress screening and supportive care for patients with lung cancer on systemic therapy : A randomised controlled trial

    NARCIS (Netherlands)

    Geerse, Olaf; Hoekstra-Weebers, J. E. H. M.; Stokroos, M H; Burgerhof, J. G. M.; Groen, H. J. M.; Kerstjens, H. A. M.; Hiltermann, T. J. N.

    Introduction: Gaining regular insight into the nature and severity of distress by a psychosocial nurse coupled with referral to psychosocial and/or paramedical healthcare provider(s) is an experimental supportive care approach. We sought to examine the effects of this approach on quality of life

  9. Effects of a wearable type lumbosacral support for low back pain among hospital workers: A randomized controlled trial.

    Science.gov (United States)

    Hagiwara, Yoshihiro; Yabe, Yutaka; Yamada, Hiroyuki; Watanabe, Takashi; Kanazawa, Kenji; Koide, Masashi; Sekiguchi, Takuya; Hatano, Hirokazu; Itoi, Eiji

    2017-03-28

    To examine the effects of a new wearable type of lumbosacral support on low back pain. A total of 121 healthcare workers participated in this study. They were randomly allocated into the experimental and control groups and the former wore the support with signals of compression on the back by poor posture for the first 3 months. The control group remained on a waiting list for the first 3 months. Medical history, musculoskeletal symptoms, feeling in good posture, sleep habits, psychological distress, Roland-Morris Disability Questionnaire, and Somatosensory Amplification Scale (SSAS) were evaluated. The range of motion (ROM) in the shoulder and hip joints as well as spinal alignment were evaluated. Our primary concern was the difference in the change of low back pain measured by visual analog scale (VAS) between the two groups. A total of 54 participants in the experimental and 53 participants in the control groups were analyzed. VAS and SSAS scores as well as lumbar spinal ROM in the experimental group significantly decreased. Low back pain (OR=0.401, 95% CI=0.168-0.954) and neck pain in the experimental group (OR=0.198, 95% CI=0.052-0.748) significantly decreased. The new lumbar support reduced VAS and SSAS scores, lumbar spinal ROM, low back pain, and neck pain. This new type of lumbar support reduced low back pain among healthcare workers.

  10. Effects of a wearable type lumbosacral support for low back pain among hospital workers: A randomized controlled trial

    Science.gov (United States)

    Hagiwara, Yoshihiro; Yabe, Yutaka; Yamada, Hiroyuki; Watanabe, Takashi; Kanazawa, Kenji; Koide, Masashi; Sekiguchi, Takuya; Hatano, Hirokazu; Itoi, Eiji

    2017-01-01

    Objective: To examine the effects of a new wearable type of lumbosacral support on low back pain. Methods: A total of 121 healthcare workers participated in this study. They were randomly allocated into the experimental and control groups and the former wore the support with signals of compression on the back by poor posture for the first 3 months. The control group remained on a waiting list for the first 3 months. Medical history, musculoskeletal symptoms, feeling in good posture, sleep habits, psychological distress, Roland-Morris Disability Questionnaire, and Somatosensory Amplification Scale (SSAS) were evaluated. The range of motion (ROM) in the shoulder and hip joints as well as spinal alignment were evaluated. Our primary concern was the difference in the change of low back pain measured by visual analog scale (VAS) between the two groups. Results: A total of 54 participants in the experimental and 53 participants in the control groups were analyzed. VAS and SSAS scores as well as lumbar spinal ROM in the experimental group significantly decreased. Low back pain (OR=0.401, 95% CI=0.168-0.954) and neck pain in the experimental group (OR=0.198, 95% CI=0.052-0.748) significantly decreased. Conclusions: The new lumbar support reduced VAS and SSAS scores, lumbar spinal ROM, low back pain, and neck pain. This new type of lumbar support reduced low back pain among healthcare workers. PMID:28132971

  11. Roodekrans trial sections: The role of structural support under very thin jointed CRC pavements subjected to heavy traffic

    CSIR Research Space (South Africa)

    Steyn, WJvdM

    2005-08-01

    Full Text Available on the exit road from a quarry and have successfully sustained 4000 equivalent 80 kN axle loads to date. The concrete pavement thickness varied from 50 mm to 140 mm and the base support consisted of either a natural or stabilized gravel layer 100 mm thick...

  12. Maxillary overdentures supported by four or six implants in the anterior region; 1-year results from a randomized controlled trial

    NARCIS (Netherlands)

    Slot, Wim; Raghoebar, Gerry M.; Vissink, Arjan; Meijer, Henny J. A.

    Objective Comparing treatment outcome of four and six bar-connected implants in the anterior maxillary region to support an overdenture during a 1-year follow-up period. Material and methods Fifty edentulous patients with lack of retention and stability of the upper denture, but with sufficient bone

  13. Effects of automated smartphone mobile recovery support and telephone continuing care in the treatment of alcohol use disorder: study protocol for a randomized controlled trial.

    Science.gov (United States)

    McKay, James R; Gustafson, David H; Ivey, Megan; McTavish, Fiona; Pe-Romashko, Klaren; Curtis, Brenda; Oslin, David A; Polsky, Daniel; Quanbeck, Andrew; Lynch, Kevin G

    2018-01-30

    New smartphone communication technology provides a novel way to provide personalized continuing care support following alcohol treatment. One such system is the Addiction version of the Comprehensive Health Enhancement Support System (A-CHESS), which provides a range of automated functions that support patients. A-CHESS improved drinking outcomes over standard continuing care when provided to patients leaving inpatient treatment. Effective continuing care can also be delivered via telephone calls with a counselor. Telephone Monitoring and Counseling (TMC) has demonstrated efficacy in two randomized trials with alcohol-dependent patients. A-CHESS and TMC have complementary strengths. A-CHESS provides automated 24/7 recovery support services and frequent assessment of symptoms and status, but does not involve regular contact with a counselor. TMC provides regular and sustained contact with the same counselor, but no ongoing support between calls. The future of continuing care for alcohol use disorders is likely to involve automated mobile technology and counselor contact, but little is known about how best to integrate these services. To address this question, the study will feature a 2 × 2 design (A-CHESS for 12 months [yes/no] × TMC for 12 months [yes/no]), in which 280 alcohol-dependent patients in intensive outpatient programs (IOPs) will be randomized to one of the four conditions and followed for 18 months. We will determine whether adding TMC to A-CHESS produces fewer heavy drinking days than TMC or A-CHESS alone and test for TMC and A-CHESS main effects. We will determine the costs of each of the four conditions and the incremental cost-effectiveness of the three active conditions. Analyses will also examine secondary outcomes, including a biological measure of alcohol use, and hypothesized moderation and mediation effects. The results of the study will yield important information on improving patient alcohol use outcomes by integrating mobile

  14. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol.

    Science.gov (United States)

    Ratanawongsa, Neda; Handley, Margaret A; Quan, Judy; Sarkar, Urmimala; Pfeifer, Kelly; Soria, Catalina; Schillinger, Dean

    2012-01-26

    Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with

  15. The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Murphy, Jill; Goldsmith, Charles H; Jones, Wayne; Oanh, Pham Thi; Nguyen, Vu Cong

    2017-05-05

    Depressive disorders are one of the leading causes of disease and disability worldwide. In Vietnam, although epidemiological evidence suggests that depression rates are on par with global averages, services for depression are very limited. In a feasibility study that was implemented from 2013 to 2015, we found that a Supported Self-management (SSM) intervention showed promising results for adults with depression in the community in Vietnam. This paper describes the Mental Health in Adults and Children: Frugal Innovations (MAC-FI) trial protocol that will assess the effectiveness of the SSM intervention, delivered by primary care and social workers, to community-based populations of adults with depression in eight Vietnamese provinces. The MAC-FI program will be assessed using a stepped-wedge, randomized controlled trial. Study participants are adults aged 18 years and over in eight provinces of Vietnam. Study participants will be screened at primary care centres and in the community by health and social workers using the Self-reporting Questionnaire-20 (SRQ-20). Patients scoring >7, indicating depression caseness, will be invited to participate in the study in either the SSM intervention group or the enhanced treatment as usual control group. Recruited participants will be further assessed using the World Health Organization's Disability Assessment Scale (WHODAS 2.0) and the Cut-down, Annoyed, Guilty, Eye-opener (CAGE) Questionnaire for alcohol misuse. Intervention-group participants will receive the SSM intervention, delivered with the support of a social worker or social collaborator, for a period of 2 months. Control- group participants will receive treatment as usual and a leaflet with information about depression. SRQ-20, WHODAS 2.0 and CAGE scores will be taken by blinded outcome assessors at baseline, after 1 month and after 2 months. The primary analysis method will be intention-to-treat. This study has the potential to add to the knowledge base about

  16. Effectiveness of preventive support groups for children of mentally ill or addicted parents: a randomized controlled trial.

    Science.gov (United States)

    van Santvoort, Floor; Hosman, Clemens M H; van Doesum, Karin T M; Janssens, Jan M A M

    2014-06-01

    In various countries preventive support groups are offered to children of mentally ill and/or addicted parents to reduce the risk that they will develop problems themselves. This study assessed the effectiveness of Dutch support groups for children aged 8-12 years old in terms of reducing negative cognitions; improving social support, competence, and parent-child interaction (direct intervention goals); and reducing emotional and behavioural problems (ultimate intervention aim). Children from 254 families were randomly assigned to the intervention or a control condition. Parents and children completed questionnaires at baseline and 3 and 6 months later. Emotional and behavioural problems of intervention group children were also assessed 1 year after the start. Univariate analyses of variance showed that children in the intervention group experienced a greater decrease in negative cognitions and sought more social support, immediately after participation and 3 months later, as compared to control group children. They also remained stable in their feelings of social acceptance (competence aspect) immediately after the intervention, whereas these feelings declined in control group children. The intervention and control groups both improved over time in terms of cognitions, competence, parent-child interaction and emotional and behavioural problem scores. Additional improvement in terms of problem scores was found in the intervention group 1 year after baseline. Further enhancement of effectiveness requires re-consideration of the support group goals; it should be studied whether the goals reflect the most important and influential risk and protective factors for this specific population. Besides, effects should be studied over a longer period.

  17. Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital - design and development of a randomised controlled trial.

    Science.gov (United States)

    Kasteleyn, Marise J; Gorter, Kees J; Stellato, Rebecca K; Rijken, Mieke; Nijpels, Giel; Rutten, Guy Ehm

    2014-01-18

    Type 2 diabetes mellitus patients with an acute coronary event (ACE) experience decreased quality of life and increased distress. According to the American Diabetes Association, discharge from the hospital is a time of increased distress for all patients. Tailored support specific to diabetes is scarce in that period. We developed an intervention based on Bandura's Social Cognitive Theory, Leventhal's Common Sense Model, and results of focus groups. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress in type 2 diabetes patients who experienced a first ACE. Randomised controlled trial. Two hundred patients are recruited in thirteen hospitals. A diabetes nurse visits the patients in the intervention group (n = 100) at home within three weeks after discharge from hospital, and again after two weeks and two months. The control group (n = 100) receives a consultation by telephone. The primary outcome is diabetes-related distress, measured with the Problem Areas in Diabetes (PAID) questionnaire. Secondary outcomes are well-being, health status, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Outcomes are measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables are obtained from the records from the primary care physician and the hospital. Differences between groups in change over time are analysed according to the intention-to-treat principle. The Holm-Bonferroni correction is used to adjust for multiplicity. Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence on the effectiveness of a supportive intervention in reducing distress in these patients. NCT01801631.

  18. Implants in free fibula flap supporting dental rehabilitation - Implant and peri-implant related outcomes of a randomized clinical trial.

    Science.gov (United States)

    Kumar, Vinay V; Ebenezer, Supriya; Kämmerer, Peer W; Jacob, P C; Kuriakose, Moni A; Hedne, Naveen; Wagner, Wilfried; Al-Nawas, Bilal

    2016-11-01

    The objective of this study was to assess the difference in success rates of implants when using two or four implant-supported-overdentures following segmental mandibular reconstruction with fibula free flap. This prospective, parallel designed, randomized clinical study was conducted with 1:1 ratio. At baseline, all participants already had segmental reconstruction of mandible with free fibula flap. The participants were randomized into two groups: Group-I received implant-supported-overdentures on two tissue-level implants and Group-II received implant-supported-overdentures on four tissue-level implants. Success rates of the implants were evaluated at 3 months, 6 months and 12 months following implant loading using marginal bone level changes as well as peri-implant indices (Buser et al., 1990). 52 patients were randomized into two treatment groups (26 each), out of which 18 patients (36 implants) of Group-I and 17 patients (68 implants) of Group-II were evaluated. One implant in Group-I was lost due to infective complications and one patient in the same group had superior barrel necrosis. There was a statistically significant increase at both time points (p = 0.03, p = 0.04 at 6 months, 12 months) in the amount of marginal bone loss in Group-I (0.4 mm, 0.5 mm at 6 months, 12 months) as compared to Group-II (0.1 mm, 0.2 mm at 6 months, 12 months). There were no clinically significant changes peri-implant parameters between both groups. Peri-implant soft tissue hyperplasia was seen in both groups, 32% of implants at 3-months, 26% at 6-months and 3% at 12-months follow-up. The results of this study show that patients with 2-implant-supported-overdentures had higher marginal bone loss as compared to patients with 4-implant-supported-overdentures. There were no clinically significant differences in peri-implant soft tissue factors in patients with 2- or 4-implant-supported-overdentures. Hyperplastic peri-implant tissues are common in the early implant

  19. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial.

    Science.gov (United States)

    Li, Jin; Qin, Shukui; Xu, Ruihua; Yau, Thomas C C; Ma, Brigette; Pan, Hongming; Xu, Jianming; Bai, Yuxian; Chi, Yihebali; Wang, Liwei; Yeh, Kun-Huei; Bi, Feng; Cheng, Ying; Le, Anh Tuan; Lin, Jen-Kou; Liu, Tianshu; Ma, Dong; Kappeler, Christian; Kalmus, Joachim; Kim, Tae Won

    2015-06-01

    In the international randomised phase 3 CORRECT trial (NCT01103323), regorafenib significantly improved overall survival versus placebo in patients with treatment-refractory metastatic colorectal cancer. Of the 760 patients in CORRECT, 111 were Asian (mostly Japanese). This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT. In this randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done in 25 hospitals in mainland China, Hong Kong, South Korea, Taiwan, and Vietnam, we recruited Asian patients aged 18 years or older with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments. Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 3 months, and adequate bone marrow, liver, and renal function, without other uncontrolled medical disorders. We randomly allocated patients (2:1; with a computer-generated unicentric randomisation list [prepared by the study funder] and interactive voice response system; block size of six; stratified by metastatic site [single vs multiple organs] and time from diagnosis of metastatic disease [regorafenib 160 mg once daily or placebo on days 1-21 of each 28 day cycle; patients in both groups were also to receive best supportive care. Participants, investigators, and the study funder were masked to treatment assignment. The primary endpoint was overall survival, and we analysed data on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01584830. Between April 29, 2012, and Feb 6, 2013, we screened 243 patients and randomly assigned 204 patients to receive either regorafenib (136 [67%]) or placebo (68 [33%]). After a median follow-up of 7·4 months (IQR 4·3-12·2), overall survival was significantly better with regorafenib

  20. A 1-year randomised controlled trial comparing zirconia versus metal-ceramic implant supported single-tooth restorations

    DEFF Research Database (Denmark)

    Hosseini, Mandana; Worsaae, Nils; Schiødt, Morten

    2011-01-01

    PURPOSE: To compare the biological, technical and aesthetic outcomes of single implant-supported all-ceramic versus metal-ceramic crowns. MATERIALS AND METHODS: Thirty-six patients with premolar agenesis were randomly treated with 38 all-ceramic (AC) and 37 metal-ceramic (MC) implant......-supported single-tooth restorations. A quasi-randomisation of consecutively included restorations in patients with one or more implants was used, i.e. a combination of parallel group (for 13 patients with one restoration) and split-mouth (for 23 patients with =2 restorations). All patients were recalled......, by blinded assessors. RESULTS: One-year after loading, no patient dropped out and no implant failed, though one MC restoration had to be remade. The marginal bone loss was not significantly different between AC and MC restorations (AC: mean 0.08 mm, SD 0.25; MC: mean 0.10 mm, SD 0.17). Seven out of 10...

  1. PRISM (Program of Resources, Information and Support for Mothers Protocol for a community-randomised trial [ISRCTN03464021

    Directory of Open Access Journals (Sweden)

    Gunn Jane

    2003-11-01

    Full Text Available Abstract Background In the year after birth one in six women has a depressive illness, and 30% are still depressed, or depressed again, when their child is 2 years old, 94% experience at least one major health problem (e.g. back pain, perineal pain, mastitis, urinary or faecal incontinence, 26% experience sexual problems and almost 20% have relationship problems with partners. Women with depression report less practical and emotional support from partners, less social support overall, more negative life events, and poorer physical health. Their perceptions of factors contributing to depression are lack of support, isolation, exhaustion and physical health problems. Fewer than one in three affected women seek help in primary care despite frequent contacts. Methods/Design PRISM aims to reduce depression and physical health problems of recent mothers through primary care strategies to increase practitioners' response to these issues, and through community-based strategies to develop broader family and community supports for recent mothers. Eligible local governments will be recruited and randomised to intervention or comparison arms, after stratification (urban/rural, size, birth numbers, extent of community activity, avoiding contiguous boundaries. Maternal depression and physical health will be measured six months after birth, in a one year cohort of mothers, in intervention and comparison communities. The sample size to detect a 20% relative reduction in depression, adjusting for cluster sampling, and estimating a population response fraction of 67% is 5740 × 2. Analysis of the physical and mental health outcomes, by intention to treat, will adjust for the correlated structure of the data.

  2. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial

    OpenAIRE

    Brown, Sarah; Smith, Isabelle L.; Brown, Julia M.; Hulme, Claire; McGinnis, Elizabeth; Stubbs, Nikki; Nelson, E. Andrea; Muir, Delia; Rutherford, Claudia; Walker, Kay; Henderson, Valerie; Wilson, Lyn; Gilberts, Rachael; Collier, Howard; Fernandez, Catherine

    2016-01-01

    Background Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual?s functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the...

  3. Treadmill training with partial body-weight support after anterior cruciate ligament reconstruction: a randomized controlled trial.

    Science.gov (United States)

    Luo, Yuan; Shen, Weizhong; Jiang, Zhong; Sha, Jiao

    2016-12-01

    [Purpose] To compare the effects of treadmill training with partial body weight support (TTPBWS) and conventional physical therapy (PT) on subjects with anterior cruciate ligament reconstructions. [Subjects and Methods] A total of 40 subjects were randomly allocated to either a treatment group or a control group. Subjects received either treadmill training with partial body weight support (treatment group) or conventional physical therapy (control group). The circumferences of the lower extremities, Holden classifications, 10-meter walking times and the International Knee Documentation Committee (IKDC) scores were compared at 12 and 24 weeks post-operation. The knee joint stability was tested at 24 weeks post-operation using a KT-1000. [Results] Significant differences were found between the two groups at the 12 weeks post-operation. For most of the measures, there was no significant difference between the groups at 24 weeks post-operation. Interestingly, for most of the measures, there was no significant difference between their values in the treatment group at 12 weeks and their values in the control group at 24 weeks post-operation. [Conclusion] The function of a subject's lower extremities can be improved and the improvement was clearly accelerated by the intervention of treadmill training with partial body weight support, without compromising the stability of the knee joints in a given follow-up period.

  4. Outcome of mentalization-based and supportive psychotherapy in patients with borderline personality disorder: a randomized trial.

    Science.gov (United States)

    Jørgensen, C R; Freund, C; Bøye, R; Jordet, H; Andersen, D; Kjølbye, M

    2013-04-01

    This study presents data from a randomized outcome study comparing mentalization-based and supportive psychotherapy for patients with borderline personality disorder (BPD). Eighty-five SCID-II diagnosed borderline patients were randomized to either i) 2 years of intensive (twice weekly) combined (individual and group), mentalization-based psychotherapy (MBT) or ii) 2 years of less-intensive (biweekly) supportive group therapy. Treatment outcome was assessed using a battery of self-report questionnaires, SCID-II interviews and therapist-rated global assessment of functioning (GAF). Fifty-eight patients completed 2 years of treatment. Significant changes in both treatment groups were identified for several outcome measures, including self-reported measures of general functioning, depression, social functioning and number of diagnostic criteria met for BPD, as outlined by the SCID-II interview. General linear modelling was used to compare treatment outcome in the two groups. Only GAF showed a significantly higher outcome in the MBT group. A trend was found for a higher rate of recovery from BPD in the MBT group. Pre-post effect sizes were high (0.5-2.1) and for the most part highly significant in both groups. The study indicates that both MBT and supportive treatment are highly effective in treating BPD when conducted by a well-trained and experienced psychodynamic staff in a well-organized clinic. © 2012 John Wiley & Sons A/S.

  5. Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting children's early self-regulation development: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Howard, Steven J; Vasseleu, Elena; Neilsen-Hewett, Cathrine; Cliff, Ken

    2018-01-24

    For children with low self-regulation in the preschool years, the likelihood of poorer intellectual, health, wealth and anti-social outcomes in adulthood is overwhelming. Yet this knowledge has not yielded a framework for understanding self-regulatory change, nor generated particularly successful methods for enacting this change. Reconciling insights from cross-disciplinary theory, research and practice, this study seeks to implement a newly developed program of low-cost and routine practices and activities for supporting early self-regulatory development within preschool contexts and to evaluate its effect on children's self-regulation, executive function and school readiness; and educator perceived knowledge, attitudes and self-efficacy related to self-regulation. The Early Start to Self-Regulation study is a cluster randomized, controlled trial for evaluating benefits of the Preschool Situational Self-Regulation Toolkit (PRSIST) program, when implemented by early childhood educators, compared with routine practice. The PRSIST program combines professional learning, adult practices, child activities and connections to the home to support children's self-regulation development. Fifty preschool centers in New South Wales, Australia, will be selected to ensure a range of characteristics, namely: National Quality Standards (NQS) ratings, geographic location and socioeconomic status. After collection of baseline child and educator data, participating centers will then be randomly allocated to one of two groups, stratified by NQS rating: (1) an intervention group (25 centers) that will implement the PRSIST program; or (2) a control group (25 centers) that will continue to engage in practice as usual. Primary outcomes at the child level will be two measures of self-regulation: Head-Toes-Knees-Shoulders task and the PRSIST observational assessment. Secondary outcomes at the child level will be adult-reported measures of child self-regulation, executive function and

  6. The effect of financial incentives on top of behavioral support on quit rates in tobacco smoking employees: study protocol of a cluster-randomized trial.

    Science.gov (United States)

    van den Brand, F A; Nagelhout, G E; Winkens, B; Evers, S M A A; Kotz, D; Chavannes, N H; van Schayck, C P

    2016-10-06

    Stimulating successful tobacco cessation among employees has multiple benefits. Employees who quit tobacco are healthier, more productive, less absent from work, and longer employable than employees who continue to use tobacco. Despite the evidence for these benefits of tobacco cessation, a successful method to stimulate employees to quit tobacco is lacking. The aim of this study is to evaluate whether adding a financial incentive to behavioral support (compared with no additional incentive) is effective and cost-effective in increasing abstinence rates in tobacco smoking employees participating in a smoking cessation group training. In this cluster-randomized trial employees in the intervention and control group both participate in a smoking cessation group training consisting of seven weekly counseling sessions of ninety minutes each. In addition to the training, employees in the intervention group receive a voucher as an incentive for being abstinent from smoking at the end of the training (€50), after three months (€50), after six months (€50), and after one year (€200). The control group does not receive any incentive. The primary outcome is carbon monoxide validated 12-month continuous abstinence from smoking (Russel's standard). Additionally, an economic evaluation is performed from a societal and an employer perspective. The present paper describes the methods and design of this cluster-randomized trial in detail. We hypothesize that the financial incentive for abstinence in the form of vouchers increases abstinence rates over and above the group training. The results of this study can provide important recommendations for enhancement of employee tobacco cessation. Dutch Trial Register: NTR5657 . First received 27-01-2016.

  7. The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes

    Science.gov (United States)

    Walker, Gemma M; Armstrong, Sarah; Gordon, Adam L; Gladman, John; Robertson, Kate; Ward, Marie; Conroy, Simon; Arnold, Gail; Darby, Janet; Frowd, Nadia; Williams, Wynne; Knowles, Sue; Logan, Pip A

    2015-01-01

    Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. PMID:26385358

  8. Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Moreno-Alcázar, Ana; Radua, Joaquim; Landín-Romero, Ramon; Blanco, Laura; Madre, Mercè; Reinares, Maria; Comes, Mercè; Jiménez, Esther; Crespo, Jose Manuel; Vieta, Eduard; Pérez, Victor; Novo, Patricia; Doñate, Marta; Cortizo, Romina; Valiente-Gómez, Alicia; Lupo, Walter; McKenna, Peter J; Pomarol-Clotet, Edith; Amann, Benedikt L

    2017-04-04

    Up to 60% of patients with bipolar disorder (BD) have a history of traumatic events, which is associated with greater episode severity, higher risk of comorbidity and higher relapse rates. Trauma-focused treatment strategies for BD are thus necessary but studies are currently scarce. The aim of this study is to examine whether Eye Movement Desensitization and Reprocessing (EMDR) therapy focusing on adherence, insight, de-idealisation of manic symptoms, prodromal symptoms and mood stabilization can reduce episode severity and relapse rates and increase cognitive performance and functioning in patients with BD. This is a single-blind, randomized controlled, multicentre trial in which 82 patients with BD and a history of traumatic events will be recruited and randomly allocated to one of two treatment arms: EMDR therapy or supportive therapy. Patients in both groups will receive 20 psychotherapeutic sessions, 60 min each, during 6 months. The primary outcome is a reduction of affective episodes after 12 and 24 months in favour of the EMDR group. As secondary outcome we postulate a greater reduction in affective symptoms in the EMDR group (as measured by the Bipolar Depression Rating Scale, the Young Mania Rating Scale and the Clinical Global Impression Scale modified for BD), and a better performance in cognitive state, social cognition and functioning (as measured by the Screen for Cognitive Impairment in Psychiatry, The Mayer-Salovey-Caruso Emotional Intelligence Test and the Functioning Assessment Short Test, respectively). Traumatic events will be evaluated by The Holmes-Rahe Life Stress Inventory, the Clinician-administered PTSD Scale and the Impact of Event Scale. The results of this study will provide evidence whether a specific EMDR protocol for patients with BD is effective in reducing affective episodes, affective symptoms and functional, cognitive and trauma symptoms. The trial is registered at ClinicalTrials.gov, identifier: NCT02634372 . Registered on

  9. Emotion Recognition from Single-Trial EEG Based on Kernel Fisher’s Emotion Pattern and Imbalanced Quasiconformal Kernel Support Vector Machine

    Directory of Open Access Journals (Sweden)

    Yi-Hung Liu

    2014-07-01

    Full Text Available Electroencephalogram-based emotion recognition (EEG-ER has received increasing attention in the fields of health care, affective computing, and brain-computer interface (BCI. However, satisfactory ER performance within a bi-dimensional and non-discrete emotional space using single-trial EEG data remains a challenging task. To address this issue, we propose a three-layer scheme for single-trial EEG-ER. In the first layer, a set of spectral powers of different EEG frequency bands are extracted from multi-channel single-trial EEG signals. In the second layer, the kernel Fisher’s discriminant analysis method is applied to further extract features with better discrimination ability from the EEG spectral powers. The feature vector produced by layer 2 is called a kernel Fisher’s emotion pattern (KFEP, and is sent into layer 3 for further classification where the proposed imbalanced quasiconformal kernel support vector machine (IQK-SVM serves as the emotion classifier. The outputs of the three layer EEG-ER system include labels of emotional valence and arousal. Furthermore, to collect effective training and testing datasets for the current EEG-ER system, we also use an emotion-induction paradigm in which a set of pictures selected from the International Affective Picture System (IAPS are employed as emotion induction stimuli. The performance of the proposed three-layer solution is compared with that of other EEG spectral power-based features and emotion classifiers. Results on 10 healthy participants indicate that the proposed KFEP feature performs better than other spectral power features, and IQK-SVM outperforms traditional SVM in terms of the EEG-ER accuracy. Our findings also show that the proposed EEG-ER scheme achieves the highest classification accuracies of valence (82.68% and arousal (84.79% among all testing methods.

  10. Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial.

    Science.gov (United States)

    van Gaalen, Johanna L; Bakker, Moira J; van Bodegom-Vos, Leti; Snoeck-Stroband, Jiska B; Assendelft, Willem J J; Kaptein, Ad A; van der Meer, Victor; Taube, Christian; Thoonen, Bart P; Sont, Jacob K

    2012-11-21

    Internet-based self-management (IBSM) support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS): dissemination of the IBSM program; intermediate strategy (IS): MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals); and extended strategy (ES): IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions) are primarily targeted at general practices, randomisation will occur at practice level.In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations); self-management related outcomes (health education impact, medication adherence, and illness perceptions); and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption. Follow-up is six months per patient. This study

  11. Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment.

    Science.gov (United States)

    Sakane, Naoki; Kotani, Kazuhiko; Takahashi, Kaoru; Sano, Yoshiko; Tsuzaki, Kokoro; Okazaki, Kentaro; Sato, Juichi; Suzuki, Sadao; Morita, Satoshi; Izumi, Kazuo; Kato, Masayuki; Ishizuka, Naoki; Noda, Mitsuhiko; Kuzuya, Hideshi

    2013-01-29

    Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach.The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in individual characteristics

  12. Can computerized decision support help patients make complex treatment decisions? A randomized controlled trial of an individualized menopause decision aid.

    Science.gov (United States)

    Col, Nananda F; Ngo, Long; Fortin, Jennifer M; Goldberg, Robert J; O'Connor, Annette M

    2007-01-01

    To compare the effectiveness of an individualized decision aid (DA) with standard educational materials on decisions about menopausal treatments and to assess the feasibility of integrating this DA into clinical practice, with and without coaching. We conducted a 3-armed randomized controlled trial in 3 clinics, enrolling menopausal women between the ages of 45 and 65 years with primary care appointments. Of the 145 women included, 99 completed a 2-week follow-up. The control group received generic educational materials, 1 intervention group received an individualized computer-generated DA mailed to patients and their clinicians before clinic appointment, and the 2nd intervention group received the same DA along with coached care before clinic appointment (DA + CC). Decisional conflict, satisfaction, and knowledge were measured 2 weeks after clinic appointment. Participants' mean age was 52 years, and 97% were white. Most women (98%) read all or most of the documents. Decisional conflict was significantly lower in both intervention groups but not in the control group. DA reduced decisional conflict from preintervention to postintervention (pre-post change) by 0.70 (SD = 0.56) points (on a 1-5 scale), compared to reductions of 0.51 (SD = 0.51) and 0.09 (SD = 0.44) for the DA + CC group and the control group, respectively. Satisfaction with the decision made was significantly higher at 2 weeks in the DA v. control group. Self-reported knowledge significantly improved in DA + CC compared to controls. Our decision aid lowered decisional conflict and improved patient satisfaction; adding coaching provided little additional benefit.

  13. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application.

    Science.gov (United States)

    Garfield, Craig F; Lee, Young Seok; Kim, Hyung Nam; Rutsohn, Joshua; Kahn, Janine Yasmin; Mustanski, Brian; Mohr, David C

    2016-05-01

    To determine whether parents of Very Low Birth Weight (VLBW) infants in the Neonatal Intensive Care Unit (NICU) transitioning home with the NICU-2-Home smartphone application have greater parenting self-efficacy, are better prepared for discharge and have shorter length of stay (LOS) than control parents. A four-week pilot randomized controlled trial during the transition home with 90 VLBW parents randomized to usual care (n=44) or usual care plus NICU-2-Home (n=46), a smartphone application designed for VLBW parents. Parenting Sense of Competence Scale (PSOC) was assessed at baseline, day after discharge, and two weeks post-discharge. Preparedness for discharge and length of stay (LOS) were secondary outcomes. Analyses by usage were also included. While parents of VLBW infants in the intervention group did not show an improvement in PSOC during the transition when compared directly to controls, after accounting for actual mean app usage, PSOC improved 7% (2.71 points/time greater; 95%CI = 1.45, 6.27) for intervention versus controls. Compared to controls, above-average users increased their PSOC score by 14% (6.84 points/time; 95%CL = 5.02, 8.67), average users by 11% (4.58 points/time; 95%CL = 2.89, 6.27) and below-average users by 6% (2.41 points/time; 95%CL = 0.04, 4.79). Moderate evidence showed LOS was shorter for above-average users compared to the control group (β = 12.2. SE = 6.9, p = 0.085). A smartphone application used by parents of VLBW infants during the transition home from the NICU can improve parenting self-efficacy, discharge preparedness, and LOS with improved benefits based on usage.

  14. A Randomized Controlled Trial of 7-Day Intensive and Standard Weekly Cognitive Therapy for PTSD and Emotion-Focused Supportive Therapy

    Science.gov (United States)

    Ehlers, Anke; Hackmann, Ann; Grey, Nick; Wild, Jennifer; Liness, Sheena; Albert, Idit; Deale, Alicia; Stott, Richard; Clark, David M.

    2014-01-01

    Objective Psychological treatments for posttraumatic stress disorder (PTSD) are usually delivered once or twice weekly over several months. It is unclear whether they can be successfully delivered over a shorter period of time. This clinical trial had two goals, (1) to investigate the acceptability and efficacy of a 7-day intensive version of cognitive therapy for PTSD, and (2) to investigate whether cognitive therapy has specific treatment effects by comparing intensive and standard weekly cognitive therapy with an equally credible alternative treatment. Method Patients with chronic PTSD (N=121) were randomly allocated to 7-day intensive or standard 3-month weekly cognitive therapy for PTSD, 3-month weekly emotion-focused supportive therapy, or a 14-week waitlist condition. Primary outcomes were PTSD symptoms and diagnosis as assessed by independent assessors and self-report. Secondary outcomes were disability, anxiety, depression, and quality of life. Measures were taken at initial assessment, 6 weeks and 14 weeks (post-treatment/wait). For groups receiving treatment, measures were also taken at 3 weeks, and follow-ups at 27 and 40 weeks after randomization. All analyses were intent-to-treat. Results At post-treatment/wait assessment, 73%, 77%, 43%, 7% of the intensive cognitive therapy, standard cognitive therapy, supportive therapy, and waitlist groups, respectively, had recovered from PTSD. All treatments were well tolerated and were superior to waitlist on all outcome measures, with the exception of no difference between supportive therapy and waitlist on quality of life. For primary outcomes, disability and general anxiety, intensive and standard cognitive therapy were superior to supportive therapy. Intensive cognitive therapy achieved faster symptom reduction and comparable overall outcomes to standard cognitive therapy. Conclusions Cognitive therapy for PTSD delivered intensively over little more than a week is as effective as cognitive therapy delivered

  15. The impact of Multimedia Software Support on the Knowledge and Self-Care Behaviors of Patients with Type 2 Diabetes: a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Moloud Farmahini Farahani

    2016-01-01

    Full Text Available Introduction: Education is the most effective and economical part of diabetes treatment. The purpose of this study was to investigate the effect of a training program with multimedia software on the knowledge and self-care behaviors of patients with type 2 diabetes. Methods: This study was a randomized controlled clinical trial in which 60 patients referred to diabetes clinic at Arak city were divided randomly into experimental (n=30 and control (n=30 groups. The instruments for collecting data were "Summary of Diabetes self-care activities questionnaire" and "knowledge of self-care in patients with diabetes". Data were collected before and 2 months after the intervention in the both groups. Educational program with equal content was applied for both experimental group (self-care program with multimedia software support & control group (lecture and presentation with PowerPoint. Data analysis was done using SPSS Ver.13. Results: Implementation of the self-care program with multimedia software support resulted in improvements in patients’ self-care behaviors in the experimental group, whereas these behaviors had not significant changes in the control group after eight weeks. There was a significant difference in the mean score of knowledge in both the experiment and control groups before and after the intervention. Conclusion: Considering beneficial effects of training program with multimedia software support on the knowledge and self-care behaviors and the importance of this issue, suggested that the patients preferably provide terms of use of educational software for themselves.

  16. Group Cognitive-Behavior Therapy and Supportive Art and Sport Interventions on Bam Earthquake Related Post Traumatic Stress Symptoms in Children: A Field Trial

    Directory of Open Access Journals (Sweden)

    Narges Joshaghani

    2009-12-01

    Full Text Available "n Objective: "n "nThe main objective of this study is to evaluate the effect of psychological therapies and art/sport supportive interventions separately,and in combination on post traumatic stress symptoms in children and compare them with a control group . "nMethods: In a field trial, we evaluated the efficacy of group behavioral therapy, art and sport supportive interventions in Bam earthquake children survivors with PTSD symptoms and compared it with a control group. Before and after interventions we evaluated the PTSD symptoms using K-SADS-PL semi-structural interview for each group and compared them using appropriate statistical methods. "nResults: The participants were 200 individuals who were randomized in four groups according to an intervention program including: Group behavioral therapy; Group behavioral therapy plus art and sport interventions; Art and sport interventions; and control group. During the interventions, 39 individuals were excluded. None of the participants had severed PTSD or other psychiatry disorders that needed pharmacological interventions. In interventional groups, the reduction of total PTSD symptoms and the symptoms of re-experience, avoidance and hyper arousal was not statistically significant. However, in the control group, the PTSD symptoms increased during the study which was statistically significant. "nConclusion: Group behavior therapy and supportive interventions (art and sport may have preventive effects on PTSD symptoms.

  17. Efficacy of a Micro-Prompting Technology in Reducing Support Needed by People With Severe Acquired Brain Injury in Activities of Daily Living: A Randomized Control Trial.

    Science.gov (United States)

    OʼNeill, Brian; Best, Catherine; OʼNeill, Lauren; Ramos, Sara D S; Gillespie, Alex

    2017-11-29

    To evaluate the effectiveness of an automated interactive prompting technology in supporting the morning routine of persons with acquired brain injury. The morning routine included maintaining personal hygiene and dressing. An inpatient neurorehabilitation hospital. Persons with acquired brain injury who required prompting when following their morning routine (n = 24), but were not limited by physical disability or dysphasia, took part in the study. Participants (67% with traumatic brain injury) had impairment on indices of memory and executive function. A randomized control trial evaluated the effect of an automated interactive micro-prompting device on the number of prompts by trained staff required for successful completion of the morning routine. Study-specific checklists assessed sequence performance, errors, and verbal prompts required over baseline, rehabilitation as usual, intervention, and return to baseline conditions. The intervention significantly reduced the support required to complete the task compared with usual rehabilitation. Micro-prompting technology is an effective assistive technology for cognition, which reduces support needs in people with significant cognitive impairments.

  18. Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450

    Directory of Open Access Journals (Sweden)

    Hutton JL

    2005-01-01

    Full Text Available Abstract Background The optimal management for severe sprains (Grades II and III of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1 the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast® brace and Bledsoe® boot in comparison to Tubigrip®, and (2 to compare the cost of each strategy, including subsequent health care costs. Methods/design Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. Discussion This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

  19. Safety Studies for Use of Adipose Tissue-Derived Mesenchymal Stromal/Stem Cells in a Rabbit Model for Osteoarthritis to Support a Phase I Clinical Trial.

    Science.gov (United States)

    Riester, Scott M; Denbeigh, Janet M; Lin, Yang; Jones, Dakota L; de Mooij, Tristan; Lewallen, Eric A; Nie, Hai; Paradise, Christopher R; Radel, Darcie J; Dudakovic, Amel; Camilleri, Emily T; Larson, Dirk R; Qu, Wenchun; Krych, Aaron J; Frick, Matthew A; Im, Hee-Jeong; Dietz, Allan B; Smith, Jay; van Wijnen, Andre J

    2017-03-01

    Adipose-derived mesenchymal stem cells (AMSCs) offer potential as a therapeutic option for clinical applications in musculoskeletal regenerative medicine because of their immunomodulatory functions and capacity for trilineage differentiation. In preparation for a phase I clinical trial using AMSCs to treat patients with osteoarthritis, we carried out preclinical studies to assess the safety of human AMSCs within the intra-articular joint space. Culture-expanded human AMSCs grown in human platelet-lysate were delivered via intra-articular injections into normal healthy rabbit knees and knees at risk for the development of osteoarthritis after bilateral medial anterior hemimeniscectomy. Treatment outcomes and safety were evaluated by assessing the general health, function, and behavior of the animals. Joint tissues were analyzed by x-ray, magnetic resonance imaging, and histopathology. Intra-articular AMSC therapy was well tolerated in this study. We did not observe adverse systemic reactions, nor did we find evidence of damage to intra-articular joint tissues. Thus, the data generated in this study show a favorable safety profile for AMSCs within the joint space in support of a phase I clinical trial evaluating the clinical utility of AMSCs to treat osteoarthritis. Stem Cells Translational Medicine 2017;6:910-922. © 2016 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

  20. Controlled rehabilitative and supportive care intervention trials in patients with high-grade gliomas and their caregivers

    DEFF Research Database (Denmark)

    Piil, K; Juhler, M; Jakobsen, J

    2016-01-01

    and Embase were searched for literature published from 1995 to May 2013. Data from eight studies were reviewed for substantive methods and results. Methodological quality was described and assessed using the scoring system for appraising mixed methods research and concomitantly appraising qualitative...... training improves functional outcome and massage therapy reduces stress. Patients and caregivers found that telephone follow-up and a specialist nurse function was an effective and useful way to achieve information and support. Finally, psycho-education increased feelings of mastery among caregivers...

  1. INSPIRE (INvestigating Social and PractIcal suppoRts at the End of life): Pilot randomised trial of a community social and practical support intervention for adults with life-limiting illness.

    Science.gov (United States)

    McLoughlin, Kathleen; Rhatigan, Jim; McGilloway, Sinead; Kellehear, Allan; Lucey, Michael; Twomey, Feargal; Conroy, Marian; Herrera-Molina, Emillio; Kumar, Suresh; Furlong, Mairead; Callinan, Joanne; Watson, Max; Currow, David; Bailey, Christopher

    2015-11-24

    For most people, home is the preferred place of care and death. Despite the development of specialist palliative care and primary care models of community based service delivery, people who are dying, and their families/carers, can experience isolation, feel excluded from social circles and distanced from their communities. Loneliness and social isolation can have a detrimental impact on both health and quality of life. Internationally, models of social and practical support at the end of life are gaining momentum as a result of the Compassionate Communities movement. These models have not yet been subjected to rigorous evaluation. The aims of the study described in this protocol are: (1) to evaluate the feasibility, acceptability and potential effectiveness of The Good Neighbour Partnership (GNP), a new volunteer-led model of social and practical care/support for community dwelling adults in Ireland who are living with advanced life-limiting illness; and (2) to pilot the method for a Phase III Randomised Controlled Trial (RCT). The INSPIRE study will be conducted within the Medical Research Council (MRC) Framework for the Evaluation of Complex Interventions (Phases 0-2) and includes an exploratory two-arm delayed intervention randomised controlled trial. Eighty patients and/or their carers will be randomly allocated to one of two groups: (I) Intervention: GNP in addition to standard care or (II) Control: Standard Care. Recipients of the GNP will be asked for their views on participating in both the study and the intervention. Quantitative and qualitative data will be gathered from both groups over eight weeks through face-to-face interviews which will be conducted before, during and after the intervention. The primary outcome is the effect of the intervention on social and practical need. Secondary outcomes are quality of life, loneliness, social support, social capital, unscheduled health service utilisation, caregiver burden, adverse impacts, and satisfaction

  2. An interactive health communication application for supporting parents managing childhood long-term conditions: outcomes of a randomized controlled feasibility trial.

    Science.gov (United States)

    Swallow, Veronica M; Knafl, Kathleen; Santacroce, Sheila; Campbell, Malcolm; Hall, Andrew G; Smith, Trish; Carolan, Ian

    2014-12-03

    Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents' management ability-the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers' involvement between groups. We recruited 55 parents of 39 children (42% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73%) and control group parents (22/29, 76%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks

  3. Radionuclide analysis of environmental field trial samples at STUK. Report on Task FIN A 847 of the Finnish Support Programme to IAEA Safeguards

    International Nuclear Information System (INIS)

    Rantavaara, A.; Klemola, S.; Saxen, R.; Ikaeheimonen, T.K.; Moring, M.

    1994-12-01

    Radionuclide determinations on seventeen field trial test samples were carried out for the International Atomic Energy Agency by the Finnish Centre for Radiation and Nuclear Safety (STUK). All the samples, i.e., samples of sea water, grass and biota were analysed for gamma emitting nuclides. 3 H was determined in water, 90 Sr in grass and 238 Pu, 239 Pu, 240 Pu and 241 Am in biota samples. To avoid losses of radionuclides before gamma activity measurements, the sequence of treatments was adjusted considering the unknown radionuclide composition. The radionuclide contents found in the samples were roughly the same or lower than contents in same types of environmental samples in the Northern hemisphere. The ratios of Pu and Am nuclides in two of the biota samples referred to an origin other than the global atmospheric fallout. The work was carried out under Task FIN A 847 of the Finnish Support Programme to IAEA Safeguards. (orig.) (21 refs., 3 figs., 7 tabs.)

  4. The impact of luteal phase support on endometrial estrogen and progesterone receptor expression: a randomized control trial

    Directory of Open Access Journals (Sweden)

    Brezina Paul R

    2012-02-01

    Full Text Available Abstract Background To assess the impact of luteal phase support on the expression of estrogen receptor (ER alpha and progesterone receptors B (PR-B on the endometrium of oocyte donors undergoing controlled ovarian hyperstimulation (COH. Methods A prospective, randomized study was conducted in women undergoing controlled ovarian hyperstimulation for oocyte donation. Participants were randomized to receive no luteal support, vaginal progesterone alone, or vaginal progesterone plus orally administered 17 Beta estradiol. Endometrial biopsies were obtained at 4 time points in the luteal phase and evaluated by tissue microarray for expression of ER alpha and PR-B. Results One-hundred and eight endometrial tissue samples were obtained from 12 patients. No differences were found in expression of ER alpha and PR-B among all the specimens with the exception of one sample value. Conclusions The administration of progesterone during the luteal phase of COH for oocyte donor cycles, either with or without estrogen, does not significantly affect the endometrial expression of ER alpha and PR.

  5. Storytelling in the Early Bereavement Period to Reduce Emotional Distress Among Surrogates Involved in a Decision to Limit Life Support in the ICU: A Pilot Feasibility Trial.

    Science.gov (United States)

    Barnato, Amber E; Schenker, Yael; Tiver, Greer; Dew, Mary Amanda; Arnold, Robert M; Nunez, Eduardo R; Reynolds, Charles F

    2017-01-01

    Surrogate decision makers involved in decisions to limit life support for an incapacitated patient in the ICU have high rates of adverse emotional health outcomes distinct from normal processes of grief and bereavement. Narrative self-disclosure (storytelling) reduces emotional distress after other traumatic experiences. We sought to assess the feasibility, acceptability, and tolerability of storytelling among bereaved surrogates involved in a decision to limit life support in the ICU. Pilot single-blind trial. Five ICUs across three hospitals within a single health system between June 2013 and November 2014. Bereaved surrogates of ICU patients. Storytelling and control conditions involved printed bereavement materials and follow-up assessments. Storytelling involved a single 1- to 2-hour home or telephone visit by a trained interventionist who elicited the surrogate's story. The primary outcomes were feasibility (rates of enrollment, intervention receipt, 3- and 6-mo follow-up), acceptability (closed and open-ended end-of-study feedback at 6 mo), and tolerability (acute mental health services referral). Of 53 eligible surrogates, 32 (60%) consented to treatment allocation. Surrogates' mean age was 55.5 (SD, 11.8), and they were making decisions for their parent (47%), spouse (28%), sibling (13%), child (3%), or other relation (8%). We allocated 14 to control and 18 to storytelling, 17 of 18 (94%) received storytelling, 14 of 14 (100%) and 13 of 14 (94%) control subjects and 16 of 18 (89%) and 17 of 18 (94%) storytelling subjects completed their 3- and 6-month telephone assessments. At 6 months, nine of 13 control participants (69%) and 16 of 17 storytelling subjects (94%) reported feeling "better" or "much better," and none felt "much worse." One control subject (8%) and one storytelling subject (6%) said that the study was burdensome, and one control subject (8%) wished they had not participated. No subjects required acute mental health services referral. A

  6. A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol.

    Science.gov (United States)

    Mastellos, Nikolaos; Andreasson, Anna; Huckvale, Kit; Larsen, Mark; Curcin, Vasa; Car, Josip; Agreus, Lars; Delaney, Brendan

    2015-02-03

    Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. EudraCT: 2014-001314-25.

  7. Home blood pressure monitoring with nurse-led telephone support among patients with hypertension and a history of stroke: a community-based randomized controlled trial.

    Science.gov (United States)

    Kerry, Sally M; Markus, Hugh S; Khong, Teck K; Cloud, Geoffrey C; Tulloch, Jenny; Coster, Denise; Ibison, Judith; Oakeshott, Pippa

    2013-01-08

    Adequate control of blood pressure reduces the risk of recurrent stroke. We conducted a randomized controlled study to determine whether home blood pressure monitoring with nurse-led telephone support would reduce blood pressure in patients with hypertension and a history of stroke. We recruited 381 participants (mean age 72 years) from outpatient and inpatient stroke clinics between Mar. 1, 2007, and Aug. 31, 2009. Nearly half (45%, 170) of the participants had some disability due to stroke. Participants were visited at home for a baseline assessment and randomly allocated to home blood pressure monitoring (n = 187) or usual care (n = 194). Those in the intervention group were given a monitor, brief training and telephone support. Participants who had home blood pressure readings consistently over target (target < 130/80 mm Hg) were advised to consult their family physician. The main outcome measure was a fall in systolic blood pressure after 12 months, measured by an independent researcher unaware of group allocation. Despite more patients in the intervention group than in the control group having changes to antihypertensive treatment during the trial period (60.1% [98/163] v. 47.6% [78/164], p = 0.02), the fall in systolic blood pressure from baseline did not differ significantly between the groups (adjusted mean difference 0.3 mm Hg, 95% confidence interval -3.6 to 4.2 mm Hg). Subgroup analysis showed significant interaction with disability due to stroke (p = 0.03 at 6 months) and baseline blood pressure (p = 0.03 at 12 months). Overall, home monitoring did not improve blood pressure control in patients with hypertension and a history of stroke. It was associated with a fall in systolic pressure in patients who had uncontrolled blood pressure at baseline and those without disability due to stroke. ClinicalTrials.gov registration NCT00514800.

  8. Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors.

    Science.gov (United States)

    Johns, Shelley A; Brown, Linda F; Beck-Coon, Kathleen; Talib, Tasneem L; Monahan, Patrick O; Giesler, R Brian; Tong, Yan; Wilhelm, Laura; Carpenter, Janet S; Von Ah, Diane; Wagner, Christina D; de Groot, Mary; Schmidt, Karen; Monceski, Diane; Danh, Marie; Alyea, Jennifer M; Miller, Kathy D; Kroenke, Kurt

    2016-10-01

    Cancer-related fatigue (CRF) is a disruptive symptom for many survivors. Despite promising evidence for efficacy of mindfulness-based stress reduction (MBSR) in reducing CRF, no trials comparing it to an active comparator for fatigued survivors have been published. The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms. Breast (n = 60) and colorectal (n = 11) cancer survivors (stage 0-III) with clinically significant CRF after completing chemotherapy and/or radiation therapy an average of 28 months prior to enrollment were randomized to MBSR or psychoeducation/support groups (PES). MBSR focused on mindfulness training; PES focused on CRF self-management. Outcomes included CRF interference (primary), CRF severity and global improvement, vitality, depression, anxiety, sleep disturbance, and pain. Outcomes were assessed at baseline (T1), post-intervention (T2), and 6-month follow-up (T3) using intent-to-treat analysis. Between-group differences in CRF interference were not significant at any time point; however, there was a trend favoring MBSR (d = -0.46, p = 0.073) at T2. MBSR participants reported significantly greater improvement in vitality (d = 0.53, p = 0.003) and were more likely to report CRF as moderately to completely improved compared to the PES group (χ2 (1) = 4.1765, p = 0.041) at T2. MBSR participants also reported significantly greater reductions in pain at T2 (d = 0.53, p = 0.014). In addition, both MBSR and PES produced moderate-to-large and significant within-group improvements in all fatigue outcomes, depression, anxiety, and sleep at T2 and T3 compared to T1. MBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted. ClinicalTrials.gov Identifier: NCT01724333.

  9. Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: Cluster-randomised controlled trial (findings of the SMADS study).

    Science.gov (United States)

    Zimmermann, Thomas; Puschmann, Egina; van den Bussche, Hendrik; Wiese, Birgitt; Ernst, Annette; Porzelt, Sarah; Daubmann, Anne; Scherer, Martin

    2016-11-01

    =0.51. A complex, nurse-led intervention, implemented as a collaborative care model, increased perceived self-efficacy in patients with symptoms of anxiety, depression or somatisation compare to control patients. For the first time in the German healthcare system, the SMADS trial validated the belief that a nurse can successfully complement the work of a general practitioner - particularly in supporting self-management of patients with psychosomatic symptoms and their psychosocial needs. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. A randomized controlled trial of a senior centre group programme for increasing social support and preventing depression in elderly people living at home in Norway

    Directory of Open Access Journals (Sweden)

    Bøen Hege

    2012-05-01

    Full Text Available Abstract Background Late-life depression is a common condition and a challenging public health problem. A lack of social support is strongly associated with psychological distress. Senior centres seem to be suitable arenas for community-based health promotion interventions, although few studies have addressed this subject. The objectives were to examine the effect of a preventive senior centre group programme consisting of weekly meetings, on social support, depression and quality of life. Methods A questionnaire was sent to a random sample of 4,000 persons over 65 in Oslo, and a total of 2,387 completed questionnaires were obtained. These subjects served as a basis for recruitment of participants for a trial, with scores on HSCL-10 being used as a main inclusion criterion. A total of 138 persons were randomized into an intervention group (N = 77 and control group (N = 61. Final analyses included 92 persons. Social support (OSS-3, depression (BDI, life satisfaction and health were measured in interviews at baseline and after 12 months (at the end of the intervention programme. Perceptions of benefits from the intervention were also measured. Mean scores, SD, SE and CI were used to describe the changes in outcomes. Effect sizes were calculated based on the original scales and as Cohen’s d. Paired sample tests and ANOVA were used to test group differences. Results There was an increase in social support in both groups, but greatest in the intervention group. The level of depression increased for both groups, but more so in the control than the intervention group. There was a decrease in life satisfaction, although the decrease was largest among controls. There were almost no differences in reported health between groups. However, effect sizes were small and differences were not statistically significant. In contrast, most of the participants said the intervention meant much to them and led to increased use of the centre. Conclusions In

  11. Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

    Science.gov (United States)

    Matthews, Lynsay; Pugmire, Juliana; Moore, Laurence; Kelson, Mark; McConnachie, Alex; McIntosh, Emma; Morgan-Trimmer, Sarah; Murphy, Simon; Hughes, Kathryn; Coulman, Elinor; Utkina-Macaskill, Olga; Simpson, Sharon Anne

    2017-10-25

    HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s). To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals. 12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI) > 30 kg/m 2 and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual

  12. Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    DePaul Vincent G

    2011-10-01

    Full Text Available Abstract Background Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP, a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT in community-dwelling, ambulatory, adults within 1 year of stroke. Methods/Design A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1 using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used. Discussion In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that

  13. Mobile Health Technology for Atrial Fibrillation Management Integrating Decision Support, Education, and Patient Involvement: mAF App Trial.

    Science.gov (United States)

    Guo, Yutao; Chen, Yundai; Lane, Deirdre A; Liu, Lihong; Wang, Yutang; Lip, Gregory Y H

    2017-12-01

    Mobile Health technology for the management of patients with atrial fibrillation is unknown. The simple mobile AF (mAF) App was designed to incorporate clinical decision-support tools (CHA 2 DS 2 -VASc [Congestive heart failure, Hypertension, Age ≥75 years, Diabetes Mellitus, Prior Stroke or TIA, Vascular disease, Age 65-74 years, Sex category], HAS-BLED [Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly], SAMe-TT 2 R 2 [Sex, Age App vs usual care) in a cluster randomized design pilot study. Patients' knowledge, quality of life, drug adherence, and anticoagulation satisfaction were evaluated at baseline, 1 month, and 3 months. Usability, feasibility, and acceptability of the mAF App were assessed at 1 month. A total of 113 patients were randomized to mAF App intervention (mean age, 67.4 years; 57.5% were male; mean follow-up, 69 days), and 96 patients were randomized to usual care (mean age, 70.9 years; 55.2% were male; mean follow-up, 95 days). More than 90% of patients reported that the mAF App was easy, user-friendly, helpful, and associated with significant improvements in knowledge compared with the usual care arm (P values for trend App versus usual care (all P App arm versus usual care, with anxiety and depression reduced (all P App, integrating clinical decision support, education, and patient-involvement strategies, significantly improved knowledge, drug adherence, quality of life, and anticoagulation satisfaction. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  14. Combination Therapy Versus Exercise and Orthotic Support in the Management of Pain in Plantar Fasciitis: A Randomized Controlled Trial.

    Science.gov (United States)

    Cinar, Eda; Saxena, Shikha; Uygur, Fatma

    2018-04-01

    This study aimed at estimating the effectiveness of two commonly used modalities-extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT)-each combined with usual care (exercises and orthotic supports) in comparison to only usual care to relieve pain in patients with plantar fasciitis (PF). Participants with PF were randomly allocated into 3 groups: ESWT (n = 25), LLLT (n = 24), and control (n = 17). All participants received a home exercise program with orthotic support. The ESWT group received 2000 shock waves with 0.02 mJ/mm 2 for 3 sessions, once a week; LLLT group received gallium-aluminum-arsenide laser with 850 nm wavelength for 10 sessions, 3 times a week. Pain was measured by Foot Function Index-pain subscale (FFI-p) and Numerical Rating Scale for pain (NRS-p). The scores were recorded at baseline, third week, and third month after the treatment. Analysis was performed using repeated measures ANOVA. There was a significant improvement in pain over the 3 months in all groups on both FFI-p ( P < .001) and NRS-p ( P < .001). In NRS-p, LLLT group had significantly lower pain than ESWT ( P = .002) at the third week and control ( P = .043) and ESWT ( P = .003) at third month. In FFI-p total score, ESWT group had higher pain than LLLT ( P = .003) and control ( P = .035) groups at third week and LLLT ( P = .010) group at third month. When LLLT and ESWT were combined with usual care, LLLT was found to be more effective than ESWT in reducing pain in PF at short-term follow-up. Level II, comparative study.

  15. Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products.

    Science.gov (United States)

    Cavagnaro, Joy; Silva Lima, Beatriz

    2015-07-15

    The utility of animal models of disease for assessing the safety of novel therapeutic modalities has become an increasingly important topic of discussion as research and development efforts focus on improving the predictive value of animal studies to support accelerated clinical development. Medicines are approved for marketing based upon a determination that their benefits outweigh foreseeable risks in specific indications, specific populations, and at specific dosages and regimens. No medicine is 100% safe. A medicine is less safe if the actual risks are greater than the predicted risks. The purpose of preclinical safety assessment is to understand the potential risks to aid clinical decision-making. Ideally preclinical studies should identify potential adverse effects and design clinical studies that will minimize their occurrence. Most regulatory documents delineate the utilization of conventional "normal" animal species to evaluate the safety risk of new medicines (i.e., new chemical entities and new biological entities). Animal models of human disease are commonly utilized to gain insight into the pathogenesis of disease and to evaluate efficacy but less frequently utilized in preclinical safety assessment. An understanding of the limitations of the animal disease models together with a better understanding of the disease and how toxicity may be impacted by the disease condition should allow for a better prediction of risk in the intended patient population. Importantly, regulatory authorities are becoming more willing to accept and even recommend data from experimental animal disease models that combine efficacy and safety to support clinical development. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  17. Peer support and improved quality of life among persons living with HIV on antiretroviral treatment: A randomised controlled trial from north-eastern Vietnam

    Directory of Open Access Journals (Sweden)

    Van Tam Vu

    2012-05-01

    Full Text Available Abstract Background Among people living with HIV (PLHIV on antiretroviral therapy (ART, it is important to determine how quality of life (QOL may be improved and HIV-related stigma can be lessened over time. This study assessed the effect of peer support on QOL and internal stigma during the first year after initiating ART among a cohort of PLHIV in north-eastern Vietnam. Methods A sub-sample study of a randomised controlled trial was implemented between October 2008 and November 2010 in Quang Ninh, Vietnam. In the intervention group, participants (n = 119 received adherence support from trained peer supporters who visited participants’ houses biweekly during the first two months, thereafter weekly. In the control group, participants (n = 109 were treated according to standard guidelines, including adherence counselling, monthly health check and drug refills. Basic demographics were measured at baseline. QOL and internal stigma were measured using a Vietnamese version of the WHOQOL-HIVBREF and Internal AIDS-related Stigma Scale instruments at baseline and 12 months. T-tests were used to detect the differences between mean values, multilevel linear regressions to determine factors influencing QOL. Results Overall, QOL improved significantly in the intervention group compared to the control group. Among participants initiating ART at clinical stages 3 and 4, education at high school level or above and having experiences of a family member dying from HIV were also associated with higher reported QOL. Among participants at clinical stage 1 and 2, there was no significant effect of peer support, whereas having children was associated with an increased QOL. Viral hepatitis was associated with a decreased QOL in both groups. Lower perceived stigma correlated significantly but weakly with improved QOL, however, there was no significant relation to peer support. Conclusion The peer support intervention improved QOL after 12 months among ART

  18. Peer support and improved quality of life among persons living with HIV on antiretroviral treatment: a randomised controlled trial from north-eastern Vietnam.

    Science.gov (United States)

    Van Tam, Vu; Larsson, Mattias; Pharris, Anastasia; Diedrichs, Björn; Nguyen, Hoa Phuong; Nguyen, Chuc Thi Kim; Ho, Phuc Dang; Marrone, Gaetano; Thorson, Anna

    2012-05-18

    Among people living with HIV (PLHIV) on antiretroviral therapy (ART), it is important to determine how quality of life (QOL) may be improved and HIV-related stigma can be lessened over time. This study assessed the effect of peer support on QOL and internal stigma during the first year after initiating ART among a cohort of PLHIV in north-eastern Vietnam. A sub-sample study of a randomised controlled trial was implemented between October 2008 and November 2010 in Quang Ninh, Vietnam. In the intervention group, participants (n = 119) received adherence support from trained peer supporters who visited participants' houses biweekly during the first two months, thereafter weekly. In the control group, participants (n = 109) were treated according to standard guidelines, including adherence counselling, monthly health check and drug refills. Basic demographics were measured at baseline. QOL and internal stigma were measured using a Vietnamese version of the WHOQOL-HIVBREF and Internal AIDS-related Stigma Scale instruments at baseline and 12 months. T-tests were used to detect the differences between mean values, multilevel linear regressions to determine factors influencing QOL. Overall, QOL improved significantly in the intervention group compared to the control group. Among participants initiating ART at clinical stages 3 and 4, education at high school level or above and having experiences of a family member dying from HIV were also associated with higher reported QOL. Among participants at clinical stage 1 and 2, there was no significant effect of peer support, whereas having children was associated with an increased QOL. Viral hepatitis was associated with a decreased QOL in both groups. Lower perceived stigma correlated significantly but weakly with improved QOL, however, there was no significant relation to peer support. The peer support intervention improved QOL after 12 months among ART patients presenting at clinical stages 3 and 4 at baseline, but

  19. Telephone-Delivered Exercise Advice and Behavior Change Support by Physical Therapists for People with Knee Osteoarthritis: Protocol for the Telecare Randomized Controlled Trial.

    Science.gov (United States)

    Hinman, Rana S; Lawford, Belinda J; Campbell, Penny K; Briggs, Andrew M; Gale, Janette; Bills, Caroline; French, Simon D; Kasza, Jessica; Forbes, Andrew; Harris, Anthony; Bunker, Stephen J; Delany, Clare M; Bennell, Kim L

    2017-05-01

    Exercise and physical activity are a core component of knee osteoarthritis (OA) care, yet access to physical therapists is limited for many people. Telephone service delivery models may increase access. Determine the effectiveness of incorporating exercise advice and behavior change support by physical therapists into an existing Australian nurse-led musculoskeletal telephone service for adults with knee OA. Randomized controlled trial with nested qualitative studies. Community, Australia-wide. One hundred seventy-five people ≥45 years of age with knee symptoms consistent with a clinical diagnosis of knee OA. Eight musculoskeletal physical therapists will provide exercise advice and support. Random allocation to receive existing care or exercise advice in addition to existing care. Existing care is a minimum of one phone call from a nurse for advice on OA self-management. Exercise advice involves 5-10 calls over 6 months from a physical therapist trained in behavior change support to prescribe, monitor, and progress a strengthening exercise program and physical activity plan. Outcomes will be measured at baseline and at 6 and 12 months. Primary outcomes are knee pain and physical function. Secondary outcomes include other measures of knee pain, self-efficacy, physical activity and its mediators, kinesiophobia, health service usage, work productivity, participant-perceived change, and satisfaction. Additional measures include adherence, adverse events, therapeutic alliance, satisfaction with telephone-delivered therapy, and expectation of outcome. Semi-structured interviews with participants with knee OA and therapists will be conducted. Physical therapists cannot be blinded. This study will determine if incorporating exercise advice and behavior change support by physical therapists into a nurse-led musculoskeletal telephone service improves outcomes for people with knee OA. Findings will inform development and implementation of telerehabilitation services.

  20. Effectiveness of supporting intensive care units on implementing the guideline 'End-of-life care in the intensive care unit, nursing care': a cluster randomized controlled trial.

    Science.gov (United States)

    Noome, Marijke; Dijkstra, Boukje M; van Leeuwen, Evert; Vloet, Lilian C M

    2017-06-01

    The aim of this study was to examine the effectiveness of supporting intensive care units on implementing the guidelines. Quality of care can be achieved through evidence-based practice. Guidelines can facilitate evidence-based practice, such as the guidelines 'End-of-life care in the intensive care unit, nursing care'. Before intensive care nurses are able to use these guidelines, they needs to be implemented in clinical practice. Implementation is a complex process and may need support. Cluster randomized controlled trial. Intensive care nurses of eight intensive care units in the intervention group followed a supportive programme that educated them on implementation, strategies, goals, project management and leadership. The intervention group focused on a stepwise approach to implement the guidelines. The control group (n = 5) implemented the guidelines independently or used the standard implementation plan supplementary to the guideline. The effectiveness of the programme was measured using questionnaires for nurses, interviews with nurses and a questionnaire for family of deceased patients, in the period from December 2014-December 2015. Overall, an increase in adherence to the guidelines was found in both groups. Overall, use of the guidelines in the intervention group was higher, but on some aspects the control group showed a higher score. Care for the patient and the overall nursing care scored significantly higher according to family in the intervention group. The increase in adherence to the guidelines and the significantly higher satisfaction of family in the intervention group indicate that the supportive programme had a more positive effect. © 2016 John Wiley & Sons Ltd.

  1. Addition of non-invasive ventilatory support to combined aerobic and resistance training improves dyspnea and quality of life in heart failure patients: a randomized controlled trial.

    Science.gov (United States)

    Bittencourt, Hugo Souza; Cruz, Cristiano Gonçalves; David, Bruno Costa; Rodrigues, Erenaldo; Abade, Camille Magalhães; Junior, Roque Aras; Carvalho, Vitor Oliveira; Dos Reis, Francisco Borges Faria; Gomes Neto, Mansueto

    2017-11-01

    To test the hypothesis that combined aerobic and resistance training and non-invasive ventilatory support result in additional benefits compared with combined aerobic and resistance training alone in heart failure patients. A randomized, single-blind, controlled study. Cardiac rehabilitation center. A total of 46 patients with New York Heart Association class II/III heart failure were randomly assigned to a 10-week program of combined aerobic and resistance training, plus non-invasive ventilatory support ( n = 23) or combined aerobic and resistance training alone ( n = 23). Before and after intervention, results for the following were obtained: 6-minute walk test, forced vital capacity, forced expiratory volume at one second, maximal inspiratory muscle pressure, and maximal expiratory muscle pressure, with evaluation of dyspnea by the London Chest Activity of Daily Living scale, and quality of life with the Minnesota Living With Heart Failure questionnaire. Of the 46 included patients, 40 completed the protocol. The combined aerobic and resistance training plus non-invasive ventilatory support, as compared with combined aerobic and resistance training alone, resulted in significantly greater benefit for dyspnea (mean change: 4.8 vs. 1.3, p = 0.004), and quality of life (mean change: 19.3 vs. 6.8, p = 0.017 ). In both groups, the 6-minute walk test improved significantly (mean change: 45.7 vs. 44.1, p = 0.924), but without a statistically significant difference. Non-invasive ventilatory support combined with combined aerobic and resistance training provides additional benefits for dyspnea and quality of life in moderate heart failure patients. ClinicalTrials.gov identifier: NCT02384798. Registered 03 April 2015.

  2. Rationale, design, and baseline findings from a pilot randomized trial of an IVR-Supported physical activity intervention for cancer prevention in the Deep South: The DIAL study

    Directory of Open Access Journals (Sweden)

    Dori Pekmezi

    2017-12-01

    Full Text Available Telephone-delivered interventions do not require frequent clinic visits, literacy, or costly technology and thus may represent promising approaches to promoting physical activity in the Deep South, a largely rural U.S. region, with generally lower physical activity, income, and education levels. Building on past Interactive Voice Response (IVR system-based HIV studies and extensive formative research (11 focus groups on physical activity intervention needs/preferences in the Deep South, the resulting IVR-supported physical activity intervention is now being tested in a randomized controlled trial with a waitlist control. The sample (n = 63 includes mostly obese (Mean BMI = 30.1 adults (Mean age = 43 years in Birmingham, AL. Both genders (55.6% male and African Americans (58.7% are well-represented. Most participants reported at least some college (92%, full time employment (63.5%, and household income <$50,000 per year (61.9%. Baseline physical activity (Mean = 39.6 min/week, SD = 56.4, self-efficacy, self-regulation, and social support were low. However, high physical activity enjoyment and outcome expectations bode well. Self-report physical activity was associated with physical activity enjoyment (r = 0.36 and social support (friends r = 0.25, p's < 0.05 at baseline. Consequently, these may be important variables to emphasize in our program. Depression and anxiety were negatively correlated with some early indicators of behavior change (e.g., physical activity self-regulation; r's = -0.43 and −0.46, respectively, p's < 0.01 and thus may require additional attention. Such technology-supported strategies have great potential to reach underserved populations and address physical activity-related health disparities in this region.

  3. Influence of misfit on the occurrence of veneering porcelain fractures (chipping) in implant-supported metal-ceramic fixed dental prostheses: an in vitro pilot trial.

    Science.gov (United States)

    Löfgren, Nils; Larsson, Christel; Mattheos, Nikos; Janda, Martin

    2017-11-01

    Technical complications such as veneer fractures are more common in implant-supported than tooth-supported restorations. The underlying causes have not been fully identified. The aim of this study was to evaluate whether misfit between the restoration and the implant may affect the risk of veneer fractures. Twenty standardized five-unit implant-supported metal-ceramic fixed dental prostheses (FDP)s were manufactured and fixed in acrylic blocks. The test group consisted of ten FDPs fixed with a 150-μm misfit at the distal abutment. The remaining ten FDPs were fixed without misfit and acted as a control group. All FDPS underwent cyclic loading for a total of 100,000 cycles at 30-300 N. The FDPs were checked for cracks or chip-off fractures regularly. After cyclic load, the retorque value of all abutment screws was checked. Cracks within the veneering porcelain were noted in nine FDPs in the test group and one FDP in the control group. This difference was statistically significant (P veneering porcelain occurred in three FDPs in the test group. No fractures occurred in the control group. This difference was not statistically significant. There were no significant differences in retorque values neither between the groups nor between different abutment positions in the FDPs. Within the limitations of this in vitro pilot trial, it is suggested that misfit between a restoration and the supporting implant may increase the risk of cracking and/or chipping of the veneering porcelain for metal-ceramic FDPs. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Comparison of cognitive behavioral therapy and supportive psychotherapy for the treatment of depression following traumatic brain injury: a randomized controlled trial.

    Science.gov (United States)

    Ashman, Teresa; Cantor, Joshua B; Tsaousides, Theodore; Spielman, Lisa; Gordon, Wayne

    2014-01-01

    To determine the efficacy of 2 different interventions (cognitive behavioral therapy [CBT] and supportive psychotherapy [SPT]) to treat post-traumatic brain injury (TBI) depression. A sample of 77 community-dwelling individuals with a TBI, and a diagnosis of depression. Participants were randomized into treatment conditions either CBT or SPT and received up to 16 sessions of individual psychotherapy. Participants completed the Structured Clinical Interview for DSM-IV and self-report measures of depression (Beck Depression Inventory-Second Edition), anxiety (State-Trait Anxiety Inventory), perceived social support (Interpersonal Support Evaluation List), stressful life events (Life Experiences Survey), and quality of life (QOL) before beginning and immediately following treatment. No significant differences were found at baseline between CBT and SPT groups on demographic factors (sex, age, education, race, and time since injury) or baseline measures of depression, anxiety, participation, perceived social support, stressful life events, or QOL. Analyses of variance revealed significant time effects for the Beck Depression Inventory-Second Edition, State-Trait Anxiety Inventory, and QOL outcome measures but no group effects. Intention-to-treat mixed effects analyses did not find any significant difference in patterns of scores of the outcome measures between the CBT and SPT intervention groups. Both forms of psychotherapy were efficacious in improving diagnoses of depression and anxiety and reducing depressive symptoms. These findings suggest that in this sample of individuals with TBI, CBT was not more effective in treating depression than SPT, though further research is needed with larger sample sizes to identify different components of these interventions that may be effective with different TBI populations. ClinicalTrials.gov Identifier: NCT00211835.

  5. Effects of post-discharge nurse-led telephone supportive care for patients with chronic kidney disease undergoing peritoneal dialysis in China: a randomized controlled trial.

    Science.gov (United States)

    Li, Juan; Wang, Huizhen; Xie, Hongzhen; Mei, Guiping; Cai, Wenzhi; Ye, Junsheng; Zhang, Jianlin; Ye, Guirong; Zhai, Huimin

    2014-05-01

    Patients with end-stage renal failure (ESRF) need integrated health care to maintain a desirable quality of life. Studies suggest that post-discharge nurseled telephone support has a positive effect for patients suffering from chronic diseases. But the post-discharge care is under-developed in mainland China and the effects of post-discharge care on patients with peritoneal dialysis have not been conclusive. The purpose of this study is to test the effectiveness of postdischarge nurse-led telephone support on patients with peritoneal dialysis in mainland China. A randomized controlled trial was conducted in the medical department of a regional hospital in Guangzhou. 135 patients were recruited, 69 in the study group and 66 in the control group. The control group received routine hospital discharge care. The study group received post-discharge nurse-led telephone support. The quality of life (Kidney Disease Quality of Life Short Form, KDQOL-SF), blood chemistry, complication control, readmission and clinic visit rates were observed at three time intervals: baseline before discharge (T1), 6 (T2) and 12 (T3) weeks after discharge. Statistically significant effects were found for symptom/problem, work status, staff encouragement, patient satisfaction and energy/fatigue in KDQOL-SF and 84-day (12-week) clinic visit rates between the two groups. The study group had more significant improvement than the control group for sleep, staff encouragement at both T2 and T3, and pain at T2 and patient satisfaction at T3. No significant differences were observed between the two groups for the baseline measures, other dimensions in KDQOL-SF, blood chemistry, complication control, readmission rates at all time intervals and clinic visit rates at the first two time intervals. Post-discharge nurse-led telephone support for patients undergoing peritoneal dialysis is effective to enhance patients' well-being in the transition from hospital to home in mainland China. Copyright © 2014

  6. INSPIRE (INvestigating Social and PractIcal suppoRts at the End of life): Pilot randomised trial of a community social and practical support intervention for adults with life-limiting illness.

    LENUS (Irish Health Repository)

    McLoughlin, Kathleen

    2015-11-24

    For most people, home is the preferred place of care and death. Despite the development of specialist palliative care and primary care models of community based service delivery, people who are dying, and their families\\/carers, can experience isolation, feel excluded from social circles and distanced from their communities. Loneliness and social isolation can have a detrimental impact on both health and quality of life. Internationally, models of social and practical support at the end of life are gaining momentum as a result of the Compassionate Communities movement. These models have not yet been subjected to rigorous evaluation. The aims of the study described in this protocol are: (1) to evaluate the feasibility, acceptability and potential effectiveness of The Good Neighbour Partnership (GNP), a new volunteer-led model of social and practical care\\/support for community dwelling adults in Ireland who are living with advanced life-limiting illness; and (2) to pilot the method for a Phase III Randomised Controlled Trial (RCT).

  7. A 1-year randomised controlled trial comparing zirconia versus metal-ceramic implant supported single-tooth restorations.

    Science.gov (United States)

    Hosseini, Mandana; Worsaae, Nils; Schiodt, Morten; Gotfredsen, Klaus

    2011-01-01

    To compare the biological, technical and aesthetic outcomes of single implant-supported all-ceramic versus metal-ceramic crowns. Thirty-six patients with premolar agenesis were randomly treated with 38 all-ceramic (AC) and 37 metal-ceramic (MC) implant-supported single-tooth restorations. A quasi-randomisation of consecutively included restorations in patients with one or more implants was used, i.e. a combination of parallel group (for 13 patients with one restoration) and split-mouth (for 23 patients with ≥2 restorations). All patients were recalled for baseline and 1-year followup examinations. Biological and technical outcomes, including complications, were clinically and radiographically registered. The Copenhagen Index Score and visual analogue scale (VAS) score were used to assess professional and patient-reported aesthetic outcomes, respectively, by blinded assessors. One-year after loading, no patient dropped out and no implant failed, though one MC restoration had to be remade. The marginal bone loss was not significantly different between AC and MC restorations (AC: mean 0.08 mm, SD 0.25; MC: mean 0.10 mm, SD 0.17). Seven out of 10 inflammatory reactions were registered at AC restorations. Two technical complications, one loss of retention and one chipping of veneering porcelain were recorded at two metal-ceramic crowns. The marginal adaptation of the all-ceramic crowns was significantly less optimal than the metal-ceramic crowns (P = 0.014). The professional-reported colour match of all-ceramic crowns was significantly better than metal-ceramic crowns (P = 0.031), but other aesthetic parameters as well as the VAS scores demonstrated no statistically significant difference between AC and MC restorations. Marginal bone loss and the aesthetic outcomes were not significantly different between AC and MC restorations in this short-term follow-up study, though inflammatory reactions in the peri-implant mucosa as well as less optimal marginal adaptation were

  8. Participation in Training for Depression Care Quality Improvement: A Randomized Trial of Community Engagement or Technical Support.

    Science.gov (United States)

    Chung, Bowen; Ngo, Victoria K; Ong, Michael K; Pulido, Esmeralda; Jones, Felica; Gilmore, James; Stoker-Mtume, Norma; Johnson, Megan; Tang, Lingqi; Wells, Kenneth Brooks; Sherbourne, Cathy; Miranda, Jeanne

    2015-08-01

    Community engagement and planning (CEP) could improve dissemination of depression care quality improvement in underresourced communities, but whether its effects on provider training participation differ from those of standard technical assistance, or resources for services (RS), is unknown. This study compared program- and staff-level participation in depression care quality improvement training among programs enrolled in CEP, which trained networks of health care and social-community agencies jointly, and RS, which provided technical support to individual programs. Matched programs from health care and social-community service sectors in two communities were randomly assigned to RS or CEP. Data were from 1,622 eligible staff members from 95 enrolled programs. Primary outcomes were any staff trained (for programs) and total hours of training (for staff). Secondary staff-level outcomes were hours of training in specific depression collaborative care components. CEP programs were more likely than RS programs to participate in any training (p=.006). Within health care sectors, CEP programs were more likely than RS programs to participate in training (p=.016), but within social-community sectors, there was no difference in training by intervention. Among staff who participated in training, mean training hours were greater among CEP programs versus RS programs for any type of training (p<.001) and for training related to each component of depression care (p<.001) except medication management. CEP may be an effective strategy to promote staff participation in depression care improvement efforts in underresourced communities.

  9. A randomised controlled trial of a computerised intervention for children with social communication difficulties to support peer collaboration.

    Science.gov (United States)

    Murphy, Suzanne M; Faulkner, Dorothy M; Reynolds, Laura R

    2014-11-01

    An intervention aiming to support children with social communication difficulties was tested using a randomised controlled design. Children aged 5-6 years old (n=32) were tested and selected for participation on the basis of their scores on the Test of Pragmatic Skills (TPS) and were then randomly assigned to the intervention arm or to the delayed intervention control group. Following previous research which suggested that computer technology may be particularly useful for this group of children, the intervention included a collaborative computer game which the children played with an adult. Subsequently, children's performance as they played the game with a classmate was observed. Micro-analytic observational methods were used to analyse the audio-recorded interaction of the children as they played. Pre- and post-intervention measures comprised the Test of Pragmatic Skills, children's performance on the computer game and verbal communication measures that the children used during the game. This evaluation of the intervention shows promise. At post-test, the children who had received the intervention, by comparison to the control group who had not, showed significant gains in their scores on the Test of Pragmatic Skills (p=.009, effect size r=-.42), a significant improvement in their performance on the computer game (p=.03, r=-.32) and significantly greater use of high-quality questioning during collaboration (pgame and about their partners (p=.02, r=-.34) suggesting that the intervention increased their confidence and enjoyment. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. The Feldenkrais Method improves functioning and body balance in people with intellectual disability in supported employment: A randomized clinical trial.

    Science.gov (United States)

    Torres-Unda, Jon; Polo, Vanesa; Dunabeitia, Iratxe; Bidaurrazaga-Letona, Iraia; García-Gil, María; Rodriguez-Larrad, Ana; Irazusta, Jon

    2017-11-01

    Loss of functioning and age-related health problems tend to appear earlier in individuals with intellectual disability (ID) than in their non-disabled peers. The Feldenkrais method (FM) is a movement-based form of learning that enhances body balance and physical functioning. We carried out an intervention based on Awareness Through Movement, a form of the FM. Thirty-two middle-aged (48.94±6.01years old) adults with ID who were in supported employment were recruited and randomly assigned to the experimental group (EG) or control group (CG). The EG received 30 Awareness Through Movement classes while the CG did not receive any movement-based intervention. Physical functioning (body balance, gait speed and chair stands) was assessed with the Short Physical Performance Battery (SPPB) and balance by stabilometry. After 30 FM classes, individuals in the EG had significantly improved their chair stand test score (p<0.005) and SPPB total score (p<0.005), and reduced their sway area (p<0.05) in the stabilometric test. These results indicate that the FM could be a good tool for the prevention of loss of functioning and body balance in middle-aged individuals with ID. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. The effect of arm support combined with rehabilitation games on upper-extremity function in subacute stroke: a randomized controlled trial.

    Science.gov (United States)

    Prange, Gerdienke B; Kottink, Anke I R; Buurke, Jaap H; Eckhardt, Martine M E M; van Keulen-Rouweler, Bianca J; Ribbers, Gerard M; Rietman, Johan S

    2015-02-01

    Use of rehabilitation technology, such as (electro)mechanical devices or robotics, could partly relieve the increasing strain on stroke rehabilitation caused by an increasing prevalence of stroke. Arm support (AS) training showed improvement of unsupported arm function in chronic stroke. To examine the effect of weight-supported arm training combined with computerized exercises on arm function and capacity, compared with dose-matched conventional reach training in subacute stroke patients. In a single-blind, multicenter, randomized controlled trial, 70 subacute stroke patients received 6 weeks of training with either an AS device combined with computerized exercises or dose-matched conventional training (CON). Arm function was evaluated pretraining and posttraining by Fugl-Meyer assessment (FM), maximal reach distance, Stroke Upper Limb Capacity Scale (SULCS), and arm pain via Visual Analogue Scale, in addition to perceived motivation by Intrinsic Motivation Inventory posttraining. FM and SULCS scores and reach distance improved significantly within both groups. These improvements and experienced pain did not differ between groups. The AS group reported higher interest/enjoyment during training than the CON group. AS training with computerized exercises is as effective as conventional therapy dedicated to the arm to improve arm function and activity in subacute stroke rehabilitation, when applied at the same dose. © The Author(s) 2014.

  12. The use of cell phone support for non-adherent HIV-infected youth and young adults: an initial randomized and controlled intervention trial.

    Science.gov (United States)

    Belzer, Marvin E; Naar-King, Sylvie; Olson, Johanna; Sarr, Moussa; Thornton, Sarah; Kahana, Shoshana Y; Gaur, Aditya H; Clark, Leslie F

    2014-04-01

    This randomized behavioral trial examined whether youth living with HIV (YLH) receiving cell-phone support with study funded phone plans, demonstrated improved adherence and viral control during the 24 week intervention and 24 weeks post-intervention compared to controls. Monday through Friday phone calls confirmed medications were taken, provided problem-solving support, and referred to services to address adherence barriers. Of 37 participants (ages 15-24), 62 % were male and 70 % were African American. Self-reported adherence was significantly higher in the intervention group compared to the control at 24 and 48 weeks for the past month (P = 0.007) and log 10 HIV VL was significantly lower at both 24 weeks (2.82 versus 4.52 P = 0.002) and 48 weeks (3.23 versus 4.23 P = 0.043). Adherence and viral load showed medium to large effect sizes across the 48 week study. This is the first study to demonstrate sustained clinically significant reductions in HIV VL using youth friendly technology.

  13. The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohamed; Azizan, Nurul Ain; Hairi, Farizah Mohd; Thangiah, Nithiah; Dahlui, Maznah; Bulgiba, Awang; Murray, Liam J

    2014-01-01

    Death rates due to hypertension in low and middle income countries are higher compared to high income countries. The present study is designed to combine life style modification and home blood pressure monitoring for control of hypertension in the context of low and middle income countries. The study is a two armed, parallel group, un-blinded, cluster randomized controlled trial undertaken within lower income areas in Kuala Lumpur. Two housing complexes will be assigned to the intervention group and the other two housing complexes will be allocated in the control group. Based on power analysis, 320 participants will be recruited. The participants in the intervention group (n = 160) will undergo three main components in the intervention which are the peer support for home blood pressure monitoring, face to face health coaching on healthy diet and demonstration and training for indoor home based exercise activities while the control group will receive a pamphlet containing information on hypertension. The primary outcomes are systolic and diastolic blood pressure. Secondary outcome measures include practice of self-blood pressure monitoring, dietary intake, level of physical activity and physical fitness. The present study will evaluate the effect of lifestyle modification and peer support home blood pressure monitoring on blood pressure control, during a 6 month intervention period. Moreover, the study aims to assess whether these effects can be sustainable more than six months after the intervention has ended.

  14. Increasing physical activity through an Internet-based motivational intervention supported by pedometers in a sample of sedentary students: A randomised controlled trial.

    Science.gov (United States)

    Miragall, Marta; Domínguez-Rodríguez, Alejandro; Navarro, Jessica; Cebolla, Ausiàs; Baños, Rosa M

    2018-04-01

    The aim of this study was to analyse the effect of an Internet-based motivational intervention (IMI) supported by pedometers (in comparison with IMI alone and non-intervention) on increasing daily steps and changing constructs related to physical activity (PA) in a sample of sedentary students. A randomised-controlled trial was conducted with 76 sedentary or low-active college students. The purpose of the IMI was to deliver information to increase motivation and set individualised PA goals. It involved a 3-week intervention and a 3-months follow-up. Objective measures were used to measure daily steps, and self-report questionnaires to assess different constructs related to PA. Results revealed that IMI supported by pedometers condition increased significantly more the daily steps (post-intervention: M = 2069; SD = 1827; follow-up: M = 2227; SD = 2477) and enjoyment than non-intervention condition at both points in time. Moreover, results showed that IMI alone condition increased more the scores in variables involved in PA behaviour than non-intervention condition. This study shows the effectiveness of a self-administered IMI using pedometers in increasing PA and enjoyment, and the effectiveness of the IMI alone in changing different theoretical constructs related to the PA behaviour.

  15. Combined task delegation, computerized decision support, and feedback improve cardiovascular risk for type 2 diabetic patients: a cluster randomized trial in primary care.

    Science.gov (United States)

    Cleveringa, Frits G W; Gorter, Kees J; van den Donk, Maureen; Rutten, Guy E H M

    2008-12-01

    The Diabetes Care Protocol combines task delegation (a practice nurse), computerized decision support, and feedback every 3 months. We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care. In a cluster randomized trial, mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models. Throughout the Netherlands, 26 intervention practices included 1,699 patients and 29 control practices 1,692 patients. The difference in A1C change was not significant, whereas total cholesterol, LDL cholesterol, and blood pressure improved significantly more in the intervention group. The 10-year coronary heart disease risk estimate of the UK Prospective Diabetes Study improved 1.4% more in the intervention group. Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients.

  16. Work-focused cognitive-behavioural therapy and individual job support to increase work participation in common mental disorders: a randomised controlled multicentre trial.

    Science.gov (United States)

    Reme, Silje Endresen; Grasdal, Astrid Louise; Løvvik, Camilla; Lie, Stein Atle; Øverland, Simon

    2015-10-01

    Common mental disorders (CMDs) are a major cause of rising disability benefit expenditures. We urgently need evidence on programmes that can increase work participation in CMDs. The aim of this study was to evaluate the effectiveness of work-focused cognitive-behavioural therapy (CBT) and individual job support for people struggling with work participation due to CMDs. A randomised controlled multicentre trial (RCT) including 1193 participants was conducted. Participants were on sick leave, at risk of going on sick leave or on long-term benefits. The intervention integrated work-focused CBT with individual job support. The control group received usual care. The main outcome was objectively ascertained work participation at 12 months follow-up, with changes in mental health and health-related quality of life as secondary outcomes. A larger proportion of participants in the intervention group had increased or maintained their work participation at follow-up compared to the control group (44.2% vs 37.2%, p=0.015). The difference remained significant after 18 months (difference 7.8%, p=0.018), and was even stronger for those on long-term benefits (difference 12.2%, p=0.007). The intervention also reduced depression (t=3.23, p≤0.001) and anxiety symptoms (t=2.52, p=0.012) and increased health-related quality of life (t=2.24, p=0.026) more than usual care. A work-focused CBT and individual job support was more effective than usual care in increasing or maintaining work participation for people with CMDs. The effects were profound for people on long-term benefits. This is the first large-scale RCT to demonstrate an effect of a behavioural intervention on work participation for the large group of workers with CMDs. ClinicalTrials.gov, registration number: NCT01146730. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. Applying STOPP Guidelines in Primary Care Through Electronic Medical Record Decision Support: Randomized Control Trial Highlighting the Importance of Data Quality.

    Science.gov (United States)

    Price, Morgan; Davies, Iryna; Rusk, Raymond; Lesperance, Mary; Weber, Jens

    2017-06-15

    Potentially Inappropriate Prescriptions (PIPs) are a common cause of morbidity, particularly in the elderly. We sought to understand how the Screening Tool of Older People's Prescriptions (STOPP) prescribing criteria, implemented in a routinely used primary care Electronic Medical Record (EMR), could impact PIP rates in community (non-academic) primary care practices. We conducted a mixed-method, pragmatic, cluster, randomized control trial in research naïve primary care practices. Phase 1: In the randomized controlled trial, 40 fully automated STOPP rules were implemented as EMR alerts during a 16-week intervention period. The control group did not receive the 40 STOPP rules (but received other alerts). Participants were recruited through the OSCAR EMR user group mailing list and in person at user group meetings. Results were assessed by querying EMR data PIPs. EMR data quality probes were included. Phase 2: physicians were invited to participate in 1-hour semi-structured interviews to discuss the results. In the EMR, 40 STOPP rules were successfully implemented. Phase 1: A total of 28 physicians from 8 practices were recruited (16 in intervention and 12 in control groups). The calculated PIP rate was 2.6% (138/5308) (control) and 4.11% (768/18,668) (intervention) at baseline. No change in PIPs was observed through the intervention (P=.80). Data quality probes generally showed low use of problem list and medication list. Phase 2: A total of 5 physicians participated. All the participants felt that they were aware of the alerts but commented on workflow and presentation challenges. The calculated PIP rate was markedly less than the expected rate found in literature (2.6% and 4.0% vs 20% in literature). Data quality probes highlighted issues related to completeness of data in areas of the EMR used for PIP reporting and by the decision support such as problem and medication lists. Users also highlighted areas for better integration of STOPP guidelines with

  18. Basic life support trained nurses ventilate more efficiently with laryngeal mask supreme than with facemask or laryngeal tube suction-disposable--a prospective, randomized clinical trial.

    Science.gov (United States)

    Gruber, Elisabeth; Oberhammer, Rosmarie; Balkenhol, Karla; Strapazzon, Giacomo; Procter, Emily; Brugger, Hermann; Falk, Markus; Paal, Peter

    2014-04-01

    In some emergency situations resuscitation and ventilation may have to be performed by basic life support trained personnel, especially in rural areas where arrival of advanced life support teams can be delayed. The use of advanced airway devices such as endotracheal intubation has been deemphasized for basically-trained personnel, but it is unclear whether supraglottic airway devices are advisable over traditional mask-ventilation. In this prospective, randomized clinical single-centre trial we compared airway management and ventilation performed by nurses using facemask, laryngeal mask Supreme (LMA-S) and laryngeal tube suction-disposable (LTS-D). Basic life support trained nurses (n=20) received one-hour practical training with each device. ASA 1-2 patients scheduled for elective surgery were included (n=150). After induction of anaesthesia and neuromuscular block nurses had two 90-second attempts to manage the airway and ventilate the patient with volume-controlled ventilation. Ventilation failed in 34% of patients with facemask, 2% with LMA-S and 22% with LTS-D (P<0.001). In patients who could be ventilated successfully mean tidal volume was 240±210 ml with facemask, 470±120 ml with LMA-S and 470±140 ml with LTS-D (P<0.001). Leak pressure was lower with LMA-S (23.3±10.8 cm H2O, 95% CI 20.2-26.4) than with LTS-D (28.9±13.9 cm·H2O, 95% CI 24.4-33.4; P=0.047). After one hour of introductory training, nurses were able to use LMA-S more effectively than facemask and LTS-D. High ventilation failure rates with facemask and LTS-D may indicate that additional training is required to perform airway management adequately with these devices. High-level trials are needed to confirm these results in cardiac arrest patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  19. Microdialysis Assessment of Cerebral Perfusion during Cardiac Arrest, Extracorporeal Life Support and Cardiopulmonary Resuscitation in Rats - A Pilot Trial.

    Directory of Open Access Journals (Sweden)

    Andreas Schober

    Full Text Available Cerebral metabolic alterations during cardiac arrest, cardiopulmonary resuscitation (CPR and extracorporeal cardiopulmonary life support (ECLS are poorly explored. Markers are needed for a more personalized resuscitation and post-resuscitation care. Aim of this study was to investigate early metabolic changes in the hippocampal CA1 region during ventricular fibrillation cardiac arrest (VF-CA and ECLS versus conventional CPR. Male Sprague-Dawley rats (350g underwent 8min untreated VF-CA followed by ECLS (n = 8; bloodflow 100ml/kg, mechanical CPR (n = 18; 200/min until return of spontaneous circulation (ROSC. Shams (n = 2 were included. Glucose, glutamate and lactate/pyruvate ratio were compared between treatment groups and animals with and without ROSC. Ten animals (39% achieved ROSC (ECLS 5/8 vs. CPR 5/18; OR 4,3;CI:0.7-25;p = 0.189. During VF-CA central nervous glucose decreased (0.32±0.1mmol/l to 0.04±0.01mmol/l; p<0.001 and showed a significant rise (0.53±0.1;p<0.001 after resuscitation. Lactate/pyruvate (L/P ratio showed a 5fold increase (31 to 164; p<0.001; maximum 8min post ROSC. Glutamate showed a 3.5-fold increase to (2.06±1.5 to 7.12±5.1μmol/L; p<0.001 after CA. All parameters normalized after ROSC with no significant differences between ECLS and CPR. Metabolic changes during ischemia and resuscitation can be displayed by cerebral microdialysis in our VF-CA CPR and ECLS rat model. We found similar microdialysate concentrations and patterns of normalization in both resuscitation methods used. Institutional Protocol Number: GZ0064.11/3b/2011.

  20. Microdialysis Assessment of Cerebral Perfusion during Cardiac Arrest, Extracorporeal Life Support and Cardiopulmonary Resuscitation in Rats – A Pilot Trial

    Science.gov (United States)

    Schober, Andreas; Warenits, Alexandra M.; Testori, Christoph; Weihs, Wolfgang; Hosmann, Arthur; Högler, Sandra; Sterz, Fritz; Janata, Andreas; Scherer, Thomas; Magnet, Ingrid A. M.; Ettl, Florian; Laggner, Anton N.; Herkner, Harald; Zeitlinger, Markus

    2016-01-01

    Cerebral metabolic alterations during cardiac arrest, cardiopulmonary resuscitation (CPR) and extracorporeal cardiopulmonary life support (ECLS) are poorly explored. Markers are needed for a more personalized resuscitation and post—resuscitation care. Aim of this study was to investigate early metabolic changes in the hippocampal CA1 region during ventricular fibrillation cardiac arrest (VF-CA) and ECLS versus conventional CPR. Male Sprague-Dawley rats (350g) underwent 8min untreated VF-CA followed by ECLS (n = 8; bloodflow 100ml/kg), mechanical CPR (n = 18; 200/min) until return of spontaneous circulation (ROSC). Shams (n = 2) were included. Glucose, glutamate and lactate/pyruvate ratio were compared between treatment groups and animals with and without ROSC. Ten animals (39%) achieved ROSC (ECLS 5/8 vs. CPR 5/18; OR 4,3;CI:0.7–25;p = 0.189). During VF-CA central nervous glucose decreased (0.32±0.1mmol/l to 0.04±0.01mmol/l; p<0.001) and showed a significant rise (0.53±0.1;p<0.001) after resuscitation. Lactate/pyruvate (L/P) ratio showed a 5fold increase (31 to 164; p<0.001; maximum 8min post ROSC). Glutamate showed a 3.5-fold increase to (2.06±1.5 to 7.12±5.1μmol/L; p<0.001) after CA. All parameters normalized after ROSC with no significant differences between ECLS and CPR. Metabolic changes during ischemia and resuscitation can be displayed by cerebral microdialysis in our VF-CA CPR and ECLS rat model. We found similar microdialysate concentrations and patterns of normalization in both resuscitation methods used. Institutional Protocol Number: GZ0064.11/3b/2011 PMID:27175905

  1. Microdialysis Assessment of Cerebral Perfusion during Cardiac Arrest, Extracorporeal Life Support and Cardiopulmonary Resuscitation in Rats - A Pilot Trial.

    Science.gov (United States)

    Schober, Andreas; Warenits, Alexandra M; Testori, Christoph; Weihs, Wolfgang; Hosmann, Arthur; Högler, Sandra; Sterz, Fritz; Janata, Andreas; Scherer, Thomas; Magnet, Ingrid A M; Ettl, Florian; Laggner, Anton N; Herkner, Harald; Zeitlinger, Markus

    2016-01-01

    Cerebral metabolic alterations during cardiac arrest, cardiopulmonary resuscitation (CPR) and extracorporeal cardiopulmonary life support (ECLS) are poorly explored. Markers are needed for a more personalized resuscitation and post-resuscitation care. Aim of this study was to investigate early metabolic changes in the hippocampal CA1 region during ventricular fibrillation cardiac arrest (VF-CA) and ECLS versus conventional CPR. Male Sprague-Dawley rats (350g) underwent 8min untreated VF-CA followed by ECLS (n = 8; bloodflow 100ml/kg), mechanical CPR (n = 18; 200/min) until return of spontaneous circulation (ROSC). Shams (n = 2) were included. Glucose, glutamate and lactate/pyruvate ratio were compared between treatment groups and animals with and without ROSC. Ten animals (39%) achieved ROSC (ECLS 5/8 vs. CPR 5/18; OR 4,3;CI:0.7-25;p = 0.189). During VF-CA central nervous glucose decreased (0.32±0.1mmol/l to 0.04±0.01mmol/l; p<0.001) and showed a significant rise (0.53±0.1;p<0.001) after resuscitation. Lactate/pyruvate (L/P) ratio showed a 5fold increase (31 to 164; p<0.001; maximum 8min post ROSC). Glutamate showed a 3.5-fold increase to (2.06±1.5 to 7.12±5.1μmol/L; p<0.001) after CA. All parameters normalized after ROSC with no significant differences between ECLS and CPR. Metabolic changes during ischemia and resuscitation can be displayed by cerebral microdialysis in our VF-CA CPR and ECLS rat model. We found similar microdialysate concentrations and patterns of normalization in both resuscitation methods used. Institutional Protocol Number: GZ0064.11/3b/2011.

  2. Improving Pediatric Basic Life Support Performance Through Blended Learning With Web-Based Virtual Patients: Randomized Controlled Trial.

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    Lehmann, Ronny; Thiessen, Christiane; Frick, Barbara; Bosse, Hans Martin; Nikendei, Christoph; Hoffmann, Georg Friedrich; Tönshoff, Burkhard; Huwendiek, Sören

    2015-07-02

    E-learning and blended learning approaches gain more and more popularity in emergency medicine curricula. So far, little data is available on the impact of such approaches on procedural learning and skill acquisition and their comparison with traditional approaches. This study investigated the impact of a blended learning approach, including Web-based virtual patients (VPs) and standard pediatric basic life support (PBLS) training, on procedural knowledge, objective performance, and self-assessment. A total of 57 medical students were randomly assigned to an intervention group (n=30) and a control group (n=27). Both groups received paper handouts in preparation of simulation-based PBLS training. The intervention group additionally completed two Web-based VPs with embedded video clips. Measurements were taken at randomization (t0), after the preparation period (t1), and after hands-on training (t2). Clinical decision-making skills and procedural knowledge were assessed at t0 and t1. PBLS performance was scored regarding adherence to the correct algorithm, conformance to temporal demands, and the quality of procedural steps at t1 and t2. Participants' self-assessments were recorded in all three measurements. Procedural knowledge of the intervention group was significantly superior to that of the control group at t1. At t2, the intervention group showed significantly better adherence to the algorithm and temporal demands, and better procedural quality of PBLS in objective measures than did the control group. These aspects differed between the groups even at t1 (after VPs, prior to practical training). Self-assessments differed significantly only at t1 in favor of the intervention group. Training with VPs combined with hands-on training improves PBLS performance as judged by objective measures.

  3. Characteristics of COPD patients according to GOLD classification and clinical phenotypes in the Russian Federation: the SUPPORT trial

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    Arkhipov V

    2017-11-01

    Full Text Available Vladimir Arkhipov,1 Daria Arkhipova,2 Marc Miravitlles,3 Andrey Lazarev,4 Ekaterina Stukalina5 1Clinical Pharmacology and Therapy Department, Russian Medical Academy of Postgraduate Education, Moscow, Russian Federation; 2Clinical Pharmacology and Propaedeutic Internal Diseases Department, First Moscow State Medical University, Moscow, Russian Federation; 3Pneumology Department, Hospital Universitari Vall d’Hebron, Ciber de Enfermedades Respiratorias (CIBERES, Barcelona, Spain; 4AstraZeneca Pharmaceuticals, Moscow, Russian Federation; 5AstraZeneca LP, Gaithersburg, MD, USA Background: The high prevalence of COPD in the Russian Federation has been demonstrated in several epidemiological studies. However, there are still no data on the clinical characteristics of these patients according to Global Initiative for Chronic Obstructive Lung Disease (GOLD groups and phenotypes, which could provide additional understanding of the burden of COPD, routine clinical practice, and ways to improve the treatment of patients with COPD in Russia.Patients and methods: SUPPORT was an observational multicenter study designed to obtain data about the distribution of patients with previously diagnosed COPD according to the severity of bronchial obstruction, symptom severity, risk of exacerbation, COPD phenotypes, and treatment of COPD. We included patients with a previous diagnosis of COPD who visited one of 33 primary-care centers for any reason in 23 cities in Russia.Results: Among the 1,505 patients with a previous diagnosis of COPD who attended the primary-care centers and were screened for the study, 1,111 had a spirometry-confirmed diagnosis and were included in the analysis. Up to 53% of the patients had severe or very severe COPD (GOLD stages III–IV, and 74.3% belonged to the GOLD D group. The majority of patients were frequent exacerbators (exacerbators with chronic bronchitis [37.3%], exacerbators without chronic bronchitis [14%], while 35.8% were

  4. Face-to-face Information and Emotional Support from Trained Nurses Reduce Pain During Screening Mammography: Results from a Randomized Controlled Trial.

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    Fernández-Feito, Ana; Lana, Alberto; Cabello-Gutiérrez, Lourdes; Franco-Correia, Sara; Baldonedo-Cernuda, Ricardo; Mosteiro-Díaz, Pilar

    2015-12-01

    Pain and discomfort during breast examination can affect a woman's adherence to breast cancer-screening programs. The aim of this study was to determine whether a nursing intervention protocol that provides verbal information and support to women could reduce pain during mammography. A randomized controlled trial of 436 Spanish women aged 50-69 who attended a breast-screening program was performed. The experimental group received a customized nursing intervention that provided face-to-face information and emotional support during the examination. Pain and anxiety were measured using a visual analogue scale and the State-Trait Anxiety Inventory, respectively. Data regarding several potential confounders were also collected. The adjusted means of pain level in the study group were obtained from multiple linear regressions, and the adjusted odds ratios (OR) and 95% confidence intervals (CI) were obtained via logistic regression. After the intervention, the level of pain was significantly lower (p = .03) in the experimental group (0.98 ± 2.28) compared with the group treated with normal care (1.48 ± 2.29). Consequently, the probability of feeling pain during mammography was lower among women in the experimental group (OR = 0.44; 95% CI: 0.24-0.81). The intervention was more effective among women with the highest anxiety levels (OR = 0.33; 95% CI: 0.11-0.98), who did not expect pain (OR = 0.28; 95% CI: 0.08-0.97), and who did not fear the outcome of the mammography (OR = 0.18; 95% CI: 0.04-0.85). Providing verbal information, as well as supporting the women during the test, is a simple and achievable intervention for nurses and can help to reduce pain during screening mammography. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  5. Effects of a supportive educational nursing care programme on fatigue and quality of life in patients with heart failure: a randomised controlled trial.

    Science.gov (United States)

    Wang, Tzu-Chieh; Huang, Jin-Long; Ho, Wen-Chao; Chiou, Ai-Fu

    2016-04-01

    Fatigue is a common symptom in patients with heart failure that is easy to ignore. In addition, fatigue may affect patients' physical function and psychosocial conditions that can impair their quality of life. An effective nursing care programme is required to alleviate patients' fatigue and improve their quality of life. To investigate the effects of a supportive educational nursing care programme on fatigue and quality of life in patients with heart failure. A randomised controlled trial design was used. Ninety-two patients with heart failure were randomly assigned to an intervention group (n=47) or a control group (n=45). The patients in the intervention group participated in 12 weeks of a supportive educational nursing care programme including fatigue assessment, education, coaching self-care and evaluation. The intervention was conducted by a cardiac nurse during four face-to-face interviews and three follow-up telephone interviews. Fatigue and quality of life were assessed at the baseline and 4 weeks, 8 weeks and 12 weeks after enrollment in both groups. The participants in the intervention group exhibited a significant decrease in the level of fatigue after 12 weeks, whereas those in the control group exhibited no significant changes. Compared with the control group, the intervention group exhibited a significantly greater decrease in the level of fatigue and significantly greater improvement in quality of life after 12 weeks of intervention. The supportive educational nursing care programme was recommended to alleviate fatigue and improve quality of life in patients with heart failure. © The European Society of Cardiology 2015.

  6. Helping adolescents to better support their peers with a mental health problem: A cluster-randomised crossover trial of teen Mental Health First Aid.

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    Hart, Laura M; Morgan, Amy J; Rossetto, Alyssia; Kelly, Claire M; Mackinnon, Andrew; Jorm, Anthony F

    2018-02-01

    teen Mental Health First Aid (tMHFA) is a classroom-based training programme for students aged 15-18 years to improve supportive behaviours towards peers, increase mental health literacy and reduce stigma. This research evaluated tMHFA by comparing it to a matched emergency Physical First Aid (PFA) training programme. A cluster-randomised crossover trial matched four public schools in two pairs and then randomised each to first receive tMHFA or PFA for all Year 10 students. In the subsequent calendar year, the new Year 10 cohort received the opposite intervention, giving eight cohorts. Online surveys were administered at baseline and 1 week post-training, measuring quality of first aid intentions, mental health literacy, problem recognition and stigmatising beliefs, towards fictional adolescents with depression and suicidality (John) and social anxiety (Jeanie). A total of 1942 students were randomised (979 received tMHFA, 948 received PFA), 1605 (84%) analysed for the John vignette at baseline and 1116 (69% of baseline) provided post-training data. The primary outcomes, 'helpful first aid intentions' towards John/Jeanie, showed significant group-by-time interactions with medium effect sizes favouring tMHFA ( ds = 0.50-0.58). Compared to PFA, tMHFA students also reported significantly greater improvements in confidence supporting a peer ( ds = 0.22-0.37) and number of adults rated as helpful ( ds = 0.45-0.46) and greater reductions in stigmatising beliefs ( ds = 0.12-0.40) and 'harmful first aid intentions' towards John/Jeanie ( ds = 0.15-0.41). tMHFA is an effective and feasible programme for increasing supportive first aid intentions and mental health literacy in adolescents in the short term. tMHFA could be widely disseminated to positively impact on help seeking for adolescent mental illness.

  7. Protocol for the Mindful Student Study: a randomised controlled trial of the provision of a mindfulness intervention to support university students' well-being and resilience to stress

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    Dufour, Geraldine; Benton, Alice; Howarth, Emma; Vainre, Maris; Croudace, Timothy J; Stochl, Jan; Jones, Peter B

    2016-01-01

    Introduction Levels of stress in UK university students are high, with an increase in the proportion of students seeking help in recent years. Academic pressure is reported as a major trigger. Mindfulness training has been shown to reduce stress and is popular among students, but its effectiveness in this context needs to be ascertained. In this pragmatic randomised controlled trial, we hypothesise that the provision of a preventative mindfulness intervention in universities could reduce students' psychological distress during the examination period (primary outcome), improve their resilience to stress up to at least 1 year later, reduce their use of mental health support services and improve academic performance. Methods and analysis At least 550 University of Cambridge students free from active crises or severe mental illness will be randomised to joining an 8-week mindfulness course or to mental health provision as usual (one-to-one allocation rate). Psychological distress will be measured using the Clinical Outcomes in Routine Evaluation Outcome Measure at baseline, postintervention, examination term and 1-year follow-up. Other outcomes are use of mental health services, inability to sit examinations or special circumstance requests, examination grades, well-being, altruism and coping measured with ecological momentary assessment. Outcome assessment and intention-to-treat primary analysis using linear mixed models adjusted for baseline scores will be blind to intervention allocation. We will also conduct per-protocol, subgroup and secondary outcome analyses. An Independent Data Monitoring and Ethics Committee will be set up. We will systematically monitor for, and react to, possible adverse events. An advisory reference group will comprise student representatives, members of the University Counselling Service and other student welfare staff. Ethics and dissemination Approval has been obtained from Cambridge Psychology Research Ethics Committee (PRE.2015

  8. A pilot randomized controlled trial of a post-discharge program to support emerging adults with type 1 diabetes mellitus transition from pediatric to adult care.

    Science.gov (United States)

    Steinbeck, Katharine S; Shrewsbury, Vanessa A; Harvey, Vanessa; Mikler, Kara; Donaghue, Kim C; Craig, Maria E; Woodhead, Helen J

    2015-12-01

    There is a paucity of randomized controlled trials (RCT) examining transition from pediatric to adult care in type 1 diabetes mellitus (T1DM). This study aimed to determine if transition in T1DM is more effective with a comprehensive transition program (CTP) compared with standard clinical practice (SCP). This RCT recruited as young people left pediatric diabetes services. The trial co-ordinator provided CTP participants with standardized telephone communication support at week 1, and 3, 6, and 12 months post-discharge from pediatric care. SCP participants were briefly contacted at 6 and 12 months post-discharge to confirm transfer status; they received no other post-discharge contact as per usual practice. At 12 months, the primary outcomes were engagement and retention in the adult service and secondary outcomes included hemoglobin A1c (HbA1c), diabetes-related hospitalizations, microvascular complication appearance, and global self-worth. Most CTP participants (11/14) and all SCP (12/12) participants (P = 0.2) transferred to an adult diabetes service; the median time to transfer was 14-15 wk. Overall, participants' frequency of adult diabetes service visits was sub-optimal but their retention in adult care was high. The only group difference was a higher HbA1c at baseline and follow-up in the CTP group. However, a general linear model found that follow-up HbA1c increased by 1.2% for each percentage increase in baseline HbA1c [95% confidence interval (0.4, 1.9; P = 0.01)], independent of treatment group. Despite the challenges in recruiting adequate numbers, these findings provide valuable insights for future T1DM transition RCTs that are needed to build a more solid evidence-base in this field. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Development, effectiveness and cost-effectiveness of a new out-patient Breathlessness Support Service: study protocol of a phase III fast-track randomised controlled trial

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    Bausewein Claudia

    2012-09-01

    Full Text Available Abstract Background Breathlessness is a common and distressing symptom affecting many patients with advanced disease both from malignant and non-malignant origin. A combination of pharmacological and non-pharmacological measures is necessary to treat this symptom successfully. Breathlessness services in various compositions aim to provide comprehensive care for patients and their carers by a multiprofessional team but their effectiveness and cost-effectiveness have not yet been proven. The Breathlessness Support Service (BSS is a newly created multiprofessional and interdisciplinary outpatient service at a large university hospital in South East London. The aim of this study is to develop and evaluate the effectiveness and cost effectiveness of this multidisciplinary out–patient BSS for the palliation of breathlessness, in advanced malignant and non-malignant disease. Methods The BSS was modelled based on the results of qualitative and quantitative studies, and systematic literature reviews. A randomised controlled fast track trial (RCT comprising two groups: 1 intervention (immediate access to BSS in addition to standard care; 2 control group (standard best practice and access to BSS after a waiting time of six weeks. Patients are included if suffering from breathlessness on exertion or at rest due to advanced disease such as cancer, chronic obstructive pulmonary disease (COPD, chronic heart failure (CHF, interstitial lung disease (ILD or motor neurone disease (MND that is refractory to maximal optimised medical management. Both quantitative and qualitative outcomes are assessed in face to-face interviews at baseline, after 6 and 12 weeks. The primary outcome is patients' improvement of mastery of breathlessness after six weeks assessed on the Chronic Respiratory Disease Questionnaire (CRQ. Secondary outcomes for patients include breathlessness severity, symptom burden, palliative care needs, service use, and respiratory measures (spirometry

  10. Study Protocol for a randomized controlled trial of mentalization based therapy against specialist supportive clinical management in patients with both eating disorders and symptoms of borderline personality disorder.

    Science.gov (United States)

    Robinson, Paul; Barrett, Barbara; Bateman, Anthony; Hakeem, Az; Hellier, Jennifer; Lemonsky, Fenella; Rutterford, Clare; Schmidt, Ulrike; Fonagy, Peter

    2014-02-21

    The NOURISHED study: Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders.Eating Disorders (ED) and Borderline Personality Disorder (BPD) are both difficult to treat and the combination presents particular challenges. Both are associated with vulnerability to loss of mentalization (awareness of one's own and others' emotional state). In BPD, Mentalization Based therapy (MBT) has been found effective in reducing symptoms. In this trial we investigate the effectiveness and cost-effectiveness of MBT adapted for Eating disorders (Mentalization Based Therapy for Eating Disorders (MBT-ED)) compared to a standard comparison treatment, Specialist Supportive Clinical Management (SSCM-ED) in patients with a combination of an Eating Disorder and either a diagnosis of BPD or a history of self-harm and impulsivity in the previous 12 months. We will complete a multi-site single-blind randomized controlled trial (RCT) of MBT-ED vs SSCM-ED. Participants will be recruited from three Eating Disorder Services and two Borderline Personality Disorder Services in London. Participants allocated to MBT-ED will receive one year of weekly group and individual therapy and participants allocated to SSCM-ED will receive 20 sessions of individual therapy over 1 year. In addition, participants in both groups will have access to up to 5 hours of dietetic advice. The primary outcome measure is the global score on the Eating Disorders Examination. Secondary outcome measures include total score on the Zanarini BPD scale, the Object Relations Inventory, the Depression Anxiety Stress Scales, quality of life and cost-effectiveness. Measures are taken at recruitment and at 6 month intervals up to 18 months. This is the first Randomised Controlled Trial of MBT-ED in patients with eating disorders and symptoms of BPD and will provide evidence to inform therapy decisions in this group of patients. During MBT-ED mentalization is encouraged, while in SSCM-ED it is not overtly

  11. Results of a pilot randomised controlled trial to measure the clinical and cost effectiveness of peer support in increasing hope and quality of life in mental health patients discharged from hospital in the UK.

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    Simpson, Alan; Flood, Chris; Rowe, Julie; Quigley, Jody; Henry, Susan; Hall, Cerdic; Evans, Richard; Sherman, Paul; Bowers, Len

    2014-02-05

    Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment, experience relapse and readmission to hospital, and sometimes attempt suicide. The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged. This pilot randomised controlled trial with economic evaluation aimed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope, reduce loneliness, improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only, with follow-up at one and three-months post-discharge. A total of 46 service users were recruited to the study; 23 receiving peer support and 23 in the care-as-usual arm. While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures, there is an indication that hope may be further increased in those in receipt of peer support. The total cost per case for the peer support arm of the study was £2154 compared to £1922 for the control arm. The mean difference between costs was minimal and not statistically significant. However, further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness. Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support. The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered; the length and frequency of support provided; and the contact between peer supporters and mental health staff. There is no conclusive evidence to

  12. A randomized double-blinded controlled trial of hCG as luteal phase support in natural cycle frozen embryo transfer.

    Science.gov (United States)

    Lee, Vivian Chi Yan; Li, Raymond Hang Wun; Yeung, William Shu Biu; Pak Chung, H O; Ng, Ernest Hung Yu

    2017-05-01

    Does the use of hCG as luteal phase support in natural cycle frozen embryo transfer (FET) increase the ongoing pregnancy rate? The use of hCG in natural cycle FET did not improve the ongoing pregnancy rate. The use of luteal phase support in stimulated cycles has been associated with higher live-birth rates and the results are similar when using hCG or progesterone. This is a randomized double-blinded controlled trial of 450 women recruited between August 2013 and October 2015. Women with regular cycles undergoing natural cycle FET were recruited. Serial serum hormonal concentrations were used to time natural ovulation and at least Day 2 cleavage embryos were replaced. Patients were randomized into either: (i) the treatment group, receiving 1500 IU hCG on the day of FET and 6 days after FET, or (ii) the control group, receiving normal saline on these 2 days. The ongoing pregnancy rate [60/225 (26.7%) in the treatment group vs 70/225 (31.3%) in the control group, odds ratio 1.242 (95% CI 0.825-1.869)], implantation rate and miscarriage rate were comparable between the two groups. In the treatment group, there were significantly more cycles with top quality embryos transferred and a significantly higher serum oestradiol level, but a comparable serum progesterone level, 6 days after FET. However, no significant differences were observed in serum oestradiol and progesterone levels 6 days after FET between the pregnant and non-pregnant women. In the multivariate logistic regression, the number of embryos transferred was the only significant factor predictive of the ongoing pregnancy rate after natural cycle FET. This study only included FET with cleavage stage embryos and only hCG, not vaginal progesterone, was used as luteal phase support. The findings in this study do not support the use of hCG for luteal phase support in natural cycle FET. No external funding was used and there were no competing interests. clinicaltrial.gov identifier: NCT01931384. 23/8/2013. 30

  13. A randomized controlled trial of 7-day intensive and standard weekly cognitive therapy for PTSD and emotion-focused supportive therapy.

    Science.gov (United States)

    Ehlers, Anke; Hackmann, Ann; Grey, Nick; Wild, Jennifer; Liness, Sheena; Albert, Idit; Deale, Alicia; Stott, Richard; Clark, David M

    2014-03-01

    Psychological treatments for posttraumatic stress disorder (PTSD) are usually delivered once or twice a week over several months. It is unclear whether they can be successfully delivered over a shorter period of time. This clinical trial had two goals: to investigate the acceptability and efficacy of a 7-day intensive version of cognitive therapy for PTSD and to investigate whether cognitive therapy has specific treatment effects by comparing intensive and standard weekly cognitive therapy with an equally credible alternative treatment. Patients with chronic PTSD (N=121) were randomly allocated to 7-day intensive cognitive therapy for PTSD, 3 months of standard weekly cognitive therapy, 3 months of weekly emotion-focused supportive therapy, or a 14-week waiting list condition. The primary outcomes were change in PTSD symptoms and diagnosis as measured by independent assessor ratings and self-report. The secondary outcomes were change in disability, anxiety, depression, and quality of life. Evaluations were conducted at the baseline assessment and at 6 and 14 weeks (the posttreatment/wait assessment). For groups receiving treatment, evaluations were also conducted at 3 weeks and follow-up assessments at 27 and 40 weeks after randomization. All analyses were intent-to-treat. At the posttreatment/wait assessment, 73% of the intensive cognitive therapy group, 77% of the standard cognitive therapy group, 43% of the supportive therapy group, and 7% of the waiting list group had recovered from PTSD. All treatments were well tolerated and were superior to waiting list on nearly all outcome measures; no difference was observed between supportive therapy and waiting list on quality of life. For primary outcomes, disability, and general anxiety, intensive and standard cognitive therapy were superior to supportive therapy. Intensive cognitive therapy achieved faster symptom reduction and comparable overall outcomes to standard cognitive therapy. Cognitive therapy for PTSD

  14. Effect of nature-based sounds' intervention on agitation, anxiety, and stress in patients under mechanical ventilator support: a randomised controlled trial.

    Science.gov (United States)

    Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Zayeri, Farid; Vaismoradi, Mojtaba; Jasper, Melanie

    2013-07-01

    Few studies have been conducted to investigate the effect of nature-based sounds (N-BS) on agitation, anxiety level and physiological signs of stress in patients under mechanical ventilator support. Non-pharmacological nursing interventions such as N-BS can be less expensive and efficient ways to alleviate anxiety and adverse effects of sedative medications in patients under mechanical ventilator support. This study was conducted to identify the effect of the nature-based sounds' intervention on agitation, anxiety level and physiological stress responses in patients under mechanical ventilation support. A randomized placebo-controlled trial design was used to conduct this study. A total of 60 patients aged 18-65 years under mechanical ventilation support in an intensive care unit were randomly assigned to the control and experimental groups. The patients in the intervention group received 90 min of N-BS. Pleasant nature sounds were played to the patients using media players and headphones. Patients' physiological signs were taken immediately before the intervention and at the 30th, 60th, 90th minutes and 30 min after the procedure had finished. The physiological signs of stress assessed were heart rate, respiratory rate, and blood pressure. Data were collected over eight months from Oct 2011 to June 2012. Anxiety levels and agitation were assessed using the Faces Anxiety Scale and Richmond Agitation Sedation Scale, respectively. The experimental group had significantly lower systolic blood pressure, diastolic blood pressure, anxiety and agitation levels than the control group. These reductions increased progressively in the 30th, 60th, 90th minutes, and 30 min after the procedure had finished indicating a cumulative dose effect. N-BS can provide an effective method of decreasing potentially harmful physiological responses arising from anxiety in mechanically ventilated patients. Nurses can incorporate N-BS intervention as a non-pharmacologic intervention into the

  15. Comparative effectiveness trial of family-supported smoking cessation intervention versus standard telephone counseling for chronically ill veterans using proactive recruitment

    Directory of Open Access Journals (Sweden)

    Bastian LA

    2012-09-01

    reported high self-efficacy for quitting (mean = 5.7; SD = 1.5. At 5-months follow-up, we found no differences in smoking cessation by arm: 19.8% in the family-supported intervention and 22.0% in the standard arm. The following factors were associated with smoking cessation at 5 months: having cardiovascular disease or other diagnosis compared to cancer, lower nicotine dependence, older age, and higher self-efficacy.Conclusions: This comparative effectiveness trial among chronically ill veterans did not find differences in smoking cessation by type of intervention. Future studies should expand upon our findings and consider tailoring proactive telephone-based interventions based on age and type of disease.Keywords: smoking cessation, veterans, social support, counseling, proactive, family

  16. ‘Placement budgets’ for supported employment – improving competitive employment for people with mental illness: study protocol of a multicentre randomized controlled trial

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    Nordt Carlos

    2012-10-01

    Full Text Available Abstract Background Vocational integration of people with mental illness is poor despite their willingness to work. The ‘Individual Placement and Support’ (IPS model which emphasises rapid and direct job placement and continuing support to patient and employer has proven to be the most effective vocational intervention programme. Various studies have shown that every second patient with severe mental illness was able to find competitive employment within 18 months. However, the goal of taking up employment within two months was rarely achieved. Thus, we aim to test whether the new concept of limited placement budgets increases the effectiveness of IPS. Methods/Design Six job coaches in six out-patients psychiatric clinics in the Canton of Zurich support unemployed patients of their clinic who seek competitive employment. Between June 2010 and May 2011 patients (N=100 are randomly assigned to three different placement budgets of 25h, 40h, or 55h working hours of job coaches. Support lasts two years for those who find a job. The intervention ends for those who fail to find competitive employment when the respective placement budgets run out. The primary outcome measure is the time between study inclusion and first competitive employment that lasted three months or longer. Over a period of three years interviews are carried out every six months to measure changes in motivation, stigmatization, social network and social support, quality of life, job satisfaction, financial situation, and health conditions. Cognitive and social-cognitive tests are conducted at baseline to control for confounding variables. Discussion This study will show whether the effectiveness of IPS can be increased by the new concept of limited placement budgets. It will also be examined whether competitive employment leads in the long term to an improvement of mental illness, to a transfer of the psychiatric support system to private and vocational networks, to an increase

  17. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial.

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    Lindsay S Elliott

    Full Text Available In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients.This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110 were randomized to pharmacogenetic profiling (n = 57. The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53 received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR, 0.65; 95% confidence interval (CI, 0.32-1.28; P = 0.21 and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27-0.82; P = 0.007. The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31-1.21; P = 0.16 and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34-0.99; P = 0.045. Differences in composite outcomes at 60 days (exploratory endpoints

  18. Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol.

    Science.gov (United States)

    DePaul, Vincent G; Wishart, Laurie R; Richardson, Julie; Lee, Timothy D; Thabane, Lehana

    2011-10-21

    Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP), a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT) in community-dwelling, ambulatory, adults within 1 year of stroke. A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1) using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used. In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that outcomes will be optimized through the application of a task

  19. APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Conceição, Eva M; Machado, Paulo P P; Vaz, Ana Rita; Pinto-Bastos, Ana; Ramalho, Sofia; Silva, Cátia; Arrojado, Filipa

    2016-03-01

    Despite evidence of successful weight loss for bariatric surgery patients, some patients experience considerable weight regain over the long term. Given the strong association between post-surgery health behaviors and outcomes, aftercare intervention to address key behaviors appears to be a reasonable relapse-prevention strategy. As the burden of obesity rates increases in healthcare centers, an internet-based program appears to be a reasonable strategy for supporting bariatric surgery patients in the long term. The primary purpose of the current project is to develop and test the efficacy and perceived utility of APOLO-Bari. This study is a randomized control trial, which will be conducted in two hospital centers in the North of Portugal; it includes a control group receiving treatment as usual and an intervention group receiving the APOLO-Bari program for one year in addition to treatment as usual. A total of 180 male and female participants who underwent bariatric surgery (gastric sleeve or gastric bypass surgery) for 12 to 20 months will be recruited. Both groups will complete a similar set of questionnaires at baseline, every 4 months until the end of the intervention, and at 6 and 12 months follow-up. Assessment includes anthropometric variables and psychological self-report measures. The primary outcome measure will be weight regain measured at the end of treatment, and at 6 and 12 months follow-up. The secondary aims are to test the cost-effectiveness of the intervention and to investigate psychological predictors and trajectories of weight regain. APOLO-Bari was developed to address the weight regain problem in the bariatric population by offering additional guidance to bariatric patients during the postoperative period. The program includes: (a) a psychoeducational cognitive-behavioral-based self-help manual, (b) a weekly feedback messaging system that sends a feedback statement related to information reported by the participant, and (c) interactive chat

  20. Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Dekker, Kim; Benjamins, Jeroen S; Van Straten, Annemieke; Hofman, Winni F; Van Someren, Eus J W

    2015-07-04

    DSM-V criteria for insomnia disorder are met by 6 to 10% of the adult population. Insomnia has severe consequences for health and society. One of the most common treatments provided by primary caregivers is pharmacological treatment, which is far from optimal and has not been recommended since a 2005 consensus report of the National Institutes of Health. The recommended treatment is Cognitive Behavioral Therapy for Insomnia. Effectiveness, however, is still limited. Only a few studies have evaluated the effectiveness of chronobiological treatments, including the timed application of bright light, physical activity and body warming. Another opportunity for optimization of treatment is based on the idea that the people suffering from insomnia most likely represent a heterogeneous mix of subtypes, with different underlying causes and expected treatment responses. The present study aims to evaluate the possibility for optimizing insomnia treatment along the principles of personalized and stratified medicine. It evaluates the following: 1. The relative effectiveness of internet-supported cognitive behavioral therapy, bright light, physical activity and body warming; 2. Whether the effectiveness of internet-supported cognitive behavioral therapy for insomnia can be augmented by simultaneous or prior application of bright light, physical activity and body warming; and 3. Whether the effectiveness of the interventions and their combination are moderated by the insomnia subtype. In a repeated measures, placebo-controlled, randomized clinical trial that included 160 people diagnosed with insomnia disorder, we are evaluating the relative effectiveness of 4 intervention weeks. Primary outcome is subjective sleep efficiency, quantified using a sleep diary. Secondary outcomes include other complaints of sleep and daytime functioning, health-related cost estimates and actigraphic objective sleep estimates. Compliance will be monitored both subjectively and objectively using

  1. The effectiveness of Stepping Stones Triple P parenting support in parents of children with borderline to mild intellectual disability and psychosocial problems: a randomized controlled trial.

    Science.gov (United States)

    Kleefman, Marijke; Jansen, Daniëlle E M C; Stewart, Roy E; Reijneveld, Sijmen A

    2014-10-28

    Children with borderline to mild intellectual disability (BMID) have been shown to be at increased risk for psychosocial problems. The presence of these psychosocial problems leads to parenting stress. Stepping Stones Triple P (SSTP) is a parenting support program to support parents with children with BMID and psychosocial problems. The aim of this study was to evaluate the effectiveness of SSTP compared to Care as Usual (CAU) in reducing psychosocial problems in children with BMID. We conducted a randomized controlled trial in the Northern provinces of the Netherlands. Parents of children aged 5 to 12 with borderline (IQ 70 to 85) or mild (IQ 70 to 50) ID and psychosocial problems were invited. Psychosocial problems were identified using the Strengths and Difficulties Questionnaire (SDQ) parent report (≥14). Measurements were assessed before the intervention (T0), immediately after the intervention (T1) and after a follow-up of six months (T2). SSTP takes 8 to 10 individual sessions of 40-90 minutes, provided over 10 to 12 weeks. CAU concerned any service, except SSTP. Primary outcomes were the child's psychosocial problems (SDQ parent and teacher forms and the Eyberg Child Behavior Inventory, ECBI). Secondary outcomes were parenting stress (Parenting Stress Index, PSI) and parenting skills (Alabama Parenting Questionnaire, APQ). In total 209 parents of children aged 5 to 12 with BMID were allocated blindly to either SSTP (n =111) or CAU (n =98). In the intention to treat analyses, SSTP achieved no significantly better effect than CAU for the SDQ parent report, the ECBI and the APQ on the short- and long- term. In the short term, SSTP was significantly more effective than CAU for the SDQ teacher report (B = -2.25, 95% CI -3.79 to -0.71) and the PSI (B = -7.06, 95% CI -12.11 to -2.01). For both SDQ teacher report and PSI, there was no statistically significant effect in the long term. Dropout from SSTP was considerable (49%), with the effects being

  2. [Treatment of patients with type 2 diabetes mellitus: cardiovascular safety of incretin-based therapy supported by the ELIXA and TECOS trials].

    Science.gov (United States)

    Avogaro, Angelo

    2016-04-01

    The risk of morbidity and mortality from cardiovascular disease in patients with type 2 diabetes is about 2-fold higher compared to their non-diabetic counterparts. In December 2008, the Food and Drug Administration published guidelines for the evaluation of cardiovascular risk in new antidiabetic therapies. A shift of emphasis occurred from short-term glycated hemoglobin-centered trials to trials testing cardiovascular safety. The SAVOR-TIMI 53 and the EXAMINE trials with the dipeptidyl peptidase 4 (DPP-4) inhibitors saxagliptin and alogliptin were cardiovascular neutral. The publication of the results of the TECOS trial with sitagliptin, another DPP-4 inhibitor, the American Diabetes Association 2015 presentation of the ELIXA trial with lixisenatide, the first cardiovascular safety trial with glucagon-like peptide 1 receptor agonists, have also been completed. They both show cardiovascular neutrality in very high-risk diabetic patients. The results of these trials are interpreted in the context of diabetic treatment.

  3. Modafinil zur behandlung der tumorfatigue : eine interventionsstudie

    NARCIS (Netherlands)

    Wirz, S.; Nadstawek, J.; Kühn, K. U.; Vater, S.; Junker, U.; Wartenberg, H. C.

    2010-01-01

    the authors conducted an open-label investigation examining the effects of modafinil in reducing fatigue in patients with cancer, undergoing cancer treatment, and receiving opioid therapy. after approval by the local Ethics Committee and informed consent cancer patients who reported fatigue -

  4. Die Behandlung menschliches Embryos und Menschenwurde

    OpenAIRE

    Matsui, Fumio

    2002-01-01

    We are confronted with an old and new problem, which has come up with the progress of modern biotechnologies: what is a life or when does a life begin? The expectation of order-made medicine has build up since the discovery of Embryo Stem cell called "a dream master cell", while there is any condemnation against the destruction of human embryo in order to gain it. It is a question whether a human embryo is a human being in the world. Human dignity(=HD) is a principle that keeps human embryos ...

  5. Arthroskopische Behandlung von Knorpelverletzungen am Sprunggelenk

    DEFF Research Database (Denmark)

    Thomas, M.; Jordan, J M; Hamborg-Petersen, E

    2016-01-01

    Ankle sprains are the most relevant injuries of the lower extremities and can lead to damage to ligaments and osteochondral lesions. Up to 50 % of patients with a sprained ankle later develop a lesion of the cartilage in the ankle joint or an osteochondral lesion of the talus. This can lead...... to osteoarthritis of the injured ankle joint. Spontaneous healing is possible in all age groups in cases of a bone bruise in the subchondral bone but in isolated chondral injuries is only useful in pediatric patients. In many cases chondral and osteochondral injuries lead to increasing demarcation of the affected...... has a chance of healing in pediatric patients. Conservative measures for adults should only be considered as adjuvant treatment to surgery.Based on a comprehensive analysis of the current literature, this article gives an overview and critical analysis of the current concepts for treatment of chondral...

  6. Die behandlung von rükenschmerzen

    DEFF Research Database (Denmark)

    Van Tulder, M. W.

    2001-01-01

    ), and data analysis. Results: acute low back pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) and muscle relaxants relieve pain more than placebo; advice to stay active speeds up recovery and reduces chronic disability; bed rest and specific back exercises are not effective. Results: chronic low back pain...

  7. The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chiatti, Carlos; Masera, Filippo; Rimland, Joseph M; Cherubini, Antonio; Scarpino, Osvaldo; Spazzafumo, Liana; Lattanzio, Fabrizia

    2013-05-28

    integration of existing services in an ambitious holistic design. The analysis of different interventions is expected to provide sound evidence of the effectiveness and cost of programs supporting AD patients in the community. ClinicalTrials.gov: NCT01700556.

  8. Single crowns in the resorbed posterior maxilla supported by either 6-mm implants or by 11-mm implants combined with sinus floor elevation surgery : A 1-year randomised controlled trial

    NARCIS (Netherlands)

    Guljé, Felix L; Raghoebar, Gerry M; Vissink, Arjan; Meijer, Henny J A

    2014-01-01

    Purpose: The aim of this randomised controlled trial was to assess the clinical performance of single crowns in the posterior maxilla supported by either 6-mm or 11-mm implants combined with maxillary sinus floor elevation. Materials and methods: 41 consecutive patients with one missing premolar or

  9. A randomized trial using telehealth technology to link caregivers with dementia care experts for in-home caregiving support: FamTechCare protocol.

    Science.gov (United States)

    Williams, Kristine; Blyler, Diane; Vidoni, Eric D; Shaw, Clarissa; Wurth, JoEllen; Seabold, Denise; Perkhounkova, Yelena; Van Sciver, Angela

    2018-03-05

    The number of persons with dementia (PWD) in the United States is expected to reach 16 million by 2050. Due to the behavioral and psychological symptoms of dementia, caregivers face challenging in-home care situations that lead to a range of negative health outcomes such as anxiety and depression for the caregivers and nursing home placement for PWD. Supporting Family Caregivers with Technology for Dementia Home Care (FamTechCare) is a multisite randomized controlled trial evaluating the effects of a telehealth intervention on caregiver well-being and PWD behavioral symptoms. The FamTechCare intervention provides individualized dementia-care strategies to in-home caregivers based on video recordings that the caregiver creates of challenging care situations. A team of dementia care experts review videos submitted by caregivers and provide interventions to improve care weekly for the experimental group. Caregivers in the control group receive feedback for improving care based on a weekly phone call with the interventionist and receive feedback on their videos at the end of the 3-month study. Using linear mixed modeling, we will compare experimental and control group outcomes (PWD behavioral symptoms and caregiver burden) after 1 and 3 months. An exploratory descriptive design will identify a typology of interventions for telehealth support for in-home dementia caregivers. Finally, the cost for FamTechCare will be determined and examined in relation to hypothesized effects on PWD behavioral symptoms, placement rates, and caregiver burden. This research will provide the foundation for future research for telehealth interventions with this population, especially for families in rural or remote locations. © 2018 Wiley Periodicals, Inc.

  10. Varied overground walking training versus body-weight-supported treadmill training in adults within 1 year of stroke: a randomized controlled trial.

    Science.gov (United States)

    DePaul, Vincent G; Wishart, Laurie R; Richardson, Julie; Thabane, Lehana; Ma, Jinhui; Lee, Timothy D

    2015-05-01

    Although task-related walking training has been recommended after stroke, the theoretical basis, content, and impact of interventions vary across the literature. There is a need for a comparison of different approaches to task-related walking training after stroke. To compare the impact of a motor-learning-science-based overground walking training program with body-weight-supported treadmill training (BWSTT) in ambulatory, community-dwelling adults within 1 year of stroke onset. In this rater-blinded, 1:1 parallel, randomized controlled trial, participants were stratified by baseline gait speed. Participants assigned to the Motor Learning Walking Program (MLWP) practiced various overground walking tasks under the supervision of 1 physiotherapist. Cognitive effort was encouraged through random practice and limited provision of feedback and guidance. The BWSTT program emphasized repetition of the normal gait cycle while supported on a treadmill and assisted by 1 to 3 therapy staff. The primary outcome was comfortable gait speed at postintervention assessment (T2). In total, 71 individuals (mean age = 67.3; standard deviation = 11.6 years) with stroke (mean onset = 20.9 [14.1] weeks) were randomized (MLWP, n = 35; BWSTT, n = 36). There was no significant between-group difference in gait speed at T2 (0.002 m/s; 95% confidence interval [CI] = -0.11, 0.12; P > .05). The MLWP group improved by 0.14 m/s (95% CI = 0.09, 0.19), and the BWSTT group improved by 0.14 m/s (95% CI = 0.08, 0.20). In this sample of community-dwelling adults within 1 year of stroke, a 15-session program of varied overground walking-focused training was not superior to a BWSTT program of equal frequency, duration, and in-session step activity. © The Author(s) 2014.

  11. Support and Assessment for Fall Emergency Referrals (SAFER 1) trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial.

    Science.gov (United States)

    Snooks, Helen; Cheung, Wai-Yee; Close, Jacqueline; Dale, Jeremy; Gaze, Sarah; Humphreys, Ioan; Lyons, Ronan; Mason, Suzanne; Merali, Yasmin; Peconi, Julie; Phillips, Ceri; Phillips, Judith; Roberts, Stephen; Russell, Ian; Sánchez, Antonio; Wani, Mushtaq; Wells, Bridget; Whitfield, Richard

    2010-01-26

    Many emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital attendance. The SAFER 1 trial will assess the costs and benefits of a new healthcare technology--hand-held computers with computerised clinical decision support (CCDS) software--to help paramedics decide who needs hospital attendance, and who can be safely left at home with referral to community falls services. Pragmatic cluster randomised trial with a qualitative component. We shall allocate 72 paramedics ('clusters') at random between receiving the intervention and a control group delivering care as usual, of whom we expect 60 to complete the trial.Patients are eligible if they are aged 65 or older, live in the study area but not in residential care, and are attended by a study paramedic following an emergency call for a fall. Seven to 10 days after the index fall we shall offer patients the opportunity to opt out of further follow up. Continuing participants will receive questionnaires after one and 6 months, and we shall monitor their routine clinical data for 6 months. We shall interview 20 of these patients in depth. We shall conduct focus groups or semi-structured interviews with paramedics and other stakeholders.The primary outcome is the interval to the first subsequent reported fall (or death). We shall analyse this and other measures of outcome, process and cost by 'intention to treat'. We shall analyse qualitative data thematically. Since the SAFER 1 trial received funding in August 2006, implementation has come to terms with ambulance service reorganisation and a new national electronic patient record in England. In response to these hurdles the research team has adapted the research design, including aspects of the intervention, to meet the needs of the ambulance services.In conclusion this complex emergency care trial will provide rigorous evidence on the clinical and cost

  12. Influence of visual and auditory biofeedback on partial body weight support treadmill training of individuals with chronic hemiparesis: a randomized controlled clinical trial.

    Science.gov (United States)

    Brasileiro, A; Gama, G; Trigueiro, L; Ribeiro, T; Silva, E; Galvão, É; Lindquist, A

    2015-02-01

    Stroke is an important causal factor of deficiency and functional dependence worldwide. To determine the immediate effects of visual and auditory biofeedback, combined with partial body weight supported (PBWS) treadmill training on the gait of individuals with chronic hemiparesis. Randomized controlled trial. Outpatient rehabilitation hospital. Thirty subjects with chronic hemiparesis and ability to walk with some help. Participants were randomized to a control group that underwent only PBWS treadmill training; or experimental I group with visual biofeedback from the display monitor, in the form of symbolic feet as the subject took a step; or experimental group II with auditory biofeedback associated display, using a metronome at 115% of the individual's preferred cadence. They trained for 20 minutes and were evaluated before and after training. Spatio-temporal and angular gait variables were obtained by kinematics from the Qualisys Motion Analysis system. Increases in speed and stride length were observed for all groups over time (speed: F=25.63; Ptraining of individuals with chronic hemiparesis, in short term. Additional studies are needed to determine whether, in long term, the biofeedback will promote additional benefit to the PBWS treadmill training. The findings of this study indicate that visual and auditory biofeedback does not bring immediate benefits on PBWS treadmill training of individuals with chronic hemiparesis. This suggest that, for additional benefits are achieved with biofeedback, effects should be investigated after long-term training, which may determine if some kind of biofeedback is superior to another to improve the hemiparetic gait.

  13. Nutritional support of bone marrow transplant recipients: a prospective, randomized clinical trial comparing total parental nutrition to an enteral feeding program

    Energy Technology Data Exchange (ETDEWEB)

    Szeluga, D.J.

    1985-01-01

    Allogeneic and autologous bone marrow transplantation (BMT) have been associated with nutritionally-depleting side effects. Total parental nutrition (TPN) has become the standard, but it has not been demonstrated that TPN is the appropriate method of nutritional support. Therefore, in a prospective, randomized clinical trial TPN and enteral feeding were compared for their effectiveness in maintaining the nutritional status of patients through the first 29 post-transplant days. Nutritional assessment included measurement of serum proteins, body weight, anthropometry and isotope dilution analysis of body composition. Total body water (TBW) and extracellular fluid (ECF) were quantified by standard radioisotope dilution techniques using tritiated water and /sup 169/ytterbium-diethylenetriaminepentaacetate, respectively as the tracers. Consenting patients 10-58 years of age were stratified by type of BMT (autologous or allogeneic) and randomized to either TPN plus ad libitum oral feeding or the individualized enteral feeding program (EFP), which included one-on-one counseling, meal-by-meal menu selection, special snacks and tube feeding. There were no differences in the rate of hematologic recovery, incidence of graft-versus-host disease, organ toxicity, length of hospitalization or survival. Therefore, the observed changes in body composition were not clinically significant. Even allowing for increased dietary service, the EFP was only half as expensive as TPN. It was concluded that TPN is not superior to the EFP and therefore, TPN should be reserved for patients who demonstrate intolerance to enteral feeding.

  14. Effects of supportive-expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors: a randomized control trial.

    Science.gov (United States)

    Tabrizi, Fatemeh Moghaddam; Radfar, Moloud; Taei, Zeynab

    2016-09-01

    Evaluation of the effect of supportive expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors. A randomized control trial including breast cancer patients who had completed chemotherapy and randomly allocated into two groups: intervention (n = 41) and control (n = 40). The intervention consisted of twelve weekly 90-min sessions for groups of six to eight breast cancer survivors. Data were obtained pre-to -post the intervention and at 8-week follow-up. The data were analyzed using a repeated-measures analysis of variance (ANOVA). The findings revealed a significant reduction in loneliness scores (F = 69.85, p hope (F = 20.8, p life from pre- to post-intervention, and then over the 8-week follow-up period in the intervention group, while scores of control participants did not show this pattern during the study. The strongest effects were found for global quality of life (effect size) = 0.59), for future perspectives (effect size = 0.51), emotional functioning (effect size = 0.35) and social functioning (effect size = 0.31). The intervention was effective on loneliness, hope and quality of life in the intervention group. The intervention needs further evaluation in a larger study and with other cancer types. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  15. Value of conventionally fractionated radiotherapy for the local treatment of HIV associated Kaposi`s sarcoma; Wertigkeit konventionell fraktionierter Radiotherapie bei der lokalen Behandlung des HIV-assoziierten Kaposi-Sarkoms

    Energy Technology Data Exchange (ETDEWEB)

    Saran, F. [Abt. fuer Strahlentherapie und Onkologie, Zentrum der Radiologie, Frankfurt Univ. (Germany); Adamietz, I.A. [Abt. fuer Strahlentherapie und Onkologie, Zentrum der Radiologie, Frankfurt Univ. (Germany); Mose, S. [Abt. fuer Strahlentherapie und Onkologie, Zentrum der Radiologie, Frankfurt Univ. (Germany); Thilmann, C. [Abt. fuer Strahlentherapie und Onkologie, Zentrum der Radiologie, Frankfurt Univ. (Germany); Boettcher, H.D. [Abt. fuer Strahlentherapie und Onkologie, Zentrum der Radiologie, Frankfurt Univ. (Germany)

    1995-10-01

    partielle Remission (PR) (55%), und 12/111 wurden als unveraendert (NC) beurteilt (11%). Die Gesamtansprechrate (CR + PR) betrug 89%. Zwei Patienten mit Laesionen der Mundhoehle zeigten eine Mukositis RTOG Grad IV nach Gesamtdosen von 10 und 14 Gy. Bei 71/106 bestrahlten Laesionen der Haut (67%) wurde eine radiogen induzierte Reaktion ersten Grades (RTOG) gesehen. Durch eine Radiotherapie mit einer Gesamtreferenzdosis von 20 Gy in konventioneller Fraktionierung ist eine Palliation bei HIV-assoziierten Kaposi-Sarkomen moeglich. Der Anteil von Patienten mit kompletter Remission ist jedoch mit 34 bis 47% geringer als im Vergleich zu Gesamtdosen >20 Gy (66 bis 100%). Unsere Ergebnisse unterstuetzen die Vermutung einer dosisabhaengigen Wirkung der Radiotherapie von Kaposi-Sarkomen. Es sollten daher bei Behandlung von HIV-assoziierten Kaposi-Sarkomen in der Radiotherapie Gesamtreferenzdosen von zum Beispiel 30 Gy mit 5mal 2 Gy/Woche bzw. 24 Gy, 5mal 1,6 Gy fuer Schleimhautlaesionen gewaehlt werden, da dadurch die Rate an kompletten Remissionen verdoppelt werden kann. (orig./MG)

  16. A multicentre, randomised controlled, non-inferiority trial, comparing nasal high flow with nasal continuous positive airway pressure as primary support for newborn infants with early respiratory distress born in Australian non-tertiary special care nurseries (the HUNTER trial): study protocol

    Science.gov (United States)

    Manley, Brett J; Roberts, Calum T; Arnolda, Gaston R B; Wright, Ian M R; Owen, Louise S; Dalziel, Kim M; Foster, Jann P; Davis, Peter G; Buckmaster, Adam G

    2017-01-01

    Introduction Nasal high-flow (nHF) therapy is a popular mode of respiratory support for newborn infants. Evidence for nHF use is predominantly from neonatal intensive care units (NICUs). There are no randomised trials of nHF use in non-tertiary special care nurseries (SCNs). We hypothesise that nHF is non-inferior to nasal continuous positive airway pressure (CPAP) as primary support for newborn infants with respiratory distress, in the population cared for in non-tertiary SCNs. Methods and analysis The HUNTER trial is an unblinded Australian multicentre, randomised, non-inferiority trial. Infants are eligible if born at a gestational age ≥31 weeks with birth weight ≥1200 g and admitted to a participating non-tertiary SCN, are 1 hour. Infants are randomised to treatment with either nHF or CPAP. The primary outcome is treatment failure within 72 hours of randomisation, as determined by objective oxygenation, apnoea or blood gas criteria or by a clinical decision that urgent intubation and mechanical ventilation, or transfer to a tertiary NICU, is required. Secondary outcomes include incidence of pneumothorax requiring drainage, duration of respiratory support, supplemental oxygen and hospitalisation, costs associated with hospital care, cost-effectiveness, parental stress and satisfaction and nursing workload. Ethics and dissemination Multisite ethical approval for the study has been granted by The Royal Children’s Hospital, Melbourne, Australia (Trial Reference No. 34222), and by each participating site. The trial is currently recruiting in eight centres in Victoria and New South Wales, Australia, with one previous site no longer recruiting. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences. Trial registration number Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001203640; pre-results. PMID:28645982

  17. Siloxides as supporting ligands in uranium(III)-mediated small-molecule activation

    Energy Technology Data Exchange (ETDEWEB)

    Mougel, Victor; Camp, Clement; Pecaut, Jacques; Mazzanti, Marinella [CEA-Grenoble (France). Lab. de Reconnaissance Ionique et Chimie de Coordination; Coperet, Christophe [ETH Zuerich (Switzerland). Lab. of Inorganic Chemistry; Maron, Laurent; Kefalidis, Christos E. [Toulouse Univ. (France). LPCNO, CNRS et INSA, UPS

    2012-12-03

    Siloxides support the reduction of small molecules with uranium complexes. The treatment of [U{N(SiMe_3)_2}{sub 3}] with HOSi(OtBu){sub 3} (3 equiv.) yielded a novel homoleptic uranium(III) siloxide complex 1, which acted as a two-electron reducing agent toward CS{sub 2} and CO{sub 2}. Uranium(III) siloxide complex 1 also reduced toluene to afford a diuranium inverted-sandwich complex. [German] Siloxide unterstuetzen die Reduktion kleiner Molekuele durch Uran-Komplexe. Die Behandlung von [U{N(SiMe_3)_2}{sub 3}] mit HOSi(OtBu){sub 3} (3 Aequiv.) liefert den neuartigen homoleptischen Uran(III)-Siloxid-Komplex 1, der als Zwei-Elektronen-Reduktionsmittel fuer CS{sub 2} und CO{sub 2} (siehe Schema) wirkt. Komplex 1 reduziert ausserdem Toluol und bildet einen invertierten Diuran-Sandwichkomplex.

  18. PRISM (Program of Resources, Information and Support for Mothers: a community-randomised trial to reduce depression and improve women's physical health six months after birth [ISRCTN03464021

    Directory of Open Access Journals (Sweden)

    Mitchell Creina

    2006-02-01

    Full Text Available Abstract Background In the year after birth one in six women has a depressive illness, 94% experience at least one major health problem (e.g. back pain, perineal pain, mastitis, urinary or faecal incontinence, 26% experience sexual problems and almost 20% have relationship problems with partners. Women with depression report less practical and emotional support from partners, less social support, more negative life events, and poorer physical health and see factors contributing to depression as lack of support, isolation, exhaustion and physical health problems. Fewer than one in three seek help in primary care despite frequent health care contacts. Methods Primary care and community-based strategies embedded in existing services were implemented in a cluster-randomised trial involving 16 rural and metropolitan communities, pair-matched, within the State of Victoria, Australia. Intervention areas were also provided with a community development officer for two years. The primary aim was to reduce the relative risk of depression by 20% in mothers six months after birth and to improve their physical health. Primary outcomes were obtained by postal questionnaires. The analysis was by intention-to-treat, unmatched, adjusting for the correlated nature of the data. Results 6,248 of 10,144 women (61.6% in the intervention arm and 5057/ 8,411 (60.1% in the comparison arm responded at six months, and there was no imbalance in major covariates between the two arms. Women's mental health scores were not significantly different in the intervention arm and the comparison arm (MCS mean score 45.98 and 46.30, mean EPDS score 6.91 and 6.82, EPDS ≥ 13 ('probable depression' 15.7% vs. 14.9%, Odds ratioadj 1.06 (95%CI 0.91–1.24. Women's physical health scores were not significantly different in intervention and comparison arms (PCS mean scores 52.86 and 52.88. Conclusion The combined community and primary care interventions were not effective in reducing

  19. Effect on return to work or education of Individual Placement and Support modified for people with mood and anxiety disorders: results of a randomised clinical trial.

    Science.gov (United States)

    Hellström, Lone; Bech, Per; Hjorthøj, Carsten; Nordentoft, Merete; Lindschou, Jane; Eplov, Lene Falgaard

    2017-10-01

    The effect of Individual Placement and Support (IPS) on return to work or education among people with mood or anxiety disorders is unclear, while IPS increases return to work for people with severe mental illness. We examined the effect of IPS modified for people with mood and anxiety disorders (IPS-MA) on return to work and education compared with services as usual (SAU). In a randomised clinical superiority trial, 326 participants with mood and anxiety disorders were centrally randomised to IPS-MA, consisting of individual mentor support and career counselling (n=162) or SAU (n=164). The primary outcome was competitive employment or education at 24 months, while weeks of competitive employment or education, illness symptoms and level of functioning, and well-being were secondary outcomes. After 24 months, 44.4% (72/162) of the participants receiving IPS-MA had returned to work or education compared with 37.8% (62/164) following SAU (OR=1.34, 95% CI: 0.86 to 2.10, p=0.20). We found no difference in mean number of weeks in employment or education (IPS-MA 32.4 weeks vs SAU 26.7 weeks, p=0.14), level of depression (Hamilton Depression 6-Item Scale score IPS-MA 5.7 points vs SAU 5.0 points, p=0.12), level of anxiety (Hamilton Anxiety 6-Item Scale score IPS-MA 5.8 points vs SAU 5.1 points, p=0.17), level of functioning (Global Assessment of Functioning IPS-MA 59.1 points vs SAU 59.5 points, p=0.81) or well-being measured by WHO-Five Well-being Index (IPS-MA 49.6 points vs SAU 48.5 points, p=0.83) at 24 months. The modified version of IPS, IPS-MA, was not superior to SAU in supporting people with mood or anxiety disorders in return to work at 24 months. NCT01721824. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Effects of a Home-Based and Volunteer-Administered Physical Training, Nutritional, and Social Support Program on Malnutrition and Frailty in Older Persons: A Randomized Controlled Trial.

    Science.gov (United States)

    Luger, Eva; Dorner, Thomas Ernst; Haider, Sandra; Kapan, Ali; Lackinger, Christian; Schindler, Karin

    2016-07-01

    The aim of this study was to examine the effects of a home-based and volunteer-administered physical training and nutritional intervention program compared with social support intervention on nutritional and frailty status in prefrail and frail community-dwelling older persons. This was a randomized controlled trial in which community-dwelling persons (mean age = 83 years) were recruited and randomly assigned to the physical training and nutritional intervention group (PTN, n = 39) and the social support group (SoSu, n = 41). The study was conducted by trained lay nonprofessionals. The community-dwelling older persons in both groups were visited twice a week by trained nonprofessional volunteers (buddies) in Vienna, Austria. Eighty prefrail and frail adults aged 65 years or older. In the PTN group, both the buddies and older persons performed 6 strength exercises within a circuit training session and discussed nutrition-related aspects. The active control group (SoSu) had the opportunity to perform cognitive training in addition to the social contact. Outcome measures as nutritional (Mini Nutritional Assessment long form [MNA-LF]) and frailty status (Frailty Instrument for Primary Care of the Survey of Health, Ageing and Retirement in Europe [SHARE-FI]) were obtained at baseline and after 12 weeks. Significant improvements in the MNA-LF score (1.54 points, 95% confidence interval [CI] 0.51-2.56; P = .004) and the SHARE-FI score (-0.71 discrete factor score values, 95% CI -1.07, -0.35; P malnutrition and frailty in older persons living at home. Furthermore, social support alone also can result in improvement. In particular, older adults with impaired nutritional status at baseline can benefit more from the intervention. Such a home visit program might also have the potential to prevent future health risks and could allay isolation and loneliness. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier

  1. Does additional support provided through e-mail or SMS in a Web-based Social Marketing program improve children's food consumption? A Randomized Controlled Trial.

    Science.gov (United States)

    Rangelov, Natalie; Della Bella, Sara; Marques-Vidal, Pedro; Suggs, L Suzanne

    2018-02-16

    The FAN Social Marketing program was developed to improve dietary and physical activity habits of families with children in Ticino, Switzerland. The aim of this study was to examine if the effects of the program on children's food intake differed by intervention group. Effects of the FAN program were tested through a Randomized Controlled Trial. The program lasted 8 weeks, during which participants received tailored communication about nutrition and physical activity. Families were randomly allocated to one of three groups, where the parent received the intervention by the Web (G1), Web + e-mail (G2) or Web + SMS (G3). Children in all groups received tailored print letters by post. Children's food consumption was assessed at baseline and immediate post intervention using a 7-day food diary. Generalized linear mixed models with child as a random effect and with time, treatment group, and the time by treatment interaction as fixed effects were used to test the impact of the intervention. Analyses were conducted with a sample of 608 children. After participating in FAN the marginal means of daily consumption of fruit changed from 0.95 to 1.12 in G1, from 0.82 to 0.94 in G2, and from 0.93 to 1.18 in G3. The margins of the daily consumption of sweets decreased in each group (1.67 to 1.56 in G1, 1.71 to 1.49 in G2, and 1.72 to 1.62 in G3). The change in vegetable consumption observed from pre to post intervention in G3 (from 1.13 to 1.21) was significantly different from that observed in G1 (from 1.21 to 1.17). A well-designed Web-based Social Marketing intervention complemented with print letters can help improve children's consumption of water, fruit, soft drinks, and sweets. The use of SMS to support greater behavior change, in addition to Web-based communication, resulted only in a small significant positive change for vegetables, while the use of e-mail in addition to Web did not result in any significant difference. The trial was retrospectively registered in the

  2. Esthetic and Clinical Performance of Implant-Supported All-Ceramic Crowns Made with Prefabricated or CAD/CAM Zirconia Abutments: A Randomized, Multicenter Clinical Trial.

    Science.gov (United States)

    Wittneben, J G; Gavric, J; Belser, U C; Bornstein, M M; Joda, T; Chappuis, V; Sailer, I; Brägger, U

    2017-02-01

    Patients' esthetic expectations are increasing, and the options of the prosthetic pathways are currently evolving. The objective of this randomized multicenter clinical trial was to assess and compare the esthetic outcome and clinical performance of anterior maxillary all-ceramic implant crowns (ICs) based either on prefabricated zirconia abutments veneered with pressed ceramics or on CAD/CAM zirconia abutments veneered with hand buildup technique. The null hypothesis was that there is no statistically significant difference between the 2 groups. Forty implants were inserted in sites 14 to 24 (FDI) in 40 patients in 2 centers, the Universities of Bern and Geneva, Switzerland. After final impression, 20 patients were randomized into group A, restored with a 1-piece screw-retained single crown made of a prefabricated zirconia abutment with pressed ceramic as the veneering material using the cut-back technique, or group B using an individualized CAD/CAM zirconia abutment (CARES abutment; Institut Straumann AG) with a hand buildup technique. At baseline, 6 mo, and 1 y clinical, esthetic and radiographic parameters were assessed. Group A exhibited 1 dropout patient and 1 failure, resulting in a survival rate of 94.7% after 1 y, in comparison to 100% for group B. No other complications occurred. Clinical parameters presented stable and healthy peri-implant soft tissues. Overall, no or only minimal crestal bone changes were observed with a mean DIB (distance from the implant shoulder to the first bone-to-implant contact) of -0.15 mm (group A) and 0.12 mm (group B) at 1 y. There were no significant differences at baseline, 6 mo, and 1 y for DIB values between the 2 groups. Pink esthetic score (PES) and white esthetic score (WES) values at all 3 examinations indicated stability over time for both groups and pleasing esthetic outcomes. Both implant-supported prosthetic pathways represent a valuable treatment option for the restoration of single ICs in the anterior maxilla

  3. Improving social functioning and reducing social isolation and loneliness among people with enduring mental illness: Report of a randomised controlled trial of supported socialisation.

    Science.gov (United States)

    Sheridan, Ann J; Drennan, Jonathan; Coughlan, Barbara; O'Keeffe, Donal; Frazer, Kate; Kemple, Mary; Alexander, Denise; Howlin, Frances; Fahy, Anne; Kow, Veronica; O'Callaghan, Eadbhard

    2015-05-01

    This randomised controlled trial examined if for people with enduring mental illness, being supported to socialise leads to improved social functioning, increased self-esteem and extended social networks; a reduction in social isolation, social, emotional and family loneliness and a reduction in illness symptoms, namely depression. A prospective randomised controlled trial was undertaken from November 2007 to September 2011. Service users with a diagnosis of enduring mental illness (>18 years) were invited to participate. Participants were randomly allocated to intervention or control group conditions in a 1:1 ratio. Intervention group participants were matched with a volunteer partner, asked to engage in social/leisure activities for 2 hours weekly over a 9-month period, and received a €20 stipend monthly. Control group participants received a €20 monthly stipend and were asked to engage in a weekly social/leisure activity. Social functioning, the primary outcome, was measured using the Social Functioning Scale (SFS) at three time points (baseline, midpoint and endpoint). In all, 107 people completed this study. There were no significant differences between control and intervention groups at the commencement of the intervention on demographic characteristics or the main outcome measures of interest. Overall social functioning positively changed throughout the three time points from a mean of 99·7 (standard deviation (SD) = 15.1) at baseline, to a mean of 106.0 (SD = 27.0) at the endpoint for the control group, and from a mean of 100·4 (SD = 15.0) at Time 1 for the intervention group, to a mean of 104.1 (SD = 23.4) at the endpoint for the intervention group. The intervention showed no statistical differences between the control and intervention groups on primary or secondary outcome measures. The stipend and the stipend plus volunteer partner led to an increase in recreational social functioning; a decrease in levels of social loneliness, in depression and in

  4. A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa.

    Science.gov (United States)

    Peltzer, Karl; Weiss, Stephen M; Soni, Manasi; Lee, Tae Kyoung; Rodriguez, Violeta J; Cook, Ryan; Alcaide, Maria Luisa; Setswe, Geoffrey; Jones, Deborah L

    2017-12-16

    We evaluate the impact of clinic-based PMTCT community support by trained lay health workers in addition to standard clinical care on PMTCT infant outcomes. In a cluster randomized controlled trial, twelve community health centers (CHCs) in Mpumalanga Province, South Africa, were randomized to have pregnant women living with HIV receive either: a standard care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n  = 357), or an enhanced intervention (EI) condition of SC PMTCT plus the "Protect Your Family" intervention (EI; 6 CHCs; n  = 342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions and those in the EI, four antenatal and two postnatal PMTCT plus "Protect Your Family" sessions led by trained lay health workers. Maternal PMTCT and HIV knowledge were assessed. Infant HIV status at 6 weeks postnatal was drawn from clinic PCR records; at 12 months, HIV status was assessed by study administered DNA PCR. Maternal adherence was assessed by dried blood spot at 32 weeks, and infant adherence was assessed by maternal report at 6 weeks. The impact of the EI was ascertained on primary outcomes (infant HIV status at 6 weeks and 12 months and ART adherence for mothers and infants), and secondary outcomes (HIV and PMTCT knowledge and HIV transmission related behaviours). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention on study outcomes. In all, 699 women living with HIV were recruited during pregnancy (8-24 weeks), and assessments were completed at baseline, at 32 weeks pregnant (61.7%), and at 6 weeks (47.6%), 6 months (50.6%) and 12 months (59.5%) postnatally. Infants were tested for HIV at 6 weeks and 12 months, 73.5% living infants were tested at 6 weeks and 56.7% at 12 months. There were no significant differences between SC and EI on infant HIV status at 6 weeks and at 12 months, and no

  5. Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial.

    Science.gov (United States)

    Pfaeffli Dale, Leila; Whittaker, Robyn; Jiang, Yannan; Stewart, Ralph; Rolleston, Anna; Maddison, Ralph

    2015-10-21

    Mobile technology has the potential to deliver behavior change interventions (mHealth) to reduce coronary heart disease (CHD) at modest cost. Previous studies have focused on single behaviors; however, cardiac rehabilitation (CR), a component of CHD self-management, needs to address multiple risk factors. The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program (Text4Heart) to improve adherence to recommended lifestyle behaviors (smoking cessation, physical activity, healthy diet, and nonharmful alcohol use) in addition to usual care (traditional CR). A 2-arm, parallel, randomized controlled trial was conducted in New Zealand adults diagnosed with CHD. Participants were recruited in-hospital and were encouraged to attend center-based CR (usual care control). In addition, the intervention group received a personalized 24-week mHealth program, framed in social cognitive theory, sent by fully automated daily short message service (SMS) text messages and a supporting website. The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score (≥3) at 3 and 6 months. Secondary outcomes included clinical outcomes, medication adherence score, self-efficacy, illness perceptions, and anxiety and/or depression at 6 months. Baseline and 6-month follow-up assessments (unblinded) were conducted in person. Eligible patients (N=123) recruited from 2 large metropolitan hospitals were randomized to the intervention (n=61) or the control (n=62) group. Participants were predominantly male (100/123, 81.3%), New Zealand European (73/123, 59.3%), with a mean age of 59.5 (SD 11.1) years. A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months (AOR 2.55, 95% CI 1.12-5.84; P=.03), but not at 6 months (AOR 1.93, 95% CI 0.83-4.53; P=.13). The intervention group reported significantly greater medication adherence score (mean difference: 0

  6. Efficacy of a training intervention on the quality of practitioners' decision support for patients deciding about place of care at the end of life: A randomized control trial: Study protocol

    Directory of Open Access Journals (Sweden)

    Murray Mary Ann

    2008-04-01

    Full Text Available Abstract Background Most people prefer home palliation but die in an institution. Some experience decisional conflict when weighing options regarding place of care. Clinicians can identify patients' decisional needs and provide decision support, yet generally lack skills and confidence in doing so. This study aims to determine whether the quality of clinicians' decision support can be improved with a brief, theory-based, skills-building intervention. Theory The Ottawa Decision Support Framework (ODSF guides an evidence based, practical approach to assist clinicians in providing high-quality decision support. The ODSF proposes that decisional needs [personal uncertainty, knowledge, values clarity, support, personal characteristics] strongly influence the quality of decisions patients make. Clinicians can improve decision quality by providing decision support to address decisional needs [clarify decisional needs, provide facts and probabilities, clarify values, support/guide deliberation, monitor/facilitate progress]. Methods/Design The efficacy of a brief education intervention will be assessed in a two-phase study. In phase one a focused needs assessment will be conducted with key informants. Phase two is a randomized control trial where clinicians will be randomly allocated to an intervention or control group. The intervention, informed by the needs assessment, knowledge transfer best practices and the ODSF, comprises an online tutorial; an interactive skills building workshop; a decision support protocol; performance feedback, and educational outreach. Participants will be assessed: a at baseline (quality of decision support; b after the tutorial (knowledge; and c four weeks after the other interventions (quality of decision support, intention to incorporate decision support into practice and perceived usefulness of intervention components. Between group differences in the primary outcome (quality of decision support scores will be analyzed

  7. Efficacy of a training intervention on the quality of practitioners' decision support for patients deciding about place of care at the end of life: A randomized control trial: Study protocol

    Science.gov (United States)

    Murray, Mary Ann; O'Connor, Annette; Stacey, Dawn; Wilson, Keith G

    2008-01-01

    Background Most people prefer home palliation but die in an institution. Some experience decisional conflict when weighing options regarding place of care. Clinicians can identify patients' decisional needs and provide decision support, yet generally lack skills and confidence in doing so. This study aims to determine whether the quality of clinicians' decision support can be improved with a brief, theory-based, skills-building intervention. Theory The Ottawa Decision Support Framework (ODSF) guides an evidence based, practical approach to assist clinicians in providing high-quality decision support. The ODSF proposes that decisional needs [personal uncertainty, knowledge, values clarity, support, personal characteristics] strongly influence the quality of decisions patients make. Clinicians can improve decision quality by providing decision support to address decisional needs [clarify decisional needs, provide facts and probabilities, clarify values, support/guide deliberation, monitor/facilitate progress]. Methods/Design The efficacy of a brief education intervention will be assessed in a two-phase study. In phase one a focused needs assessment will be conducted with key informants. Phase two is a randomized control trial where clinicians will be randomly allocated to an intervention or control group. The intervention, informed by the needs assessment, knowledge transfer best practices and the ODSF, comprises an online tutorial; an interactive skills building workshop; a decision support protocol; performance feedback, and educational outreach. Participants will be assessed: a) at baseline (quality of decision support); b) after the tutorial (knowledge); and c) four weeks after the other interventions (quality of decision support, intention to incorporate decision support into practice and perceived usefulness of intervention components). Between group differences in the primary outcome (quality of decision support scores) will be analyzed using ANOVA. Discussion

  8. A Randomized Controlled Trial of Group Coping-Oriented Therapy vs Supportive Therapy in Schizophrenia: Results of a 2-Year Follow-up.

    Science.gov (United States)

    Schaub, Annette; Mueser, Kim T; von Werder, Thomas; Engel, Rolf; Möller, Hans-Jürgen; Falkai, Peter

    2016-07-01

    Over the past 30 years, illness management programs and cognitive-behavioral therapy for psychosis have gained prominence in the treatment of schizophrenia. However, little is known about the long-term benefits of these types of programs when delivered during inpatient treatment following a symptom exacerbation. To evaluate this question, we conducted a randomized controlled trial comparing the long-term effects of a group-based coping-oriented program (COP) that combined the elements of illness management with cognitive behavioral-therapy for psychosis, with an equally intensive supportive therapy (SUP) program. 196 inpatients with DSM-IV schizophrenia were randomized to COP or SUP, each lasting 12 sessions provided over 6-8 weeks. Outcome measures were collected in the hospital at baseline and post-assessment, and following discharge into the community 1 and 2 years later. We compared the groups on rehospitalizations, symptoms, psychosocial functioning, and knowledge about psychosis. Intent-to-treat analyses indicated that patients in COP learned significantly more information about psychosis, and had greater reductions in overall symptoms and depression/anxiety over the treatment and follow-up period than patients in SUP. Patients in both groups improved significantly in other symptoms and psychosocial functioning. There were no differences between the groups in hospitalization rates, which were low. People with schizophrenia can benefit from short-term COPs delivered during the inpatient phase, with improvements sustaining for 2 years following discharge from the hospital. More research is needed to evaluate the long-term impact of coping-oriented and similar programs provided during inpatient treatment. © The Author 2016. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  9. Continued Follow-Up of Phambili Phase 2b Randomized HIV-1 Vaccine Trial Participants Supports Increased HIV-1 Acquisition among Vaccinated Men.

    Science.gov (United States)

    Moodie, Zoe; Metch, Barbara; Bekker, Linda-Gail; Churchyard, Gavin; Nchabeleng, Maphoshane; Mlisana, Koleka; Laher, Fatima; Roux, Surita; Mngadi, Kathryn; Innes, Craig; Mathebula, Matsontso; Allen, Mary; Bentley, Carter; Gilbert, Peter B; Robertson, Michael; Kublin, James; Corey, Lawrence; Gray, Glenda E

    2015-01-01

    The Phase 2b double-blinded, randomized Phambili/HVTN 503 trial evaluated safety and efficacy of the MRK Ad5 gag/pol/nef subtype B HIV-1 preventive vaccine vs placebo in sexually active HIV-1 seronegative participants in South Africa. Enrollment and vaccinations stopped and participants were unblinded but continued follow-up when the Step study evaluating the same vaccine in the Americas, Caribbean, and Australia was unblinded for non-efficacy. Final Phambili analyses found more HIV-1 infections amongst vaccine than placebo recipients, impelling the HVTN 503-S recall study. HVTN 503-S sought to enroll all 695 HIV-1 uninfected Phambili participants, provide HIV testing, risk reduction counseling, physical examination, risk behavior assessment and treatment assignment recall. After adding HVTN 503-S data, HIV-1 infection hazard ratios (HR vaccine vs. placebo) were estimated by Cox models. Of the 695 eligible, 465 (67%) enrolled with 230 from the vaccine group and 235 from the placebo group. 38% of the 184 Phambili dropouts were enrolled. Enrollment did not differ by treatment group, gender, or baseline HSV-2. With the additional 1286 person years of 503-S follow-up, the estimated HR over Phambili and HVTN 503-S follow-up was 1.52 (95% CI 1.08-2.15, p = 0.02, 82 vaccine/54 placebo infections). The HR was significant for men (HR = 2.75, 95% CI 1.49, 5.06, p = 0.001) but not for women (HR = 1.12, 95% CI 0.73, 1.72, p = 0.62). The additional follow-up from HVTN 503-S supported the Phambili finding of increased HIV-1 acquisition among vaccinated men and strengthened the evidence of lack of vaccine effect among women. clinicaltrials.gov NCT00413725 SA National Health Research Database DOH-27-0207-1539.

  10. The effect of peer-group size on the delivery of feedback in basic life support refresher training: a cluster randomized controlled trial.

    Science.gov (United States)

    Cho, Youngsuk; Je, Sangmo; Yoon, Yoo Sang; Roh, Hye Rin; Chang, Chulho; Kang, Hyunggoo; Lim, Taeho

    2016-07-04

    Students are largely providing feedback to one another when instructor facilitates peer feedback rather than teaching in group training. The number of students in a group affect the learning of students in the group training. We aimed to investigate whether a larger group size increases students' test scores on a post-training test with peer feedback facilitated by instructor after video-guided basic life support (BLS) refresher training. Students' one-rescuer adult BLS skills were assessed by a 2-min checklist-based test 1 year after the initial training. A cluster randomized controlled trial was conducted to evaluate the effect of student number in a group on BLS refresher training. Participants included 115 final-year medical students undergoing their emergency medicine clerkship. The median number of students was 8 in the large groups and 4 in the standard group. The primary outcome was to examine group differences in post-training test scores after video-guided BLS training. Secondary outcomes included the feedback time, number of feedback topics, and results of end-of-training evaluation questionnaires. Scores on the post-training test increased over three consecutive tests with instructor-led peer feedback, but not differ between large and standard groups. The feedback time was longer and number of feedback topics generated by students were higher in standard groups compared to large groups on the first and second tests. The end-of-training questionnaire revealed that the students in large groups preferred the smaller group size compared to their actual group size. In this BLS refresher training, the instructor-led group feedback increased the test score after tutorial video-guided BLS learning, irrespective of the group size. A smaller group size allowed more participations in peer feedback.

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