WorldWideScience

Sample records for adherence intervention trial

  1. Adherence to yoga and exercise interventions in a 6-month clinical trial

    OpenAIRE

    de Haas M; Zajdel D; Kishiyama S; Flegal KE; BS, Oken

    2007-01-01

    Abstract Background To determine factors that predict adherence to a mind-body intervention in a randomized trial. Design We analyzed adherence data from a 3-arm trial involving 135 generally healthy seniors 65–85 years of age randomized to a 6-month intervention consisting of: an Iyengar yoga class with home practice, an exercise class with home practice, or a wait-list control group. Outcome measures included cognitive function, mood, fatigue, anxiety, health-related quality of life, and ph...

  2. Adherence to yoga and exercise interventions in a 6-month clinical trial

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    Haas M

    2007-11-01

    Full Text Available Abstract Background To determine factors that predict adherence to a mind-body intervention in a randomized trial. Design We analyzed adherence data from a 3-arm trial involving 135 generally healthy seniors 65–85 years of age randomized to a 6-month intervention consisting of: an Iyengar yoga class with home practice, an exercise class with home practice, or a wait-list control group. Outcome measures included cognitive function, mood, fatigue, anxiety, health-related quality of life, and physical measures. Adherence to the intervention was obtained by class attendance and biweekly home practice logs. Results The drop-out rate was 13%. Among the completers of the two active interventions, average yoga class attendance was 77% and home practice occurred 64% of all days. Average exercise class attendance was 69% and home exercise occurred 54% of all days. There were no clear effects of adherence on the significant study outcomes (quality of life and physical measures. Class attendance was significantly correlated with baseline measures of depression, fatigue, and physical components of health-related quality of life. Significant differences in baseline measures were also found between study completers and drop-outs in the active interventions. Adherence was not related to age, gender, or education level. Conclusion Healthy seniors have good attendance at classes with a physically active intervention. Home practice takes place over half of the time. Decreased adherence to a potentially beneficial intervention has the potential to decrease the effect of the intervention in a clinical trial because subjects who might sustain the greatest benefit will receive a lower dose of the intervention and subjects with higher adherence rates may be functioning closer to maximum ability before the intervention. Strategies to maximize adherence among subjects at greater risk for low adherence will be important for future trials, especially complementary

  3. Predictors of short- and long-term adherence with a Mediterranean-type diet intervention: the PREDIMED randomized trial

    OpenAIRE

    Downer, Mary Kathryn; Gea, Alfredo; Stampfer, Meir; Sánchez-Tainta, Ana; Corella, Dolores; Salas-Salvadó, Jordi; Ros, Emilio; Estruch, Ramón; Fitó, Montserrat; Gómez-Gracia, Enrique; Arós, Fernando; Fiol, Miquel; De-la-Corte, Francisco Jose Garcia; Serra-Majem, Lluís; Pinto, Xavier

    2016-01-01

    Background Dietary intervention success requires strong participant adherence, but very few studies have examined factors related to both short-term and long-term adherence. A better understanding of predictors of adherence is necessary to improve the design and execution of dietary intervention trials. This study was designed to identify participant characteristics at baseline and study features that predict short-term and long-term adherence with interventions promoting the Mediterranean-ty...

  4. Predictors of short- and long-term adherence with a Mediterranean-type diet intervention: the PREDIMED randomized trial

    OpenAIRE

    Downer, Mary Kathryn; Gea, Alfredo; Stampfer, Meir; Sánchez-Tainta, Ana; Corella, Dolores; Salas-Salvadó, Jordi; Ros, Emilio; Estruch, Ramón; Fitó, Montserrat; Gómez-Gracia, Enrique; Arós, Fernando; Fiol, Miquel; De-la-Corte, Francisco Jose Garcia; Serra-Majem, Lluís; Pinto, Xavier

    2016-01-01

    Background: Dietary intervention success requires strong participant adherence, but very few studies have examined factors related to both short-term and long-term adherence. A better understanding of predictors of adherence is necessary to improve the design and execution of dietary intervention trials. This study was designed to identify participant characteristics at baseline and study features that predict short-term and long-term adherence with interventions promoting the Mediterranean-t...

  5. Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial

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    Goswami NJ

    2013-07-01

    Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days

  6. Randomized controlled trial of a mobile phone intervention for improving adherence to naltrexone for alcohol use disorders.

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    Susan A Stoner

    Full Text Available Naltrexone is a front-line treatment for alcohol use disorders, but its efficacy is limited by poor medication adherence. This randomized controlled trial evaluated whether a mobile health intervention could improve naltrexone adherence.Treatment-seeking participants with an alcohol use disorder (N = 76 were randomized to intervention and control conditions. All participants received naltrexone (50 mg/day with a medication event monitoring system (MEMS and a prepaid smartphone, and received a daily text message querying medication side effects, alcohol use, and craving. Those in the intervention arm received additional medication reminders and adherence assessment via text message.The primary outcome, proportion of participants with adequate adherence (defined as ≥80% of prescribed doses taken through Week 8, did not differ between groups in intent-to-treat analyses (p = .34. Mean adherence at study midpoint (Week 4 was 83% in the intervention condition and 77% in the control condition (p = .35. Survival analysis found that the intervention group sustained adequate adherence significantly longer (M = 19 days [95% CI = 0.0-44.0] than those in the control group (M = 3 days [95% CI = 0.0-8.1] during the first month of treatment (p = .04. Medication adherence did not predict drinking outcomes.These results suggest that in the context of daily monitoring and assessment via cell phone, additional text message reminders do not further improve medication adherence. Although this initial trial does not provide support for the efficacy of text messaging to improve adherence to pharmacotherapy for alcohol use disorders, additional trials with larger samples and alternate designs are warranted.ClinicalTrials.gov: NCT01349985.

  7. A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies

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    Sheridan Stacey L

    2011-12-01

    Full Text Available Abstract Background Efficacious strategies for the primary prevention of coronary heart disease (CHD are underused, and, when used, have low adherence. Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice. Methods We conducted a randomized trial of a CHD prevention intervention (including a computerized decision aid and automated tailored adherence messages at one university general internal medicine practice. After obtaining informed consent and collecting baseline data, we randomized patients (men and women age 40-79 with no prior history of cardiovascular disease to either the intervention or usual care. We then saw them for two additional study visits over 3 months. For intervention participants, we administered the decision aid at the primary study visit (1 week after baseline visit and then mailed 3 tailored adherence reminders at 2, 4, and 6 weeks. We assessed our outcomes (including the predicted likelihood of angina, myocardial infarction, and CHD death over 10 years (CHD risk and self-reported adherence between groups at 3 month follow-up. Data collection occurred from June 2007 through December 2009. All study procedures were IRB approved. Results We randomized 160 eligible patients (81 intervention; 79 control and followed 96% to study conclusion. Mean predicted CHD risk at baseline was 11.3%. The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points (95% CI 8% to 42%, with the biggest effect for aspirin. It also changed predicted CHD risk by -1.1% (95% CI -0.16% to -2%, with a larger effect in a pre-specified subgroup of high risk patients. Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk. Clinical trials registration number ClinicalTrials

  8. A Multifaceted Prospective Memory Intervention to Improve Medication Adherence: Design of a Randomized Control Trial

    Science.gov (United States)

    Insel, Kathie C.; Einstein, Gilles O.; Morrow, Daniel G.; Hepworth, Joseph T.

    2012-01-01

    Adherence to prescribed antihypertensive agents is critical because control of elevated blood pressure is the single most important way to prevent stroke and other end organ damage. Unfortunately, nonadherence remains a significant problem. Previous interventions designed to improve adherence have demonstrated only small benefits of strategies that target single facets such as understanding medication directions. The intervention described here is informed by prospective memory theory and performance of older adults in laboratory-based paradigms and uses a comprehensive, multifaceted approach to improve adherence. It incorporates multiple strategies designed to support key components of prospective remembering involved in taking medication. The intervention is delivered by nurses in the home with an education control group for comparison. Differences between groups in overall adherence following the intervention and 6 months later will be tested. Systolic and diastolic blood pressure levels also will be examined between groups and as it relates to adherence. Intra-individual regression is planned to examine change in adherence over time and its predictors. Finally, we will examine the association between executive function/working memory and adherence, predicting that adherence will be related to executive/working memory in the control group but not in the intervention group. PMID:23010608

  9. Evaluation of a community pharmacy-based intervention for improving patient adherence to antihypertensives: a randomised controlled trial

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    McDowell Jenny

    2010-02-01

    Full Text Available Abstract Background The majority of patients using antihypertensive medications fail to achieve their recommended target blood pressure. Poor daily adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target blood pressure. There is no single intervention to improve adherence with antihypertensives that is consistently effective. Community pharmacists are in an ideal position to promote adherence to chronic medications. This study aims to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications - Hypertension Adherence Program in Pharmacy (HAPPY. Methods/Design The HAPPY trial is a multi-centre prospective randomised controlled trial. Fifty-six pharmacies have been recruited from three Australian states. To identify potential patients, a software application (MedeMine CVD extracted data from a community pharmacy dispensing software system (FRED Dispense®. The pharmacies have been randomised to either 'Pharmacist Care Group' (PCG or 'Usual Care Group' (UCG. To check for 'Hawthorne effect' in the UCG, a third group of patients 'Hidden Control Group' (HCG will be identified in the UCG pharmacies, which will be made known to the pharmacists at the end of six months. Each study group requires 182 patients. Data will be collected at baseline, three and six months in the PCG and at baseline and six months in the UCG. Changes in patient adherence and persistence at the end of six months will be measured using the self-reported Morisky score, the Tool for Adherence Behaviour Screening and medication refill data. Discussion To our knowledge, this is the first research testing a comprehensive package of evidence-based interventions that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient

  10. Efficacy of a brief multifactorial adherence-based intervention in reducing blood pressure: a randomized clinical trial

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    Leiva A

    2014-12-01

    Full Text Available Alfonso Leiva,1 Antonio Aguiló,2 Marta Fajó-Pascual,3 Lucia Moreno,4 Ma Carmen Martín,5 Elena Marina  Garcia,6 Rosa Elena Duro,7 Francisca Serra,8 Pilar Dagosto,9 Ana Aurelia Iglesias-Iglesias,10 Rosa Maria Company,11 Aina Yañez,12 Joan Llobera13 On behalf of The Adherence Group 1Primary Care Research Unit of Mallorca, Baleares Health Services-IbSalut, Mallorca, 2Research Group on Evidence, Lifestyles and Health, Universitat Illes Balears, Palma, 3Faculty of Health and Sport Sciences, University of Zaragoza, Huesca, 4Son Cladera Health Centre, Baleares Health Services-IbSalut, Mallorca, 5Actur Sur Health Centre, Aragon Health Services-Salud, Aragón, Zaragoza, 6Coll D’en Rabassa Health Centre, Baleares Health Services-IbSalut, Mallorca, 7San Agustín Health Centre, Baleares Health Services-IbSalut, Mallorca, 8Santa María Health Centre, Baleares Health Services-IbSalut, Mallorca, 9Sineu Health Centre, Baleares Health Services-IbSalut, Mallorca, 10Santa Ponça Health Centre, Baleares Health Services-IbSalut, Mallorca, 11Department of Pharmacy, Manacor Hospital-Llevant Sector, Baleares Health Services-IbSalut, Mallorca 12Montuiri Health Centre, Baleares Health Services-IbSalut, Mallorca, 13Fundació d’Investigació Sanitaria Illes Balears (FISIB, Son Espases Hospital, Baleares Health Services-IbSalut, Mallorca, SpainBackground: Lowering blood pressure (BP by antihypertensive (AHT drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to AHT medications reduces their effectiveness and increases the risk of adverse events.Objective: To evaluate the effectiveness of a multifactorial adherence-based intervention in a primary care setting in lowering BP.Methods/design: Multicenter parallel randomized controlled trial. Thirty two nurses in 28 primary care centers of three Spanish regions. Patients aged 18–80 years, taking AHT drugs with uncontrolled BP (n=221 were randomized to a control group

  11. Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial.

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    Habteyes Hailu Tola

    Full Text Available Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB treatment adherence based on Health Belief Model (HBM.A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs (14 HCs intervention and 16 HCs control groups. A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence.At enrollment, the level of non-adherence among intervention (19.4% and control (19.6% groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline to 9.5% (at endpoint, while it increased among control group from 19.4% (baseline to 25.4% (endpoint. Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI (0.18-0.53, p < 0.001.Psychological counseling and educational interventions, which were guided by HBM, significantly

  12. 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

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    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

  13. Study protocol for a randomized controlled trial to assess the feasibility of an open label intervention to improve hydroxyurea adherence in youth with sickle cell disease

    Science.gov (United States)

    Smaldone, Arlene; Findley, Sally; Bakken, Suzanne; Matiz, L. Adriana; Rosenthal, Susan L.; Jia, Haomiao; Matos, Sergio; Manwani, Deepa; Green, Nancy S.

    2016-01-01

    Background Community health workers (CHW) are increasingly recognized as a strategy to improve health outcomes for the underserved with chronic diseases but has not been formally explored in adolescents with sickle cell disease (SCD). SCD primarily affects African American, Hispanic and other traditionally underserved populations. Hydroxyurea (HU), an oral, once-daily medication, is the only approved therapeutic drug for sickle cell disease and markedly reduces symptoms, morbidity and mortality and improves quality of life largely by increasing hemoglobin F blood levels. This paper presents the rationale, study design and protocol for an open label randomized controlled trial to improve parent-youth partnerships in self-management and medication adherence to HU in adolescents with SCD. Methods/Design A CHW intervention augmented by text messaging was designed for adolescents with SCD ages 10–18 years and their parents to improve daily HU adherence. Thirty adolescent parent dyads will be randomized with 2:1 intervention group allocation. Intervention dyads will establish a relationship with a culturally aligned CHW to identify barriers to HU use, identify cues to build a habit, and develop a dyad partnership to improve daily HU adherence and achieve their individualized “personal best” hemoglobin F target. Intervention feasibility, acceptability and efficacy will be assessed via a 2-site trial. Outcomes of interest are HU adherence, dyad self-management communication, quality of life, and resource use. Discussion Despite known benefits, poor HU adherence is common. If feasible and acceptable, the proposed intervention may improve health of underserved adolescents with SCD by enhancing long-term HU adherence. PMID:27327779

  14. Exercise and Motor Training in People with Parkinson's Disease: A Systematic Review of Participant Characteristics, Intervention Delivery, Retention Rates, Adherence, and Adverse Events in Clinical Trials

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    Natalie E. Allen

    2012-01-01

    Full Text Available There is research evidence that exercise and motor training are beneficial for people with Parkinson's disease (PD, and clinicians seek to implement optimal programs. This paper summarizes important factors about the nature and reporting of randomized controlled trials of exercise and/or motor training for people with PD which are likely to influence the translation of research into clinical practice. Searches identified 53 relevant trials with 90 interventions conducted for an average duration of 8.3 (SD 4.2 weeks. Most interventions were fully supervised (74% and conducted at a facility (79%. Retention rates were high with 69% of interventions retaining ≥85% of their participants; however adherence was infrequently reported, and 72% of trials did not report adverse events. Overall, the labor-intensive nature of most interventions tested in these trials and the sparse reporting of adherence and adverse events are likely to pose difficulties for therapists attempting to balance benefits and costs when selecting protocols that translate to sustainable clinical practice for people with PD.

  15. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description

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    Matos Margarida G

    2008-07-01

    Full Text Available Abstract Background Research on the motivational model proposed by Self-Determination Theory (SDT provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors, and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation. Although obesity is notoriously difficult to reverse and its recidivism is high, adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term. The purposes of this study are twofold: i to describe a 3-year randomized controlled trial (RCT aimed at testing a novel obesity treatment program based on SDT, and ii to present the rationale behind SDT's utility in facilitating and explaining health behavior change, especially physical activity/exercise, during obesity treatment. Methods Study design, recruitment, inclusion criteria, measurements, and a detailed description of the intervention (general format, goals for the participants, intervention curriculum, and main SDT strategies are presented. The intervention consists of a 1-year group behavioral program for overweight and moderately obese women, aged 25 to 50 (and pre-menopausal, recruited from the community at large through media advertisement. Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team (30 2 h sessions in total, and go through a program covering most topics considered critical for successful weight control. These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines. Comparison group receive a general health education curriculum. After the program, all subjects are follow-up for a period of 2 years. Discussion Results from this RCT will contribute to a better understanding of how motivational characteristics, particularly those related to physical activity/exercise behavioral self

  16. A pilot controlled trial to determine the feasibility, acceptability and effectiveness of a PAPA-based online intervention to address practical and perceptual barriers to medication adherence in Inflammatory Bowel Disease.

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    Sarah Chapman

    2015-11-01

    The intervention was effective in addressing perceptual barriers to adherence, as well as having a positive impact on IBD-related illness perceptions: increasing treatment control beliefs, and reducing concerns and emotional response. Fewer episodes of non-adherence were reported in the Intervention Group compared to the Control Group. Satisfaction with information about IBD medication improved following the intervention. However, the number of reported practical barriers was similar between the Intervention and Control groups, suggesting that other support might need to be incorporated into the intervention. Limitations of this study include potential bias due to drop-out, potential lack of generalisability to patient populations not recruited online and a reliance on self-report rather than objective outcome measures. However, this controlled trial suggests that the IBD-Helper intervention may be an effective, feasible and acceptable method of addressing perceptual barriers to adherence.

  17. A randomized clinical trial of a peri-operative behavioral intervention to improve physical activity adherence and functional outcomes following total knee replacement

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    Zheng Hua

    2011-10-01

    Full Text Available Abstract Background Total knee replacement (TKR is a common and effective surgical procedure to relieve advanced knee arthritis that persists despite comprehensive medical treatment. Although TKR has excellent technical outcomes, significant variation in patient-reported functional improvement post-TKR exists. Evidence suggests that consistent post-TKR exercise and physical activity is associated with functional gain, and that this relationship is influenced by emotional health. The increasing use of TKR in the aging US population makes it critical to find strategies that maximize functional outcomes. Methods/Design This randomized clinical trial (RCT will test the efficacy of a theory-based telephone-delivered Patient Self-Management Support intervention that seeks to enhance adherence to independent exercise and activity among post- TKR patients. The intervention consists of 12 sessions, which begin prior to surgery and continue for approximately 9 weeks post-TKR. The intervention condition will be compared to a usual care control condition using a randomized design and a probabilistic sample of men and women. Assessments are conducted at baseline, eight weeks, and six- and twelve- months. The project is being conducted at a large healthcare system in Massachusetts. The study was designed to provide greater than 80% power for detecting a difference of 4 points in physical function (SF36/Physical Component Score between conditions (standard deviation of 10 at six months with secondary outcomes collected at one year, assuming a loss to follow up rate of no more than 15%. Discussion As TKR use expands, it is important to develop methods to identify patients at risk for sub-optimal functional outcome and to effectively intervene with the goal of optimizing functional outcomes. If shown efficacious, this peri-TKR intervention has the potential to change the paradigm for successful post-TKR care. We hypothesize that Patient Self-Management Support

  18. Adherence to physical and mental activity interventions: Coping plans as a mediator and prior adherence as a moderator.

    NARCIS (Netherlands)

    Evers, A.W.M.; Klusmann, V.; Schwarzer, R.; Heuser, I.

    2012-01-01

    Objective. Adherence to behavioural intervention programmes is a necessary condition for beneficial outcomes to be achieved. This study tested whether social cognitive variables and coping plans predict adherence. Design and methods. Adherence was examined in a randomized controlled trial with healt

  19. Microbicide clinical trial adherence: insights for introduction

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    Cynthia Woodsong

    2013-04-01

    Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  20. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-01-01

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs. PMID:23561044

  1. Understanding adherence to web-based interventions

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    Kelders, S.M.

    2012-01-01

    Although eHealth technologies and especially web-based interventions for the promotion of health and health related behavior have been shown to be effective, the impact is hindered by non-adherence: while many eHealth interventions reach a large group of participants, not all of these participants c

  2. Cost-effectiveness of a tailored intervention designed to increase breast cancer screening among a non-adherent population: a randomized controlled trial

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    Ishikawa Yoshiki

    2012-09-01

    Full Text Available Abstract Background Although the percentage of women who initiate breast cancer screening is rising, the rate of continued adherence is poor. The purpose of this study was to examine the effectiveness and cost-effectiveness of a tailored print intervention compared with a non-tailored print intervention for increasing the breast cancer screening rate among a non-adherent population. Methods In total, 1859 participants aged 51–59 years (except those aged 55 years were recruited from a Japanese urban community setting. Participants were randomly assigned to receive either a tailored print reminder (tailored intervention group or non-tailored print reminder (non-tailored intervention group. The primary outcome was improvement in the breast cancer screening rate. The screening rates and cost-effectiveness were examined for each treatment group (tailored vs. non-tailored and each intervention subgroup during a follow-up period of five months. All analyses followed the intention-to-treat principle. Results The number of women who underwent a screening mammogram following the reminder was 277 (19.9% in the tailored reminder group and 27 (5.8% in the non-tailored reminder group. A logistic regression model revealed that the odds of a woman who received a tailored print reminder undergoing mammography was 4.02 times those of a women who had received a non-tailored print reminder (95% confidence interval, 2.67–6.06. The cost of one mammography screening increase was 2,544 JPY or 30 USD in the tailored intervention group and 4,366 JPY or 52 USD in the non-tailored intervention group. Conclusions Providing a tailored print reminder was an effective and cost-effective strategy for improving breast cancer screening rates among non-adherent women.

  3. Enhancing antiepileptic drug adherence: a randomized controlled trial.

    Science.gov (United States)

    Brown, Ian; Sheeran, Paschal; Reuber, Markus

    2009-12-01

    Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (Pintention intervention may be an easy-to-administer and effective means of promoting AED adherence. PMID:19864187

  4. Communication style and exercise compliance in physiotherapy (CONNECT. A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods

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    Lonsdale Chris

    2012-06-01

    Full Text Available Abstract Background Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist’s recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients’ autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists’ recommendations. The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists’ autonomy-supportive communication on low back pain patients’ adherence to physical activity and exercise therapy recommendations. Methods/Design This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12 in Dublin, Ireland (population = 1.25 million will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics will not receive this training. Participants (N = 292 with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as

  5. Improving patient adherence to lifestyle advice (IMPALA: a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol

    Directory of Open Access Journals (Sweden)

    Grol Richard

    2008-01-01

    Full Text Available Abstract Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management. Methods A cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited. In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline. Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52

  6. [e-Health interventions and improvement in treatment adherence].

    Science.gov (United States)

    Sieben, Angelien; Bredie, S J H Bas; van Laarhoven, C J H M Kees; Schoonhoven, Lisette; Burger, David M; van Onzenoort, Hein A W

    2014-01-01

    Poor adherence to medication is one of the most important determinants in the treatment of patients with chronic disorders. e-Health-based interventions may be able to improve treatment adherence. This article gives an overview of the available e-Health interventions and the extent to which they can improve adherence. We searched in the PubMed, Cinahl, PsycInfo, and Embase databases for e-Health interventions that aimed at improving adherence to treatment. Of the 16 included studies, 15 used a website and one used an app. Ten studies showed a significant improvement in treatment adherence by using the intervention. e-Health interventions were generally complex. Simple interventions were the most successful in improving treatment adherence.

  7. Efficacy of a Parent–Youth Teamwork Intervention to Promote Adherence in Pediatric Asthma

    OpenAIRE

    Duncan, Christina L.; Hogan, Mary Beth; Tien, Karen J.; Graves, Montserrat M.; Chorney, Jill MacLaren; Zettler, Melissa DeMore; Koven, Lesley; Wilson, Nevin W; Dinakar, Chitra; Portnoy, Jay

    2012-01-01

    Objective To determine whether a parent–youth teamwork intervention improved medication adherence and related outcomes among youth with asthma. Methods We used a randomized clinical trial with 48 youth (aged 9–15 years) assigned to 1 of 3 groups: Teamwork Intervention (TI), Asthma Education (AE), or Standard Care (SC). Treatment occurred across 2 months, with a 3-month follow-up assessment. Adherence to inhaled corticosteroids was assessed via the MDILog-II. Parent–adolescent conflict, asthma...

  8. Potential Interventions to Support Adherence to HIV Preexposure Prophylaxis (PrEP): A Systematic Review

    Science.gov (United States)

    Marcus, Julia L.; Buisker, Timothy; Horvath, Tara; Amico, K. Rivet; Fuchs, Jonathan D.; Buchbinder, Susan P.; Grant, Robert M.; Liu, Albert Y.

    2014-01-01

    Objectives Adherence is critical for maximizing the effectiveness of preexposure prophylaxis (PrEP) in preventing HIV infection. Strategies for promoting adherence to HIV treatment, and their potential application to PrEP adherence, have received considerable attention. However, adherence promotion strategies for prevention medications have not been well characterized and may be more applicable to PrEP. We aimed to identify adherence support interventions that have been effective in other prevention fields and could be applied in the HIV prevention context to support pill taking among PrEP users. Methods To identify adherence support interventions that could be evaluated and applied in the PrEP context, we conducted a systematic review across the following prevention fields: hypertension, latent tuberculosis infection, hyperlipidemia, oral contraceptives, osteoporosis, malaria prophylaxis, and post-exposure prophylaxis for HIV infection. We included randomized controlled trials that evaluated the efficacy of interventions to improve adherence to daily oral medications prescribed for primary prevention in healthy individuals or for secondary prevention in asymptomatic individuals. Results Our searches identified 585 studies, of which 48 studies met the eligibility criteria and were included in the review; nine evaluated multiple strategies, yielding 64 separately tested interventions. Interventions with the strongest evidence for improving adherence included complex, resource-intensive interventions, which combined multiple adherence support approaches, and low-cost, low-intensity interventions that provided education or telephone calls for adherence support. Conclusions Our review identified adherence interventions with strong evidence of efficacy across prevention fields and provides recommendations for evaluating these interventions in upcoming PrEP studies. PMID:24580813

  9. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  10. Predictors of Low Clopidogrel Adherence Following Percutaneous Coronary Intervention

    OpenAIRE

    Muntner, Paul; Mann, Devin M.; Woodward, Mark; Choi, James W.; Stoler, Robert C; Shimbo, Daichi; Farkouh, Michael E.; Kim, Michael C.

    2011-01-01

    Few data are available on factors associated with low adherence or early clopidogrel discontinuation following percutaneous coronary intervention (PCI). Patients (n=284) were evaluated prior to hospital discharge following PCI to identify factors associated with low adherence to clopidogrel 30 days later. Pre-PCI adherence to daily medications was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8) and categorized as low, medium, or high (scores

  11. Predictors of adherence to a Mediterranean-type diet in the PREDIMED trial.

    OpenAIRE

    I. Zazpe; Estruch, R.; E. Toledo; Sanchez-Tainta, A. (Ana); Corella, D; Bullo, M.; Fiol, M.; Iglesias, P.; Gomez-Gracia, E. (Enrique); Aros, F. (Fernando); E. Ros; Schröder, H.; Serra-Majem, L; Pinto, X.; Lamuela-Raventos, R.M. (Rosa María)

    2010-01-01

    BACKGROUND: Determinants of dietary changes obtained with a nutritional intervention promoting the Mediterranean diet have been rarely evaluated. AIM: To identify predictors of higher success of an intervention aimed to increase adherence to a Mediterranean diet (MeDiet) in individuals at high cardiovascular risk participating in a trial for primary prevention of cardiovascular disease: the PREDIMED (PREvención con DIeta MEDiterránea) trial. Candidate predictors included demographic ...

  12. Food environments are relevant to recruitment and adherence in dietary modification trials

    OpenAIRE

    Feathers, Alexandra; Aycinena, Ana C.; Lovasi, Gina S.; Rundle, Andrew; Gaffney, Ann Ogden; Richardson, John; Hershman, Dawn; Koch, Pam; Contento, Isobel; Greenlee, Heather

    2015-01-01

    Few studies have examined the built environment's role in recruitment to and adherence in dietary intervention trials. Using data from a randomized dietary modification trial of urban Latina breast cancer survivors, we tested the hypotheses that neighborhood produce access could act as a potential barrier and/or facilitator to recruitment, and that a participant's produce availability would be associated with increased fruit/vegetable intake, one of the intervention's targets. Eligible women ...

  13. Interventional tools to improve medication adherence: review of literature

    Science.gov (United States)

    Costa, Elísio; Giardini, Anna; Savin, Magda; Menditto, Enrica; Lehane, Elaine; Laosa, Olga; Pecorelli, Sergio; Monaco, Alessandro; Marengoni, Alessandra

    2015-01-01

    Medication adherence and persistence is recognized as a worldwide public health problem, particularly important in the management of chronic diseases. Nonadherence to medical plans affects every level of the population, but particularly older adults due to the high number of coexisting diseases they are affected by and the consequent polypharmacy. Chronic disease management requires a continuous psychological adaptation and behavioral reorganization. In literature, many interventions to improve medication adherence have been described for different clinical conditions, however, most interventions seem to fail in their aims. Moreover, most interventions associated with adherence improvements are not associated with improvements in other outcomes. Indeed, in the last decades, the degree of nonadherence remained unchanged. In this work, we review the most frequent interventions employed to increase the degree of medication adherence, the measured outcomes, and the improvements achieved, as well as the main limitations of the available studies on adherence, with a particular focus on older persons. PMID:26396502

  14. Sublingual immunotherapy in youngsters : adherence in a randomized clinical trial

    NARCIS (Netherlands)

    Roder, E.; Berger, M. Y.; de Groot, H.; van Wijk, R. Gerth

    2008-01-01

    Background Adherence is essential for effective treatment. Although several trials on the efficacy of sublingual immunotherapy (SLIT) in youngsters have been published, few contain data on medication intake. Objective We aimed to quantify adherence both to study protocol and medication intake as wel

  15. Adherence to the physical activity intervention in the Lifestyle Interventions and Independence for Elders pilot (LIFE-P) study.

    Science.gov (United States)

    Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) was a trial to examine the effects of physical activity on measures of disability risk in previously sedentary older adults at risk for disability. We examined adherence and retention to the LIPE-P physical activity (PA) interventio...

  16. Alcohol use, antiretroviral therapy adherence, and preferences regarding an alcohol-focused adherence intervention in patients with human immunodeficiency virus

    Directory of Open Access Journals (Sweden)

    Kekwaletswe CT

    2014-03-01

    Full Text Available Connie T Kekwaletswe,1 Neo K Morojele1,21Alcohol and Drug Abuse Research Unit, Medical Research Council, Pretoria, 2School of Public Health, University of the Witwatersrand, Johannesburg, South AfricaBackground: The primary objectives of this study were to determine the association between alcohol and antiretroviral therapy (ART adherence and the perceived appropriateness and acceptability of elements of an adherence counseling program with a focus on alcohol-related ART nonadherence among a sample of ART recipients in human immunodeficiency virus (HIV clinics in Tshwane, South Africa.Methods: We conducted a cross-sectional study with purposive sampling. The sample comprised 304 male and female ART recipients at two President's Emergency Plan For AIDS Relief-supported HIV clinics. Using an interview schedule, we assessed patients' alcohol use (Alcohol Use Disorders Identification Test, other drug use, level of adherence to ART, and reasons for missing ART doses (AIDS Clinical Trials Group adherence instrument. Additionally, patients’ views were solicited on: the likely effectiveness of potential facilitators; the preferred quantity, duration, format, and setting of the sessions; the usefulness of having family members/friends attend sessions along with the patient; and potential skill sets to be imparted.Results: About half of the male drinkers’ and three quarters of the female drinkers’ Alcohol Use Disorders Identification Test scores were suggestive of hazardous or harmful drinking. Average self-reported ART adherence was 89.7%. There was a significant association between level of alcohol use and degree of ART adherence. Overall, participants perceived two clinic-based sessions, each of one hour’s duration, in a group format, and facilitated by a peer or adherence counselor, as most appropriate and acceptable. Participants also had a favorable attitude towards family and friends accompanying them to the sessions. They also favored an

  17. Correlates of Adherence to a Telephone-Based Multiple Health Behavior Change Cancer Preventive Intervention for Teens: The Healthy for Life Program (HELP)

    Science.gov (United States)

    Mays, Darren; Peshkin, Beth N.; Sharff, McKane E.; Walker, Leslie R.; Abraham, Anisha A.; Hawkins, Kirsten B.; Tercyak, Kenneth P.

    2012-01-01

    This study examined factors associated with teens' adherence to a multiple health behavior cancer preventive intervention. Analyses identified predictors of trial enrollment, run-in completion, and adherence (intervention initiation, number of sessions completed). Of 104 teens screened, 73% (n = 76) were trial eligible. White teens were more…

  18. Effectiveness of an interactive postgraduate educational intervention with patient participation on the adherence to a physiotherapy guideline for hip and knee osteoarthritis: a randomised controlled trial

    NARCIS (Netherlands)

    Peter, W.; Wees, P.J. van der; Verhoef, J.; Jong, Z. de; Bodegom-Vos, L. van; Hilberdink, W.K.; Fiocco, M.; Vlieland, T.P.

    2015-01-01

    PURPOSE: To determine the effectiveness of an interactive educational intervention on a physiotherapy guideline for hip and knee osteoarthritis. METHOD: Physiotherapists were randomly allocated to a 3-h interactive educational course with the collaboration of three patient partners or no interventio

  19. Interventions to Improve Adherence in Patients with Immune-Mediated Inflammatory Disorders: A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Fanny Depont

    Full Text Available In patients with immune-mediated inflammatory disorders, poor adherence to medication is associated with increased healthcare costs, decreased patient satisfaction, reduced quality of life and unfavorable treatment outcomes.To determine the impact of different interventions on medication adherence in patients with immune-mediated inflammatory disorders.Systematic review.MEDLINE, EMBASE and Cochrane Library.Included studies were clinical trials and observational studies in adult outpatients treated for psoriasis, Crohn's disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or multiple sclerosis.Intervention approaches were classified into four categories: educational, behavioral, cognitive behavioral, and multicomponent interventions. The risk of bias/study limitations of each study was assessed using the GRADE system.Fifteen studies (14 clinical trials and one observational study met eligibility criteria and enrolled a total of 1958 patients. Forty percent of the studies (6/15 was conducted in patients with inflammatory bowel disease, half (7/15 in rheumatoid arthritis patients, one in psoriasis patients and one in multiple sclerosis patients. Seven out of 15 interventions were classified as multicomponent, four as educational, two as behavioral and two as cognitive behavioral. Nine studies, of which five were multicomponent interventions, had no serious limitations according to GRADE criteria. Nine out of 15 interventions showed an improvement of adherence: three multicomponent interventions in inflammatory bowel disease; one intervention of each category in rheumatoid arthritis; one multicomponent in psoriasis and one multicomponent in multiple sclerosis.The assessment of interventions designed for increasing medication adherence in IMID is rare in the literature and their methodological quality may be improved in upcoming studies. Nonetheless, multicomponent interventions showed the strongest evidence for

  20. Clinical pharmacist interventions to support adherence to thrombopreventive therapy

    DEFF Research Database (Denmark)

    Hedegaard, Ulla

    individualised interventions and team-based care, e.g. integrating a clinical pharmacist with particular focus on patients’ drug-related problems. One approach with growing evidence of improving medication adherence is motivational interviewing (MI). So far, no clinical pharmacist intervention using MI has......-based patient interview and three follow-up telephone calls. There was no difference in the primary outcome, the composite medication possession ratio (MPR) for antiplatelets, anticoagulants and statins during the year after hospitalisation, as assessed by analysing prescription refill records. At 12 months...... to the one in the first study, except that the patient interview was more structured using the Drug Adherence Work-up (DRAW) tool and an adherence questionnaire for identifying potential adherence and lifestyle-related problems. At 12 months, 20.3% of the patients in the intervention group (N=231) were non...

  1. Interventions to Improve Medication Adherence in Hypertensive Patients: Systematic Review and Meta-analysis.

    Science.gov (United States)

    Conn, Vicki S; Ruppar, Todd M; Chase, Jo-Ana D; Enriquez, Maithe; Cooper, Pamela S

    2015-12-01

    This systematic review applied meta-analytic procedures to synthesize medication adherence interventions that focus on adults with hypertension. Comprehensive searching located trials with medication adherence behavior outcomes. Study sample, design, intervention characteristics, and outcomes were coded. Random-effects models were used in calculating standardized mean difference effect sizes. Moderator analyses were conducted using meta-analytic analogues of ANOVA and regression to explore associations between effect sizes and sample, design, and intervention characteristics. Effect sizes were calculated for 112 eligible treatment-vs.-control group outcome comparisons of 34,272 subjects. The overall standardized mean difference effect size between treatment and control subjects was 0.300. Exploratory moderator analyses revealed interventions were most effective among female, older, and moderate- or high-income participants. The most promising intervention components were those linking adherence behavior with habits, giving adherence feedback to patients, self-monitoring of blood pressure, using pill boxes and other special packaging, and motivational interviewing. The most effective interventions employed multiple components and were delivered over many days. Future research should strive for minimizing risks of bias common in this literature, especially avoiding self-report adherence measures. PMID:26560139

  2. Adherence Process Research on Developmental Interventions: Filling in the Middle.

    Science.gov (United States)

    Hogue, Aaron

    2002-01-01

    Presents a framework and some practical examples for using rigorous implementation research to inform program outcomes and foster program development for developmental interventions. Focuses on: (1) role of process research, specifically developing developmental interventions; (2) characteristics of adherence process research; and (3)…

  3. Improving adherence to medication in stroke survivors (IAMSS: a randomised controlled trial: study protocol

    Directory of Open Access Journals (Sweden)

    Johnston Marie

    2010-02-01

    Full Text Available Abstract Background Adherence to therapies is a primary determinant of treatment success, yet the World Health Organisation estimate that only 50% of patients who suffer from chronic diseases adhere to treatment recommendations. In a previous project, we found that 30% of stroke patients reported sub-optimal medication adherence, and this was associated with younger age, greater cognitive impairment, lower perceptions of medication benefits and higher specific concerns about medication. We now wish to pilot a brief intervention aimed at (a helping patients establish a better medication-taking routine, and (b eliciting and modifying any erroneous beliefs regarding their medication and their stroke. Methods/Design Thirty patients will be allocated to a brief intervention (2 sessions and 30 to treatment as usual. The primary outcome will be adherence measured over 3 months using Medication Event Monitoring System (MEMS pill containers which electronically record openings. Secondary outcomes will include self reported adherence and blood pressure. Discussion This study shall also assess uptake/attrition, feasibility, ease of understanding and acceptability of this complex intervention. Trial Registration Current Controlled Trials ISRCTN38274953

  4. Gamification and Adherence to Web-Based Mental Health Interventions: A Systematic Review

    Science.gov (United States)

    O'Neill, Noelle; van Woerden, Hugo; Eslambolchilar, Parisa; Jones, Matt; John, Ann

    2016-01-01

    Background Adherence to effective Web-based interventions for common mental disorders (CMDs) and well-being remains a critical issue, with clear potential to increase effectiveness. Continued identification and examination of “active” technological components within Web-based interventions has been called for. Gamification is the use of game design elements and features in nongame contexts. Health and lifestyle interventions have implemented a variety of game features in their design in an effort to encourage engagement and increase program adherence. The potential influence of gamification on program adherence has not been examined in the context of Web-based interventions designed to manage CMDs and well-being. Objective This study seeks to review the literature to examine whether gaming features predict or influence reported rates of program adherence in Web-based interventions designed to manage CMDs and well-being. Methods A systematic review was conducted of peer-reviewed randomized controlled trials (RCTs) designed to manage CMDs or well-being and incorporated gamification features. Seven electronic databases were searched. Results A total of 61 RCTs met the inclusion criteria and 47 different intervention programs were identified. The majority were designed to manage depression using cognitive behavioral therapy. Eight of 10 popular gamification features reviewed were in use. The majority of studies utilized only one gamification feature (n=58) with a maximum of three features. The most commonly used feature was story/theme. Levels and game leaders were not used in this context. No studies explicitly examined the role of gamification features on program adherence. Usage data were not commonly reported. Interventions intended to be 10 weeks in duration had higher mean adherence than those intended to be 6 or 8 weeks in duration. Conclusions Gamification features have been incorporated into the design of interventions designed to treat CMD and well

  5. Non-adherence to telemedicine interventions for drug users: systematic review

    Directory of Open Access Journals (Sweden)

    Taís de Campos Moreira

    2014-06-01

    Full Text Available OBJECTIVE To estimate rates of non-adherence to telemedicine strategies aimed at treating drug addiction. METHODS A systematic review was conducted of randomized controlled trials investigating different telemedicine treatment methods for drug addiction. The following databases were consulted between May 18, 2012 and June 21, 2012: PubMed, PsycINFO, SciELO, Wiley (The Cochrane Library, Embase, Clinical trials and Google Scholar. The Grading of Recommendations Assessment, Development and Evaluation was used to evaluate the quality of the studies. The criteria evaluated were: appropriate sequence of data generation, allocation concealment, blinding, description of losses and exclusions and analysis by intention to treat. There were 274 studies selected, of which 20 were analyzed. RESULTS Non-adherence rates varied between 15.0% and 70.0%. The interventions evaluated were of at least three months duration and, although they all used telemedicine as support, treatment methods differed. Regarding the quality of the studies, the values also varied from very poor to high quality. High quality studies showed better adherence rates, as did those using more than one technique of intervention and a limited treatment time. Mono-user studies showed better adherence rates than poly-user studies. CONCLUSIONS Rates of non-adherence to treatment involving telemedicine on the part of users of psycho-active substances differed considerably, depending on the country, the intervention method, follow-up time and substances used. Using more than one technique of intervention, short duration of treatment and the type of substance used by patients appear to facilitate adherence.

  6. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa.

    Directory of Open Access Journals (Sweden)

    Jessica E Haberer

    Full Text Available Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation.Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda, we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to 80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort.The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use. Please see later in the article for the Editors' Summary.

  7. Effect of a Multi-Dimensional and Inter-Sectoral Intervention on the Adherence of Psychiatric Patients.

    Directory of Open Access Journals (Sweden)

    Anne Pauly

    Full Text Available In psychiatry, hospital stays and transitions to the ambulatory sector are susceptible to major changes in drug therapy that lead to complex medication regimens and common non-adherence among psychiatric patients. A multi-dimensional and inter-sectoral intervention is hypothesized to improve the adherence of psychiatric patients to their pharmacotherapy.269 patients from a German university hospital were included in a prospective, open, clinical trial with consecutive control and intervention groups. Control patients (09/2012-03/2013 received usual care, whereas intervention patients (05/2013-12/2013 underwent a program to enhance adherence during their stay and up to three months after discharge. The program consisted of therapy simplification and individualized patient education (multi-dimensional component during the stay and at discharge, as well as subsequent phone calls after discharge (inter-sectoral component. Adherence was measured by the "Medication Adherence Report Scale" (MARS and the "Drug Attitude Inventory" (DAI.The improvement in the MARS score between admission and three months after discharge was 1.33 points (95% CI: 0.73-1.93 higher in the intervention group compared to controls. In addition, the DAI score improved 1.93 points (95% CI: 1.15-2.72 more for intervention patients.These two findings indicate significantly higher medication adherence following the investigated multi-dimensional and inter-sectoral program.German Clinical Trials Register DRKS00006358.

  8. Correlates of Adherence to a Telephone-Based Multiple Health Behavior Change Cancer Preventive Intervention for Teens: The Healthy for Life Program (HELP)

    OpenAIRE

    Mays, Darren; Peshkin, Beth N.; Sharff, McKane E.; Walker, Leslie R.; Abraham, Anisha A.; Hawkins, Kirsten; Tercyak, Kenneth P.

    2011-01-01

    This study examined factors associated with teens’ adherence to a multiple health behavior cancer preventive intervention. Analyses identified predictors of trial enrollment, run-in completion, and adherence (intervention initiation, number of sessions completed). Of 104 teens screened, 73% (n = 76) were trial-eligible. White teens were more likely to enroll than non-whites (χ2 [1] df = 4.49, p = 0.04). Among enrolled teens, 76% (n = 50) completed the run-in; there were no differences between...

  9. Effect of a telephonic intervention on the adherence of patients

    Directory of Open Access Journals (Sweden)

    A. V. Stewart

    2003-02-01

    Full Text Available The effectiveness of a telephonic intervention in increasingpatients’ adherence to a health behaviour modification programme was tested. Patients were randomly assigned to two groups, the Experimental group receiving the telephonic intervention. Patients in the Experimental group showed greater adherence to the programme than the Control group (p=0.007. Their knowledge of hypertension improved (p=0.001 and was better than the control group (p=0.03, their exercise capacity improved (p=0.003 but not significantly more than the control group (p=0.09. They had a greater reduction in weight (p=0.004 which was significantly different from the Control group (p= 0.03. They were significantly less tired than the Control group (p=0.008. The Experimental group showed a reduction inthe number of patients with headaches (p=0.05 and dizziness (p=0.001. These changes were significant within the Experimental group but not between the two groups. The self reported risk factor modification revealed that more patients in the Experimental group could control their stress (p=0.05; more were controlling their salt intake (p=0.02 and more knew and were adhering to their medication regime (p=0.05. Both groups showed small reductions in blood pressure. The telephonic intervention involving the support of a health-care practitioner and a family member appeared to be effective in changing aspects of health behaviour.

  10. Interventional tools to improve medication adherence: review of literature

    Directory of Open Access Journals (Sweden)

    Costa E

    2015-09-01

    Full Text Available Elísio Costa,1 Anna Giardini,2 Magda Savin,3 Enrica Menditto,4 Elaine Lehane,5 Olga Laosa,6 Sergio Pecorelli,7,8 Alessandro Monaco,7 Alessandra Marengoni9On behalf of the A1 Action group “Prescription and Adherence to Medical Plans”, European Innovation Partnership on Active and Healthy Ageing1UCIBIO, REQUIMTE, Faculty of Pharmacy, University of Porto, Porto, Portugal; 2Psychology Unit, Salvatore Maugeri Foundation, IRCCS, Scientific Institute of Montescano (PV, Pavia, Italy; 3European Association of Pharmaceutical Full-line Wholesalers, Brussels, Belgium; 4CIRFF/Center of Pharmacoeconomics, School of Pharmacy, University of Naples FedericoII, Nápoles, Italy; 5Catherine McAuley School of Nursing and Midwifery, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland; 6Centro de Investigación Clínica del Anciano Fundación para la Investigación Biomédica, Hospital Universitario de Getafe, Madrid, Spain; 7Italian Medicines Agency – AIFA, Rome, Italy; 8University of Brescia, Brescia, Italy; 9Department of Clinical and Experimental Science, University of Brescia, Brescia, Italy Abstract: Medication adherence and persistence is recognized as a worldwide public health problem, particularly important in the management of chronic diseases. Nonadherence to medical plans affects every level of the population, but particularly older adults due to the high number of coexisting diseases they are affected by and the consequent polypharmacy. Chronic disease management requires a continuous psychological adaptation and behavioral reorganization. In literature, many interventions to improve medication adherence have been described for different clinical conditions, however, most interventions seem to fail in their aims. Moreover, most interventions associated with adherence improvements are not associated with improvements in other outcomes. Indeed, in the last decades, the degree of nonadherence remained unchanged. In this work, we

  11. ‘It’s not about money, it’s about my health’: determinants of participation and adherence among women in an HIV-HSV2 prevention trial in Johannesburg, South Africa

    OpenAIRE

    MacPhail, Catherine; Delany-Moretlwe, Sinead; Mayaud, Philippe

    2012-01-01

    High levels of adherence in clinical trials are essential for producing accurate intervention efficacy estimates. Adherence to clinical trial products and procedures is dependent on the motivations that drive participants. Data are presented to document reasons for trial participation and adherence to daily aciclovir for HSV-2 and HIV-1 genital shedding suppression among 300 HIV-1/HSV-2 seropositive women in South Africa. In-depth interviews after exit from the trial with 31 randomly selected...

  12. Discontinuing financial incentives for adherence to antipsychotic depot medication: long-term outcomes of a cluster randomised controlled trial

    Science.gov (United States)

    Priebe, Stefan; Bremner, Stephen A; Pavlickova, Hana

    2016-01-01

    Objectives In a cluster randomised controlled trial, offering financial incentives improved adherence to antipsychotic depot medication over a 1-year period. Yet, it is unknown whether this positive effect is sustained once the incentives stop. Methods and analyses Patients in the intervention and control group were followed up for 2 years after the intervention. Primary and secondary outcomes were assessed at 6 months and 24 months post intervention. Assessments were conducted between September 2011 and November 2014. Results After the intervention period, intervention and control groups did not show any statistically significant differences in adherence, neither in the first 6 months (71% and 77%, respectively) nor in the following 18 months (68%, 74%). There were no statistically significant differences in secondary outcomes, that is, adherence ≥95% and untoward incidents either. Conclusions It may be concluded that incentives to improve adherence to antipsychotic maintenance medication are effective only for as long as they are provided. Once they are stopped, adherence returns to approximately baseline level with no sustained benefit. Trial registration number ISRCTN77769281; Results. PMID:27655261

  13. A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults.

    Science.gov (United States)

    Garofalo, Robert; Kuhns, Lisa M; Hotton, Anna; Johnson, Amy; Muldoon, Abigail; Rice, Dion

    2016-05-01

    HIV-positive adolescents and young adults often experience suboptimal medication adherence, yet few interventions to improve adherence in this group have shown evidence of efficacy. We conducted a randomized trial of a two-way, personalized daily text messaging intervention to improve adherence to antiretroviral therapy (ART) among N = 105 poorly adherent HIV-positive adolescents and young adults, ages 16-29. Adherence to ART was assessed via self-reported visual analogue scale (VAS; 0-100 %) at 3 and 6-months for mean adherence level and proportion ≥90 % adherent. The average effect estimate over the 6-month intervention period was significant for ≥90 % adherence (OR = 2.12, 95 % CI 1.01-4.45, p < .05) and maintained at 12-months (6 months post-intervention). Satisfaction scores for the intervention were very high. These results suggest both feasibility and initial efficacy of this approach. Given study limitations, additional testing of this intervention as part of a larger clinical trial with objective and/or clinical outcome measures of adherence is warranted. PMID:26362167

  14. A randomized controlled trial examining the efficacy of motivational counseling with observed therapy for antiretroviral therapy adherence.

    Science.gov (United States)

    Goggin, Kathy; Gerkovich, Mary M; Williams, Karen B; Banderas, Julie W; Catley, Delwyn; Berkley-Patton, Jannette; Wagner, Glenn J; Stanford, James; Neville, Sally; Kumar, Vinutha K; Bamberger, David M; Clough, Lisa A

    2013-07-01

    This study determined whether motivational interviewing-based cognitive behavioral therapy (MI-CBT) adherence counseling combined with modified directly observed therapy (MI-CBT/mDOT) is more effective than MI-CBT counseling alone or standard care (SC) in increasing adherence over time. A three-armed randomized controlled 48-week trial with continuous electronic drug monitored adherence was conducted by randomly assigning 204 HIV-positive participants to either 10 sessions of MI-CBT counseling with mDOT for 24 weeks, 10 sessions of MI-CBT counseling alone, or SC. Poisson mixed effects regression models revealed significant interaction effects of intervention over time on non-adherence defined as percent of doses not-taken (IRR = 1.011, CI = 1.000-1.018) and percent of doses not-taken on time (IRR = 1.006, CI = 1.001-1.011) in the 30 days preceding each assessment. There were no significant differences between groups, but trends were observed for the MI-CBT/mDOT group to have greater 12 week on-time and worse 48 week adherence than the SC group. Findings of modest to null impact on adherence despite intensive interventions highlights the need for more effective interventions to maintain high adherence over time.

  15. Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD: protocol for the ICEPOC study

    Directory of Open Access Journals (Sweden)

    Prados-Torres Daniel

    2011-02-01

    Full Text Available Abstract Background Low therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment. The therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD is extremely poor according to most studies. The research about COPD adherence has mainly focussed on quantifying its effect, and few studies have researched factors that affect non-adherence. Our study will evaluate the effectiveness of a multifactor intervention to improve the therapeutic adherence of COPD patients. Methods/Design A randomized controlled clinical trial with 140 COPD diagnosed patients selected by a non-probabilistic method of sampling. Subjects will be randomly allocated into two groups, using the block randomization technique. Every patient in each group will be visited four times during the year of the study. Intervention: Motivational aspects related to adherence (beliefs and behaviour: group and individual interviews; cognitive aspects: information about illness; skills: inhaled technique training. Reinforcement of the cognitive-emotional aspects and inhaled technique training will be carried out in all visits of the intervention group. Discussion Adherence to a prescribed treatment involves a behavioural change. Cognitive, emotional and motivational aspects influence this change and so we consider the best intervention procedure to improve adherence would be a cognitive and emotional strategy which could be applied in daily clinical practice. Our hypothesis is that the application of a multifactor intervention (COPD information, dose reminders and reinforcing audiovisual material, motivational aspects and inhalation technique training to COPD patients taking inhaled treatment will give a 25% increase in the number of patients showing therapeutic adherence in this group compared to the control group. We will

  16. Multifaceted medication adherence intervention for patients with hypertension in secondary care

    DEFF Research Database (Denmark)

    Hedegaard, Ulla; Hallas, Jesper; Nielsen, Lene Ravn-Vestergaard;

    Background and Objectives Medication adherence is often suboptimal among patients with hypertension. Non-adherence is a multi-dimensional problem and a successful adherence intervention requires multiple components to address the underlying reason for non-adherence. The objective of the present...... study was to describe the content and process outcomes of an adherence program developed for hypertensive patients in a hospital setting. Methods The intervention development was based on adherence and behavioral theories, and evidence of effective interventions. The intervention was pharmacist...... to the questionnaire, 44.2% of the patients had at least one item indicated an adherence problem. The DRAW©-tool used at the interview, identified 416 problems, 60% medication-related and 40% life style-related. In total 528 actions were taken divided into 8 categories. Motivational interviewing was the most frequent...

  17. Distress Tolerance as a Predictor of Adherence to a Yoga Intervention: Moderating Roles of BMI and Body Image.

    Science.gov (United States)

    Baird, Scarlett O; Hopkins, Lindsey B; Medina, Johnna L; Rosenfield, David; Powers, Mark B; Smits, Jasper A J

    2016-01-01

    This study tested whether distress tolerance, body image, and body mass index (BMI) predicted adherence to a yoga intervention. Participants were 27 women who participated in a yoga intervention as part of a randomized controlled trial. Attendance and distress tolerance were assessed weekly, and body image and BMI were measured at baseline. Multilevel modeling revealed a three-way interaction of distress tolerance, BMI, and body image (p body image concerns, distress tolerance was positively associated with adherence regardless of BMI (p = .009). However, for those with poor body image, increases in distress tolerance were associated with increases in adherence among overweight participants (p body image concerns, BMI, and their interaction. Research and clinical implications are discussed. PMID:26530475

  18. Developing an adherence support intervention for patients on antiretroviral therapy in the context of the recent IDU-driven HIV/AIDS epidemic in Estonia.

    Science.gov (United States)

    Laisaar, Kaja-Triin; Uusküla, Anneli; Sharma, Anjali; DeHovitz, Jack A; Amico, K Rivet

    2013-01-01

    There is limited data on and experience with interventions for antiretroviral therapy (ART) adherence support for patients on ART in Eastern Europe. We sought to identify a feasible adherence support intervention for delivery amongst HIV-positive adults receiving care in Estonia, where the HIV/AIDS epidemic has been mainly concentrated among injection drug users (IDUs). Our application of intervention mapping (IM) strategies used existing literature, formative research and multidisciplinary team input to produce a brief clinic-based intervention entitled the Situated Optimal Adherence Intervention Estonia (sOAI Estonia) which uses both Next-Step Counseling (NSC) and Information-Motivation-Behavioral Skills (IMB) Model approach to facilitate integration of ART into the context and demands of daily life. We present the intervention development process, the resulting sOAI Estonia approach, and describe a randomized controlled trial (RCT) which is under way to evaluate the intervention (results due in spring 2013). PMID:23391132

  19. Long-term dietary intervention trials: critical issues and challenges

    Directory of Open Access Journals (Sweden)

    Crichton Georgina E

    2012-07-01

    Full Text Available Abstract Background There are many challenges involved in running randomised controlled dietary intervention trials that investigate health outcomes. The aim of this paper was to evaluate the recruitment process, retention of participants and challenges faced in our dairy intervention trial, and to provide strategies to combat the difficulties of running long-term dietary intervention trials. Methods A 12-month, randomised, two-way crossover study was conducted in overweight adults with habitually low dairy food consumption to assess the effects of a high dairy intake (4 servings of reduced-fat dairy per day compared with a low dairy intake (1 serving of reduced-fat dairy per day on measures of cardiometabolic and cognitive health. On completion of the high dairy intake phase, each participant was interviewed about their experience in the trial and responses were used to evaluate the key issues for study participants. Results Although the recruitment target was achieved, high rates of attrition (49.3% and difficulties maintaining participant compliance (reported by 37.8% of participants were major threats to the viability of the study. Factors that contributed to the high attrition included inability to comply with the dietary requirements of the study protocol (27.0%, health problems or medication changes (24.3% and time commitment (10.8%. Conclusion Attrition and adherence to study requirements present challenges to trials requiring longer-term dietary change. Including a run-in period to further assess the motivation, commitment and availability of participants, maintaining regular contact with participants during control phases, minimising time commitment, providing flexibility with dietary requirements, facilitating positive experiences, and stringent monitoring of diet are some key recommendations for future dietary intervention trials. Trial registration Australia and New Zealand Clinical Trials Registry (ACTRN 12608000538347

  20. Supporting patients : pharmacy based interventions to improve medication adherence

    OpenAIRE

    Kooij, M. J.

    2015-01-01

    For many patients it is not easy to adhere to the agreed treatment with medication. Adherence has been defined as “the extent to which a person’s behaviour - taking medication - corresponds with agreed recommendations from a health care provider”. Numerous factors influence this taking behaviour and non-adherence must not be seen as the patients’ problem only. Health care providers, including pharmacists, should support patients to adhere. The overall aim of this thesis was to evaluate interv...

  1. A behavioral family intervention to improve adherence and metabolic control in children with IDDM

    OpenAIRE

    Bonner, Melanie Jean

    1992-01-01

    The present study evaluated the effectiveness of a behavioral family intervention on adherence and metabolic control in insulin dependent diabetic children (IODM). Specifically, assumption of regimen responsibilities between the parent and child were manipulated to facilitate regimen adherence. The intervention delivered was a target-specific behavioral contract extended sequentially across four target behaviors (Le., blood glucose testing, insulin injections, diet, and exercise). Regimen...

  2. Nutrition Intervention Trials in Linxian, China

    Science.gov (United States)

    Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population

  3. Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

    Directory of Open Access Journals (Sweden)

    Alfredo D. Oliveira-Filho

    2014-12-01

    Full Text Available Background: Effective interventions to improve medication adherence are usually complex and expensive. Objective: To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD. Method: A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4. The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates. Results: 61 patients were randomized to intervention (n = 30 and control (n = 31 groups. The mean age of the patients was 61 years (SD 12.73, 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3. Medication adherence was correlated to intervention (p = 0.04 and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups. Conclusion: The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes.

  4. Dissemination strategies and adherence predictors for web-based interventions-how efficient are patient education sessions and email reminders?

    Science.gov (United States)

    Schweier, R; Romppel, M; Richter, C; Grande, G

    2016-06-01

    The Internet offers the potential to efficaciously deliver health interventions at a low cost and with a low threshold across any distance. However, since many web-based interventions are confronted with low use and adherence, proactive dissemination strategies are needed. We, therefore, tested the efficacy of a 1-h patient education session as part of a rehabilitation program and an email reminder 4 weeks later on the publicity and use of a web-based intervention aimed at lifestyle changes in patients with either coronary heart disease or chronic back pain (CBP) and examined adherence predictors. The website www.lebensstil-aendern.de is a cost-free, German-language website providing more than 1000 patient narratives about successful lifestyle changes. To test the efficacy of the dissemination strategies and to examine adherence predictors, we conducted a sequential controlled trial with heart and CBP patients recruited from German inpatient rehabilitation centers. The dissemination strategies were found to be efficient. Use rates, however, remained low. The email reminder and internal health locus of control emerged as notable factors in motivating patients to participate in the web-based intervention. Other factors that have been suggested to be related to nonuse, e.g. sociodemographic characteristics and medical condition, did not predict use or adherence. PMID:27107431

  5. Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial.

    Directory of Open Access Journals (Sweden)

    Xiaoqiu Liu

    2015-09-01

    Full Text Available Mobile text messaging and medication monitors (medication monitor boxes have the potential to improve adherence to tuberculosis (TB treatment and reduce the need for directly observed treatment (DOT, but to our knowledge they have not been properly evaluated in TB patients. We assessed the effectiveness of text messaging and medication monitors to improve medication adherence in TB patients.In a pragmatic cluster-randomised trial, 36 districts/counties (each with at least 300 active pulmonary TB patients registered in 2009 within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China, were randomised using stratification and restriction to one of four case-management approaches in which patients received reminders via text messages, a medication monitor, combined, or neither (control. Patients in the intervention arms received reminders to take their drugs and reminders for monthly follow-up visits, and the managing doctor was recommended to switch patients with adherence problems to more intensive management or DOT. In all arms, patients took medications out of a medication monitor box, which recorded when the box was opened, but the box gave reminders only in the medication monitor and combined arms. Patients were followed up for 6 mo. The primary endpoint was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor box. Secondary endpoints included additional adherence and standard treatment outcome measures. Interventions were not masked to study staff and patients. From 1 June 2011 to 7 March 2012, 4,292 new pulmonary TB patients were enrolled across the 36 clusters. A total of 119 patients (by arm: 33 control, 33 text messaging, 23 medication monitor, 30 combined withdrew from the study in the first month because they were reassessed as not having TB by their managing doctor (61 patients or were switched to a different

  6. Improving adherence to venous thromoembolism prophylaxis using multiple interventions

    Directory of Open Access Journals (Sweden)

    Al-Tawfiq Jaffar

    2011-01-01

    Full Text Available Objective : In hospital, deep vein thrombosis (DVT increases the morbidity and mortality in patients with acute medical illness. DVT prophylaxis is well known to be effective in preventing venous thromoembolism (VTE. However, its use remains suboptimal. The objective of this study was to evaluate the impact of quality improvement project on adherence with VTE prophylaxis guidelines and on the incidence of hospital-acquired VTEs in medical patients. Methods : The study was conducted at Saudi Aramco Medical Services Organization from June 2008 to August 2009. Quality improvement strategies included education of physicians, the development of a protocol, and weekly monitoring of compliance with the recommendations for VTE prophylaxis as included in the multidisciplinary rounds. A feedback was provided whenever a deviation from the protocol occurs. Results : During the study period, a total of 560 general internal medicine patients met the criteria for VTE prophylaxis. Of those, 513 (91% patients actually received the recommended VTE prophylaxis. The weekly compliance rate in the initial stage of the intervention was 63% (14 of 22 and increased to an overall rate of 100% (39 of 39 (P = 0.002. Hospital-acquired DVT rate was 0.8 per 1000 discharges in the preintervention period and 0.5 per 1000 discharges in the postintervention period, P = 0.51. However, there was a significant increase in the time-free period of the VTE and we had 11 months with no single DVT. Conclusion : In this study, the use of multiple interventions increased VTE prophylaxis compliance rate.

  7. Effectiveness of pharmaceutical care for drug treatment adherence in patients with systemic lupus erythematosus in Rio de Janeiro, Brazil: study protocol for a randomized controlled trial

    OpenAIRE

    Oliveira-Santos, Marise; Verani, José Fernando de Souza; Camacho, Luiz Antônio Bastos; de Andrade, Carlos Augusto Ferreira; Ferrante-Silva, Rosele; Klumb, Evandro Mendes

    2016-01-01

    Background Treatment adherence is a primary determinant of the success and effectiveness of healthcare. Lack of adherence can lead to treatment failure and death. Although studies have shown that pharmaceutical intervention can improve drug treatment for patients with chronic diseases, studies on pharmaceutical care are not only inconsistent, they are scarce and limited to developed countries, include few patients, and are not studied in randomized clinical trials. Systemic lupus erythematosu...

  8. Adherence is a multi-dimensional construct in the POUNDS LOST trial

    OpenAIRE

    Donald A. Williamson; Anton, Stephen D.; Han, Hongmei; Champagne, Catherine M.; Allen, Ray; LeBlanc, Eric; Ryan, Donna H.; McManus, Katherine; Laranjo, Nancy; Vincent J Carey; Loria, Catherine M.; Bray, George A; Sacks, Frank M.

    2009-01-01

    Research on the conceptualization of adherence to treatment has not addressed a key question: Is adherence best defined as being a uni-dimensional or multi-dimensional behavioral construct? The primary aim of this study was to test which of these conceptual models best described adherence to a weight management program. This ancillary study was conducted as a part of the POUNDS LOST trial that tested the efficacy of four dietary macro-nutrient compositions for promoting weight loss. A sample ...

  9. Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Widdershoven Jos

    2011-10-01

    Full Text Available Abstract Background Frequent rehospitalisations and poorer survival chances in heart failure (HF patients may partly be explained by poor medication adherence. There are multiple medication-related reasons for suboptimal adherence, but psychological reasons may also be important. A novel TELEmonitoring device may improve MEDication adherence in HF patients (TELEMED-HF. TELEMED-HF is a randomized, controlled clinical intervention trial designed to examine (1 the efficacy and cost-efficiency of an electronic medication adherence support system in improving and monitoring HF patients' medication adherence; (2 the effect of medication adherence on hospitalizations and health care consumption; as well as on (3 clinical characteristics, and Quality of Life (QoL; and (4 clinical, sociodemographic, and psychological determinants of medication adherence. Methods/Design Consecutive patients with chronic, systolic HF presenting to the outpatient clinic of the TweeSteden Hospital, The Netherlands, will be approached for study participation and randomly assigned (1:1 following blocked randomization procedures to the intervention (n = 200 or usual care arm (n = 200. Patients in the intervention arm use the medication support device for six months in addition to usual care. Post-intervention, patients return to usual care only and all patients participate in four follow-up occasions over 12 months. Primary endpoints comprise objective and subjective medication adherence, healthcare consumption, number of hospitalizations, and cost-effectiveness. Secondary endpoints include disease severity, physical functioning, and QoL. Discussion The TELEMED-HF study will provide us a comprehensive understanding of medication adherence in HF patients, and will show whether telemonitoring is effective and cost-efficient in improving adherence and preventing hospitalization in HF patients. Trial registration number NCT01347528.

  10. Impact of a chronic kidney disease registry and provider education on guideline adherence – a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Drawz Paul E

    2012-07-01

    Full Text Available Abstract Background Low adherence to chronic kidney disease (CKD guidelines may be due to unrecognized CKD and lack of guideline awareness on the part of providers. The goal of this study was to evaluate the impact of provider education and access to a CKD registry on guideline adherence. Methods We conducted a cluster randomized controlled trial at the Louis Stokes Cleveland VAMC. One of two primary care clinics was randomized to intervention. Providers from both clinics received a lecture on CKD guidelines at study initiation. Providers in the intervention clinic were given access to and shown how to use a CKD registry, which identifies patients with CKD and is automatically updated daily. Eligible patients had at least one primary care visit in the last year, had CKD based on eGFR, and had not received renal replacement therapy. The primary outcome was parathyroid hormone (PTH adherence, defined by at least one PTH measurement during the 12 month study. Secondary outcomes were measurement of phosphorus, hemoglobin, proteinuria, achievement of goal blood pressure, and treatment with a diuretic or renin-angiotensin system blocker. Results There were 418 and 363 eligible patients seen during the study in the control and intervention clinics, respectively. Compared to pre-intervention, measurement of PTH increased in both clinics (control clinic: 16% to 23%; intervention clinic: 13% to 28%. Patients in the intervention clinic were more likely to have a PTH measured during the study (adjusted odds ratio = 1.53; 95% CI (1.01, 2.30; P = 0.04. However, the intervention was not associated with a consistent improvement in secondary outcomes. Only 5 of the 37 providers in the intervention clinic accessed the registry. Conclusions An intervention that included education on CKD guidelines and access to a CKD patient registry marginally improved guideline adherence over education alone. Adherence to the primary process measure improved in both

  11. Development of adherence metrics for caloric restriction interventions

    Science.gov (United States)

    Objective measures are needed to quantify dietary adherence during caloric restriction (CR) while participants are freeliving. One method to monitor adherence is to compare observed weight loss to the expected weight loss during a prescribed level of CR. Normograms (graphs)of expected weight loss ca...

  12. Development of adherence metrics for caloric restriction interventions

    Science.gov (United States)

    Objective measures are needed to quantify dietary adherence during caloric restriction (CR) while participants are freeliving. One method to monitor adherence is to compare observed weight loss to the expected weight loss during a prescribed level of CR. Normograms (graphs) of expected weight loss c...

  13. Development and content of a group-based intervention to improve medication adherence in non-adherent patients with rheumatoid arthritis.

    OpenAIRE

    Zwikker, H.; Bemt, B. van den; Ende, C. van den; W. van Lankveld; Broeder, A. den; Hoogen, F. van den; Mosselaar, B. van de; Dulmen, S. van

    2012-01-01

    Objective: To describe the systematic development and content of a short intervention to improve medication adherence to disease-modifying anti-rheumatic drugs in non-adherent patients with rheumatoid arthritis (RA). Methods: The intervention mapping (IM) framework was used to develop the intervention. The following IM steps were conducted: (1) a needs assessment; (2) formulation of specific intervention objectives; (3) inventory of methods and techniques needed to design the intervention and...

  14. A pilot randomized controlled clinical trial to improve antiepileptic drug adherence in young children with epilepsy.

    Science.gov (United States)

    Modi, Avani C; Guilfoyle, Shanna M; Mann, Krista A; Rausch, Joseph R

    2016-03-01

    The primary aim was to examine the preliminary efficacy of a family tailored problem-solving intervention to improve antiepileptic drug (AED) adherence in families of children with new-onset epilepsy. Secondary aims were to assess changes in targeted mechanisms and treatment feasibility and acceptability. Fifty families (M(age) = 7.6 ± 3.0; 80% Caucasian; 42% idiopathic localization related) completed baseline questionnaires and were given an electronic monitor to observe daily AED adherence. If adherence was ≤ 95% in the first 7 months of the study, families were randomized (Supporting Treatment Adherence Regimens (STAR): n = 11; Treatment as Usual (TAU): n = 12). Twenty-one families were not randomized due to adherence being ≥95%. The STAR intervention included four face-to-face and two telephone problem-solving sessions over 8 weeks. Significant group differences in adherence were found during active intervention (weeks 4-6; TAU = -12.0 vs. STAR = 18.1, p < 0.01; and weeks session 6-8: TAU = -9.7 vs. STAR = 15.3, p < 0.05). Children who received the STAR intervention exhibited improved adherence compared to children in the TAU group during active treatment. Significant changes in epilepsy knowledge and management were noted for the STAR group. Families expressed benefitting from the STAR intervention. Future studies should include a larger sample size and booster intervention sessions to maintain treatment effects over time.

  15. Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial

    OpenAIRE

    Hilbink, Mirrian; Lacroix, Joyca; Bremer - van der Heiden, Linda; Van Halteren, Aart; Teichert, Martina; van Lieshout, Jan

    2016-01-01

    Background Research shows that more than half of the people taking medication for a chronic condition are non-adherent. Nonadherence hinders disease control with a burden on patient quality of life and healthcare systems. We developed a tool that provides insight into nonadherence risks and barriers for medication-adherence including an intervention strategy to overcome those barriers. This study aims to assess the effectiveness of using this adherence tool in starters with cardiovascular or ...

  16. Predictors of Adherence in the Women’s Health Initiative Calcium and Vitamin D Trial

    OpenAIRE

    Brunner, R.; Dunbar-Jacob, J.; LeBoff, M. S.; Granek, I.; BOWEN, D; Snetselaar, L. G.; Shumaker, S A.; Ockene, J.; Rosal, M.; Wactawski-Wende, J.; Cauley, J.; Cochrane, B.; Tinker, L.; Jackson, R.; Wang, C.Y.

    2009-01-01

    The authors analyzed data from the Women’s Health Initiative (WHI) Calcium and Vitamin D Supplementation Trial (CaD) to learn more about factors affecting adherence to clinical trial study pills (both active and placebo). Most participants (36,282 postmenopausal women aged 50–79 years) enrolled in CaD 1 year after joining either a hormone trial or the dietary modification trial of WHI. The WHI researchers measured adherence to study pills by weighing the amount of remaining pills at an annual...

  17. Adherence to drug–drug interaction alerts in high-risk patients: a trial of context-enhanced alerting

    Science.gov (United States)

    Duke, Jon D; Li, Xiaochun; Dexter, Paul

    2013-01-01

    Objective Drug–drug interaction (DDI) alerting is an important form of clinical decision support, yet physicians often fail to attend to critical DDI warnings due to alert fatigue. We previously described a model for highlighting patients at high risk of a DDI by enhancing alerts with relevant laboratory data. We sought to evaluate the effect of this model on alert adherence in high-risk patients. Methods A 6-month randomized controlled trial involving 1029 outpatient physicians was performed. The target interactions were all DDIs known to cause hyperkalemia. Alerts in the intervention group were enhanced with the patient's most recent potassium and creatinine levels. The control group received unmodified alerts. High -risk patients were those with baseline potassium >5.0 mEq/l and/or creatinine ≥1.5 mg/dl (132 μmol/l). Results We found no significant difference in alert adherence in high-risk patients between the intervention group (15.3%) and the control group (16.8%) (p=0.71). Adherence in normal risk patients was significantly lower in the intervention group (14.6%) than in the control group (18.6%) (p<0.01). In neither group did physicians increase adherence in patients at high risk. Conclusions Physicians adhere poorly to hyperkalemia-associated DDI alerts even in patients with risk factors for a clinically significant interaction, and the display of relevant laboratory data in these alerts did not improve adherence levels in the outpatient setting. Further research is necessary to determine optimal strategies for conveying patient-specific DDI risk. PMID:23161895

  18. Motivational Interviewing (MINT) Improves Continuous Positive Airway Pressure (CPAP) Acceptance and Adherence: A Randomized Controlled Trial

    Science.gov (United States)

    Olsen, Sara; Smith, Simon S.; Oei, Tian P. S.; Douglas, James

    2012-01-01

    Objective: Adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnoea (OSA) is poor. We assessed the effectiveness of a motivational interviewing intervention (motivational interview nurse therapy [MINT]) in addition to best practice standard care to improve acceptance and adherence to CPAP therapy in people with…

  19. Adherence to Self-Care Interventions for Depression or Anxiety: A Systematic Review

    Science.gov (United States)

    Simco, Russell; McCusker, Jane; Sewitch, Maida

    2014-01-01

    Objective: The objective of this study was to synthesise and describe adherence to intervention in published studies of supported self-care for depression or anxiety, and to identify participant characteristics associated with higher adherence. Methods: We searched the databases EMBASE, MEDLINE, CINAHL, and PSYCINFO for the period from January…

  20. Adherence to diet on diabetic patients: effects of an intervention program

    OpenAIRE

    María De Lourdes Rodríguez Campuzano; Antonia Rentería Rodríguez; Juan Carlos García Rodríguez

    2013-01-01

    The purpose of the present study was to assess the effect of an intervention program on the self-reported adherence to a prescribed diet for diabetic patients. Because of the impact and consequences of this chronic illness, it is important to make the necessary efforts in order to achieve this dietary adherence goal, since diet is one of the main bases for the treatment of diabetes. According to an interbehavioral approach, an intervention program was designed and applied to ninety diabetic p...

  1. Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol).

    NARCIS (Netherlands)

    Loon, M.S. Koelewijn-van; Steenkiste, B. van; Ronda, G.; Wensing, M.J.P.; Stoffers, H.E.; Elwyn, G.; Grol, R.P.T.M.; Weijden, T.T. van der

    2008-01-01

    BACKGROUND: Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on

  2. Adherence and Attrition in a Web-Based Lifestyle Intervention for People with Metabolic Syndrome.

    Directory of Open Access Journals (Sweden)

    Leila Jahangiry

    2014-09-01

    Full Text Available The aim of this study was to determine adherence and attrition rates in a lifestyle intervention for people with metabolic syndrome.Adherence and attrition data from a randomized controlled trial were collected. Participants were classified as adherence group if they completed assessments at 3 and 6 months follow-up and as attrition group if they did not. Physical activity and quality of life was measured using the International Physical Activity Questionnaire (IPAQ and the Short Form Health Survey (SF-36. Generalized Estimating Equations (GEE was used to explore predictors of attrition.The mean age of participants (n=160 was 44.1 years. Attrition rate in the intervention and control groups at first follow-up were the same (20%. However, the control group had significantly higher attrition rate (%33.7 compared to the intervention group (%20 at 6 months follow up. Results showed that low educated participants were more likely to not stay in the study than better educated participants (OR=2.95,CI:1.39-6.33,P=0.05. According with length of the study, attrition was decreased at six month (OR=0.66,CI:0.52-0.83,P<0.001. Also, some aspects of health-related quality of life contributed to the attrition rate. Those who had higher scores on general health (OR=0.66,CI:0.54-0.97,P=0.023, social functioning (OR=0.44,CI:0.40-0.76,P=0.032, role emotional (OR=0.74,CI:0.54-0.98,P=0.18, vitality (OR=0.55,CI:0.38-0.90,P=0.015 and mental health (OR=0.63,CI:0.45-0.85,P=0.033 were more likely to stay in the study.It remains a concern that Web-based lifestyle programs may fail to reach those who need it most. Participant in the study generally had better quality of life than those who were lost to follow up.

  3. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes.

    Directory of Open Access Journals (Sweden)

    Michael H Chung

    2011-03-01

    Full Text Available BACKGROUND: Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting. METHODS AND FINDINGS: A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine were randomized to one of four arms: counseling (three counseling sessions around HAART initiation, alarm (pocket electronic pill reminder carried for 6 months, counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49-1.01; p = 0.055 and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml (HR 0.41; 95% CI 0.21-0.81; p = 0.01 compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p = 0.7 or viral failure (HR 0.99; 95% CI 0.53-1.84; p = 1.0 compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution. CONCLUSIONS: Intensive early adherence counseling at HAART initiation resulted

  4. The Effects of a Problem Solving-Based Intervention on Depressive Symptoms and HIV Medication Adherence Are Independent

    NARCIS (Netherlands)

    Gross, Robert; Bellamy, Scarlett L.; Chapman, Jennifer; Han, Xiaoyan; O'Duor, Jacqueline; Strom, Brian L.; Houts, Peter S.; Palmer, Steven C.; Coyne, James C.

    2014-01-01

    Depression and depressive symptoms predict poor adherence to medical therapy, but the association is complex, nonspecific, and difficult to interpret. Understanding this association may help to identify the mechanism explaining the results of interventions that improve both medical therapy adherence

  5. Interventional tools to improve medication adherence: review of literature

    OpenAIRE

    Costa E; Giardini A; Savin M.; Menditto E; Lehane EA; Laosa O; Pecorelli S; Monaco A.; Marengoni A

    2015-01-01

    Elísio Costa,1 Anna Giardini,2 Magda Savin,3 Enrica Menditto,4 Elaine Lehane,5 Olga Laosa,6 Sergio Pecorelli,7,8 Alessandro Monaco,7 Alessandra Marengoni9On behalf of the A1 Action group “Prescription and Adherence to Medical Plans”, European Innovation Partnership on Active and Healthy Ageing1UCIBIO, REQUIMTE, Faculty of Pharmacy, University of Porto, Porto, Portugal; 2Psychology Unit, Salvatore Maugeri Foundation, IRCCS, Scientific Institute of Montescano (PV), Pavia, Ita...

  6. Interventional tools to improve medication adherence: review of literature

    OpenAIRE

    Costa, Elisio

    2015-01-01

    Elísio Costa,1 Anna Giardini,2 Magda Savin,3 Enrica Menditto,4 Elaine Lehane,5 Olga Laosa,6 Sergio Pecorelli,7,8 Alessandro Monaco,7 Alessandra Marengoni9On behalf of the A1 Action group “Prescription and Adherence to Medical Plans”, European Innovation Partnership on Active and Healthy Ageing1UCIBIO, REQUIMTE, Faculty of Pharmacy, University of Porto, Porto, Portugal; 2Psychology Unit, Salvatore Maugeri Foundation, IRCCS, Scientific Institute of Montescano (PV)...

  7. Adherence in single-parent households in a long-term asthma clinical trial.

    Science.gov (United States)

    Spicher, Mary; Bollers, Nancy; Chinn, Tamara; Hall, Anita; Plunkett, Anne; Rodgers, Denise; Sundström, D A; Wilson, Laura

    2012-01-01

    Adherence of participants in a long-term clinical trial is necessary to assure validity of findings. This article examines adherence differences between single-parent and two-parent families in the Childhood Asthma Management Program (CAMP). Adherence was defined as the percentage of completed daily diary cards and scheduled study visits during the course of the trial. Logistic regression and ordinal logistic regression analyses were used. Children from single-parent families had a lower percentage of completed diary cards (72% vs. 84%) than two-parent families. Single-parent families were also more likely to reschedule visits (62% vs. 45%) and miss more clinic visits (23% vs. 17%) than two-parent families. Suggestions are given for study coordinators to assist participants in completing a long-term clinical trial. Many suggestions may be adapted for nurses in inpatient or outpatient settings for assisting parents of patients with chronic diseases.

  8. ‘It’s not about money, it’s about my health’: determinants of participation and adherence among women in an HIV-HSV2 prevention trial in Johannesburg, South Africa

    OpenAIRE

    MacPhail, Catherine

    2012-01-01

    Catherine MacPhail,1 Sinead Delany-Moretlwe,1 Philippe Mayaud21Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa; 2Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UKAbstract: High levels of adherence in clinical trials are essential for producing accurate intervention efficacy estimates. Adherence to clinical trial products and procedures is dep...

  9. Interventions to improve adherence to exercise for chronic musculoskeletal pain in adults

    OpenAIRE

    Jordan, JL; Holden, MA; Mason, EE; Foster, NE

    2010-01-01

    BACKGROUND: Chronic musculoskeletal pain (CMP) is a major health problem, accounting for approximately one-quarter of general practice (GP) consultations in the United Kingdom (UK). Exercise and physical activity is beneficial for the most common types of CMP, such as back and knee pain. However, poor adherence to exercise and physical activity may limit long-term effectiveness. OBJECTIVES: To assess the effects of interventions to improve adherence to exercise and physical activity for peopl...

  10. Modeling Determinants of Medication Attitudes and Poor Adherence in Early Nonaffective Psychosis: Implications for Intervention

    OpenAIRE

    Drake, Richard J; Nordentoft, Merete; Haddock, Gillian; Arango, Celso; Fleischhacker, W. Wolfgang; Glenthøj, Birte; Leboyer, Marion; Leucht, Stefan; Leweke, Markus; McGuire, Phillip; Meyer-Lindenberg, Andreas; Rujescu, Dan; Sommer, Iris E.; Kahn, René S; Lewis, Shon W.

    2015-01-01

    We aimed to design a multimodal intervention to improve adherence following first episode psychosis, consistent with current evidence. Existing literature identified medication attitudes, insight, and characteristics of support as important determinants of adherence to medication: we examined medication attitudes, self-esteem, and insight in an early psychosis cohort better to understand their relationships. Existing longitudinal data from 309 patients with early Diagnostic and Statistical Ma...

  11. Type 2 diabetes: cost-effectiveness of medication adherence and lifestyle interventions

    Science.gov (United States)

    Nerat, Tomaž; Locatelli, Igor; Kos, Mitja

    2016-01-01

    Introduction Type 2 diabetes is a major burden for the payer, however, with proper medication adherence, diet and exercise regime, complication occurrence rates, and consequently costs can be altered. Aims The aim of this study was to conduct a cost-effectiveness analysis on real patient data and evaluate which medication adherence or lifestyle intervention is less cost demanding for the payer. Methods Medline was searched systematically for published type 2 diabetes interventions regarding medication adherence and lifestyle in order to determine their efficacies, that were then used in the cost-effectiveness analysis. For cost-effectiveness analysis-required disease progression simulation, United Kingdom Prospective Diabetes Study Outcomes model 2.0 and Slovenian type 2 diabetes patient cohort were used. The intervention duration was set to 1, 2, 5, and 10 years. Complications and drug costs in euro (EUR) were based on previously published type 2 diabetes costs from the Health Care payer perspective in Slovenia. Results Literature search proved the following interventions to be effective in type 2 diabetes patients: medication adherence, the Mediterranean diet, aerobic, resistance, and combined exercise. The long-term simulation resulted in no payer net savings. The model predicted following quality-adjusted life-years (QALY) gained and incremental costs for QALY gained (EUR/QALYg) after 10 years of intervention: high-efficacy medication adherence (0.245 QALY; 9,984 EUR/QALYg), combined exercise (0.119 QALY; 46,411 EUR/QALYg), low-efficacy medication adherence (0.075 QALY; 30,967 EUR/QALYg), aerobic exercise (0.069 QALY; 80,798 EUR/QALYg), the Mediterranean diet (0.057 QALY; 27,246 EUR/QALYg), and resistance exercise (0.050 QALY; 111,847 EUR/QALYg). Conclusion The results suggest that medication adherence intervention is, regarding cost-effectiveness, superior to diet and exercise interventions from the payer perspective. However, the latter could also be utilized

  12. Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence.

    Science.gov (United States)

    Spence, Patrick; Nel, Annalene; van Niekerk, Neliëtte; Derrick, Tiffany; Wilder, Susan; Devlin, Bríd

    2016-06-01

    Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female HIV transmission. Post-use assay results from three Ring-004 clinical trials showed that of the 25mg drug load, approximately 4mg of dapivirine is released from the matrix ring over a 28-day use period. Data obtained by both in vitro and in vivo studies indicate that dapivirine is released according to a diffusion mechanism, as determined by conformance of both data sets to the Higuchi equation. This, coupled with the low variability associated with batch production over two manufacturing sites and 20 batches of material, provides evidence that post-use ring analysis can contribute to the assessment of adherence to ring use. Limitations of this method include the potential of intra-participant and inter-participant variability and uncertainty associated with measuring the low amount of dapivirine actually released relative to the drug load. Therefore, residual drug levels should not serve as the only direct measurement for microbicide adherence in vaginal ring clinical trials but should preferably be used as part of a multi-pronged approach towards understanding and assessing adherence to vaginal ring use. PMID:27016673

  13. ‘It’s not about money, it’s about my health’: determinants of participation and adherence among women in an HIV-HSV2 prevention trial in Johannesburg, South Africa

    Directory of Open Access Journals (Sweden)

    MacPhail C

    2012-08-01

    Full Text Available Catherine MacPhail,1 Sinead Delany-Moretlwe,1 Philippe Mayaud21Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, South Africa; 2Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UKAbstract: High levels of adherence in clinical trials are essential for producing accurate intervention efficacy estimates. Adherence to clinical trial products and procedures is dependent on the motivations that drive participants. Data are presented to document reasons for trial participation and adherence to daily aciclovir for HSV-2 and HIV-1 genital shedding suppression among 300 HIV-1/HSV-2 seropositive women in South Africa. In-depth interviews after exit from the trial with 31 randomly selected women stratified by age and time since HIV diagnosis confirmed high levels of adherence measured during the trial. Main reasons for trial participation were related to seeking high-quality health care, which explains high levels of adherence in both study arms. Concerns that women would abuse reimbursements, fabricate data, and share or dump pills were not corroborated. Altruism is not a primary motivator in these settings where access to quality services is an issue. This study provides further evidence that good adherence of daily medication is possible in developing countries, particularly where study activities resonate with participants or fill an unmet need.Keywords: adherence, trial, HIV prevention, South Africa

  14. Development of a Patient-Centered Antipsychotic Medication Adherence Intervention

    Science.gov (United States)

    Pyne, Jeffrey M.; Fischer, Ellen P.; Gilmore, LaNissa; McSweeney, Jean C.; Stewart, Katharine E.; Mittal, Dinesh; Bost, James E.; Valenstein, Marcia

    2014-01-01

    Objective: A substantial gap exists between patients and their mental health providers about patient's perceived barriers, facilitators, and motivators (BFMs) for taking antipsychotic medications. This article describes how we used an intervention mapping (IM) framework coupled with qualitative and quantitative item-selection methods to…

  15. Interventions to increase medication adherence in African-American and Latino populations: a literature review.

    Science.gov (United States)

    Hu, Daniel; Juarez, Deborah Taira; Yeboah, Michelle; Castillo, Theresa P

    2014-01-01

    The objective of this systematic review was to investigate the effectiveness of interventions to improve medication adherence in ethnic minority populations. A literature search from January 2000 to August 2012 was conducted through PubMed/Medline, Web of Science, The Cochrane Library, and Google Scholar. Search terms used included: medication (MeSH), adherence, medication adherence (MeSH), compliance (MeSH), persistence, race, ethnicity, ethnic groups (MeSH), minority, African-American, Hispanic, Latino, Asian, Pacific Islander, and intervention. Studies which did not have ≥75% of the sample population comprised of individuals of any one ethnic background were excluded, unless the authors performed sub-group analyses by race/ethnicity. Of the 36 studies identified, 20 studies showed significant post-intervention differences. Sample population sizes ranged from 10 to 520, with a median of 126.5. The studies in this review were conducted with patients of mainly African-American and Latino descent. No studies were identified which focused on Asians, Pacific Islanders, or Native Americans. Interventions demonstrating mixed results included motivational interviewing, reminder devices, community health worker (CHW) delivered interventions, and pharmacist-delivered interventions. Directly observed therapy (DOT) was a successful intervention in two studies. Interventions which did not involve human contact with patients were ineffective. In this literature review, studies varied significantly in their methods and design as well as the populations studied. There was a lack of congruence among studies in the way adherence was measured and reported. No single intervention has been seen to be universally successful, particularly for patients from ethnic minority backgrounds.

  16. European Nicotinamide Diabetes Intervention Trial (ENDIT)

    DEFF Research Database (Denmark)

    Gale, E A M; Bingley, P J; Emmett, C L;

    2004-01-01

    BACKGROUND: Results of studies in animals and human beings suggest that type 1 diabetes is preventable. Nicotinamide prevents autoimmune diabetes in animal models, possibly through inhibition of the DNA repair enzyme poly-ADP-ribose polymerase and prevention of beta-cell NAD depletion. We aimed...... to assess whether high dose nicotinamide prevents or delays clinical onset of diabetes in people with a first-degree family history of type 1 diabetes. METHOD: We did a randomised double-blind placebo-controlled trial of nicotinamide in 552 relatives with confirmed islet cell antibody (ICA) levels of 20...... secretion. INTERPRETATION: Large-scale controlled trials of interventions designed to prevent the onset of type 1 diabetes are feasible, but nicotinamide was ineffective at the dose we used....

  17. Interventions to improve adherence to first-line antibiotics in respiratory tract infections

    DEFF Research Database (Denmark)

    Llor, Carl; Monedero, María José; García, Guillermo;

    2015-01-01

    intervention (II), aimed to improve the adherence to recommendations on first-line antibiotics in patients with respiratory tract infections (RTIs). Methods: General practitioners (GPs) from different regions of Spain were offered two different interventions on antibiotic prescribing. They registered all...... included training and access to point-of-care tests in practice. Results: The GPs registered 15 073 RTIs before the intervention and 12 760 RTIs after. The antibiotic prescribing rate reduced from 27.7% to 19.8%. Prescribing of first-choice antibiotics increased after the intervention in both groups...

  18. Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence

    Directory of Open Access Journals (Sweden)

    Prevost A Toby

    2010-11-01

    % confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I. Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II. Discussion This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed. Trial details Funder: Medical Research Council (MRC Grant number: G0500274 ISRCTN: 14352545 Date trial stated: June 2007 Expected end date: December 2009 Expected reporting date: December 2010

  19. The Nurse-Led Telephone Follow-Up on Medication and Dietary Adherence among Patients after Myocardial Infarction: A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Najafi, Seyed Saeed; Shaabani, Maryam; Momennassab, Marzieh; Aghasadeghi, Kamran

    2016-01-01

    Background: Adherence to dietary and medication regimen plays an important role in successful treatment and reduces the negative complications and severity of the disease. Therefore, the present study aimed to investigate the effect of nurse-led telephone follow-up on the level of adherence to dietary and medication regimen among patients after Myocardial Infarction (MI). Methods: This non-blinded randomized controlled clinical trial was conducted on 100 elderly patients with MI who had referred to the cardiovascular clinics in Shiraz. Participants were selected and randomly assigned to intervention and control groups using balanced block randomization method. The intervention group received a nurse-led telephone follow-up. The data were collected using a demographic questionnaire, Morisky’s 8-item medication adherence questionnaire, and dietary adherence questionnaire before and three months after the intervention. Data analysis was done by the SPSS statistical software (version 21), using paired t-test for intra-group and Chi-square and t-test for between groups comparisons. Significance level was set at0.05). However, a statistically significant difference was found between the two groups in this regard after the intervention (P<0.05). The mean differences of dietary and medication adherence scores between pre- and post-tests were significantly different between the two groups. Independent t-test showed these differences (P=0.001). Conclusion: The results of the present study confirmed the positive effects of nurse-led telephone follow-up as a method of tele-nursing on improvement of adherence to dietary and medication regimen in the patients with MI. Trial Registration Number: IRCT201409148505N8 PMID:27382586

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

    Directory of Open Access Journals (Sweden)

    Kathleen M MacQueen

    2014-09-01

    Full Text Available Introduction: 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. Discussion: 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

  1. Technology and adherence in web-based interventions for weight control: a systematic review

    NARCIS (Netherlands)

    Kelders, Saskia M.; Kok, Robin N.; Gemert-Pijnen, van Julia E.W.C.; Haugtvedt, C.P.; Stibe, A.

    2011-01-01

    While technology based health interventions can be effective, high attrition rates are commonly observed in research and practice and are a major issue in eHealth. Research on adherence has recently gained some scientific attention, but little has been done as to how technology itself engages users.

  2. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    OpenAIRE

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2013-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was hig...

  3. Effectiveness of motivational interviewing to improve therapeutic adherence in patients over 65 years old with chronic diseases: A cluster randomized clinical trial in primary care.

    OpenAIRE

    Ruiz Moral, Roger; Pérula de Torres, Luis Ángel; Pulido Ortega, Laura; Criado Larumbe, Margarita; Roldán Villalobos, Ana; Fernández García, José Ángel; Parras Rejano, Juan Manuel

    2015-01-01

    Objective: To evaluate the effectiveness of motivational interviewing (MI) in improving medication adherence in older patients being treated by polypharmacy. Methods: Cluster randomized clinical trial in 16 primary care centers with 27 health care providers and 154 patients. Thirty-two health care providers were assigned to an experimental (EG) or control group (CG). Interventions: MI training program and review of patient treatments. Providers in the EG carried out MI, whereas...

  4. Improving medication adherence with a targeted, technology-driven disease management intervention.

    Science.gov (United States)

    Lawrence, David B; Allison, Wanda; Chen, Joyce C; Demand, Michael

    2008-06-01

    Treatment adherence is critical in managing chronic disease, but achieving it remains an elusive goal across many prevalent conditions. As part of its care management strategy, BlueCross BlueShield of South Carolina (BCBSSC) implemented the Longitudinal Adherence Treatment Evaluation program, a behavioral intervention to improve medication adherence among members with cardiovascular disease and/or diabetes. The objectives of this study were to 1) assess the effectiveness of telephonic intervention in influencing reinitiation of medication therapy, and 2) evaluate the rate and timing of medication reinitiation. BCBSSC applied algorithms against pharmacy claims data to identify patients prescribed targeted medications who were 60 or more days overdue for refills. This information was provided to care managers to address during their next patient contact. Care managers received focused training on techniques for medication behavior change, readiness to change, motivational interviewing, and active listening. Training also addressed common barriers to adherence and available resources, including side effect management, mail order benefits, drug assistance programs, medication organizers, and reminder systems. Overdue refills were tracked for 12 months, with medication reinitiation followed for an additional 3 months. In the intervention group, 94 patients were identified with 123 instances of late medication refills. In the age- and gender-matched comparison group, 61 patients were identified with 76 late refills. The intervention group had a significantly higher rate of medication reinitiation (59.3%) than the control group (42.1%; P management intervention promoting patient behavior change increased the number of patients who reinitiated therapy after a period of nonadherence and decreased the time from nonadherence to adherence.

  5. A Comparison between The Effectiveness of Short Message Service and Reminder Cards Regarding Medication Adherence in Patients with Hypertension: A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Maslakpak, Masumeh Hemmati; Safaie, Mahsa

    2016-01-01

    Background: Hypertension is increasing rapidly in developing countries. Today, modern technologies are suggested as the tools used to enhance medication adherence. This study aimed to compare the effectiveness of short message service (SMS) to reminder cards with regard to medication adherence in patients with hypertension. Methods: The present study is a randomized controlled clinical trial. The subjects consisted of 123 patients with hypertension at the clinical-educational center of Sayyed-Al Shohada, Urmia, who met the study criteria. Selected based on the convenience method, the samples were randomly divided into three groups: the SMS group, the reminder-cards group, and the control group. The subjects in the SMS group were sent 6 text messages a week for three months, and the subjects in the reminder-cards group were trained in how and in what order to use their cards. Hill-Bone medication adherence scale was completed by all the participants before and three months after the intervention. Data analysis was performed in SPSS software, using one-way ANOVA. Hill-Bone medication adherence scale was completed by all the participants before and three months after the intervention. Data analysis was performed in SPSS software, using one-way ANOVA. Results: The results of ANOVA test demonstrated that the mean scores of medication adherence were statistically different among the three groups of control (46.63±2.99), SMS (57.70±2.75) and the reminder cards (57.51±2.69) after the intervention (P0.05). Conclusion: The findings of the present research demonstrated that training and distance-monitoring via SMS and reminder cards promote medication adherence of patients. Therefore, healthcare teams and nurses are recommended to apply such training methods. Trial Registration Number: IRCT2015110917059N2 PMID:27382587

  6. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  7. Cost-effectiveness of a community pharmacist intervention in patients with depression: a randomized controlled trial (PRODEFAR Study.

    Directory of Open Access Journals (Sweden)

    Maria Rubio-Valera

    Full Text Available Non-adherence to antidepressants generates higher costs for the treatment of depression. Little is known about the cost-effectiveness of pharmacist's interventions aimed at improving adherence to antidepressants. The study aimed to evaluate the cost-effectiveness of a community pharmacist intervention in comparison with usual care in depressed patients initiating treatment with antidepressants in primary care.Patients were recruited by general practitioners and randomized to community pharmacist intervention (87 that received an educational intervention and usual care (92. Adherence to antidepressants, clinical symptoms, Quality-Adjusted Life-Years (QALYs, use of healthcare services and productivity losses were measured at baseline, 3 and 6 months.There were no significant differences between groups in costs or effects. From a societal perspective, the incremental cost-effectiveness ratio (ICER for the community pharmacist intervention compared with usual care was €1,866 for extra adherent patient and €9,872 per extra QALY. In terms of remission of depressive symptoms, the usual care dominated the community pharmacist intervention. If willingness to pay (WTP is €30,000 per extra adherent patient, remission of symptoms or QALYs, the probability of the community pharmacist intervention being cost-effective was 0.71, 0.46 and 0.75, respectively (societal perspective. From a healthcare perspective, the probability of the community pharmacist intervention being cost-effective in terms of adherence, QALYs and remission was of 0.71, 0.76 and 0.46, respectively, if WTP is €30,000.A brief community pharmacist intervention addressed to depressed patients initiating antidepressant treatment showed a probability of being cost-effective of 0.71 and 0.75 in terms of improvement of adherence and QALYs, respectively, when compared to usual care. Regular implementation of the community pharmacist intervention is not recommended.ClinicalTrials.gov NCT

  8. Improving adherence to antiretroviral treatment in Uganda with a low-resource facility-based intervention

    Directory of Open Access Journals (Sweden)

    Celestino Obua

    2014-06-01

    Full Text Available Objective: To assess the effects of facility-based interventions using existing resources to improve overall patient attendance and adherence to antiretroviral therapy (ART at ART-providing facilities in Uganda. Methods: This was an interventional study which tracked attendance and treatment adherence of two distinct cohorts: experienced patients who had been on treatment for at least 12 months prior to the intervention and patients newly initiated on ART before or during the intervention. The interventions included instituting appointment system, fast-tracking, and giving longer prescriptions to experienced stable patients. Mixed-effects models were used to examine intervention effects on the experienced patients, while Cox proportional hazards models were used to determine the intervention effects on time until newly treated patients experienced gaps in medication availability. Results: In all, 1481 patients’ files were selected for follow-up from six facilities – 720 into the experienced cohort, and 761 into the newly treated cohort. Among patients in the experienced cohort, the interventions were associated with a significant reduction from 24.4 to 20.3% of missed appointments (adjusted odds ratio (AOR: 0.67; 95% confidence interval (CI: 0.59–0.77; a significant decrease from 20.2 to 18.4% in the medication gaps of three or more days (AOR: 0.69; 95% CI: 0.60–0.79; and a significant increase from 4.3 to 9.3% in the proportion of patients receiving more than 30 days of dispensed medication (AOR: 2.35; 95% CI: 1.91–2.89. Among newly treated patients, the interventions were associated with significant reductions of 44% (adjusted hazard rate (AHR: 0.56, 95% CI: 0.42–0.74 and 38% (AHR: 0.62; 95% CI: 0.45–0.85 in the hazards of experiencing a medication gap of 7 and 14 days or more, respectively. Conclusions: Patients’ adherence was improved with low-cost and easily implemented interventions using existing health facilities

  9. The cameroon mobile phone sms (CAMPS trial: a protocol for a randomized controlled trial of mobile phone text messaging versus usual care for improving adherence to highly active anti-retroviral therapy

    Directory of Open Access Journals (Sweden)

    Mba Robert

    2011-01-01

    Full Text Available Abstract Background This trial aims at testing the efficacy of weekly reminder and motivational text messages, compared to usual care in improving adherence to Highly Active Antiretroviral Treatment in patients attending a clinic in Yaoundé, Cameroon. Methods and Design This is a single-centered randomized controlled single-blinded trial. A central computer generated randomization list will be generated using random block sizes. Allocation will be determined by sequentially numbered sealed opaque envelopes. 198 participants will either receive the mobile phone text message or usual care. Our hypothesis is that weekly motivational text messages can improve adherence to Highly Active Antiretroviral Treatment and other clinical outcomes in the control group by acting as a reminder, a cue to action and opening communication channels. Data will be collected at baseline, three months and six months. A blinded program secretary will send out text messages and record delivery. Our primary outcomes are adherence measured by the visual analogue scale, self report, and pharmacy refill data. Our secondary outcomes are clinical: weight, body mass index, opportunistic infections, all cause mortality and retention; biological: Cluster Designation 4 count and viral load; and quality of life. Analysis will be by intention-to-treat. Covariates and subgroups will be taken into account. Discussion This trial investigates the potential of SMS motivational reminders to improve adherence to Highly Active Antiretroviral Treatment in Cameroon. The intervention targets non-adherence due to forgetfulness and other forms of non-adherence. Trial Registration Pan-African Clinical Trials Registry PACTR201011000261458 http://clinicaltrials.gov/NCT01247181

  10. The relationship between treatment attendance, adherence, and outcome in a caregiver-mediated intervention for low-resourced families of young children with autism spectrum disorder.

    Science.gov (United States)

    Carr, Themba; Shih, Wendy; Lawton, Kathy; Lord, Catherine; King, Bryan; Kasari, Connie

    2016-08-01

    Rates of participation in intervention research have not been extensively studied within autism spectrum disorder. Such research is important given the benefit of early intervention on long-term prognosis for children with autism spectrum disorder. The goals of this study were to examine how family demographic factors predicted treatment attendance and adherence in a caregiver-mediated randomized controlled trial targeting core deficits of autism spectrum disorder, and whether treatment attendance and adherence predicted outcome. In all, 147 caregiver-child dyads from a low-resourced population were randomized to in-home caregiver-mediated module or group-based caregiver education module treatment. Treatment attendance, adherence, and outcome (time spent in joint engagement) were the primary outcome variables. The majority of families who entered treatment (N = 87) maintained good attendance. Attendance was significantly predicted by socioeconomic status, site, and treatment condition. Families in caregiver-mediated module reported lower levels of treatment adherence, which was significantly predicted by site, condition, caregiver stress, and child nonverbal intelligence quotient. Dyads in caregiver-mediated module had significantly longer interactions of joint engagement, which was significantly predicted by an interaction between treatment attendance and condition. Overall, the results from this study stress the importance of considering demographic variables in research design when considering barriers to treatment attendance and adherence. PMID:26290524

  11. Attrition and Adherence in a Web-Based Distress Management Program for Implantable Cardioverter Defibrillator Patients (WEBCARE): Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Habibovic, M.; Cuijpers, P.; Alings, M.;

    2014-01-01

    . Conclusions: Current findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes....

  12. Behavioral Interventions to Enhance Adherence to Hormone Therapy in Breast Cancer Survivors: A Systematic Literature Review.

    Science.gov (United States)

    Hurtado-de-Mendoza, Alejandra; Cabling, Mark L; Lobo, Tania; Dash, Chiranjeev; Sheppard, Vanessa B

    2016-08-01

    Adjuvant hormone therapy contributes to reductions in recurrence and mortality for women with hormone receptor-positive breast cancer. However, adherence to hormone therapy is suboptimal. This is the first systematic literature review examining interventions aimed at improving hormone therapy adherence. Researchers followed the PRISMA guidelines. PubMed-Medline, CINAHL, PsychInfo, Ovid-Medline, and EMBASE were searched for behavioral interventions that aimed to enhance adherence to adjuvant hormone therapy in breast cancer survivors. A total of 376 articles were screened for eligibility. Five articles met the study criteria. All interventions presented adherence outcomes after 1-year follow-up. None significantly enhanced adherence compared to the usual care in the primary analysis (odds ratios ranged from 1.03 to 2.06 for adherence and from 1.11 to 1.18 for persistence). All studies targeted patients, and only 3 studies included postmenopausal breast cancer patients. Three tested the same intervention consisting of educational materials. Only one was conducted in the United States. Only one reported participants' ethnicity. Overall, it was unclear whether the studies contained bias. The use of different terminology and operationalization of adherence made comparisons challenging. Interventions to improve adherence to adjuvant hormone therapy in US breast cancer populations that include survivors who are ethnically diverse, premenopausal, and receiving tamoxifen therapy are necessary to inform future interventions. Adoption of consistent adherence definitions/measurements will provide a clearer framework to consolidate aggregate findings. Given the limited efficacy of tested interventions, it is important to engage oncologists and researchers to develop approaches that target different components associated with hormone therapy adherence, such as doctor-patient communication or social support. PMID:27133733

  13. Adherence of non-pharmaceutically sponsored oncology trial protocols to the International Conference on Harmonization (ICH) guidelines in an academic institution outside the ICH jurisdictions and the impact of IRB implementation on this adherence

    International Nuclear Information System (INIS)

    Purpose: To assess adherence of non-pharmaceutically sponsored trials (non-PSTs) to ICH protocol structure guidelines and to estimate the effect of implementing Institutional Review Boards (IRB) review on this adherence. Methods: This is a retrospective exploratory study where 60 non-PST clinical trial protocols (CTPs) were reviewed and halved to IRB-reviewed CTPs (IRCTPs) and non-lRB-reviewed CTPs (non-lRCTPs). Adherence score (AS) was calculated as the number of fulfilled items or sub-items divided by their total number. Results: Three adherence patterns were encountered: (1) items consistently present in both groups e.g. general and background information, objectives, inclusion criteria and intervention details, (2) items consistently absent in both groups and included contact information of investigators and trial sites, product accountability, randomization codes management, interim analyses and many other statistical aspects, and (3) items variably present in both groups where the effect of IRB was verifiable. Trial site details, potential benefits, discontinuation and exclusion criteria, and follow up for adverse events were more encountered in IRCTPs than non-IRCTPs. Withdrawal criteria monitoring of treatment compliance showed a reverse pattern (p < 0.05 for all). The total AS, administrative AS and ethics AS for IRCTPs was 43%, 22% and 70% compared to 38%, 16% and 33% for non-IRCTPs (p < 0.003, <0.001, 0.004), respectively. The scientific AS was 54% for both groups (p = 0.87). Conclusions: IRB-implementation at NCl-Egypt improved ethical and administrative sections of academic protocols. However, this improvement is modest and needs further actions including adoption of protocol templates. Scientific sections were as good after IRB-implementation as they were before that

  14. Adherence to diet on diabetic patients: effects of an intervention program

    Directory of Open Access Journals (Sweden)

    María De Lourdes Rodríguez Campuzano

    2013-07-01

    Full Text Available The purpose of the present study was to assess the effect of an intervention program on the self-reported adherence to a prescribed diet for diabetic patients. Because of the impact and consequences of this chronic illness, it is important to make the necessary efforts in order to achieve this dietary adherence goal, since diet is one of the main bases for the treatment of diabetes. According to an interbehavioral approach, an intervention program was designed and applied to ninety diabetic patients from different Mexican public health institutions. This program was developed in three stages. The first stage consisted of a pre-test to assess body weight and habits related to daily meals. The second stage comprehended an intervention divided in two parts, the first one to provide patients with useful knowledge about diabetes and nutrition and the second one to train several behavioral techniques a post-test was applied to participants. Results showed that each intervention’s part had a positive effect on self-reported adherence to diet, and so the complete program. These results were supported by weight data. In this sense, it was found a statistically significant difference between pre and post-test values. It is suggested to continue these efforts in order to contribute on the solution of this public health problem.

  15. Interventions to enhance adherence to dietary advice for preventing and managing chronic diseases in adults: a study protocol

    OpenAIRE

    Gravel Karine; Ratté Stéphane; Lapointe Annie; Desroches Sophie; Légaré France; Thirsk Jayne

    2011-01-01

    Abstract Background Adoption of a healthy diet has been identified as the cornerstone in the prevention and management of chronic diseases. However, non-adherence to lifestyle changes raises an important issue since adherence level to dietary advice is a key determinant of the effectiveness of dietary treatment. Therefore, based on the results of a Cochrane systematic review on interventions for enhancing adherence to dietary advice for preventing and managing chronic diseases in adults, the ...

  16. The effect of different intervention programs on treatment adherence of HIV-infected children, a retrospective study.

    Science.gov (United States)

    van der Plas, Atie; Scherpbier, Henriette; Kuijpers, Taco; Pajkrt, Dasja

    2013-01-01

    In HIV-infected children, long-term adherence to combination anti-retroviral therapy (cART) is difficult. In this retrospective study, we evaluated the effect of two different treatment adherence programs on treatment adherence (as indicated by cART failures) and the need for additional supportive care measures in a cohort of 31 HIV-infected children between 3 and 18 years of age. In a follow-up period of 6 years, we evaluated the treatment adherence at baseline (before introduction of any treatment adherence program in 2004) and compared this to cART failures during two treatment adherence programs (in respectively 2006 and 2009). The need for additional supportive care measures (the frequency of hospitalizations, daily observed treatment, use of child protection service, attendance of special schools, and placement in foster homes) was also evaluated at these three time points. The first treatment adherence program focused on increasing patient's obedience by imposing negative measures in case of treatment failure, whereas the second program aimed to increase treatment adherence by rewarding optimal medication intake. Prior to start of any treatment adherence intervention program, cART failures were observed in 29% of the pediatric patients. After introduction of the first treatment adherence program, cART failures decreased to 6%. During the second treatment adherence program, the cART failures remained equally low (10%), but the need for some specific additional supportive care measures (the frequency of hospitalizations and placement in foster homes) was importantly reduced. Treatment adherence programs are effective in increasing treatment adherence to cART in HIV-infected children. A novel reward treatment interventional program as an addition to social supportive care programs is a promising new positive enforcement program and can reduce the need for additional supportive care programs. Further prospective studies are needed to evaluate the long

  17. The association of health literacy with adherence in older adults, and its role in interventions : a systematic meta-review

    NARCIS (Netherlands)

    Geboers, Bas; Brainard, Julii S.; Loke, Yoon K.; Jansen, Carel J. M.; Salter, Charlotte; Reijneveld, Sijmen A.; de Winter, Andrea F.

    2015-01-01

    Background: Low health literacy is a common problem among older adults. It is often suggested to be associated with poor adherence. This suggested association implies a need for effective adherence interventions in low health literate people. However, previous reviews show mixed results on the assoc

  18. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  19. Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

    Directory of Open Access Journals (Sweden)

    Puig-Ribera Anna

    2009-01-01

    Full Text Available Abstract Background Declining physical activity is associated with a rising burden of global disease. There is little evidence about effective ways to increase adherence to physical activity. Therefore, interventions are needed that produce sustained increases in adherence to physical activity and are cost-effective. The purpose is to assess the effectiveness of a primary care physical activity intervention in increasing adherence to physical activity in the general population seen in primary care. Method and design Randomized controlled trial with systematic random sampling. A total of 424 subjects of both sexes will participate; all will be over the age of 18 with a low level of physical activity (according to the International Physical Activity Questionnaire, IPAQ, self-employed and from 9 Primary Healthcare Centres (PHC. They will volunteer to participate in a physical activity programme during 3 months (24 sessions; 2 sessions a week, 60 minutes per session. Participants from each PHC will be randomly allocated to an intervention (IG and control group (CG. The following parameters will be assessed pre and post intervention in both groups: (1 health-related quality of life (SF-12, (2 physical activity stage of change (Prochaska's stages of change, (3 level of physical activity (IPAQ-short version, (4 change in perception of health (vignettes from the Cooperative World Organization of National Colleges, Academies, and Academic Associations of Family Physicians, COOP/WONCA, (5 level of social support for the physical activity practice (Social Support for Physical Activity Scale, SSPAS, and (6 control based on analysis (HDL, LDL and glycated haemoglobin. Participants' frequency of visits to the PHC will be registered over the six months before and after the programme. There will be a follow up in a face to face interview three, six and twelve months after the programme, with the reduced version of IPAQ, SF-12, SSPAS, and Prochaska's stages

  20. How to Increase Reach and Adherence of Web-Based Interventions: A Design Research Viewpoint.

    Science.gov (United States)

    Ludden, Geke D S; van Rompay, Thomas J L; Kelders, Saskia M; van Gemert-Pijnen, Julia E W C

    2015-01-01

    Nowadays, technology is increasingly used to increase people's well-being. For example, many mobile and Web-based apps have been developed that can support people to become mentally fit or to manage their daily diet. However, analyses of current Web-based interventions show that many systems are only used by a specific group of users (eg, women, highly educated), and that even they often do not persist and drop out as the intervention unfolds. In this paper, we assess the impact of design features of Web-based interventions on reach and adherence and conclude that the power that design can have has not been used to its full potential. We propose looking at design research as a source of inspiration for new (to the field) design approaches. The paper goes on to specify and discuss three of these approaches: personalization, ambient information, and use of metaphors. Central to our viewpoint is the role of positive affect triggered by well-designed persuasive features to boost adherence and well-being. Finally, we discuss the future of persuasive eHealth interventions and suggest avenues for follow-up research.

  1. Excellent adherence and no contamination by physiotherapists involved in a randomized controlled trial on reactivation of COPD patients: a qualitative process evaluation study

    Directory of Open Access Journals (Sweden)

    Effing TW

    2012-05-01

    Full Text Available Tanja W Effing,1,2 Manon Krabbenbos,3 Marcel E Pieterse,4 Paul DLPM van der Valk,3 Gerhard A Zielhuis,5 Huib AM Kerstjens,6 Job van der Palen,371Repatriation General Hospital, Department of Respiratory Medicine, Daw Park, 2Flinders University, School of Medicine, Adelaide, South Australia, Australia; 3Medisch Spectrum Twente, Department of Pulmonology, Enschede, 4Department of Psychology, Health and Technology, Enschede, 5Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen, Nijmegen, 6Department of Pulmonology, University Medical Center Groningen, University of Groningen, Groningen, 7Department of Research Methodology, Measurement and Data Analysis, University of Twente, The Netherlands Objective: To assess the adherence of physiotherapists to the study protocol and the occurrence of contamination bias during the course of a randomized controlled trial with a recruitment period of 2 years and a 1-year follow-up (COPE-II study.Study design and setting: In the COPE-II study, intervention patients received a standardized physiotherapeutic reactivation intervention (COPE-active and control patients received usual care. The latter could include regular physiotherapy treatment. Information about the adherence of physiotherapists with the study protocol was collected by performing a single interview with both intervention and control patients. Patients were only interviewed when they were currently receiving physiotherapy. Interviews were performed during two separate time periods, 10 months apart. Nine characteristics of the COPE-active intervention were scored. Scores were converted into percentages (0%, no aspects of COPE-active; 100%, full implementation of COPE-active.Results: Fifty-one patients were interviewed (first period: intervention n = 14 and control n = 10; second period: intervention n = 18 and control n = 9. Adherence with the COPE-active protocol was high (median scores: period 1, 96.8%; period 2, 92.1%, and

  2. Cultural adaptation of an evidence-based nursing intervention to improve medication adherence among people living with HIV/AIDS (PLWHA) in China

    Science.gov (United States)

    Williams, Ann B.; Wang, Honghong; Burgess, Jane; Li, Xianhong; Danvers, Karina

    2012-01-01

    BACKGROUND Adapting nursing interventions to suit the needs and culture of a new population (cultural adaptation) is an important early step in the process of implementation and dissemination. While the need for cultural adaptation is widely accepted, research-based strategies for doing so are not well articulated. Non-adherence to medications for chronic disease is a global problem and cultural adaptation of existing evidence-based interventions could be useful. OBJECTIVES This paper aims to describe the cultural adaptation of an evidence-based nursing intervention to improve medication adherence among people living with HIV/AIDS and to offer recommendations for adaptation of interventions across cultures and borders. SITE The intervention, which demonstrated efficacy in a randomized controlled trial in North America, was adapted for the cultural and social context of Hunan Province, in south central China. SOURCES OF DATA The adaptation process was undertaken by intervention stakeholders including the original intervention study team, the proposed adaptation team, and members of a Community Advisory Board, including people living with HIV/AIDS, family members, and health care workers at the target clinical sites. PROCEDURES The adaptation process was driven by quantitative and qualitative data describing the new population and context and was guided by principles for cultural adaptation drawn from prevention science research. RESULTS The primary adaptation to the intervention was the inclusion of family members in intervention activities, in response to the cultural and social importance of the family in rural China. In a pilot test of the adapted intervention, self-reported medication adherence improved significantly in the group receiving the intervention compared to the control group (p=0.01). Recommendations for cultural adaptation of nursing interventions include 1) involve stakeholders from the beginning; 2) assess the population, need, and context; 3

  3. Evaluating a nationwide recreational football intervention: Recruitment, attendance, adherence, exercise intensity, and health effects

    DEFF Research Database (Denmark)

    Fløtum, Liljan av; Ottesen, Laila; Krustrup, Peter;

    2016-01-01

    The present study evaluated a nationwide exercise intervention with Football Fitness in a small-scale society. In all, 741 adult participants (20–72 yrs) were successfully recruited for Football Fitness training in local football clubs, corresponding to 2.1% of the adult population. A preinterven......-promoting nationwide training intervention for adult participants with an extraordinary recruitment, a high attendance rate, moderate adherence, high exercise intensity, and marked benefits in cardiovascular health profile and fitness.......The present study evaluated a nationwide exercise intervention with Football Fitness in a small-scale society. In all, 741 adult participants (20–72 yrs) were successfully recruited for Football Fitness training in local football clubs, corresponding to 2.1% of the adult population......). RHR was lowered (푃 health...

  4. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  5. Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies.

    Science.gov (United States)

    Mohr, David C; Schueller, Stephen M; Riley, William T; Brown, C Hendricks; Cuijpers, Pim; Duan, Naihua; Kwasny, Mary J; Stiles-Shields, Colleen; Cheung, Ken

    2015-07-08

    In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.

  6. Correlates of Adherence to a Telephone-Based Multiple Health Behavior Change Cancer Preventive Intervention for Teens: The Healthy for Life Program (HELP)

    Science.gov (United States)

    Mays, Darren; Peshkin, Beth N.; Sharff, McKane E.; Walker, Leslie R.; Abraham, Anisha A.; Hawkins, Kirsten; Tercyak, Kenneth P.

    2012-01-01

    This study examined factors associated with teens’ adherence to a multiple health behavior cancer preventive intervention. Analyses identified predictors of trial enrollment, run-in completion, and adherence (intervention initiation, number of sessions completed). Of 104 teens screened, 73% (n = 76) were trial-eligible. White teens were more likely to enroll than non-whites (χ2 [1] df = 4.49, p = 0.04). Among enrolled teens, 76% (n = 50) completed the run-in; there were no differences between run-in completers and non-completers. A majority of run-in completers (70%, n = 35) initiated the intervention, though teens who initiated the intervention were significantly younger than those who did not (p < 0.05). The mean number of sessions completed was 5.7 (SD = 2.6; maximum = 8). After adjusting for age, teens with poorer session engagement (e.g., less cooperative) completed fewer sessions (B = -1.97, p = 0.003, R2 = 0.24). Implications for adolescent cancer prevention research are discussed. PMID:21632437

  7. The meaning of adherence when behavioral risk patterns vary: obscured use- and method-effectiveness in HIV-prevention trials.

    Directory of Open Access Journals (Sweden)

    Marijn de Bruin

    Full Text Available BACKGROUND: Recently promising trials of innovative biomedical approaches to prevent HIV transmission have been reported. Participants' non-adherence to the prevention methods complicates the analyses and interpretation of trial results. The influence of variable sexual behaviors within and between participants of trials further obscures matters. Current methodological and statistical approaches in HIV-prevention studies, as well as ongoing debates on contradictory trial results, may fail to accurately address these topics. METHODOLOGY/PRINCIPAL FINDINGS: Through developing a cumulative probability model of infection within HIV prevention trials, we demonstrate how adherence and sexual behavior patterns impact the overall estimate of effectiveness, the effectiveness of prevention methods as a function of adherence, and conclusions about methods' true effectiveness. Applying the model to summary-level data from the CAPRISA trial, we observe markedly different values for the true method effectiveness of the microbicide, and show that if the gel would have been tested among women with slightly different sexual behavior patterns, conclusions might well have been that the gel is not effective. CONCLUSIONS/SIGNIFICANCE: Relative risk and adherence analyses in HIV prevention trials overlook the complex interplay between adherence and sexual behavior patterns. Consequently, they may not provide accurate estimates of use- and method-effectiveness. Moreover, trial conclusions are contingent upon the predominant sexual behavior pattern of participants and cannot be directly generalized to other contexts. We recommend researchers to (reexamine their data and use the cumulative probability model to estimate the true method effectiveness, which might contribute to resolving current questions about contradictory trial results. Moreover, we suggest taking into account the issues raised in the design of future trials and in population models estimating the

  8. The Meaning of Adherence When Behavioral Risk Patterns Vary: Obscured Use- and Method-Effectiveness in HIV-Prevention Trials

    NARCIS (Netherlands)

    Bruin, de M.; Viechtbauer, W.

    2012-01-01

    Background Recently promising trials of innovative biomedical approaches to prevent HIV transmission have been reported. Participants' non-adherence to the prevention methods complicates the analyses and interpretation of trial results. The influence of variable sexual behaviors within and between p

  9. The meaning of adherence when behavioral risk patterns vary: obscured use- and method-effectiveness in HIV-prevention trials

    NARCIS (Netherlands)

    M. de Bruin; W. Viechtbauer

    2012-01-01

    Background Recently promising trials of innovative biomedical approaches to prevent HIV transmission have been reported. Participants' non-adherence to the prevention methods complicates the analyses and interpretation of trial results. The influence of variable sexual behaviors within and between p

  10. Process- and patient-reported outcomes of a multifaceted medication adherence intervention for hypertensive patients in secondary care

    DEFF Research Database (Denmark)

    Hedegaard, Ulla; Hallas, Jesper; Ravn-Nielsen, Lene Vestergaard;

    2015-01-01

    potential adherence problems. OBJECTIVES: To evaluate process outcomes and patient- and pharmacist-reported outcomes of a pharmacist adherence intervention for hypertensive patients treated in hospital outpatient clinics. Secondly, to determine the agreement between two different adherence metrics...... calls. Two tools were used to identify adherence problems: The Drug Adherence Work-up (DRAW) tool and an adherence questionnaire. Process data included drug-related problems (DRPs) with recommendations to the physicians, medication- and lifestyle problems identified at the patient interview, actions......-related and 40% lifestyle-related. In connection with the interview, 528 actions were taken within 8 different categories. MI was a central technique applicable for most problems and was employed in nearly all patients (94%). About half of the patients reported increased focus on lifestyle change, and 21...

  11. Development of Motivate4Change Using the Intervention Mapping Protocol: An Interactive Technology Physical Activity and Medication Adherence Promotion Program for Hospitalized Heart Failure Patients

    OpenAIRE

    Oosterom-Calo, Rony; te Velde, Saskia J; Stut, Wim; Brug, Johannes

    2015-01-01

    Background It is important that heart failure (HF) patients adhere to their medication regimen and engage in physical activity. Evidence shows that adherence to these HF self-management behaviors can be improved with appropriate interventions. Objective To further promote medication adherence and physical activity among HF patients, we developed an intervention for hospitalized HF patients. Methods The intervention mapping protocol was applied in the development of the intervention. This enta...

  12. Developing a nicotine patch adherence intervention for HIV-positive Latino smokers.

    Science.gov (United States)

    Shadel, William G; Galvan, Frank H; Tucker, Joan S

    2016-08-01

    This paper describes two phases of formative research that had the goal of developing a treatment designed to improve adherence with the nicotine patch in HIV-positive Latino smokers. Each research phase (Phase I and II) was conducted independent of the other and used different qualitative methods to inform the development of the intervention. Phase I interviewed n=14 smokers who had previous experience using the nicotine patch to gain detailed understanding of how, when, and why they used it; their perceived barriers to using it; and their perspective on ways to improve adherence to it. Phase II provided n=35 smokers with brief smoking cessation treatment and nicotine patches, then interviewed them in "near real time" over a two month period about their use of the patch during a quit attempt (e.g., perceived barriers and facilitators). Authors of the paper extracted relevant themes emerging from the interview transcripts across the two phases. Results indicated that consistent use of the nicotine patch was associated with maintaining high motivation for use (i.e., not necessarily motivation to quit, but motivation to continue patch use); linking its use with established daily routines (e.g., with taking other medications, with brushing teeth); and maintaining realistic expectations for patch efficacy (e.g., that users may still experience some level of craving and/or withdrawal). This information will used to develop and pilot test a brief treatment module that focuses on improving nicotine patch adherence. PMID:27070097

  13. Training mental health professionals in suicide practice guideline adherence: cost-effectiveness analysis alongside a randomized controlled trial.

    NARCIS (Netherlands)

    Beurs, D.P. de; Bosmans, J.E.; Groot, M.H. de; Keijser, J. de; Duijn, E. van; Winter, R.F.P. de; Kerkhof, A.J.F.M.

    2015-01-01

    Background: There is a lack of information on the cost-effectiveness of suicide prevention interventions. The current study examines the cost-effectiveness of a multifaceted structured intervention aiming to improve adherence to the national suicide practice guideline in comparison with usual implem

  14. Dissemination Strategies and Adherence Predictors for Web-Based Interventions--How Efficient Are Patient Education Sessions and Email Reminders?

    Science.gov (United States)

    Schweier, R.; Romppel, M.; Richter, C.; Grande, G.

    2016-01-01

    The Internet offers the potential to efficaciously deliver health interventions at a low cost and with a low threshold across any distance. However, since many web-based interventions are confronted with low use and adherence, proactive dissemination strategies are needed. We, therefore, tested the efficacy of a 1-h patient education session as…

  15. Pragmatic trials of complex psychosocial interventions: methodological challenges.

    Science.gov (United States)

    Dunn, G

    2013-06-01

    Having first introduced the pragmatic health care trial, the discussion then focuses on a selected list of technical problems that are important for the design, analysis and inference from such trials. The first is lack of independence of participants' outcomes do to clustering either arising from a cluster randomized design or to the way treatment is delivered (therapist and group effects). The second and third concern the implications of non-adherence to treatment and subsequent loss to follow-up, particularly, when non-adherence is associated with missing outcome data. Finally, it is argued that pragmatism and a desire for a scientific explanation should not be regarded as mutually exclusive. PMID:23458721

  16. Modeling determinants of medication attitudes and poor adherence in early nonaffective psychosis: implications for intervention.

    Science.gov (United States)

    Drake, Richard J; Nordentoft, Merete; Haddock, Gillian; Arango, Celso; Fleischhacker, W Wolfgang; Glenthøj, Birte; Leboyer, Marion; Leucht, Stefan; Leweke, Markus; McGuire, Phillip; Meyer-Lindenberg, Andreas; Rujescu, Dan; Sommer, Iris E; Kahn, René S; Lewis, Shon W

    2015-05-01

    We aimed to design a multimodal intervention to improve adherence following first episode psychosis, consistent with current evidence. Existing literature identified medication attitudes, insight, and characteristics of support as important determinants of adherence to medication: we examined medication attitudes, self-esteem, and insight in an early psychosis cohort better to understand their relationships. Existing longitudinal data from 309 patients with early Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, nonaffective psychosis (83% first episode) were analyzed to test the hypothesis that medication attitudes, while meaningfully different from "insight," correlated with insight and self-esteem, and change in each influenced the others. Rosenberg Self-Esteem Scale, Birchwood Insight Scale, and Positive and Negative Syndrome Scale insight were assessed at presentation, after 6 weeks and 3 and 18 months. Drug Attitudes Inventory (DAI) and treatment satisfaction were rated from 6 weeks onward. Structural equation models of their relationships were compared. Insight measures' and DAI's predictive validity were compared against relapse, readmission, and remission. Analysis found five latent constructs best fitted the data: medication attitudes, self-esteem, accepting need for treatment, self-rated insight, and objective insight. All were related and each affected the others as it changed, except self-esteem and medication attitudes. Low self-reported insight at presentation predicted readmission. Good 6-week insight (unlike drug attitudes) predicted remission. Literature review and data modeling indicated that a multimodal intervention using motivational interviewing, online psychoeducation, and SMS text medication reminders to enhance adherence without damaging self-concept was feasible and appropriate. PMID:25750247

  17. Excessive daytime sleepiness and adherence to antihypertensive medications among Blacks: analysis of the counseling African Americans to control hypertension (CAATCH trial

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    Williams NJ

    2014-03-01

    Full Text Available Natasha J Williams,1 Girardin Jean-Louis,1 Abhishek Pandey,2 Joseph Ravenell,1 Carla Boutin-Foster,3 Gbenga Ogedegbe1 1Center for Healthful Behavior Change, Division of Internal Medicine, NYU Medical Center, New York, 2Department of Family Medicine, SUNY Downstate Medical Center, Brooklyn, 3Center of Excellence in Disparities Research, Weill Cornell Medical College, New York, NY, USA Background: Excessive daytime sleepiness (EDS often occurs as a result of insufficient sleep, sleep apnea, illicit substance use, and other medical and psychiatric conditions. This study tested the hypothesis that blacks exhibiting EDS would have poorer self-reported adherence to hypertensive medication using cross-sectional data from the Counseling African-Americans to Control Hypertension (CAATCH trial. Methods: A total of 1,058 hypertensive blacks (average age 57±12 years participated in CAATCH, a randomized controlled trial evaluating the effectiveness of a multilevel intervention for participants who receive care from community health centers in New York City. Data analyzed in this study included baseline sociodemographics, medical history, EDS, and medication adherence. We used the Epworth Sleepiness Scale, with a cutoff score of ≥10, to define EDS. Medication adherence was measured using an abbreviated Morisky Medication Adherence scale, with a score >0 indicating nonadherence. Results: Of the sample, 71% were female, 72% received at least a high school education, 51% reported a history of smoking, and 33% had a history of alcohol consumption. Overall, 27% of the participants exhibited EDS, and 44% of those who exhibited EDS were classified as adherent to prescribed antihypertensive medications. Multivariable logistic regression analysis, adjusting for effects of age, body mass index, sex, education, and smoking and drinking history indicated that participants who exhibited EDS were more than twice as likely to be nonadherent (odds ratio 2.28, 95

  18. Choosing a control intervention for a randomised clinical trial

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    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  19. Adherence, Compliance, and Health Risk Factor Changes following Short-Term Physical Activity Interventions

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    Lynda H. Norton

    2015-01-01

    Full Text Available Background. Low physical activity (PA levels are associated with poor health risk factor profiles. Intervention strategies to increase PA and quantify the rate and magnitude of change in risk factors are important. Methods. Interventions were conducted over 40 days to increase PA in 736 insufficiently active (<150 min/wk PA participants using either a pedometer or instructor-led group protocol. There were a further 135 active participants as controls. Major cardiovascular and metabolic risk factors, including fitness parameters, were measured before and after intervention. Results. Adherence to the interventions was higher for the group versus pedometer participants (87.1% versus 79.8% and compliance rates for achieving sufficient levels of PA (≥150 min/wk were also higher for the group participants (95.8% versus 77.6%. Total weekly PA patterns increased by 300 and 435 minutes, for the pedometer and group participants, respectively. Improvements were found for waist girth, total cholesterol, aerobic fitness, and flexibility relative to controls. The change in vigorous PA, but not moderate PA, was a significant predictor of the change in eight of 11 risk factor variables measured. Conclusions. Rapid and dramatic increases in PA among previously insufficiently active adults can result in important health benefits.

  20. Assessing adherence in the CAPRISA 004 tenofovir gel HIV prevention trial: results of a nested case-control study.

    Science.gov (United States)

    MacQueen, Kathleen M; Weaver, Mark A; van Loggerenberg, Francois; Succop, Stacey; Majola, Nelisle; Taylor, Doug; Karim, Quarraisha Abdool; Karim, Salim Abdool

    2014-05-01

    Adherence undeniably impacts product effectiveness in microbicide trials, but the connection has proven challenging to quantify using routinely collected behavioral data. We explored this relationship using a nested case-control study in the CAPRISA 004 Tenofovir (TFV) gel HIV prevention trial. Detailed 3-month recall data on sex events, condom and gel use were collected from 72 incident cases and 205 uninfected controls. We then assessed how the relationship between self-reported adherence and HIV acquisition differed between the TFV and placebo gel groups, an interaction effect that should exist if effectiveness increases with adherence. The CAPRISA 004 trial determined that randomization to TFV gel was associated with a significant reduction in risk of HIV acquisition. In our nested case-control study, however, we did not observe a meaningful decrease in the relative odds of infection-TFV versus placebo-as self-reported adherence increased. To the contrary, exploratory sub-group analysis of the case-control data identified greater evidence for a protective effect of TFV gel among participants reporting less than 80 % adherence to the protocol-defined regimen (odds ratio (OR) 0.30; 95 % CI 0.11-0.78) than among those reporting ≥ 80 % adherence (Odds Ratio 0.81; 95 % CI 0.34-1.92). The small number of cases may have inhibited our ability to detect the hypothesized interaction between adherence and effectiveness. Nonetheless, our results re-emphasize the challenges faced by investigators when adherence may be miss-measured, miss-reported, or confounded with the risk of HIV. PMID:24647763

  1. Interventions to enhance adherence to dietary advice for preventing and managing chronic diseases in adults: a study protocol

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    Gravel Karine

    2011-02-01

    Full Text Available Abstract Background Adoption of a healthy diet has been identified as the cornerstone in the prevention and management of chronic diseases. However, non-adherence to lifestyle changes raises an important issue since adherence level to dietary advice is a key determinant of the effectiveness of dietary treatment. Therefore, based on the results of a Cochrane systematic review on interventions for enhancing adherence to dietary advice for preventing and managing chronic diseases in adults, the aim of this study is to assess the importance and applicability of interventions enhancing adherence to dietary advice in the Canadian context. Methods/Design In phase 1, dietitians' opinion will be assessed through a Delphi study regarding the importance and the applicability in the Canadian context of the interventions found the most effective to enhance adherence to dietary advice through a Cochrane systematic review. In phase 2, findings of the Cochrane systematic review assessing the effects of interventions for enhancing adherence to dietary advice will be reported in a practical format on an online knowledge translation tool for dietitians and other health professionals. Discussion In recent years, there has been an increasing recognition of the failure to translate research findings into clinical practice. Therefore, knowledge translation efforts need to prioritize effective interventions that will be the most relevant for practice and end-users by adapting them to the local context. Our study will provide decision makers in the field of dietetic practice with essential knowledge on adherence for elaborating educational activities for academic or professional settings that will respond to dietitians' priorities in terms of importance and applicability to day-to-day practice.

  2. The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients

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    Krishnan Deby

    2011-01-01

    Full Text Available Abstract Background Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care. Methods/Design This is a multicentre parallel arm block randomized controlled trial (RCT of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change. Discussion The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent

  3. An economic evaluation of anticipated costs and savings of a behavior change intervention to enhance medication adherence

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    Wiegand PN

    2008-06-01

    Full Text Available Medication adherence across disease states is generally poor. Research has focused on various methods to improve medication adherence, but there is little conclusive evidence regarding specific methods efficacy. The Transtheoretical Model for Behavior Change has been used to modify existing addictive behaviors but not in medication adherence specifically. As a behavioral component is inherently related to medication adherence, it is thought that this model may be applicable. Objective: The purpose of this research is to evaluate the costs and savings of implementing a novel behavioral intervention against the cost of poor medication adherence to determine whether further development is realistic.Methods: The basic tools required to administer this intervention were determined through primary literature review and priced by vendors supplying such materials. Diabetes Mellitus Type 2 (DM2 was used as a vehicle to establish the cost of care for long-term complications of a chronic disease. The primary literature provided information regarding the cost of care for DM2 morbidity and outpatient annual drug therapy expenditure. The total cost of the behavioral intervention components and the cost of care for DM2 morbidity were applied to a theoretical cohort of 1000 patients. By dividing this cost across 1000 patients, a per-patient cost was yielded and multiplied over a 16-year timeframe. Results: It was found that the cost to implement the behavioral intervention and resultant medication costs is USD13,574 per-patient over 16 years. The cost to treat complications of diabetes mellitus is USD 36,528 per patient over the 16 years. The total amount of healthcare dollars potentially saved by utilizing this intervention is USD 22,954 per-patient. Conclusions: It appears that the cost to implement this behavioral intervention is reasonable and permits further evaluation in other chronic conditions with notoriously poor adherence levels.

  4. The impact of behavioural screening on intervention outcomes in a randomised, controlled multiple behaviour intervention trial

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    Fjeldsoe Brianna S

    2011-03-01

    Full Text Available Abstract Background With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown. Methods Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention, characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups. Results Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also

  5. Protocol for a Randomized Controlled Trial Evaluating Mobile Text Messaging to Promote Retention and Adherence to Antiretroviral Therapy for People Living With HIV in Burkina Faso

    Science.gov (United States)

    Ouedraogo, Denis; Artavia-Mora, Luis; Bedi, Arjun; Thiombiano, Boundia Alexandre

    2016-01-01

    Background Retention in care and adherence to antiretroviral therapy (ART) among people living with human immunodeficiency virus (PLHIV) is a critical challenge in many African countries including Burkina Faso. Delivering text messaging (short message service, SMS) interventions through mobile phones may help facilitate health service delivery and improve patient health. Despite this potential, no evaluations have been delivered for national scale settings to demonstrate the impact of mobile health (mHealth) for PLHIV. Objectives This study aims to test the impact of SMS text messaging reminders for PLHIV in Burkina Faso, who are under ART. The evaluation identifies whether patients who receive SMS text messages are more likely to (1) retain in care (measured as a dichotomous variable), (2) adhere to antiretroviral regimens (measured as the number of doses missed in the past 7 days), and (3) experience slower disease progression (measured with T-lymphocytes cells). The second objective is to assess its effects on the frequency of health center visits, physical and psychosocial health, nutrition and whether the type of message (text vs image) and frequency (weekly vs semiweekly) have differential impacts including the possibility of message fatigue over time. Methods This 24-month, wide-scale intervention implements a randomized controlled trial (RCT) to evaluate the impact of four variants of a mHealth intervention versus a control group. Our sample comprises adult patients (>15 years of age) undergoing antiretroviral therapy with access to mobile phone services. Multivariate regression analysis will be used to analyze the effect of the intervention on the study population. Data collection is done at baseline and three follow-up waves 6, 12, and 24 months after the intervention starts. Results The targeted 3800 patients were recruited between February 2015 and May 2015. But political uncertainty delayed the launch of the intervention until October 2015. Data

  6. Parent attendance and homework adherence predict response to a family-school intervention for children with ADHD.

    Science.gov (United States)

    Clarke, Angela T; Marshall, Stephen A; Mautone, Jennifer A; Soffer, Stephen L; Jones, Heather A; Costigan, Tracy E; Patterson, Anwar; Jawad, Abbas F; Power, Thomas J

    2015-01-01

    This study examined the relative contribution of two dimensions of parent engagement, attendance and homework adherence, to parent and child treatment response and explored whether early engagement was a stronger predictor of outcomes than later engagement. The sample consisted of parents of participants (n = 92; M age = 9.4 years, SD = 1.27; 67% male, 69% White) in a 12-session evidence-based family-school intervention for children with attention-deficit/hyperactivity disorder. Attendance was assessed using clinician records, and homework adherence was measured by rating permanent products. Outcomes included parent and teacher ratings of family involvement in education, parenting practices, and child functioning. Accounting for the contributions of baseline scores and attendance, homework adherence was a significant predictor of parental self-efficacy, the parent-teacher relationship, parenting through positive involvement, and the child's inattention to homework and homework productivity. Accounting for the contribution of baseline scores and homework adherence, attendance was a significant predictor of one outcome, the child's academic productivity. Early homework adherence appeared to be more predictive of outcomes than later adherence, whereas attendance did not predict outcomes during either half of treatment. These results indicate that, even in the context of evidence-based practice, it is the extent to which parents actively engage with treatment, rather than the number of sessions they attend, that is most important in predicting intervention response. Because attendance is limited as an index of engagement and a predictor of outcomes, increased efforts to develop interventions to promote parent adherence to behavioral interventions for children are warranted. PMID:23688140

  7. Efficacy of brief motivational interviewing to improve adherence to inhaled corticosteroids among adult asthmatics: results from a randomized controlled pilot feasibility trial

    Directory of Open Access Journals (Sweden)

    Lavoie KL

    2014-11-01

    Full Text Available Kim L Lavoie,1–3 Gregory Moullec,1,2,4 Catherine Lemiere,2 Lucie Blais,2 Manon Labrecque,2 Marie-France Beauchesne,2 Veronique Pepin,2,4 André Cartier,2 Simon L Bacon1,2,41Montreal Behavioural Medicine Centre, 2Research Centre, Hôpital du Sacré-Cœur de Montréal – A University of Montreal Affiliated Hospital, Montréal, 3Department of Psychology, University of Quebec at Montreal (UQAM, Succursale Center-Ville, Montreal, 4Department of Exercise Science, Concordia University, Montreal, Quebec, CanadaPurpose: Daily adherence to inhaled corticosteroid (ICS regimens is one of the most important factors linked to achieving optimal asthma control. Motivational interviewing (MI is a client-centered communication style that focuses on enhancing intrinsic motivation to engage in appropriate self-management behaviors. MI has been shown to improve a variety of health behaviors including medication adherence in other disorders, but its efficacy for the improvement of ICS adherence in asthmatics has yet to be examined. This pilot “proof of concept” trial assessed the feasibility of MI to improve daily ICS adherence and asthma control levels in adult asthmatics.Methods: Fifty-four poorly controlled (Asthma Control Questionnaire [ACQ] score ≥1.5, highly nonadherent (filled <50% of ICS medication in the last year adult asthmatics were recruited from the outpatient asthma clinic of a university-affiliated hospital. Participants underwent baseline assessments and were randomly assigned to MI (3×30 minutes sessions within a 6-week period, n=26 or a usual care (UC control group (n=28. ICS adherence (% pharmacy refills and asthma control (ACQ, Asthma Control Test [ACT] were measured at 6 and 12 months postintervention. Mixed model repeated measure analyses for both intent-to-treat and per-protocol were used. Results were adjusted for a priori-defined covariates including baseline adherence. Patients in the MI group also reported their impressions of

  8. Developing a Reporting Guideline for Social and Psychological Intervention Trials.

    Science.gov (United States)

    Grant, Sean; Montgomery, Paul; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Mayo-Wilson, Evan

    2013-11-01

    Social and psychological interventions are often complex. Understanding randomized controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. In this article, we explain how reporting guidelines have improved the quality of reports in medicine and describe the ongoing development of a new reporting guideline for RCTs: Consolidated Standards of Reporting Trials-SPI (an extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/CONSORT-study).

  9. Implications of the results of community intervention trials.

    Science.gov (United States)

    Sorensen, G; Emmons, K; Hunt, M K; Johnston, D

    1998-01-01

    This paper examines the results of population-level interventions conducted in three settings: entire communities, worksites, and schools. Four major conclusions are discussed: (a) Directions for the next generation of community-based interventions include targeting multiple levels of influence; addressing social inequalities in disease risk; involving communities in program planning and implementation; incorporating approaches for "tailoring" interventions; and utilizing rigorous process evaluation. (b) In addition to randomized controlled trials, it is time to use the full range of research phases available, from hypothesis generation and methods development to dissemination research. (c) The public health research agenda may have contributed to observed secular trends by placing behavioral risk factors on the social and media agendas. (d) The magnitude of the results of community intervention trials must be judged according to their potential public health or population-level effects. Small changes at the individual level may result in large benefits at the population level. PMID:9611625

  10. Therapeutic Alliance and Treatment Adherence in Two Interventions for Bulimia Nervosa: A Study of Process and Outcome

    Science.gov (United States)

    Loeb, Katharine L.; Wilson, G. Terence; Labouvie, Erich; Pratt, Elizabeth M.; Hayaki, Jumi; Walsh, B. Timothy; Agras, W. Stewart; Fairburn, Christopher G.

    2005-01-01

    The relationship between therapeutic alliance, therapist adherence to treatment protocol, and outcome was analyzed in a randomized trial of cognitive-behavioral therapy (CBT) and interpersonal psychotherapy for bulimia nervosa. Independent observers rated audiotapes of full-length therapy sessions. Purging frequency was the primary outcome…

  11. Evaluating a Nationwide Recreational Football Intervention: Recruitment, Attendance, Adherence, Exercise Intensity, and Health Effects.

    Science.gov (United States)

    Fløtum, Liljan Av; Ottesen, Laila S; Krustrup, Peter; Mohr, Magni

    2016-01-01

    The present study evaluated a nationwide exercise intervention with Football Fitness in a small-scale society. In all, 741 adult participants (20-72 yrs) were successfully recruited for Football Fitness training in local football clubs, corresponding to 2.1% of the adult population. A preintervention test battery including resting heart rate (RHR), blood pressure, and body mass measurements along with performance tests (Yo-Yo Intermittent Endurance level 1 (Yo-Yo IE1), the Arrowhead Agility Test, and the Flamingo Balance Test) were performed (n = 502). Training attendance (n = 310) was 1.6 ± 0.2 sessions per week (range: 0.6-2.9), corresponding to 28.8 ± 1.0 sessions during the 18 wk intervention period. After 18 wks mean arterial pressure (MAP) was -2.7 ± 0.7 mmHg lower (P 99 mmHg (-5.6 ± 1.5 mmHg; n = 50). RHR was lowered (P bpm after intervention (77 ± 1 to 71 ± 1 bpm). Yo-Yo IE1 performance increased by 41% (540 ± 27 to 752 ± 45 m), while agility and postural balance were improved (P < 0.05) by ~6 and ~45%, respectively. In conclusion, Football Fitness was shown to be a successful health-promoting nationwide training intervention for adult participants with an extraordinary recruitment, a high attendance rate, moderate adherence, high exercise intensity, and marked benefits in cardiovascular health profile and fitness. PMID:27437401

  12. Individualised motivational counselling to enhance adherence to antiretroviral therapy is not superior to didactic counselling in South African patients: Findings of the CAPRISA 058 randomised controlled trial

    OpenAIRE

    van Loggerenberg, Francois; Alison D. Grant; Naidoo, Kogieleum; Murrman, Marita; Gengiah, Santhanalakshmi; Gengiah, Tanuja N; Fielding, Katherine; Karim, Salim S. Abdool

    2015-01-01

    Concerns that standard didactic adherence counselling may be inadequate to maximise antiretroviral therapy (ART) adherence led us to evaluate more intensive individualised motivational adherence counselling. We randomised 297 HIV-positive ART-naïve patients in Durban, South Africa, to receive either didactic counselling, prior to ART initiation (n=150), or an intensive motivational adherence intervention after initiating ART (n=147). Study arms were similar for age (mean 35.8 years), sex (43....

  13. Effects of The Coach Approach Intervention on Adherence to Exercise in Obese Women: Assessing Mediation of Social Cognitive Theory Factors

    Science.gov (United States)

    Annesi, James J.; Unruh, Jennifer L.; Marti, C. Nathan; Gorjala, Srinivasa; Tennant, Gisele

    2011-01-01

    The link between physical activity and weight loss has precipitated interest in interventions to foster adherence to exercise. It has been suggested that treatment effects, when significant, should be analyzed to determine theory-based mediators. This research assessed possible mediation of changes in Physical Self-Concept, Exercise Self-Efficacy,…

  14. Improving adherence to lipid-lowering therapy in a community pharmacy intervention program : a cost-effectiveness analysis

    NARCIS (Netherlands)

    Vegter, Stefan; Oosterhof, Piter; van Boven, Job F M; Stuurman-Bieze, Ada G G; Hiddink, Eric G; Postma, Maarten J

    2014-01-01

    BACKGROUND: Pharmaceutical care in community pharmacies has been shown to improve adherence to chronic therapies. Long-term impact on clinical outcomes or medical cost savings, however, remains understudied. OBJECTIVE: To estimate the cost-effectiveness of a pharmaceutical care intervention program

  15. The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Julia R G Raifman

    Full Text Available BACKGROUND: Low rates of adherence to artemisinin-based combination therapy (ACT regimens increase the risk of treatment failure and may lead to drug resistance, threatening the sustainability of current anti-malarial efforts. We assessed the impact of text message reminders on adherence to ACT regimens. METHODS: Health workers at hospitals, clinics, pharmacies, and other stationary ACT distributors in Tamale, Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment. The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals. The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation. We estimated the impact of the messages on treatment completion using logistic regression. RESULTS: 1140 individuals enrolled in both the study and the text reminder system. Among individuals in the control group, 61.5% took the full course of treatment. The simple text message reminders increased the odds of adherence (adjusted OR 1.45, 95% CI [1.03 to 2.04], p-value 0.028. Receiving an additional message did not result in a significant change in adherence (adjusted OR 0.77, 95% CI [0.50 to 1.20], p-value 0.252. CONCLUSION: The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment. Further research is needed to develop the most effective text message content and frequency. TRIAL REGISTRATION: ClinicalTrials.gov NCT01722734.

  16. FACTORS ASSOCIATED TO ADHERENCE TO DIFFERENT TREATMENT SCHEMES WITH MEGLUMINE ANTIMONIATE IN A CLINICAL TRIAL FOR CUTANEOUS LEISHMANIASIS

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    Madelon Novato Ribeiro

    2014-07-01

    Full Text Available The favorable outcome of the treatment of a disease is influenced by the adherence to therapy. Our objective was to assess factors associated with adherence to treatment of patients included in a clinical trial of equivalence between the standard and alternative treatment schemes with meglumine antimoniate (MA in the treatment of cutaneous leishmaniasis (CL, in the state of Rio de Janeiro. Between 2008 and 2011, 57 patients with CL were interviewed using a questionnaire to collect socioeconomic data. The following methods were used for adherence monitoring: counting of vial surplus, monitoring card, Morisky test and modified Morisky test (without the question regarding the schedule; we observed 82.1% (vial return, 86.0% (monitoring card, 66.7% (Morisky test and 86.0% (modified Morisky test adherence. There was a strong correlation between the method of vial counting and the monitoring card and modified Morisky test. A significant association was observed between greater adherence to treatment and low dose of MA, as well as with a lower number of people sleeping in the same room. We recommend the use of the modified Morisky test to assess adherence to treatment of CL with MA, because it is a simple method and with a good performance, when compared to other methods.

  17. Evidence for Technology Interventions to Promote ART Adherence in Adult Populations: a Review of the Literature 2012-2015.

    Science.gov (United States)

    Amico, K Rivet

    2015-12-01

    Leveraging technology to enhance antiretroviral therapy (ART) adherence, and factors associated with it, has tremendous appeal as a low-cost, generalizable strategy to offer high-quality adherence support given an increasingly limited workforce. As the numbers of individuals living with HIV entering care and initiating ART are expected to increase substantially worldwide in the next decade, capacity to support ART adherence is needed and use of computers, internet, and mobile phones has the potential to offer those efficiencies-provided they are effective. This review summarizes recent advances in the evidence base for technology-driven, technology-delivered, or technology-enhanced ART adherence intervention approaches. A PubMed search limited to January 2013 through July 2015 identified 13 qualifying studies evaluating computer-delivered interventions, internet approaches, mobile phone technologies, and electronic dose monitoring with triggered messaging and data-informed counseling. Considerable support for each area has emerged, with the majority of studies reviewed demonstrating significant effects on ART adherence and clinical outcomes. Gaps are identified and recommendations offered.

  18. Intervention trial of previous nonattender invitation for breast screening.

    Science.gov (United States)

    Fleming, Padraic; Mooney, Therese; Wilson, Linda; Fitzpatrick, Patricia

    2016-11-01

    BreastCheck, the National Breast Screening Programme in the Republic of Ireland, invites women aged between 50 and 64 years biennially. A pilot intervention trial of invitation for screening of women not attending the previous appointment [previous nonattender (PNA)] was carried out that aimed at maximizing the efficiency of resources in terms of radiographer workload and scheduled appointment slots. The trial was conducted during screening round 5 at two of the regional units. The intervention arm implemented an alternative process for inviting PNA women, in which they were sent a letter inviting them to phone their screening unit to make an appointment at a convenient date/time. The control arm continued usual practice - that is, all PNA women were sent a single invitation letter with a scheduled appointment slot at a predetermined date/time. In the intervention arm, fewer PNAs took up their appointments (15.5%) compared with the control arm (18.3%; P<0.001). Uptake among PNAs fell in both arms between screening rounds 4 and 5 (intervention arm: 22.0% OSR 4, 15.5% OSR 5; control arm: 21.4% OSR 4, 18.3% OSR 5). There was a significant increase in mobile unit screening days saved because of the intervention and a significant improvement in the percentage of women reinvited for screening within 27 months in the intervention arm (85.5%). PNA recall and cancer detection rates were significantly higher compared with the general screened population. This trial showed an improvement in the efficiency of resource use. However, there was a higher cancer detection rate in PNA women. This trial provides important evidence for invitation policy for screening. PMID:26642321

  19. A cluster randomized trial to improve adherence to evidence-based guidelines on diabetes and reduce clinical inertia in primary care physicians in Belgium: study protocol [NTR 1369

    Directory of Open Access Journals (Sweden)

    Ivanova Anna

    2008-10-01

    Full Text Available Abstract Background Most quality improvement programs in diabetes care incorporate aspects of clinician education, performance feedback, patient education, care management, and diabetes care teams to support primary care physicians. Few studies have applied all of these dimensions to address clinical inertia. Aim To evaluate interventions to improve adherence to evidence-based guidelines for diabetes and reduce clinical inertia in primary care physicians. Design Two-arm cluster randomized controlled trial. Participants Primary care physicians in Belgium. Interventions Primary care physicians will be randomly allocated to 'Usual' (UQIP or 'Advanced' (AQIP Quality Improvement Programs. Physicians in the UQIP will receive interventions addressing the main physician, patient, and office system factors that contribute to clinical inertia. Physicians in the AQIP will receive additional interventions that focus on sustainable behavior changes in patients and providers. Outcomes Primary endpoints are the proportions of patients within targets for three clinical outcomes: 1 glycosylated hemoglobin Primary and secondary analysis Statistical analyses will be performed using an intent-to-treat approach with a multilevel model. Linear and generalized linear mixed models will be used to account for the clustered nature of the data, i.e., patients clustered withinimary care physicians, and repeated assessments clustered within patients. To compare patient characteristics at baseline and between the intervention arms, the generalized estimating equations (GEE approach will be used, taking the clustered nature of the data within physicians into account. We will also use the GEE approach to test for differences in evolution of the primary and secondary endpoints for all patients, and for patients in the two interventions arms, accounting for within-patient clustering. Trial Registration number: NTR 1369.

  20. Acceptability of Mobile Phone Technology for Medication Adherence Interventions among HIV-Positive Patients at an Urban Clinic

    Directory of Open Access Journals (Sweden)

    Christopher W. T. Miller

    2013-01-01

    Full Text Available Mobile phone technology is increasingly used to overcome traditional barriers limiting access to care. The goal of this study was to evaluate access and willingness to use smart and mobile phone technology for promoting adherence among people attending an urban HIV clinic. One hundred consecutive HIV-positive patients attending an urban HIV outpatient clinic were surveyed. The questionnaire evaluated access to and utilization of mobile phones and willingness to use them to enhance adherence to HIV medication. The survey also included the CASE adherence index as a measure of adherence. The average age was 46.4 (. The majority of participants were males (63%, black (93%, and Hispanic (11.4% and reported earning less than $10,000 per year (67.3%. Most identified themselves as being current smokers (57%. The vast majority reported currently taking HAART (83.5%. Approximately half of the participants reported some difficulty with adherence (CASE < 10. Ninety-six percent reported owning a mobile phone. Among owners of mobile phones 47.4% reported currently owning more than one device. Over a quarter reported owning a smartphone. About 60% used their phones for texting and 1/3 used their phone to search the Internet. Nearly 70% reported that they would use a mobile device to help with HIV adherence. Those who reported being very likely or likely to use a mobile device to improve adherence were significantly more likely to use their phone daily ( and use their phone for text messages (. The vast majority of patients in an urban HIV clinic own mobile phones and would use them to enhance adherence interventions to HIV medication.

  1. Rethinking adherence.

    Science.gov (United States)

    Steiner, John F

    2012-10-16

    In 2012, the Centers for Medicare & Medicaid Services (CMS) will introduce measures of adherence to oral hypoglycemic, antihypertensive, and cholesterol-lowering drugs into its Medicare Advantage quality program. To meet these quality goals, delivery systems will need to develop and disseminate strategies to improve adherence. The design of adherence interventions has too often been guided by the mistaken assumptions that adherence is a single behavior that can be predicted from readily available patient characteristics and that individual clinicians alone can improve adherence at the population level.Effective interventions require recognition that adherence is a set of interacting behaviors influenced by individual, social, and environmental forces; adherence interventions must be broadly based, rather than targeted to specific population subgroups; and counseling with a trusted clinician needs to be complemented by outreach interventions and removal of structural and organizational barriers. To achieve the adherence goals set by CMS, front-line clinicians, interdisciplinary teams, organizational leaders, and policymakers will need to coordinate efforts in ways that exemplify the underlying principles of health care reform. PMID:23070491

  2. A study to assess the feasibility of undertaking a randomized controlled trial of adherence with eye drops in glaucoma patients

    Directory of Open Access Journals (Sweden)

    Richardson C

    2013-10-01

    Full Text Available Cliff Richardson,1 Lisa Brunton,1 Nicola Olleveant,1 David B Henson,1 Mark Pilling,1 Jane Mottershead,2 Cecilia H Fenerty,2 Anne Fiona Spencer,2 Heather Waterman1 1School of Nursing, Midwifery and Social Work, University of Manchester, 2Royal Manchester Eye Hospital, Central Manchester Foundation Trust, Manchester, United Kingdom Background: Adherence with therapy could influence the progression of glaucoma and ultimately affect the onset of visual impairment in some individuals. This feasibility study evaluated the measures to be used for a future randomized controlled trial assessing the effects of group-based education on adherence with eye drops. Methods: People diagnosed with glaucoma within the previous 12 months attending a regional ophthalmology clinic in the North West of England were recruited. A two-session education program delivered one week apart had been devised as part of a previous project. A combined adult learning and health needs approach to education was taken. Outcomes measured were knowledge of glaucoma, self-report of adherence, illness perception, beliefs about medicines, patient enablement, and general health (Short Form-12. Adherence was also measured objectively using a Medical Events Monitoring System device. Results: Twenty-six participants consented to undertake the educational program and 19 produced analyzable data. Knowledge of glaucoma, illness perception, beliefs about medicine, and patient enablement all showed statistically significant improvements after education. Mean adherence with eye drops was maintained above 85% before and for 3 months after attendance at the educational program. Self-report exaggerated adherence by at least 10% when compared with the objective Medical Events Monitoring System data, and in fact the kappa agreement was zero. Conclusion: All questionnaires other than the Short Form-12 were considered to be valuable measures and use of a Medical Events Monitoring System device was

  3. Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study

    OpenAIRE

    Stansfeld, Stephen A; Kerry, Sally; Chandola, Tarani; Russell, Jill; Berney, Lee; Hounsome, Natalia; Lanz, Doris; Costelloe, Céire; Smuk, Melanie; Bhui, Kamaldeep

    2015-01-01

    Objectives To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees’ well-being and reduce sickness absence. Methods The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers received a facilitat...

  4. Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study

    OpenAIRE

    Stansfeld, Stephen A; Kerry, Sally; Chandola, Tarani; Russell, Jill; Berney, Lee; Hounsome, Natalia; Lanz, Doris; Costelloe, Ceire; Smuk, Melanie; Bhui, Khamaldeep

    2015-01-01

    OBJECTIVES: To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees' well-being and reduce sickness absence. METHODS: The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers rece...

  5. Developing an adherence support intervention for patients on antiretroviral therapy in the context of the recent IDU-driven HIV/AIDS epidemic in Estonia

    OpenAIRE

    Laisaar, Kaja-Triin; Uusküla, Anneli; Sharma, Anjali; Jack A Dehovitz; Amico, K. Rivet

    2013-01-01

    There is limited data on and experience with interventions for antiretroviral therapy (ART) adherence support for patients on ART in Eastern Europe. We sought to identify a feasible adherence support intervention for delivery amongst HIV-positive adults receiving care in Estonia, where the HIV/AIDS epidemic has been mainly concentrated among injection drug users. Our application of intervention mapping strategies used existing literature, formative research and multidisciplinary team input to...

  6. A Theory-Based Approach for Developing Interventions to Change Patient Behaviours: A Medication Adherence Example from Paediatric Secondary Care

    Directory of Open Access Journals (Sweden)

    Gemma Heath

    2015-12-01

    Full Text Available In this article we introduce a Health Psychology approach to changing patient behaviour, in order to demonstrate the value of Health Psychology professional practice as applied within healthcare settings. Health Psychologists are experts in understanding, predicting and changing health-related behaviours at the individual, group and population level. They combine psychological theory, research evidence and service-user views to design interventions to solve clinically relevant behavioural problems and improve health outcomes. We provide a pragmatic overview of a theory and evidence-based Intervention Mapping approach for developing, implementing and evaluating interventions to change health-related behaviour. An example of a real behaviour change intervention designed to improve medication adherence in an adolescent patient with poorly controlled asthma is described to illustrate the main stages of the intervention development process.

  7. A Theory-Based Approach for Developing Interventions to Change Patient Behaviours: A Medication Adherence Example from Paediatric Secondary Care.

    Science.gov (United States)

    Heath, Gemma; Cooke, Richard; Cameron, Elaine

    2015-01-01

    In this article we introduce a Health Psychology approach to changing patient behaviour, in order to demonstrate the value of Health Psychology professional practice as applied within healthcare settings. Health Psychologists are experts in understanding, predicting and changing health-related behaviours at the individual, group and population level. They combine psychological theory, research evidence and service-user views to design interventions to solve clinically relevant behavioural problems and improve health outcomes. We provide a pragmatic overview of a theory and evidence-based Intervention Mapping approach for developing, implementing and evaluating interventions to change health-related behaviour. An example of a real behaviour change intervention designed to improve medication adherence in an adolescent patient with poorly controlled asthma is described to illustrate the main stages of the intervention development process. PMID:27417822

  8. Do patients adhere to over-the-counter artemisinin combination therapy for malaria? evidence from an intervention study in Uganda

    Directory of Open Access Journals (Sweden)

    Cohen Jessica L

    2012-03-01

    Full Text Available Abstract Background Increasing affordability of artemisinin combination therapy (ACT in the African retail sector could be critical to expanding access to effective malaria treatment, but must be balanced by efforts to protect the efficacy of these drugs. Previous research estimates ACT adherence rates among public sector patients, but adherence among retail sector purchasers could differ substantially. This study aimed to estimate adherence rates to subsidized, over-the-counter ACT in rural Uganda. Methods An intervention study was conducted with four licensed drug shops in Eastern Uganda in December 2009. Artemether-lumefantrine (AL was made available for sale at a 95% subsidy over-the counter. Customers completed a brief survey at the time of purchase and then were randomly assigned to one of three study arms: no follow-up, follow-up after two days or follow-up after three days. Surveyors recorded the number of pills remaining through blister pack observation or through self-report if the pack was unavailable. The purpose of the three-day follow-up arm was to capture non-adherence in the sense of an incomplete treatment course ("under-dosing". The purpose of the two-day follow-up arm was to capture whether participants completed the full course too soon ("over-dosing". Results Of the 106 patients in the two-day follow-up sample, 14 (13.2% had finished the entire treatment course by the second day. Of the 152 patients in the three-day follow-up sample, 49 (32.2% were definitely non-adherent, three (2% were probably non-adherent and 100 (65.8% were probably adherent. Among the 52 who were non-adherent, 31 (59.6% had more than a full day of treatment remaining. Conclusions Overall, adherence to subsidized ACT purchased over-the-counter was found to be moderate. Further, a non-trivial fraction of those who complete treatment are taking the full course too quickly. Strategies to increase adherence in the retail sector are needed in the context of

  9. Negative results in phase III trials of complex interventions: cause for concern or just good science?

    Science.gov (United States)

    Crawford, Mike J; Barnicot, Kirsten; Patterson, Sue; Gold, Christian

    2016-07-01

    Not all interventions that show promise in exploratory trials will be supported in phase III studies. But the high failure rate in recent trials of complex mental health interventions is a concern. Proper consideration of trial processes and greater use of adaptive trial designs could ensure better use of available resources. PMID:27369475

  10. Improving the counselling skills of lay counsellors in antiretroviral adherence settings: a cluster randomised controlled trial in the Western Cape, South Africa.

    Science.gov (United States)

    Dewing, Sarah; Mathews, Cathy; Schaay, Nikki; Cloete, Allanise; Simbayi, Leickness; Louw, Johann

    2015-01-01

    Little research has investigated interventions to improve the delivery of counselling in health care settings. We determined the impact of training and supervision delivered as part of the Options: Western Cape project on lay antiretroviral adherence counsellors' practice. Four NGOs employing 39 adherence counsellors in the Western Cape were randomly allocated to receive 53 h of training and supervision in Options for Health, an intervention based on the approach of Motivational Interviewing. Five NGOs employing 52 adherence counsellors were randomly allocated to the standard care control condition. Counselling observations were analysed for 23 intervention and 32 control counsellors. Intervention counsellors' practice was more consistent with a client-centred approach than control counsellors', and significantly more intervention counsellors engaged in problem-solving barriers to adherence (91 vs. 41 %). The Options: Western Cape training and supervision package enabled lay counsellors to deliver counselling for behaviour change in a manner consistent with evidence-based approaches.

  11. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (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

    2016-01-01

    Background We assessed the effect of automated treatment adherence support delivered via mobile-phone short message system (SMS) text-messages on blood pressure. Methods and Results In this pragmatic single-blind, three-arm randomized trial (StAR), undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information-only or 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 (92%) participants. At 12-months, the mean adjusted change (95% CI) in systolic blood pressure compared to usual care was −2.2 mm Hg (−4.4 to −0.04) with information-only SMS and −1.6 mm Hg (−3.7 to 0.6) with interactive SMS. Odds ratios (95% CI) for the proportion of participants with a blood pressure <140/90mm Hg were for information-only messaging 1.42 (1.03 to 1.95) and for interactive messaging 1.41 (1.02 to 1.95) compared to usual care. Conclusions In this randomized trial of an automated adherence support program delivered by SMS text-message in a general outpatient population of adults with high blood pressure, we found a small, reduction in systolic blood pressure control compared to usual care at 12-months. There was no evidence that an interactive intervention increased this effect. Clinical Trial Registration Information ClinicalTrials.gov. Identifier: South African National Clinical Trials Register number (SANCTR DOH-27-1212-386); Pan Africa Trial Register (PACTR201411000724141). PMID:26769742

  12. Understanding and improving treatment adherence in patients with psychotic disorders: A review and a proposed intervention

    NARCIS (Netherlands)

    A.B.P. Staring (Anton); C.L. Mulder (Niels); M. van der Gaag (Mark); J.-P. Selten; A.J.M. Loonen (Anne); M.W. Hengeveld (Michiel)

    2006-01-01

    textabstractNon-adherence to treatment of patients with psychotic disorders is related to higher rates of relapse, hospitalization, and suicide. Important predictors of non-adherence include poor social structure, cognitive deficits, negative medication attitude, side effects, depression, a sealing-

  13. Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

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    Huisjes Anjoke JM

    2007-07-01

    Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN

  14. Effect of Expectation of Care on Adherence to Antihypertensive Medications Among Hypertensive Blacks: Analysis of the Counseling African Americans to Control Hypertension (CAATCH) Trial.

    Science.gov (United States)

    Grant, Andrea Barnes; Seixas, Azizi; Frederickson, Keville; Butler, Mark; Tobin, Jonathan N; Jean-Louis, Girardin; Ogedegbe, Gbenga

    2016-07-01

    Novel ideas are needed to increase adherence to antihypertensive medication. The current study used data from the Counseling African Americans to Control Hypertension (CAATCH) study, a sample of 442 hypertensive African Americans, to investigate the mediating effects of expectation of hypertension care, social support, hypertension knowledge, and medication adherence, adjusting for age, sex, number of medications, diabetes, education, income, employment, insurance status, and intervention. Sixty-six percent of patients had an income of $20,000 or less and 56% had a high school education or less, with a mean age of 57 years. Greater expectation of care was associated with greater medication adherence (P=.007), and greater social support was also associated with greater medication adherence (P=.046). Analysis also showed that expectation of care mediated the relationship between hypertension knowledge and medication adherence (Psocial support are important factors for developing interventions to increase medication adherence among blacks. PMID:26593105

  15. Adherence to process of care quality indicators after percutaneous coronary intervention in Ontario, Canada: a retrospective observational cohort study

    OpenAIRE

    Czarnecki, Andrew; Prasad, Treesa J; Wang, Julie; Wijeysundera, Harindra C; Cheema, Asim N.; Dz̆avík, Vladimír; Natarajan, Madhu K.; Simpson, Chris S.; So, Derek Y.; Syed, Jaffer; Tu, Jack V.; Ko, Dennis T

    2015-01-01

    Background Public reporting of percutaneous coronary intervention (PCI) outcomes has been established in many jurisdictions to ensure optimal delivery of care. The majority of PCI report cards examine in-hospital mortality, but relatively little is known regarding the adherence to processes of care. Methods A modified Delphi panel comprising cardiovascular experts was assembled to develop a set of PCI quality indicators. Indicators such as prescription of aspirin, dual antiplatelet therapy, s...

  16. Effect of a stewardship intervention on adherence to uncomplicated cystitis and pyelonephritis guidelines in an emergency department setting.

    Directory of Open Access Journals (Sweden)

    Michelle T Hecker

    Full Text Available OBJECTIVE: To evaluate adherence to uncomplicated urinary tract infections (UTI guidelines and UTI diagnostic accuracy in an emergency department (ED setting before and after implementation of an antimicrobial stewardship intervention. METHODS: The intervention included implementation of an electronic UTI order set followed by a 2 month period of audit and feedback. For women age 18-65 with a UTI diagnosis seen in the ED with no structural or functional abnormalities of the urinary system, we evaluated adherence to guidelines, antimicrobial use, and diagnostic accuracy at baseline, after implementation of the order set (period 1, and after audit and feedback (period 2. RESULTS: Adherence to UTI guidelines increased from 44% (baseline to 68% (period 1 to 82% (period 2 (P≤.015 for each successive period. Prescription of fluoroquinolones for uncomplicated cystitis decreased from 44% (baseline to 14% (period 1 to 13% (period 2 (P<.001 and P = .7 for each successive period. Unnecessary antibiotic days for the 200 patients evaluated in each period decreased from 250 days to 119 days to 52 days (P<.001 for each successive period. For 40% to 42% of cases diagnosed as UTI by clinicians, the diagnosis was deemed unlikely or rejected with no difference between the baseline and intervention periods. CONCLUSIONS: A stewardship intervention including an electronic order set and audit and feedback was associated with increased adherence to uncomplicated UTI guidelines and reductions in unnecessary antibiotic therapy and fluoroquinolone therapy for cystitis. Many diagnoses were rejected or deemed unlikely, suggesting a need for studies to improve diagnostic accuracy for UTI.

  17. The effect of depression and adherence in a dietary and physical activity intervention for overweight and obese adults

    OpenAIRE

    Abascal, Liana B.

    2008-01-01

    Overweight and obesity result in serious medical, economic, and psychological consequences. A better understanding of factors that lead to successful weight loss treatment is needed, including mediators and moderators of treatment effects. This study investigated the effect of depression on adherence to a dietary and physical activity behavior change intervention in a sample of overweight and obese men and women. The PACEi Men in Motion (n=441) and Women in Balance (n=401) on-line interventio...

  18. A randomized, controlled study of an educational intervention to improve recall of auxiliary medication labeling and adherence to antibiotics

    OpenAIRE

    Pham, Jade A; Pierce, William; Muhlbaier, Lawrence

    2013-01-01

    Purpose: To evaluate whether medication counseling with emphasis on auxiliary labels improves recall of auxiliary label information and adherence to medication schedules. Methods: A prospective, randomized study of an educational intervention in community pharmacies near Baltimore, Maryland. Fifty literate, English-speaking adults receiving one of the 18 commonly dispensed antibiotics were randomized to receive a counseling session or no counseling. Five to seven days after medication pickup,...

  19. Strong Relationship between Oral Dose and Tenofovir Hair Levels in a Randomized Trial: Hair as a Potential Adherence Measure for Pre-Exposure Prophylaxis (PrEP)

    OpenAIRE

    Liu, Albert Y.; Yang, Qiyun; Huang, Yong; Bacchetti, Peter; Anderson, Peter L.; Jin, Chengshi; Goggin, Kathy; Stojanovski, Kristefer; Grant, Robert; Buchbinder, Susan P.; Greenblatt, Ruth M.; Gandhi, Monica

    2014-01-01

    Background Pre-exposure prophylaxis (PrEP) trials using tenofovir-based regimens have demonstrated that high levels of adherence are required to evaluate efficacy; the incorporation of objective biomarkers of adherence in trial design has been essential to interpretation, given the inaccuracy of self-report. Antiretroviral measurements in scalp hair have been useful as a marker of long-term exposure in the HIV treatment setting, and hair samples are relatively easy and inexpensive to collect,...

  20. Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P Study, a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rejeski W Jack

    2011-05-01

    Full Text Available Abstract Background The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. Methods SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA and/or cognitive training intervention (CT in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. Results Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004, the interventions produced marked changes in cognitive and physical performance measures (p≤0.05, and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01. Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome or 2,000 participants (categorical outcome. Conclusions Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. Trial Registration Clinicaltrials.gov Identifier: NCT00688155

  1. Can Rapid Diagnostic Testing for Malaria Increase Adherence to Artemether-Lumefantrine?: A Randomized Controlled Trial in Uganda.

    Science.gov (United States)

    Saran, Indrani; Yavuz, Elif; Kasozi, Howard; Cohen, Jessica

    2016-04-01

    Most patients with suspected malaria do not receive diagnostic confirmation before beginning antimalarial treatment. We investigated the extent to which uncertainty about malaria diagnosis contributes to patient nonadherence to artemether-lumefantrine (AL) treatment through a randomized controlled trial in central Uganda. Among 1,525 patients purchasing a course of AL at private drug shops, we randomly offered 37.6% a free malaria rapid diagnostic test (RDT) and then assessed adherence through home visits 3 days later. Of these subjects, 68.4% tested positive for malaria and 65.8% adhered overall. Patients who tested positive did not have significantly higher odds of adherence than those who were not offered the test (adjusted odds ratio [OR]: 1.07, 95% confidence interval [CI]: 0.734-1.57,P= 0.719). Patients who received a positive malaria test had 0.488 fewer pills remaining than those not offered the test (95% CI: -1.02 to 0.043,P= 0.072). We found that patients who felt relatively healthy by the second day of treatment had lower odds of completing treatment (adjusted OR: 0.532, 95% CI: 0.394-0.719,P< 0.001). Our results suggest that diagnostic testing may not improve artemisinin-based combination therapy adherence unless efforts are made to persuade patients to continue taking the full course of drugs even if symptoms have resolved. PMID:26928828

  2. Medication adherence among female inmates with bipolar disorder: results from a randomized controlled trial.

    Science.gov (United States)

    Ehret, Megan J; Shelton, Deborah; Barta, William; Trestman, Robert; Maruca, Annette; Kamath, Jayesh; Golay, Leslie

    2013-02-01

    To describe the differences in medication adherence between 2 groups of inmates in the Connecticut Department of Correction diagnosed with bipolar disorder treated with either the Texas Implementation of Medication Algorithm (TIMA) for Bipolar Disorder or treatment as usual (TAU). Using a prospective longitudinal analysis of secondary data and chart data, a comparison was made between participants who were assigned either to TIMA or TAU and treated for 12 weeks for either Bipolar Disorder Type I or II. A secondary data set containing 12 weeks of medication data was combined with medical chart data, including medication administration records, which were retrospectively reviewed to determine numbers of psychotropic and other medications prescribed, number of doses per day prescribed, number of times the medications were taken, any patterns and reasons for missed doses, and side effects experienced. High rates of psychotropic medication nonadherence were observed among female inmates with bipolar disorder, with the mood stabilizers as the most frequently missed medications. Analyses revealed an interaction of Treatment Condition × Baseline Adherence × Time in Treatment × Biweekly Symptom Severity. Regardless of treatment condition, participants exhibiting high baseline adherence exhibited greater decreases in daily adherence over time; in addition, participants at Time 8 (Weeks 7 and 8) and later exhibited poorer adherence if they had more severe symptoms during those weeks. TIMA participants missed fewer doses than TAU participants. Future research is needed to uncover what factors most significantly contribute to psychotropic medication adherence. PMID:23421363

  3. Participant adherence indicators predict changes in dietary, physical activity, and clinical outcomes in church-based, diet and supervised physical activity intervention: Delta Body and Soul III

    Science.gov (United States)

    This secondary analysis evaluated the utility of several participant adherence indicators for predicting health outcome changes in a 6-month, church-based, controlled, lifestyle intervention previously proven effective for improving diet quality, physical activity, and blood lipids. Descriptive ind...

  4. The Effect of Using Assessment Instruments on Substance-abuse Outpatients' Adherence to Treatment: a Multi-centre Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Broekaert Eric

    2011-05-01

    Full Text Available Abstract Background Drop-out is an important problem in the treatment of substance use disorder. The focus of this study was to investigate the effectiveness of within treatment assessment with feedback directly to patients with multiple substance use disorder on outpatient individual treatment adherence. Feedback consisted of personal resources' and readiness to change status and progress that facilitate or hinder change, thereby using graphical representation. Methods Informed consent was obtained from both the control and experimental groups to be involved in research and follow-up. Following Zelen's single consent design, baseline participants (n = 280 were randomised (sample-size-estimation: 80%power, p=.05, 2-sided and treatment consent was obtained from those allocated to the experiment (n = 142. In both groups, equal numbers of patients did not attend sessions after allocation. So, 227 persons were analyzed according to intention-to-treat analysis (ITT: experiment n = 116;control n = 111. Excluding refusals 211 participants remained for per-protocol analysis (PP: experiment n = 100; control n = 111, The study was conducted in five outpatient treatment-centres of a large network (De Sleutel in Belgium. Participants were people with multiple substance use disorder -abuse and dependence- who had asked for treatment and who had been advised to start individual treatment after a standardised admission assessment with the European Addiction Severity Index. The experimental condition consisted of informing the patient about the intervention and of subsequent assessments plus feedback following a protocol within the first seven sessions. Assessments were made with the Readiness to Change Questionnaire and the Personal Resources Diagnostic System. The control group received the usual treatment without within treatment assessment with feedback. The most important outcome measure in this analysis of the study was the level of adherence to treatment

  5. Diabetes prevention in the real world: effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations: a systematic review and meta-analysis.

    Science.gov (United States)

    Dunkley, Alison J; Bodicoat, Danielle H; Greaves, Colin J; Russell, Claire; Yates, Thomas; Davies, Melanie J; Khunti, Kamlesh

    2014-04-01

    OBJECTIVE To summarize the evidence on effectiveness of translational diabetes prevention programs, based on promoting lifestyle change to prevent type 2 diabetes in real-world settings and to examine whether adherence to international guideline recommendations is associated with effectiveness. RESEARCH DESIGN AND METHODS Bibliographic databases were searched up to July 2012. Included studies had a follow-up of ≥12 months and outcomes comparing change in body composition, glycemic control, or progression to diabetes. Lifestyle interventions aimed to translate evidence from previous efficacy trials of diabetes prevention into real-world intervention programs. Data were combined using random-effects meta-analysis and meta-regression considering the relationship between intervention effectiveness and adherence to guidelines. RESULTS Twenty-five studies met the inclusion criteria. The primary meta-analysis included 22 studies (24 study groups) with outcome data for weight loss at 12 months. The pooled result of the direct pairwise meta-analysis shows that lifestyle interventions resulted in a mean weight loss of 2.12 kg (95% CI -2.61 to -1.63; I(2) = 91.4%). Adherence to guidelines was significantly associated with a greater weight loss (an increase of 0.3 kg per point increase on a 12-point guideline-adherence scale). CONCLUSIONS Evidence suggests that pragmatic diabetes prevention programs are effective. Effectiveness varies substantially between programs but can be improved by maximizing guideline adherence. However, more research is needed to establish optimal strategies for maximizing both cost-effectiveness and longer-term maintenance of weight loss and diabetes prevention effects.

  6. Assessment of adherence to the statistical components of consolidated standards of reporting trials statement for quality of reports on randomized controlled trials from five pharmacology journals

    Directory of Open Access Journals (Sweden)

    Sachin Satpute

    2016-01-01

    Full Text Available Background: The Consolidated Standards of Reporting Trials (CONSORT statement is a device to standardize reporting and improve the quality of controlled trials. However, little attention is paid to the statistical components in the CONSORT checklist. The present study evaluates the randomized controlled trials [RCTs] published in five high impact pharmacology journals with respect to its statistical methods. Methods: Randomized Controlled Trials [RCTs] published in the years 2013 & 2014 in five pharmacology journals with high impact factor, The Journal of Clinical Pharmacology (JCP, British Journal of Clinical Pharmacology (BJCP, European Journal of Clinical Pharmacology (EJCP, Journal of Pharmacology & Pharmacotherapeutics (JPP and Indian Journal of Pharmacology (IJP were assessed for adherence to the statistical components of CONSORT statement. Results: Of the 174 RCTs analysed, 103 described the method of sample size calculation. Of the five journals, maximum reports in JCP (34/50 and minimum in IJP (13/31 adhered to the CONSORT checklist [item 7a-sample size calculation]. Most reports mentioned the statistical methods used for analysis of data. (171/174 as per the checklist [item 12=statistical methods used]. Analysis of variance (ANOVA was the most commonly used test (88/174. The software used for statistical analysis was mentioned in 111 RCTs and SPSS was used more frequently (58/111. The exact p value was stated in 108 reports. Certain errors in statistical analysis were also noted (40/174. Conclusion: These findings show inconsistencies and non- adherence to the statistical components of the CONSORT statement especially with respect to sample size calculation. Special attention must be paid to the statistical accuracy of the reports.

  7. Assessment of adherence to the statistical components of consolidated standards of reporting trials statement for quality of reports on randomized controlled trials from five pharmacology journals

    Science.gov (United States)

    Satpute, Sachin; Mehta, Manthan; Bhete, Sandeep; Kurle, Dnyneshwar

    2016-01-01

    Background: The Consolidated Standards of Reporting Trials (CONSORT) statement is a device to standardize reporting and improve the quality of controlled trials. However, little attention is paid to the statistical components in the CONSORT checklist. The present study evaluates the randomized controlled trials [RCTs] published in five high impact pharmacology journals with respect to its statistical methods. Methods: Randomized Controlled Trials [RCTs] published in the years 2013 & 2014 in five pharmacology journals with high impact factor, The Journal of Clinical Pharmacology (JCP), British Journal of Clinical Pharmacology (BJCP), European Journal of Clinical Pharmacology (EJCP), Journal of Pharmacology & Pharmacotherapeutics (JPP) and Indian Journal of Pharmacology (IJP) were assessed for adherence to the statistical components of CONSORT statement. Results: Of the 174 RCTs analysed, 103 described the method of sample size calculation. Of the five journals, maximum reports in JCP (34/50) and minimum in IJP (13/31) adhered to the CONSORT checklist [item 7a-sample size calculation]. Most reports mentioned the statistical methods used for analysis of data. (171/174) as per the checklist [item 12=statistical methods used]. Analysis of variance (ANOVA) was the most commonly used test (88/174). The software used for statistical analysis was mentioned in 111 RCTs and SPSS was used more frequently (58/111). The exact p value was stated in 108 reports. Certain errors in statistical analysis were also noted (40/174). Conclusion: These findings show inconsistencies and non- adherence to the statistical components of the CONSORT statement especially with respect to sample size calculation. Special attention must be paid to the statistical accuracy of the reports. PMID:27453829

  8. An efficacy trial of brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial

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    Fanaian Mahnaz

    2010-02-01

    Full Text Available Abstract Background Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP are the main behavioural risk factors for chronic disease. Primary health care (PHC has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. Methods/Design The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1 telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2 nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3 semi-structured interviews/focus with nurses, managers and clients

  9. A pragmatic cluster randomised trial evaluating three implementation interventions

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    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  10. Parenting style, parent-youth conflict, and medication adherence in youth with type 2 diabetes participating in an intensive lifestyle change intervention.

    Science.gov (United States)

    Saletsky, Ronald D; Trief, Paula M; Anderson, Barbara J; Rosenbaum, Paula; Weinstock, Ruth S

    2014-06-01

    Parenting behaviors and family conflict relate to type 1 diabetes outcomes in youth. Our purpose was to understand these relationships in parents and youth with type 2 diabetes (T2DM). The TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) trial enrolled youth (10-17 years) with T2DM and parent/guardian. For this ancillary study, we enrolled a sample of youth-parent pairs (N = 137) in 1 study arm (metformin plus lifestyle intervention). They completed questionnaires measuring parenting style related to normative (e.g., completing homework) and diabetes self-care (e.g., testing blood glucose) tasks, and parent-youth verbal conflict (baseline, 6, and 12 months). Parenting style was consistent across normative and diabetes tasks, with gradual increases in autonomy perceived by youth. Conversations were generally calm, with greater conflict regarding normative than diabetes tasks at baseline (youth: p parent: p = .01), 6 months (youth: p = .02, parent: p > .05), and 12 months (youth: p > .05., parent: p = .05). A permissive parenting style toward normative tasks and a less authoritarian style toward diabetes tasks, at baseline, predicted better medication adherence (8-12 months) (normative: adjusted R2 = 0.48, p Parent-youth conflict did not predict medication adherence. Youth with T2DM who perceive more autonomy (less parental control) in day-to-day and diabetes tasks are more likely to adhere to medication regimens. It may be valuable to assess youth perceptions of parenting style and help parents understand youths' needs for autonomy. PMID:24548045

  11. Parenting style, parent-youth conflict, and medication adherence in youth with type 2 diabetes participating in an intensive lifestyle change intervention.

    Science.gov (United States)

    Saletsky, Ronald D; Trief, Paula M; Anderson, Barbara J; Rosenbaum, Paula; Weinstock, Ruth S

    2014-06-01

    Parenting behaviors and family conflict relate to type 1 diabetes outcomes in youth. Our purpose was to understand these relationships in parents and youth with type 2 diabetes (T2DM). The TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) trial enrolled youth (10-17 years) with T2DM and parent/guardian. For this ancillary study, we enrolled a sample of youth-parent pairs (N = 137) in 1 study arm (metformin plus lifestyle intervention). They completed questionnaires measuring parenting style related to normative (e.g., completing homework) and diabetes self-care (e.g., testing blood glucose) tasks, and parent-youth verbal conflict (baseline, 6, and 12 months). Parenting style was consistent across normative and diabetes tasks, with gradual increases in autonomy perceived by youth. Conversations were generally calm, with greater conflict regarding normative than diabetes tasks at baseline (youth: p parent: p = .01), 6 months (youth: p = .02, parent: p > .05), and 12 months (youth: p > .05., parent: p = .05). A permissive parenting style toward normative tasks and a less authoritarian style toward diabetes tasks, at baseline, predicted better medication adherence (8-12 months) (normative: adjusted R2 = 0.48, p Parent-youth conflict did not predict medication adherence. Youth with T2DM who perceive more autonomy (less parental control) in day-to-day and diabetes tasks are more likely to adhere to medication regimens. It may be valuable to assess youth perceptions of parenting style and help parents understand youths' needs for autonomy.

  12. [Trials for early intervention in Mie Prefectural Mental Care Center].

    Science.gov (United States)

    Harada, Masanori; Adachi, Takako; Iwasa, Takashi; Kurita, Kouji; Nakamura, Tomoki; Hama, Yukinobu; Yamamoto, Ayako; Maegawa, Sanae

    2013-01-01

    Mie Prefectural Mental Care Center is a public psychiatric hospital that has 400 beds and 250 outpatients a day. The main catchment area is Tsu City (population: 290,000). Our hospital started early intervention in Aug 2008, and opened the Youth Mental Support Center MIE (YMSC MIE) in Oct 2008. This article reports an early intervention trial in a regional area of Japan. The mission of YMSC MIE is the education, consultation, staff training, and intervention for mental health problems and early psychosis of youths. In Jul 2009, we set up the Youth Assist Clinic (YAC) to support youths with mental health problems and early psychoses. Our activities consist of school-based, community-based, and hospital-based approaches. Specific programs are as follows: 1) School-based approaches: Outreach consultation to school. Mental health lessens. Creating mental health textbooks. Education for parents and teachers. 2) Community-based approaches: To enlighten primary physicians and mental clinic psychiatrists about the importance of early psychosis. To survey their concerns regarding early psychosis. Promoting awareness of community staff and the general public. 3) Hospital-based approaches: YAC. Case manager system. Family meetings for the family including the young with mental disorders. Peer group. Looking back over our 3-year trials, especially in school and the community, we find several problems, as follows: 1) Lack of consultation skills of medical staff outside the hospital. 2) Limiting number of schools which have mental support system. 3) Support for school attendance and learning. 4) Lack of concern about early psychosis of primary physicians and mental clinic psychiatrists. 5) Staff training for early intervention. We are now getting close to improving these issues.

  13. Adherence to antiplatelet treatment with P2Y12 receptor inhibitors. Is there anything we can do to improve it? A systematic review of randomized trials.

    Science.gov (United States)

    Kubica, Aldona; Obońska, Karolina; Fabiszak, Tomasz; Kubica, Jacek

    2016-08-01

    Antiplatelet therapy is the cornerstone of treatment for patients with acute coronary syndromes (ACS) and/or undergoing percutaneous coronary interventions. Non-adherence to medication after ACS may lead to increased morbidity, mortality, and costs to the healthcare system due to elevated risk of stent thrombosis, myocardial infarction or death. Medication adherence is an issue of growing concern regarding the improvement of health system performance. Promoting medication adherence offers a rare opportunity to simultaneously improve health outcomes while reducing costs of treatment in patients with coronary artery disease (CAD). The aim of this systematic review was to critically discuss adherence to antiplatelet treatment with P2Y12 receptor inhibitors in CAD patients. After a systematic investigation of the literature in databases including PubMed, CENTRAL and Google Scholar, using appropriate keywords, and considering clinical randomized, prospective observational and retrospective studies, reporting on adherence to treatment with inhibitors of P2Y12 platelet receptors or educational interventions aimed to improve medication adherence in patients with CAD, seven articles were considered eligible for inclusion in this systematic review. Reported adherence to clopidogrel, despite catastrophic consequences of its premature discontinuation, is low. We identified several determinants of low adherence and early discontinuation of clopidogrel. We also present data on the usefulness, utilization and credibility of different methods of medication adherence assessment, and suggest and critically discuss available interventions aimed at improvement of adherence to clopidogrel, still showing the need for innovative approaches to achieve enhanced medication adherence and improve health outcomes after acute myocardial infarction. PMID:27112628

  14. Predictors and impact of non-adherence in adults with attention-deficit/hyperactivity disorder receiving OROS methylphenidate: results from a randomized, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Kooij J J Sandra

    2013-01-01

    be at increased risk of non-adherence. Clinicians and policymakers should therefore pay special attention to these individuals, as non-adherence is a significant predictor of reduced response to treatment. Trial registration EudraCT #: 2007-002111-82

  15. Do Overweight Adolescents Adhere to Dietary Intervention Messages? Twelve-Month Detailed Dietary Outcomes from Curtin University’s Activity, Food and Attitudes Program

    OpenAIRE

    Smith, Kyla L.; Kerr, Deborah A; Howie, Erin K.; Straker, Leon M

    2015-01-01

    Dietary components of adolescent obesity interventions are rarely evaluated with comprehensive reporting of dietary change. The objective was to assess dietary change in overweight adolescents, including adherence to dietary intervention. The dietary intervention was part of a multi-component intervention (CAFAP) targeting the physical activity, sedentary and healthy eating behaviors of overweight adolescents (n = 69). CAFAP was a staggered entry, within-subject, waitlist controlled clinical ...

  16. A Mobile Phone HIV Medication Adherence Intervention: Care4Today™ Mobile Health Manager

    Science.gov (United States)

    Martin, C. Andrew

    2016-01-01

    This paper presents the findings of a qualitative study designed to describe the experience of HIV medication adherence using a mobile phone application. For the purpose of this qualitative study, nine semi-structured focus group discussions were conducted over a three-month period at an AIDS service organization in Central Texas. The data were…

  17. The effect of reminder systems on patients' adherence to treatment

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    Fenerty SD

    2012-02-01

    Full Text Available Sarah D Fenerty1, Cameron West1, Scott A Davis1, Sebastian G Kaplan3, Steven R Feldman1,2,41Center for Dermatology Research, Department of Dermatology, 2Department of Pathology, 3Department of Psychiatry and Behavioral Medicine, 4Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USABackground: Patient adherence is an important component of the treatment of chronic disease. An understanding of patient adherence and its modulating factors is necessary to correctly interpret treatment efficacy and barriers to therapeutic success.Purpose: This meta-analysis aims to systematically review published randomized controlled trials of reminder interventions to assist patient adherence to prescribed medications.Methods: A Medline search was performed for randomized controlled trials published between 1968 and June 2011, which studied the effect of reminder-based interventions on adherence to self-administered daily medications.Results: Eleven published randomized controlled trials were found between 1999 and 2009 which measured adherence to a daily medication in a group receiving reminder interventions compared to controls receiving no reminders. Medication adherence was measured as the number of doses taken compared to the number prescribed within a set period of time. Meta-analysis showed a statistically significant increase in adherence in groups receiving a reminder intervention compared to controls (66.61% versus 54.71%, 95% CI for mean: 0.8% to 22.4%. Self-reported and electronically monitored adherence rates did not significantly differ (68.04% versus 63.67%, P = 1.0. Eight of eleven studies showed a statistically significant increase in adherence for at least one of the reminder group arms compared to the control groups receiving no reminder intervention.Limitations: The data are limited by imperfect measures of adherence due to variability in data collection methods. It is also likely

  18. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

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    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  19. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a

  20. The Nurse-Led Telephone Follow-Up on Medication and Dietary Adherence among Patients after Myocardial Infarction: A Randomized Controlled Clinical Trial

    OpenAIRE

    Seyed Saeed Najafi; Maryam Shaabani; Marzieh Momennassab; Kamran Aghasadeghi

    2016-01-01

    Background: Adherence to dietary and medication regimen plays an important role in successful treatment and reduces the negative complications and severity of the disease. Therefore, the present study aimed to investigate the effect of nurse-led telephone follow-up on the level of adherence to dietary and medication regimen among patients after Myocardial Infarction (MI). Methods: This non-blinded randomized controlled clinical trial was conducted on 100 elderly patients with MI who had re...

  1. The Nurse-Led Telephone Follow-Up on Medication and Dietary Adherence among Patients after Myocardial Infarction: A Randomized Controlled Clinical Trial

    OpenAIRE

    Najafi, Seyed Saeed; Shaabani, Maryam; Momennassab, Marzieh; Aghasadeghi, Kamran

    2016-01-01

    Background: Adherence to dietary and medication regimen plays an important role in successful treatment and reduces the negative complications and severity of the disease. Therefore, the present study aimed to investigate the effect of nurse-led telephone follow-up on the level of adherence to dietary and medication regimen among patients after Myocardial Infarction (MI). Methods: This non-blinded randomized controlled clinical trial was conducted on 100 elderly patients with MI who had refer...

  2. Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT

    OpenAIRE

    Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie

    2016-01-01

    Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phas...

  3. Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT

    OpenAIRE

    Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie

    2016-01-01

    Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a lar...

  4. Adherence to prophylactic antibiotic therapy of thoraco-abdominal interventions in Hospital Universitario San Jorge, Pereira

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    Jorge Enrique Machado-Alba

    2013-05-01

    Full Text Available Objective: determine adherence to the protocol of antibiotic prophylaxis in patients undergoingsurgery at Hospital Universitario San Jorge, Pereira. Materials and methods: observational descriptivestudy took information from all patients who underwent surgery between April 1 and June31, 2010. The information was taken from medical records considering the variables age, gender,type of surgery, time, day of week, antimicrobial agents used compared with those recommendedby institutional guidelines. The analysis was done using SPSS 19.0 for Windows. Results: therewere 211 patients, with a predominance of men (52,6% and average age of 45,2 ± 19,9 years.Adherence to guidelines pre-surgical prophylaxis was 44,5% of procedures. The variables malegender (OR 2,2; 95% CI 1,220 to 4,063, p=0,009, emergency surgery (OR 2,1; 95% CI 1,136 to3,889, p=0,018 and weekends surgery (OR 2,3; 95% CI 1,090 to 5,255; p=0,03 were statisticallysignificantly associated with nonadherence. Conclusion: it found low guideline for pre-surgicalantibiotic adherence associated with emergency and weekends surgeries. Should intervene witheducation and feedback the team working in the emergency and surgery department to improvethe level of compliance with guidelines.

  5. Reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications.

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    Sean P Grant

    Full Text Available BACKGROUND: Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVE/DESIGN: We conducted a two-part study that reviewed (1 reporting guidelines for and (2 the reporting quality of social and psychological intervention trials. DATA SOURCES: (1 To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2 To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1 Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2 Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. RESULTS: (1 We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2 Our review of trials (n = 239 revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information and abstracts (55%; information about blinding (15%, sequence generation (23%, and allocation concealment (17%; and details about actual delivery of experimental (43% and control interventions (34%, participant uptake (25%, and service environment (28%. Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors." CONCLUSION: Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely

  6. Dementia in residential care: education intervention trial (DIRECT; protocol for a randomised controlled trial

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    Lautenschlager Nicola T

    2010-05-01

    Full Text Available Abstract Background There is scope to improve the quality of life (QOL of people with dementia living in residential care facilities (RCF. The DIRECT study will determine if delivery of education to General Practitioners (GPs and care staff improves the quality of life of residential care recipients with cognitive impairment. Methods/Design A prospective randomised controlled trial conduced in residential aged care facilities in the metropolitan area of Perth, Western Australia. Participants are care facility residents, aged 65 years and older and with mini-mental state examination scores less than 25. GPs and care facility staff have been independently randomised to intervention or control groups. An education programme, designed to meet the perceived needs of learners, will be delivered to GPs and care staff in the intervention groups. The primary outcome of the study will be quality of life of the people with dementia, measured using the QOL-Alzheimer's Disease Scale (QOL-AD and Alzheimer Disease Related QOL Scale (ADRQL, 4 weeks and 6 months after the conclusion of the education intervention. Results Recruitment of 351 people with dementia, cared for by staff in 39 residential facilities and 55 GPs, was undertaken between May 2007 and July 2008. Collection of baseline data is complete. Education has been delivered to GPs and Care staff between September 2008 and July 2009. Follow- up data collection is underway. Discussion The study results will have tangible implications for proprietors, managers and staff from the residential care sector and policy makers. The results have potential to directly benefit the quality of life of both patients and carers. Trial registration These trial methods have been prospectively registered (ACTRN12607000417482.

  7. Insights for Exercise Adherence from a Minimal Planning Intervention to Increase Physical Activity

    Science.gov (United States)

    Chapman, Janine; Campbell, Marianne; Wilson, Carlene

    2015-01-01

    Objective: To test the impact of a minimal, online planning intervention on physical activity in Australian office workers. Method: Employees were randomized to an implementation intention intervention (n = 124) or health information control group (n = 130). Measures of physical activity, past behavior, and motivation were taken at baseline and 6…

  8. Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women

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    Duggan Catherine

    2012-05-01

    Full Text Available Abstract Background In the US, Hispanic women have a higher incidence of, and mortality from, cervical cancer than non-Hispanic white women. The reason for this disparity may be attributable to both low rates of screening and poor adherence to recommended diagnostic follow-up after an abnormal Pap test. The 'Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women' study is a collaboration between a research institution and community partners made up of members from community based organizations, the Yakima Valley Farm Workers Clinic and the Breast, Cervical, and Colon Health Program of the Yakima District . The study will assess the efficacy of two culturally-appropriate, tailored educational programs designed to increase cervical cancer screening among Hispanic women, based in the Yakima Valley, Washington, US. Methods/design A parallel randomized-controlled trial of 600 Hispanic women aged 21–64, who are non-compliant with Papanicolau (Pap test screening guidelines. Participants will be randomized using block randomization to (1 a control arm (usual care; (2 a low-intensity information program, consisting of a Spanish-language video that educates women on the importance of cervical cancer screening; or (3 a high-intensity program consisting of the video plus a ‘promotora’ or lay-community health educator-led, home based intervention to encourage cervical cancer screening. Participants who attend cervical cancer screening, and receive a diagnosis of an abnormal Pap test will be assigned to a patient navigator who will provide support and information to promote adherence to follow-up tests, and any necessary surgery or treatment. Primary endpoint: Participants will be tracked via medical record review at community-based clinics, to identify women who have had a Pap test within 7 months of baseline assessment. Medical record reviewers will be blinded to randomization arm. Secondary endpoint: An evaluation of the patient

  9. Improvement in medication adherence and self-management of diabetes with a clinical pharmacy program: a randomized controlled trial in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital

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    Catarina Gomes Cani

    2015-02-01

    Full Text Available OBJECTIVE: To evaluate the impact of a clinical pharmacy program on health outcomes in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital in Brazil. METHOD: A randomized controlled trial with a 6-month follow-up period was performed in 70 adults, aged 45 years or older, with type 2 diabetes who were taking insulin and who had an HbA1c level ≥8%. Patients in the control group (CG (n = 36 received standard care, patients in the intervention group (IG (n = 34 received an individualized pharmacotherapeutic care plan and diabetes education. The primary outcome measure was change in HbA1c. Secondary outcomes included diabetes and medication knowledge, adherence to medication, insulin injection and home blood glucose monitoring techniques and diabetes-related quality of life. Outcomes were evaluated at baseline and 6 months using questionnaires. RESULTS: Diabetes knowledge, medication knowledge, adherence to medication and correct insulin injection and home blood glucose monitoring techniques significantly improved in the intervention group but remained unchanged in the control group. At the end of the study, mean HbA1c values in the control group remained unchanged but were significantly reduced in the intervention group. Diabetes-related quality of life significantly improved in the intervention group but worsened significantly in the control group. CONCLUSION: The program improved health outcomes and resulted in better glycemic control in patients with type 2 diabetes undergoing insulin therapy.

  10. Tailored lay health worker intervention improves breast cancer screening outcomes in non-adherent Korean-American women

    OpenAIRE

    Han, Hae-Ra; Lee, H.; Kim, M. T.; Kim, K. B.

    2008-01-01

    Despite rapidly increasing incidence rates of breast cancer, recent immigrants such as Korean-American (KA) women report disproportionately lower utilization of screening tests compared with other ethnic groups. Early screening of breast cancer for this population may be greatly facilitated by indigenous lay health workers (LHWs). We conducted an intervention trial with a 6-month follow-up. Trained LHWs recruited 100 KA women 40 years of age or older who had not had a mammogram during the pas...

  11. The Effect of Two Educational Methods on Knowledge and Adherence to Treatment in Hemodialysis Patients: Clinical Trial

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    Kobra Parvan

    2015-03-01

    Full Text Available Introduction: Patients with chronic renal disease (CRD deal with many potential problems with hemodialysis for all their life. Regarding the importance of preventing dialysis adverse effects, which are in close connection with lack of knowledge and report on how to train the patients? This study aims at comparing the impact of two methods of face to face training and training pamphlet on complying and informing of hemodialysis treatments. Methods: This clinical trial study was conducted on 58 hemodialysis patients who visited Shahid Rahnemun Teaching hospital, Yazd, Iran, and had required conditions of the research. Data were collected through a questionnaire including personal-social information, several questions to assess the level of compliance and to inform the treatment method. The quantitative analysis of this study used the Statistical Package for Social Sciences SPSS version 13 and descriptive (frequency, mean, standard deviation and inferential (Chi-square, paired t-test, ANOVA, ANCOVA statistics were employed. Results: The mean scores for informing both groups (face to face and training pamphlet were significantly increased. The mean score for adherence to treatments was also significant.Conclusion: In this research, face to face training was found to be more effective than training pamphlet. It seemed to have more strong effect on increasing the level of information and adherence to treatment. To train these people, face to face training should be, thus, preferred.

  12. "Did the trial kill the intervention?" experiences from the development, implementation and evaluation of a complex intervention

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    Cox Karen

    2011-03-01

    Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.

  13. A Randomised Controlled Trial of an Energy Efficiency Intervention for Families Living in Fuel Poverty

    OpenAIRE

    Heyman, Bob; Harrington, Barbara E.; Heyman, Anna

    2011-01-01

    This paper discusses a pragmatic randomised controlled trial of a fuel poverty intervention undertaken in NE England over a four-year period, starting in 2000/2001. Home energy efficiency was measured through Standardised Assessment Procedure (SAP) ratings in each year of the trial. The trial group received an energy efficiency intervention package in year three, and the control group in year four. Year three room temperature data for a sub-sample of 100 households were obtained. A comparison...

  14. An Open Trial of an Acceptance-Based Behavioral Intervention for Weight Loss

    Science.gov (United States)

    Forman, Evan M.; Butryn, Meghan L.; Hoffman, Kimberly L.; Herbert, James D.

    2009-01-01

    Innovative approaches are urgently needed to improve behavioral treatment for weight loss. The weight regain that is so common after treatment may be a result of an environment that makes it challenging to adhere, long-term, to a dietary and physical activity regimen. This study was designed to test, via a 12-week open trial, the preliminary…

  15. A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

    Science.gov (United States)

    Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

    2012-01-01

    This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

  16. Tailored lay health worker intervention improves breast cancer screening outcomes in non-adherent Korean-American women.

    Science.gov (United States)

    Han, Hae-Ra; Lee, H; Kim, M T; Kim, K B

    2009-04-01

    Despite rapidly increasing incidence rates of breast cancer, recent immigrants such as Korean-American (KA) women report disproportionately lower utilization of screening tests compared with other ethnic groups. Early screening of breast cancer for this population may be greatly facilitated by indigenous lay health workers (LHWs). We conducted an intervention trial with a 6-month follow-up. Trained LHWs recruited 100 KA women 40 years of age or older who had not had a mammogram during the past 2 years. Ninety-three completed follow-up questionnaires. A 120-min, in-class education combined with LHW follow-up counseling and navigation assistance through the health care system was provided. Rates of breast cancer screening behaviors significantly increased at 6 months (P < 0.001); changes between pre- and post-intervention were 31.9% for mammography, 23% for clinical breast examination and 36.2% for breast self-examination. Modesty toward screening significantly decreased over time, but we did not find any significant differences in breast cancer knowledge and beliefs before and after the intervention. Results support the efficacy of this neighborhood-based, culturally sensitive intervention. Further research should seek to replicate these findings and to incorporate more self-care skills such as health literacy when designing an intervention program for linguistically and culturally isolated immigrant women. PMID:18463411

  17. Individualised motivational counselling to enhance adherence to antiretroviral therapy is not superior to didactic counselling in South African patients: findings of the CAPRISA 058 randomised controlled trial.

    Science.gov (United States)

    van Loggerenberg, Francois; Grant, Alison D; Naidoo, Kogieleum; Murrman, Marita; Gengiah, Santhanalakshmi; Gengiah, Tanuja N; Fielding, Katherine; Abdool Karim, Salim S

    2015-01-01

    Concerns that standard didactic adherence counselling may be inadequate to maximise antiretroviral therapy (ART) adherence led us to evaluate more intensive individualised motivational adherence counselling. We randomised 297 HIV-positive ART-naïve patients in Durban, South Africa, to receive either didactic counselling, prior to ART initiation (n = 150), or an intensive motivational adherence intervention after initiating ART (n = 147). Study arms were similar for age (mean 35.8 years), sex (43.1 % male), CD4+ cell count (median 121.5 cells/μl) and viral load (median 119,000 copies/ml). Virologic suppression at 9 months was achieved in 89.8 % of didactic and 87.9 % of motivational counselling participants (risk ratio [RR] 0.98, 95 % confidence interval [CI] 0.90-1.07, p = 0.62). 82.9 % of didactic and 79.5 % of motivational counselling participants achieved >95 % adherence by pill count at 6 months (RR 0.96, 95 % CI 0.85-1.09, p = 0.51). Participants receiving intensive motivational counselling did not achieve higher treatment adherence or virological suppression than those receiving routinely provided didactic adherence counselling. These data are reassuring that less resource intensive didactic counselling was adequate for excellent treatment outcomes in this setting.

  18. The resist diabetes trial: Rationale, design, and methods of a hybrid efficacy/effectiveness intervention trial for resistance training maintenance to improve glucose homeostasis in older prediabetic adults.

    Science.gov (United States)

    Marinik, Elaina L; Kelleher, Sarah; Savla, Jyoti; Winett, Richard A; Davy, Brenda M

    2014-01-01

    Advancing age is associated with reduced levels of physical activity, increased body weight and fat, decreased lean body mass, and a high prevalence of type 2 diabetes (T2D). Resistance training (RT) increases muscle strength and lean body mass, and reduces risk of T2D among older adults. The Resist Diabetes trial will determine if a social cognitive theory (SCT)-based intervention improves RT maintenance in older, prediabetic adults, using a hybrid efficacy/effectiveness approach. Sedentary, overweight/obese (BMI: 25-39.9 kg/m(2)) adults aged 50-69 (N = 170) with prediabetes (impaired fasting glucose and/or impaired glucose tolerance) completed a supervised 3-month RT (2×/wk) initiation phase and were then randomly assigned (N = 159; 94% retention) to one of two 6-month maintenance conditions: SCT or standard care. The SCT intervention consisted of faded contacts compared to standard care. Participants continue RT at an approved, self-selected community facility during maintenance. A subsequent 6-month period involves no contact for both conditions. Assessments occur at baseline and months 3 (post-initiation), 9 (post-intervention), and 15 (six months after no contact). Primary outcomes are prediabetes indices (i.e., impaired fasting and 2-hour glucose concentration) and strength. Secondary measures include insulin sensitivity, beta-cell responsiveness, and disposition index (oral glucose and C-peptide minimal model); adherence; body composition; and SCT measures. Resist Diabetes is the first trial to examine the effectiveness of a high fidelity SCT-based intervention for maintaining RT in older adults with prediabetes to improve glucose homeostasis. Successful application of SCT constructs for RT maintenance may support translation of our RT program for diabetes prevention into community settings. PMID:24252311

  19. Improving medication adherence in patients with hypertension

    DEFF Research Database (Denmark)

    Hedegaard, Ulla; Kjeldsen, Lene Juel; Pottegård, Anton;

    2015-01-01

    BACKGROUND: and Purpose: In patients with hypertension, medication adherence is often suboptimal, thereby increasing the risk of ischemic heart disease and stroke. In a randomized trial, we investigated the effectiveness of a multifaceted pharmacist intervention in a hospital setting to improve...... medication adherence in hypertensive patients. Motivational interviewing was a key element of the intervention. METHODS: Patients (N=532) were recruited from 3 hospital outpatient clinics and randomized to usual care or a 6-month pharmacist intervention comprising collaborative care, medication review......, tailored adherence counselling including motivational interviewing and telephone follow-ups. The primary outcome was composite medication possession ratio (MPR) to antihypertensive and lipid-lowering agents, at one-year follow-up, assessed by analyzing pharmacy records. Secondary outcomes at 12 months...

  20. Use of participant focus groups to identify barriers and facilitators to worksite exercise therapy adherence in randomized controlled trials involving firefighters

    Directory of Open Access Journals (Sweden)

    Mayer JM

    2013-03-01

    Full Text Available John M Mayer,1 James L Nuzzo,1 Simon Dagenais2 1School of Physical Therapy and Rehabilitation Sciences, College of Medicine, University of South Florida, Tampa, FL, 2Palladian Health, West Seneca, NY, USA Background: Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective: To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs. Methods: Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results: A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion: Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on

  1. Adherence to the Obesity-related Lifestyle Intervention Targets in the IDEFICS Study

    DEFF Research Database (Denmark)

    Kovács, Eva; Siani, Alfonso; Konstabel, Kenn;

    2014-01-01

    Background/objectives: To address behaviours associated with childhood obesity, certain target values are recommended that should be met to improve children’s health. In the IDEFICS (Identification and prevention of Dietary- and lifestyle-induced health Effects in Children and infantS) study.......5% of the cohort was classified in the highest category of water consumption, only 8.8% met the target of an intake of fruits/vegetables five times a day. The prevalence of children adhering to the recommendation regarding total screen time—below 1 h for pre-school children and 2 h for school children—was 51.......1%. The recommended amount of at least 60 min of moderate-to-vigorous physical activity per day was fulfilled by 15.2%. Family life of the child measured by various indicators was considered as satisfactory in 22.8%. Nocturnal sleep duration of 11 (10) hours or more in pre-school (school) children was achieved by 37...

  2. Effectiveness of three interventions in improving adherence to cervical cancer screening.

    Science.gov (United States)

    López-Torres Hidalgo, Jesús; Sánchez Ortiz, María P; Rabanales Sotos, Joseba; Simarro Herráez, María J; López-Torres López, Jaime; Campos Rosa, Monchi

    2016-09-01

    In countries where cervical cancer screening programmes are conducted on an opportunistic basis, an active search for women at risk should be made to increase coverage. The objective of our study was to assess the effectiveness of three primary care interventions consisting of providing written, telephone and face-to-face information to increase screening participation among women over the age of 25 years. A randomized experimental study with only one post-test control group was conducted on women aged 25-70 years. A total of 1676 women were randomly distributed into four groups and the following interventions were implemented: written briefing; telephone briefing; an invitation to attend a group meeting and no briefing (control group). The women were evaluated 2 years after the intervention. The outcome variable was participation or nonparticipation in cervical cancer screening. It proved possible to interview a total of 1122 women. Among the groups, homogeneity was tested in terms of sociodemographic characteristics and health-related variables. Women who had undergone cytological testing in the 2 years preceding evaluation had a lower mean age (P<0.001) than women who had not done so (45.5±11.0 vs. 48.8±13.0 years). The proportion of women who had participated in screening was as follows: 35.3% in the written information group [95% confidence interval (CI) 29.8-40.9]; 38.4% in the telephone information group (95% CI 32.5-44.2); 29.3% in the face-to-face information group (95% CI 22.8-35.7) and 26.1% in the control group (95% CI 21.2-30.9), with this difference proving statistically significant (P=0.005). Logistic regression showed that only the interventions based on written or telephone briefing were effective vis-à-vis the control group. In conclusion, both written and telephone information can serve to improve women's participation in opportunistic cervical cancer screening. Current preventive strategies could be optimized by means of simple interventions

  3. Participant Adherence Indicators Predict Changes in Blood Pressure, Anthropometric Measures, and Self-Reported Physical Activity in a Lifestyle Intervention: HUB City Steps

    Science.gov (United States)

    Thomson, Jessica L.; Landry, Alicia S.; Zoellner, Jamie M.; Connell, Carol; Madson, Michael B.; Molaison, Elaine Fontenot; Yadrick, Kathy

    2015-01-01

    The objective of this secondary analysis was to evaluate the utility of several participant adherence indicators for predicting changes in clinical, anthropometric, dietary, fitness, and physical activity (PA) outcomes in a lifestyle intervention, HUB City Steps, conducted in a southern, African American cohort in 2010. HUB City Steps was a…

  4. Motivation and Its Relationship to Adherence to Self-Monitoring and Weight Loss in a 16-Week Internet Behavioral Weight Loss Intervention

    Science.gov (United States)

    Webber, Kelly H.; Tate, Deborah F.; Ward, Dianne S.; Bowling, J. Michael

    2010-01-01

    Objective: To examine changes in motivation and the relationship of motivation to adherence to self-monitoring and weight loss in a 16-week Internet behavioral weight-loss intervention. Design: Two-group randomized design. Setting: This study was conducted over the Internet. Participants: Sixty-six women, ages 22-65, with a body mass index (BMI)…

  5. TextTB: A Mixed Method Pilot Study Evaluating Acceptance, Feasibility, and Exploring Initial Efficacy of a Text Messaging Intervention to Support TB Treatment Adherence

    Directory of Open Access Journals (Sweden)

    Sarah Iribarren

    2013-01-01

    Full Text Available Objective. To assess a text messaging intervention to promote tuberculosis (TB treatment adherence. Methods. A mixed-methods pilot study was conducted within a public pulmonary-specialized hospital in Argentina. Patients newly diagnosed with TB who were 18 or older, and had mobile phone access were recruited and randomized to usual care plus either medication calendar (n=19 or text messaging intervention (n=18 for the first two months of treatment. Primary outcomes were feasibility and acceptability; secondary outcomes explored initial efficacy. Results. Feasibility was evidenced by high access to mobile phones, familiarity with texting, most phones limited to basic features, a low rate of participant refusal, and many describing suboptimal TB understanding. Acceptability was evidenced by participants indicating feeling cared for, supported, responsible for their treatment, and many self-reporting adherence without a reminder. Participants in the texting group self-reported adherence on average 77% of the days whereas only 53% in calendar group returned diaries. Exploring initial efficacy, microscopy testing was low and treatment outcomes were similar in both groups. Conclusion. The texting intervention was well accepted and feasible with greater reporting of adherence using text messaging than the diary. Further evaluation of the texting intervention is warranted.

  6. The Benefits and Challenges of Preconsent in a Multisite, Pediatric Sickle Cell Intervention Trial.

    Science.gov (United States)

    Nimmer, Mark; Czachor, Jason; Turner, Laura; Thomas, Bobbe; Woodford, Ashley L; Carpenter, Karli; Gonzalez, Victor; Liem, Robert I; Ellison, Angela; Casper, T Charles; Brousseau, David C

    2016-09-01

    Enrollment of patients in sickle cell intervention trials has been challenging due to difficulty in obtaining consent from a legal guardian and lack of collaboration between emergency medicine and hematology. We utilized education and preconsent in a pediatric multisite sickle cell intervention trial to overcome these challenges. Overall, 48 patients were enrolled after being preconsented. Variable Institutional Review Board policies related to preconsent validity and its allowable duration decreased the advantages of preconsent at some sites. The utility of preconsent for future intervention trials largely depends on local Institutional Review Board policies. Preeducation may also benefit the consent process, regardless of site differences. PMID:27081930

  7. Applying Theory to Understand and Modify Nurse Intention to Adhere to Recommendations regarding the Use of Filter Needles: An Intervention Mapping Approach

    Directory of Open Access Journals (Sweden)

    Julianne Cassista

    2014-01-01

    Full Text Available The manipulation of glass ampoules involves risk of particle contamination of parenteral medication, and the use of filter needles has often been recommended in order to reduce the number of particles in these solutions. This study aims to develop a theory-based intervention to increase nurse intention to use filter needles according to clinical guideline recommendations produced by a large university medical centre in Quebec (Canada. Using the Intervention Mapping framework, we first identified the psychosocial determinants of nurse intention to use filter needles according to these recommendations. Second, we developed and implemented an intervention targeting nurses from five care units in order to increase their intention to adhere to recommendations on the use of filter needles. We also assessed nurse satisfaction with the intervention. In total, 270 nurses received the intervention and 169 completed the posttest questionnaire. The two determinants of intention, that is, attitude and perceived behavioral control, were significantly higher after the intervention, but only perceived behavioral control remained a predictor of intention. In general, nurses were highly satisfied with the intervention. This study provides support for the use of Intervention Mapping to develop, implement, and evaluate theory-based interventions in order to improve healthcare professional adherence to clinical recommendations.

  8. Reporting of factorial trials of complex interventions in community settings: a systematic review

    Directory of Open Access Journals (Sweden)

    Peters Tim J

    2011-07-01

    Full Text Available Abstract Background Standards for the reporting of factorial randomised trials remain to be established. We aimed to review the quality of reporting of methodological aspects of published factorial trials of complex interventions in community settings. Methods We searched MEDLINE, EMBASE, PsychInfo and the Cochrane Controlled Trials Register to identify factorial randomised trials of complex interventions in community settings from January 2000 to August 2009. We also conducted a citation search of two review papers published in 2003. Data were extracted by two reviewers on 22 items relating to study design, analysis and presentation. Results We identified 5941 unique titles, from which 116 full papers were obtained and 76 were included in the review. The included trials reflected a broad range of target conditions and types of intervention. The median sample size was 400 (interquartile range 191-1001. Most (88% trials employed a 2 × 2 factorial design. Few trials (21% explicitly stated the rationale for using a factorial design. Reporting of aspects of design, analysis or presentation specific to factorial trials was variable, but there was no evidence that reporting of these aspects was different for trials published before or after 2003. However, for CONSORT items that apply generally to the reporting of all trials, there was some evidence that later studies were more likely to report employing an intention-to-treat (ITT approach (78% vs 52%, present appropriate between-group estimates of effect (88% vs 63%, and present standard errors or 95% confidence intervals for such estimates (78% vs 56%. Interactions between interventions and some measure of the precision associated with such effects were reported in only 14 (18% trials. Conclusions Reports of factorial trials of complex interventions in community settings vary in the amount of information they provide regarding important methodological aspects of design and analysis. This variability

  9. An economic evaluation of anticipated costs and savings of a behavior change intervention to enhance medication adherence

    OpenAIRE

    Wiegand PN; Wertheimer AI

    2008-01-01

    Medication adherence across disease states is generally poor. Research has focused on various methods to improve medication adherence, but there is little conclusive evidence regarding specific methods efficacy. The Transtheoretical Model for Behavior Change has been used to modify existing addictive behaviors but not in medication adherence specifically. As a behavioral component is inherently related to medication adherence, it is thought that this model may be applicable. Objective: The pu...

  10. High Medication Adherence During Periconception Periods Among HIV-1–Uninfected Women Participating in a Clinical Trial of Antiretroviral Pre-exposure Prophylaxis

    OpenAIRE

    Matthews, Lynn T.; Heffron, Renee; Mugo, Nelly R.; Craig R Cohen; Hendrix, Craig W.; Celum, Connie; Bangsberg, David R.; Baeten, Jared M.

    2014-01-01

    Introduction: Pre-exposure prophylaxis (PrEP) may be an important safer conception strategy for HIV-1–uninfected women with HIV-1–infected partners. Understanding medication adherence in this population may inform whether PrEP is a feasible safer conception strategy. Methods: We evaluated predictors of pregnancy and adherence to study medication among HIV-1–uninfected women enrolled in a randomized placebo-controlled trial of PrEP among African HIV-1–serodiscordant couples. Participants were ...

  11. The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

    Directory of Open Access Journals (Sweden)

    Yang Hui

    2011-02-01

    Full Text Available Abstract Background The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM. Methods/Design A cluster randomised controlled trial involving 22 Community Health Centres (CHCs in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables. Discussion This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China. Trial Registration Current Controlled Trials ISRCTN01010526

  12. Is implementing screening for distress an efficient means to recruit patients to a psychological intervention trial?

    NARCIS (Netherlands)

    van Scheppingen, Corinne; Schroevers, Maya J.; Pool, Grieteke; Smink, Ans; Mul, Veronique E.; Coyne, James C.; Sanderman, Robbert

    2014-01-01

    ObjectivesPsychological interventions show greater efficacy when evaluated with distressed patients. We report on the feasibility of implementing screening for recruiting distressed cancer patients to a randomized controlled trial of problem-solving therapy (PST), characteristics associated with enr

  13. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg;

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  14. Evaluation of a Web-Based Intervention to Promote Hand Hygiene: Exploratory Randomized Controlled Trial

    OpenAIRE

    Yardley, Lucy; Miller, Sascha; Schlotz, Wolff; Little, Paul

    2011-01-01

    Background Hand-washing is regarded as a potentially important behavior for preventing transmission of respiratory infection, particularly during a pandemic. Objective The objective of our study was to evaluate whether a Web-based intervention can encourage more frequent hand-washing in the home, and to examine potential mediators and moderators of outcomes, as a necessary first step before testing effects of the intervention on infection rates in the PRIMIT trial (PRimary care trial of a web...

  15. HPTN 071 (PopART: a cluster-randomized trial of the population impact of an HIV combination prevention intervention including universal testing and treatment: mathematical model.

    Directory of Open Access Journals (Sweden)

    Anne Cori

    Full Text Available BACKGROUND: The HPTN 052 trial confirmed that antiretroviral therapy (ART can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples. Here, we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence. METHODS AND FINDINGS: The HPTN 071 (PopART trial is a three-arm cluster-randomized trial of 21 large population clusters in Zambia and South Africa, starting in 2013. A combination prevention package including home-based voluntary testing and counseling, and ART for HIV positive individuals, will be delivered in arms A and B, with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm. The primary endpoint is the cumulative three-year HIV incidence. We developed a mathematical model of heterosexual HIV transmission, informed by recent data on HIV-1 natural history. We focused on realistically modeling the intervention package. Parameters were calibrated to data previously collected in these communities and national surveillance data. We predict that, if targets are reached, HIV incidence over three years will drop by >60% in arm A and >25% in arm B, relative to arm C. The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial. The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention, uptake of testing and treatment, as well as ART retention and adherence. CONCLUSIONS: The HPTN 071 (PopART trial intervention could reduce HIV population-level incidence by >60% over three years. This intervention could serve as a paradigm for national or supra-national implementation. Our analysis highlights the role mathematical modeling can play in trial development and monitoring, and more widely in evaluating the

  16. A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial

    Science.gov (United States)

    Patrick, Kevin; Ybarra, Michele L; Reback, Cathy J; Rawson, Richard A; Chokron Garneau, Helene; Chavez, Kathryn; Venegas, Alexandra

    2016-01-01

    Background Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users. PMID:27341852

  17. Does adherence moderate the effect of physical or mental training on episodic memory in older women?

    OpenAIRE

    Evers, Andrea; Klusmann, Verena; Schwarzer, Ralf; Heuser, Isabella

    2012-01-01

    Objective: The aim was to investigate the overall amount of time spent on physical or mental activity training units (i.e., adherence) as a predictor of episodic memory performance in older healthy women. Methods: Women (N = 171, aged 70 - 93 years) took part in a 6-month randomized controlled trial (physical activity or computer training, 3 times weekly). Pre- and post-intervention episodic memory and adherence were assessed. Adherence covers the objectively measured frequency of training pa...

  18. [The Freiburg Intervention Trial for Obesity in Chidren (FITOC)].

    Science.gov (United States)

    Korsten-Reck, U; Wolfarth, B; Bonk, M; Keul, J; Berg, A

    2000-09-01

    Freiburg Intervention Trial for Obese Children (FITOC) is an interdisciplinary treatment program for obese children, which is established in Freiburg since 1987. Obese children at the age of 8-11 are treated in an eight months intensive period and a follow-up period of 4 months or more. Since 1990 data from 283 children coming out of 15 treatment groups (about 2 groups per year) were collected and analyzed. The program consists of regular physical training (3 times a week), comprehensive nutrition and behaviour training (overall 7 parents evenings each 4 to 6 weeks and 7 cookery courses for the kids in the same time scale). The parents evenings are filled with theoretical and practical information about nutrition as well as background information about the psychological and physiological problems in obese children. In the first examination and the regular control examinations anthropometric, biochemical and exercise physiology data are investigated. In addition, questionnaires for nutrition and behaviour are analysed on a regular basis. At each examination, depending on the progress in therapy, a new orientation with adapted goals will be discussed with the child and the parents. For the growing children a moderate reduction or long term stabilisation of weight will lead to success. Teaching goal for the children in the intensive period is to control themselves and, depending on their specific situation, to establish individual recommendations on a long term basis. The sports program should lead to an increase in self-esteem and a raise in daily energy expenditure. The team includes a physician, a nutritionist, a psychologist and a sports teacher. From 1997 the program was spread to institutions in the surroundings of Freiburg. Training for the external teams is provided for in continuous seminars. Teaching material includes a manual, forms and transparencies. The major goal is to secure quality by continuous training and close interaction between the institutions

  19. Walking the talk: the need for a trial registry for development interventions

    DEFF Research Database (Denmark)

    Rasmussen, Ole Dahl; Malchow-Møller, Nikolaj; Andersen, Thomas Barnebeck

    2011-01-01

    Recent advances in the use of randomised control trials to evaluate the effect of development interventions promise to enhance our knowledge of what works and why. A core argument supporting randomised studies is the claim that they have high internal validity. The authors argue that this claim i...... microfinance, they argue that a trial registry would also enhance external validity and foster innovative research....

  20. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    DEFF Research Database (Denmark)

    Bello, Segun; Wei, Maoling; Hilden, Jørgen;

    2016-01-01

    Background: Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided...

  1. Improving Discrete Trial Instruction by Paraprofessional Staff Through an Abbreviated Performance Feedback Intervention

    Science.gov (United States)

    Leblanc, Marie-Pierre; Ricciardi, Joseph N.; Luiselli, James K.

    2005-01-01

    We evaluated an abbreviated performance feedback intervention as a training strategy to improve discrete trial instruction of children with autism by three paraprofessional staff (assistant teachers) at a specialized day school. Feedback focused on 10 discrete trial instructional skills demonstrated by the staff during teaching sessions. Following…

  2. Assessment of quality of life as outcome in dementia and MCI intervention trials : a systematic review.

    NARCIS (Netherlands)

    Schölzel-Dorenbos, C.J.M.; Steen, M.J. van der; Engels, L.K.; Olde Rikkert, M.G.M.

    2007-01-01

    We conducted a systematic review of the use of quality of life (QoL) measures as outcome in pharmacological and nonpharmacologic intervention trials in patients with Mild Cognitive Impairment or dementia, and their proxies. Randomized controlled trials (RCTs) were identified from a search of the Spe

  3. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

    DEFF Research Database (Denmark)

    Punthakee, Z; Bosch, J; Dagenais, G;

    2012-01-01

    AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit...

  4. Mindfulness-based stress reduction for people living with HIV/AIDS: preliminary review of intervention trial methodologies and findings.

    Science.gov (United States)

    Riley, Kristen E; Kalichman, Seth

    2015-01-01

    In the context of successful antiretroviral therapy (ART) for the management of HIV infection, the harmful effects of stress remain a significant threat. Stress may increase viral replication, suppress immune response, and impede adherence to ART. Stressful living conditions of poverty, facing a chronic life-threatening illness and stigma all exacerbate chronic stress in HIV-affected populations. Stress-reduction interventions are urgently needed for the comprehensive care of people living with HIV. Mindfulness-based stress reduction (MBSR) is one approach that has shown promise as an intervention for patients facing other medical conditions for reducing disease progression, psychological distress and maladaptive behaviours. In this systematic review, we identified 11 studies that have examined MBSR as an intervention for HIV-positive populations. Of the studies, six were randomised designs, one was a quasi-experimental design, and the remaining four were pre- and post-test designs. The preliminary outcomes support MBSR to decrease emotional distress with mixed evidence for impact on disease progression. Effect sizes were generally small to moderate in magnitude. The early findings from this emerging literature must be considered preliminary and support moving forward with more rigorous controlled trials, evaluated with objective assessments in longer-term follow-ups to determine the efficacy of MBSR for people living with HIV.

  5. Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi

    Directory of Open Access Journals (Sweden)

    Ndebele Paul M

    2012-11-01

    Full Text Available Abstract Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124 obtained low scores (lower than 75% on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18 and intervention arms (n=18. The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75% during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001. Conclusions

  6. Reading and Language Intervention for Children at Risk of Dyslexia: A Randomised Controlled Trial

    Science.gov (United States)

    Duff, Fiona J.; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J.; Miles, Jeremy N. V.; Snowling, Margaret J.

    2014-01-01

    Background: Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. Methods: This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children…

  7. Review of Randomised Controlled Trials of Internet Interventions for Mental Disorders and Related Conditions

    Science.gov (United States)

    Griffiths, Kathleen M.; Christensen, Helen

    2006-01-01

    Self-help Internet interventions have the potential to enable consumers to play a central role in managing their own health. This paper contains a systematic review of 15 randomised controlled trials of the effectiveness of self-help Internet interventions for mental disorders and related conditions. Conditions addressed by the interventions…

  8. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  9. Train the Trainer Effectiveness Trials of Behavioral Intervention for Individuals with Autism: A Systematic Review

    Science.gov (United States)

    Shire, Stephanie Yoshiko; Kasari, Connie

    2014-01-01

    This systematic review examines train the trainer (TTT) effectiveness trials of behavioral interventions for individuals with autism spectrum disorder (ASD). Published methodological quality scales were used to assess studies including participant description, research design, intervention, outcomes, and analysis. Twelve studies including 9 weak…

  10. A Marginal Structural Model Analysis for Loneliness: Implications for Intervention Trials and Clinical Practice

    Science.gov (United States)

    VanderWeele, Tyler J.; Hawkley, Louise C.; Thisted, Ronald A.; Cacioppo, John T.

    2011-01-01

    Objective: Clinical scientists, policymakers, and individuals must make decisions concerning effective interventions that address health-related issues. We use longitudinal data on loneliness and depressive symptoms and a new class of causal models to illustrate how empirical evidence can be used to inform intervention trial design and clinical…

  11. A Parent-Adolescent Intervention to Increase Sexual Risk Communication: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan

    2008-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6-…

  12. A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

    Science.gov (United States)

    Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.

    2010-01-01

    Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

  13. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    Science.gov (United States)

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K.; Cole, David A.

    2009-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9-15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at post-intervention (2 months), after completion of 4 monthly booster sessions (6…

  14. Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT

    Directory of Open Access Journals (Sweden)

    Mahantshetti Niranjana S

    2010-04-01

    Full Text Available Abstract Background This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. Discussion The trial is supervised by a trial steering committee, and an independent data monitoring

  15. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  16. Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

    Science.gov (United States)

    2016-01-01

    Background Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. Objectives The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI’s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. Methods Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants’ own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance

  17. Therapist adherence in the strong without anorexia nervosa (SWAN) study: A randomized controlled trial of three treatments for adults with anorexia nervosa

    OpenAIRE

    Andony, Louise Julia; Tay, Elaine; Allen, Karina L; Wade, Tracey D.; Hay, Phillipa; Touyz, Stephen; McIntosh, Virginia V W; Treasure, Janet; Schmidt, Ulrike H.; Fairburn, Christopher G.; Erceg-Hurn, David M; Fursland, Anthea; Crosby, Ross D; Byrne, Susan M.

    2015-01-01

    Objective To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). Method The SWAN Psychother...

  18. Prevalence and predictors of patient adherence to health recommendations after acute coronary syndrome: data for targeted interventions?

    OpenAIRE

    Lee, WL; Abdullah, KL; Bulgiba, AM; Abidin, IZ

    2013-01-01

    Background: Poor adherence is a significant nursing and public health concern because it affects patients’ quality of life. It compounds the disease burden of the growing coronary heart disease population. Promoting optimal patient adherence to cardiac-health enhancing recommendations by healthcare providers can reduce mortality and morbidity risk after acute coronary syndrome (ACS).  Aim: This paper sought to examine rates and predictors of patient adherence to health recommen...

  19. Behavioural intervention trials for HIV/STD prevention in schools: are they feasible?

    OpenAIRE

    Stephenson, J M; Oakley, A; Charleston, S.; Brodala, A.; Fenton, K; Petruckevitch, A; Johnson, A. M.

    1998-01-01

    OBJECTIVE: To assess the feasibility of conducting a large randomised controlled trial (RCT) of peer led intervention in schools to reduce the risk of HIV/STD and promote sexual health. METHODS: Four secondary schools in Greater London were randomly assigned to receive peer led intervention (two experimental schools) or to act as control schools. In the experimental schools, trained volunteers aged 16-17 years (year 12) delivered the peer led intervention to 13-14 year old pupils (year ...

  20. Randomized Controlled Trial of Brief Interventions to Reduce College Students’ Drinking and Risky Sex

    OpenAIRE

    Dermen, Kurt H.; Thomas, Sherilyn N.

    2011-01-01

    The present study tested the proposition that an intervention to reduce alcohol use among college students will also reduce their risky sexual behavior. In a randomized, controlled trial, 154 heavy-drinking, predominantly White, heterosexual college students at behavioral risk for infection with HIV and other STDs were assigned to receive no intervention or a two-session, in-person, motivational interviewing-based intervention focused on either: (a) reducing alcohol risk behavior, (b) reducin...

  1. Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

    OpenAIRE

    Tadjerbashi, Kamelia; Rosales, Roberto S; Atroshi, Isam

    2014-01-01

    Background: Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods: We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arth...

  2. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Science.gov (United States)

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

    2015-05-01

    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well.

  3. The efficacy of a brief intervention to reduce alcohol misuse in patients with HIV in South Africa: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Huis in ’t Veld Diana

    2012-10-01

    Full Text Available Abstract Background Alcohol abuse comes with risks for increased morbidity and mortality among patients with HIV. This study aims to determine the prevalence of alcohol use and other risk factors in a sample of primary care patients with HIV in South Africa and to assess a brief intervention to reduce the use of alcohol in this group. Methods/Design A single-blinded randomized controlled trial is designed to determine the efficacy of a brief intervention to reduce hazardous alcohol use in patients with HIV. The study will be carried out on out-patients with HIV in two primary healthcare HIV clinics near Pretoria, South Africa. Alcohol use will be assessed with the Alcohol Use Disorder Identification Test questionnaire. Other data that will be collected relate to health-related quality of life, depression, sexual behavior, internalized AIDS stigma, HIV-related information and adherence to antiretroviral therapy (self-reported 7-day recall of missed doses, Visual Analog Scale and pill count. The intervention consists of a brief counseling session to reduce alcohol risk; the control group receives a health education leaflet. Discussion The findings will be important in the public health setting. If the intervention proves to be efficient, it could potentially be incorporated into the HIV care policy of the Ministry of Health. Trial registration Pan African Clinical trial Registry: PACTR201202000355384

  4. Screening and brief intervention targeting risky drinkers in Danish general practice - a pragmatic controlled trial

    DEFF Research Database (Denmark)

    Beich, A.; Gannik, D.; Saelan, H.;

    2007-01-01

    and brief intervention (SBI) in general practice. METHODS: A randomized PCT (brief counselling intervention vs no intervention) involving 39 Danish general practitioners (GPs). Systematic screening of 6897 adults led to inclusion of 906 risky drinkers, and research follow-up on 537 of these after 12......AIMS: Recommendations for routine alcohol screening and brief counselling intervention in primary health care rest on results from intervention efficacy studies. By conducting a pragmatic controlled trial (PCT), we aimed at evaluating the effectiveness of the WHO recommendations for screening......-14 months. Outcome measures focused on patients' acceptance of screening and intervention and their self-reported alcohol consumption. RESULTS: Patient acceptance of screening and intervention -10.3% (N = 794) of the target population (N = 7, 691) explicitly refused screening. All intervention group...

  5. The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature

    NARCIS (Netherlands)

    M. Vervloet; A.J. Linn; J.C.M. van Weert; D.H. de Bakker; M.L. Bouvy; L. van Dijk

    2012-01-01

    Background: Many patients experience difficulties in adhering to long-term treatment. Although patients' reasons for not being adherent are diverse, one of the most commonly reported barriers is forgetfulness. Reminding patients to take their medication may provide a solution. Electronic reminders (

  6. The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature.

    NARCIS (Netherlands)

    Vervloet, M.; Linn, A.J.; Weert, J.C.M. van; Bakker, D.H. de; Bouvy, M.L.; Dijk, L. van

    2012-01-01

    Background: Many patients experience difficulties in adhering to long-term treatment. Although patients’ reasons for not being adherent are diverse, one of the most commonly reported barriers is forgetfulness. Reminding patients to take their medication may provide a solution. Electronic reminders (

  7. Unraveling the EXCEL: promises and challenges of the next trial of left main percutaneous coronary intervention.

    Science.gov (United States)

    Capodanno, Davide; Tamburino, Corrado

    2012-04-01

    The Evaluation of Xience Prime or Xience V versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a multicenter, ongoing trial conducted in patients with left main disease and SYNTAX score ≤ 32 to establish the presumptive advantage of percutaneous coronary intervention (PCI) versus bypass surgery in patients with less complex coronary artery disease than those enrolled in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial. In this article, we aimed at critically discussing key features and issues relevant to design and clinical interpretation of this new contemporary trial of left main PCI.

  8. Pilot study to test the feasibility of a trial design and complex intervention on PRIoritising MUltimedication in Multimorbidity in general practices (PRIMUMpilot)

    Science.gov (United States)

    Muth, Christiane; Harder, Sebastian; Uhlmann, Lorenz; Rochon, Justine; Fullerton, Birgit; Güthlin, Corina; Erler, Antje; Beyer, Martin; van den Akker, Marjan; Perera, Rafael; Knottnerus, André; Valderas, Jose M; Gerlach, Ferdinand M; Haefeli, Walter E

    2016-01-01

    criteria were challenging and potentially inadequate, and should therefore be adjusted. Outcome measures on pain, functionality and self-reported adherence were unfeasible due to frequent missing values, an incorrect manual or potentially invalid results. Conclusions Intervention and trial design were feasible. The pilot study revealed important limitations that influenced the design and conduct of the main study, thus highlighting the value of piloting complex interventions. Trial registration number ISRCTN99691973; Results. PMID:27456328

  9. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Directory of Open Access Journals (Sweden)

    Taylor Stephanie

    2011-02-01

    Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277

  10. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ).

    Science.gov (United States)

    Zschocke, Ina; Mrowietz, Ulrich; Lotzin, Annett; Karakasili, Eleni; Reich, Kristian

    2014-04-01

    Medication adherence rates strongly depend on favorable disease outcomes. It is known that medication adherence rates are lower for topical treatment than for systemic treatment. However, to date no validated instrument for the assessment of adherence factors in topical treatment is available. The aim of this study was to develop a new questionnaire to assess adherence risk factors in topical treatment. The development of the Topical Therapy Adherence Questionnaire (TTAQ) and Patient Preference Questionnaire (PPQ) was based on a systematic literature review, and qualitative patient focus interviews and expert focus groups' input. The psychometric properties and comprehensibility of the TTAQ and PPQ were assessed in a feasibility study with 59 psoriasis patients. Our first preliminary results indicate that the TTAQ and PPQ are psychometrically sound and reliable measures for the assessment of factors influencing topical treatment adherence. The questionnaires are currently being further developed and various parameters (e.g., time point of assessment) are currently being tested in an exploratory pilot study with ca. 2,000 psoriasis patients receiving topical treatment in a European clinical trial. The use of the final versions of TTAQ and PPQ in clinical practice may facilitate the early identification of specific non-adherence factors in patients under topical treatment, which could enable designing and applying adherence-enhancing interventions according to the patient's individual needs.

  11. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials

    DEFF Research Database (Denmark)

    Savović, Jelena; Jones, Hayley E; Altman, Douglas G;

    2012-01-01

    Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses conta......Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta......-analyses containing 1973 trials. Outcome measures were classified as "mortality," "other objective," "or subjective," and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity. Intervention effect estimates seemed to be exaggerated......-blinding (vs. double-blinding) was associated with an average of 13% exaggeration of intervention effects (ratio of odds ratios, 0.87 [CrI, 0.79 to 0.96]), and between-trial heterogeneity was increased for such studies (SD increase in heterogeneity, 0.14 [CrI, 0.02 to 0.30]). For each characteristic, average...

  12. The Nordic Aortic Valve Intervention (NOTION trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Thyregod Hans Gustav

    2013-01-01

    Full Text Available Abstract Background Degenerative aortic valve (AV stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. Methods/Design This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA (intervention group compared with SAVR (control group in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR. Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012. Discussion The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis. Trial registration ClinicalTrials.gov: NCT01057173

  13. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Keeling Sally

    2008-05-01

    Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

  14. Evaluation of a pharmacist intervention on patients initiating pharmacological treatment for depression: a randomized controlled superiority trial.

    Science.gov (United States)

    Rubio-Valera, Maria; March Pujol, Marian; Fernández, Ana; Peñarrubia-María, M Teresa; Travé, Pere; López Del Hoyo, Yolanda; Serrano-Blanco, Antoni

    2013-09-01

    Major depression is associated with high burden, disability and costs. Non-adherence limits the effectiveness of antidepressants. Community pharmacists (CP) are in a privileged position to help patients cope with antidepressant treatment. The aim of the study was to evaluate the impact of a CP intervention on primary care patients who had initiated antidepressant treatment. Newly diagnosed primary care patients were randomised to usual care (UC) (92) or pharmacist intervention (87). Patients were followed up at 6 months and evaluated three times (Baseline, and at 3 and 6 months). Outcome measurements included clinical severity of depression (PHQ-9), health-related quality of life (HRQOL) (Euroqol-5D) and satisfaction with pharmacy care. Adherence was continuously registered from the computerised pharmacy records. Non-adherence was defined as refilling less than 80% of doses or having a medication-free gap of more than 1 month. Patients in the intervention group were more likely to remain adherent at 3 and 6 months follow-up but the difference was not statistically significant. Patients in the intervention group showed greater statistically significant improvement in HRQOL compared with UC patients both in the main analysis and PP analyses. No statistically significant differences were observed in clinical symptoms or satisfaction with the pharmacy service. The results of our study indicate that a brief intervention in community pharmacies does not improve depressed patients' adherence or clinical symptoms. This intervention helped patients to improve their HRQOL, which is an overall measure of patient status. PMID:23219937

  15. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP.

    Directory of Open Access Journals (Sweden)

    Albert Y Liu

    Full Text Available Pre-exposure prophylaxis (PrEP trials using tenofovir-based regimens have demonstrated that high levels of adherence are required to evaluate efficacy; the incorporation of objective biomarkers of adherence in trial design has been essential to interpretation, given the inaccuracy of self-report. Antiretroviral measurements in scalp hair have been useful as a marker of long-term exposure in the HIV treatment setting, and hair samples are relatively easy and inexpensive to collect, transport, and store for analysis. To evaluate the relationship between dose and tenofovir concentrations in hair, we examined the dose proportionality of tenofovir in hair in healthy, HIV-uninfected adults.A phase I, crossover pharmacokinetic study was performed in 24 HIV-negative adults receiving directly-observed oral tenofovir tablets administered 2, 4, and 7 doses/week for 6 weeks, with a ≥3-week break between periods. Small samples of hair were collected after each six-week period and analyzed for tenofovir concentrations. Geometric-mean-ratios compared levels between each pair of dosing conditions. Intensive plasma pharmacokinetic studies were performed during the daily-dosing period to calculate areas-under-the-time-concentration curves (AUCs.Over 90% of doses were observed per protocol. Median tenofovir concentrations in hair increased monotonically with dose. A log-linear relationship was seen between dose and hair levels, with an estimated 76% (95% CI 60-93% increase in hair level per 2-fold dose increase. Tenofovir plasma AUCs modestly predicted drug concentrations in hair.This study found a strong linear relationship between frequency of dosing and tenofovir levels in scalp hair. The analysis of quantitative drug levels in hair has the potential to improve adherence measurement in the PrEP field and may be helpful in determining exposure thresholds for protection and explaining failures in PrEP trials. Hair measures for adherence monitoring may also

  16. Randomized controlled trial of a collaborative care intervention to manage cancer-related symptoms: lessons learned

    Science.gov (United States)

    Steel, Jennifer; Geller, David A; Tsung, Allan; Marsh, J Wallis; Dew, Mary Amanda; Spring, Michael; Grady, Jonathan; Likumahuwa, Sonja; Dunlavy, Andrea; Youssef, Michael; Antoni, Michael; Butterfield, Lisa H; Schulz, Richard; Day, Richard; Helgeson, Vicki; Kim, Kevin H; Gamblin, T Clark

    2012-01-01

    Background Collaborative care interventions to treat depression have begun to be tested in settings outside of primary care. However, few studies have expanded the collaborative care model to other settings and targeted comorbid physical symptoms of depression. Purpose The aims of this report were to: (1) describe the design and methods of a trial testing the efficacy of a stepped collaborative care intervention designed to manage cancer-related symptoms and improve overall quality of life in patients diagnosed with hepatobiliary carcinoma; and (2) share the lessons learned during the design, implementation, and evaluation of the trial. Methods The trial was a phase III randomized controlled trial testing the efficacy of a stepped collaborative care intervention to reduce depression, pain, and fatigue in patients diagnosed with advanced cancer. The intervention was compared to an enhanced usual care arm. The primary outcomes included the Center for Epidemiological Studies-Depression scale, Brief Pain Inventory, and Functional Assessment of Cancer Therapy (FACT)-Fatigue, and the FACT-Hepatobiliary. Sociodemographic and disease-specific characteristics were recorded from the medical record; Natural Killer cells and cytokines that are associated with these symptoms and with disease progression were assayed from serum. Results and Discussion The issues addressed include: (1) development of collaborative care in the context of oncology (e.g., timing of the intervention, tailoring of the intervention, ethical issues regarding randomization of patients, and changes in medical treatment over the course of the study); (2) use of a website by chronically ill populations (e.g., design and access to the website, development of the website and intervention, ethical issues associated with website development, website usage, and unanticipated costs associated with website development); (3) evaluation of the efficacy of intervention (e.g., patient preferences, proxy raters

  17. Project QUIT (Quit Using Drugs Intervention Trial): A randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use

    Science.gov (United States)

    Gelberg, Lillian; Andersen, Ronald M.; Afifi, Abdelmonem A.; Leake, Barbara D.; Arangua, Lisa; Vahidi, Mani; Singleton, Kyle; Yacenda-Murphy, Julia; Shoptaw, Steve; Fleming, Michael F.; Baumeister, Sebastian E.

    2015-01-01

    Aims To assess the effect of a multi-component primary care (PC)-delivered BI for reducing risky drug use (RDU) among patients identified by screening. Design Multicenter single-blind two-arm randomized controlled trial of patients enrolled from February 2011 to November 2012 with 3-month follow-up. Randomization and allocation to trial group were computer-generated. Setting Primary care waiting rooms of 5 federally qualified health centers (FQHCs) in Los Angeles County (LAC), USA. Participants 334 adult primary care patients (171 intervention; 163 control) with RDU scores (4–26) on the WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) self-administered on tablet PCs; 261 (78%) completed follow-up. Mean age was 41.7 years; 63% were male; 38% were Caucasian. Intervention(s) and Measurement Intervention patients received brief (typically 3–4 minutes) clinician advice to quit/reduce their drug use reinforced by a video doctor message, health education booklet, and up to two 20–30 minute follow-up telephone drug use coaching sessions. Controls received usual care and cancer screening information. Primary outcome was patient self-reported use of highest scoring drug (HSD) at follow-up. Findings Intervention and control patients reported equivalent baseline HSD use; at follow-up, after adjustment for covariates in a linear regression model, intervention patients reported using their HSD an average of 2.21 fewer days in the previous month than controls (p0.10). Conclusions A clinician-delivered brief intervention with follow-up counseling calls may decrease drug use among risky users compared with usual care in low-income community health centers of Los Angeles County, USA. PMID:26471159

  18. Improving the adherence of type 2 diabetes mellitus patients with pharmacy care: a systematic review of randomized controlled trials

    OpenAIRE

    Antoine, Sunya-Lee; Pieper, Dawid; Mathes, Tim; Eikermann, Michaela

    2014-01-01

    Background Oral medication for patients with type 2 diabetes mellitus plays an important role in diabetes care and is associated with a high level self-care behavior and self-management. However, poor adherence to diabetes treatment is common which causes severe health complications and increased mortality. Barriers to adherence may consist of complex treatment regimens often along with long-term multi-therapies, side effects due to the medication as well as insufficient, incomprehensible or ...

  19. A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare': Study protocol

    Directory of Open Access Journals (Sweden)

    Hare David L

    2011-02-01

    Full Text Available Abstract Background Coronary heart disease (CHD and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL, decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare for depression and CHD secondary prevention, with Usual Care (UC. Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group. The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake, medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1, 6 months (post-intervention (Time 2, 12 months (Time 3 and 24 months follow-up for longer term effects (Time 4. We are comparing depression (Cardiac Depression Scale [CDS] and HRQOL (Short Form-12 [SF-12] scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of

  20. Effect of assertive outreach after suicide attempt in the AID (assertive intervention for deliberate self harm) trial

    DEFF Research Database (Denmark)

    Morthorst, Britt; Krogh, Jesper; Erlangsen, Annette;

    2012-01-01

    OBJECTIVE: To assess whether an assertive outreach intervention after suicide attempt could reduce the frequency of subsequent suicidal acts, compared with standard treatment. DESIGN: Randomised, parallel group, superiority trial with blinded outcome assessment. SETTING: Outpatient intervention a...

  1. Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial

    Science.gov (United States)

    Ondersma, Steven J.; Beatty, Jessica R.; Svikis, Dace S.; Strickler, Ronald C.; Tzilos, Golfo K.; Chang, Grace; Divine, W.; Taylor, Andrew R.; Sokol, Robert J.

    2015-01-01

    Background Although screening and brief intervention (SBI) for unhealthy alcohol use has demonstrated efficacy in some trials, its implementation has been limited. Technology-delivered approaches are a promising alternative, particularly during pregnancy when the importance of alcohol use is amplified. The present trial evaluated the feasibility and acceptability of an interactive, empathic, video-enhanced, and computer-delivered SBI (e-SBI) plus three separate tailored mailings, and estimated intervention effects. Methods We recruited 48 pregnant women who screened positive for alcohol risk at an urban prenatal care clinic. Participants were randomly assigned to the e-SBI plus mailings or to a control session on infant nutrition, and were reevaluated during their postpartum hospitalization. The primary outcome was 90-day period-prevalence abstinence as measured by timeline follow-back interview. Results Participants rated the intervention as easy to use and helpful (4.7-5.0 on a 5-point scale). Blinded follow-up evaluation at childbirth revealed medium-size intervention effects on 90-day period prevalence abstinence (OR = 3.4); similarly, intervention effects on a combined healthy pregnancy outcome variable (live birth, normal birthweight, and no NICU stay) were also of moderate magnitude in favor of e-SBI participants (OR=3.3). As expected in this intentionally under-powered pilot trial, these effects were non-significant (p = .19 and .09, respectively). Conclusions This pilot trial demonstrated the acceptability and preliminary efficacy of a computer-delivered screening and brief intervention (e-SBI) plus tailored mailings for alcohol use in pregnancy. These findings mirror the promising results of other trials using a similar approach, and should be confirmed in a fully-powered trial. PMID:26010235

  2. High-intensity compared to moderate-intensity training for exercise initiation, enjoyment, adherence, and intentions: an intervention study

    OpenAIRE

    Heinrich, Katie M.; Patel, Pratik M; O’Neal, Joshua L; Heinrich, Bryan S

    2014-01-01

    Background Understanding exercise participation for overweight and obese adults is critical for preventing comorbid conditions. Group-based high-intensity functional training (HIFT) provides time-efficient aerobic and resistance exercise at self-selected intensity levels which can increase adherence; behavioral responses to HIFT are unknown. This study examined effects of HIFT as compared to moderate-intensity aerobic and resistance training (ART) on exercise initiation, enjoyment, adherence,...

  3. The Role of Substance Use and Mental Health Problems in Medication Adherence Among HIV-Infected MSM.

    Science.gov (United States)

    White, Jaclyn M; Gordon, Janna R; Mimiaga, Matthew J

    2014-12-01

    Mental health and substance abuse problems are highly prevalent among HIV-infected men who have sex with men (MSM) and frequently interfere with antiretroviral therapy (ART) adherence. Novel interventions that address underlying psychosocial health problems are necessary for improving ART adherence to enhance HIV-related health outcomes and suppress HIV viral load in an effort to prevent transmission to uninfected partners. This brief review describes the mental health problems and specific substances that pose the greatest threat to medication adherence among MSM and summarizes findings from recent intervention trials that simultaneously address ART adherence and comorbid psychosocial factors among HIV-infected MSM. PMID:26789859

  4. Effectiveness of training health professionals to provide smoking cessation interventions: systematic review of randomised controlled trials.

    OpenAIRE

    Silagy, C; Lancaster, T.; Gray, S.; Fowler, G

    1994-01-01

    OBJECTIVE--To assess the effectiveness of interventions that train healthcare professionals in methods for improving the quality of care delivered to patients who smoke. DESIGN--Systematic literature review. SETTING--Primary care medical and dental practices in the United States and Canada. Patients were recruited opportunistically. SUBJECTS--878 healthcare professionals and 11,228 patients who smoked and were identified in eight randomised controlled trials. In each of these trials healthcar...

  5. Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions

    OpenAIRE

    Stines, Lisa R.; Feeny, Norah C.

    2008-01-01

    In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are i...

  6. Percutaneous coronary intervention in the Occluded Artery Trial: Procedural success, hazard, and outcomes over 5 years

    OpenAIRE

    Buller, C; Rankin, J.; Carere, R; P. Buszman; Pfisterer, M.; Dzavik, V; Thomas, B.; Forman, S.; Ruzyllo, W; Mancini, G.; Michalis, L; de Abreu, G.; Lamas, G.; Hochman, J

    2009-01-01

    BACKGROUND: The Occluded Artery Trial (OAT) was a 2,201-patient randomized clinical trial comparing routine stent-based percutaneous coronary intervention (PCI) versus optimal medical therapy alone in stable myocardial infarction (MI) survivors with persistent infarct-related artery occlusion identified day 3 to 28 post MI. Intent-to-treat analysis showed no difference between strategies with respect to the incidence of new class IV congestive heart failure, MI, or death. The influence of PCI...

  7. Guidelines for Developing Yoga Interventions for Randomized Trials

    Directory of Open Access Journals (Sweden)

    Karen J. Sherman

    2012-01-01

    Full Text Available Little guidance is available to assist researchers in developing treatment protocols for research on yoga for health concerns. Because yoga is a complex multifactorial mind-body discipline historically developed for nonmedical purposes, numerous decisions must be made in order to thoughtfully develop such protocols. In this paper, a systematic approach is proposed to assist researchers in selecting an intervention that is appropriate for the condition under consideration and explicitly developed. Researchers need to consider the type or “style” of yoga, the components to include (e.g., breathing exercises, postures as well as the specific protocol for each component, the dose to be delivered (frequency, duration of practice, and the total duration of practice, and issues related to selection of instructors and monitoring the fidelity to the intervention. Each of these domains and the key issues for the development of protocols is discussed. Finally, some areas for further research related to protocol development are recommended.

  8. Impact of NGO training and support intervention on diarrhoea management practices in a rural community of Bangladesh: an uncontrolled, single-arm trial.

    Directory of Open Access Journals (Sweden)

    Ahmed S Rahman

    Full Text Available PURPOSE/OBJECTIVE: The evolving Non-Governmental Organization (NGO sector in Bangladesh provides health services directly, however some NGOs indirectly provide services by working with unlicensed providers. The primary objective of this study was to examine the impact of NGO training of unlicensed providers on diarrhoea management and the scale up of zinc treatment in rural populations. METHODS: An uncontrolled, single-arm trial for a training and support intervention on diarrhoea outcomes was employed in a rural sub-district of Bangladesh during 2008. Two local NGOs and their catchment populations were chosen for the study. The intervention included training of unlicensed health care providers in the management of acute childhood diarrhoea, particularly emphasizing zinc treatment. In addition, community-based promotion of zinc treatment was carried out. Baseline and endline ecologic surveys were carried out in intervention and control villages to document changes in treatments received for diarrhoea in under-five children. RESULTS: Among surveyed household with an active or recent acute childhood diarrhoea episode, 69% sought help from a health provider. Among these, 62.8% visited an unlicensed private provider. At baseline, 23.9% vs. 22% of control and intervention group children with diarrhoea had received zinc of any type. At endline (6 months later this had changed to 15.3% vs. 30.2%, respectively. The change in zinc coverage was significantly higher in the intervention villages (p<0.01. Adherence with giving zinc for 10 days or more was significantly higher in the intervention households (9.2% vs. 2.5%; p<0.01. Child's age, duration of diarrhoea, type of diarrhoea, parental year of schooling as well as oral rehydration solution (ORS and antibiotic usage were significant predictors of zinc usage. CONCLUSION: Training of unlicensed healthcare providers through NGOs increased zinc coverage in the diarrhoea management of under-five children in

  9. Partner randomized controlled trial: study protocol and coaching intervention

    OpenAIRE

    Garbutt Jane M; Highstein Gabrielle; Yan Yan; Strunk Robert C

    2012-01-01

    Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes ...

  10. The working mechanisms of an environmentally tailored physical activity intervention for older adults: a randomized controlled trial

    OpenAIRE

    Mudde Aart N; de Vries Hein; van Stralen Maartje M; Bolman Catherine; Lechner Lilian

    2009-01-01

    Abstract Background The aim of this study was to explore the working mechanisms of a computer tailored physical activity intervention for older adults with environmental information compared to a basic tailored intervention without environmental information. Method A clustered randomized controlled trial with two computer tailored interventions and a no-intervention control group was conducted among 1971 adults aged ≥ 50. The two tailored interventions were developed using Intervention Mappin...

  11. Therapist Adherence to Good Psychiatric Practice in a Short-Term Treatment for Borderline Personality Disorder.

    Science.gov (United States)

    Kolly, Stéphane; Despland, Jean-Nicolas; de Roten, Yves; Marquet, Pierre; Kramer, Ueli

    2016-07-01

    Therapist adherence describes the quality of interventions according to the imperatives of a treatment model. We examined the relationship between therapist adherence and symptom change in the context of a short-term treatment with respect good psychiatric management (GPM) principles. Based on a parent trial, borderline personality disorder patients (N = 40) benefited from a 10-session intervention. Adherence to GPM was assessed using a GPM Adherence Scale (GPMAS). The psychometric properties of the GPMAS were excellent, and the adherence to GPM explained 16% of the general symptom improvement (t(1) = 2.38, β = 0.40, p = 0.02) and 23% of the borderline symptom improvement (t(1) = 2.46, β = 0.48, p = 0.02). Because GPM adherence predicts the outcome after only 10 sessions, GPMAS is a valuable measure early on in psychiatric practice as part of an initial step to longer-term treatment, to quickly detect problems and correct them. PMID:27187770

  12. A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Adang Eddy

    2011-03-01

    Full Text Available Abstract Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service, have been allocated randomly to either the intervention group (CI strategy or the control group (ED strategy. The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285

  13. The IMEA project: an intervention based on microfinance, entrepreneurship, and adherence to treatment for women with HIV/AIDS living in poverty.

    Science.gov (United States)

    Arrivillaga, Marcela; Salcedo, Juan Pablo; Pérez, Mauricio

    2014-10-01

    A number of issues affect adherence to treatment and quality of life among women living with HIV/AIDS. In particular, women living in poverty have a higher risk of mortality due to their vulnerable conditions and socioeconomic exclusion. The objective of this study was to evaluate the effectiveness of an intervention that combines microfinance, entrepreneurship and adherence to treatment (IMEA) for women with HIV/AIDS and living in poverty in Cali, Colombia. A pre-post research design without a control was utilized, and 48 women were included in the study. The evaluation showed effectiveness of the program in the majority of the results (knowledge of HIV and treatment, adherence to treatment, self-efficacy, and the formation of a microenterprise) (p < 0.001); the global indicator increased from 28.3% to 85.5% (p < 0.001). The findings of this study demonstrate that the intervention was partially effective; the health outcomes showed beneficial effects. However, at the end of the study and throughout the follow-up phase, only one third of the participants were able to develop and maintain a legal operating business. It is concluded that the IMEA project should be tested in other contexts and that its consequent results should be analyzed; so it could be converted into a large scale public health program.

  14. Comparison of Research Designs for Two Controlled Trials of Mass Media Interventions

    OpenAIRE

    Flynn, Brian S.; Worden, John K.; Bunn, Janice Yanushka

    2009-01-01

    This paper compares two controlled trials of mass media interventions, factors influencing their designs, and design lessons learned from these experiences. Mass media evaluations based on a scientific research model are motivated by gaps in knowledge. The results of such research are intended to serve the needs of consensus development processes through which confident recommendations can be made for intervention strategies that should be more widely applied. For these purposes, the scientif...

  15. Controlled trial of pharmacist intervention in general practice: the effect on prescribing costs.

    OpenAIRE

    Rodgers, S.; Avery, A J; Meechan, D; Briant, S; Geraghty, M.; Doran, K; Whynes, D K

    1999-01-01

    BACKGROUND: It has been suggested that the employment of pharmacists in general practice might moderate the growth in prescribing costs. However, empirical evidence for this proposition has been lacking. We report the results of a controlled trial of pharmacist intervention in United Kingdom general practice. AIM: To determine whether intervention practices made savings relative to controls. METHOD: An evaluation of an initiative set up by Doncaster Health Authority. Eight practices agreed to...

  16. Promoting First Relationships: Randomized Trial of a Relationship-Based Intervention for Toddlers in Child Welfare

    OpenAIRE

    Spieker, Susan J.; Oxford, Monica L.; Kelly, Jean F.; Nelson, Elizabeth M.; Fleming, Charles B.

    2012-01-01

    We conducted a community based, randomized control trial of Promoting First Relationships (PFR; Kelly, Sandoval, Zuckerman, & Buehlman, 2008) to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10 – 24 months; N = 210) with a recent placement disruption were randomized to 10-week PFR or a comparison condition. Community agency providers were trained to use PFR in the intervention for caregivers. From baseline to post-intervention follow-up, observational rati...

  17. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Côté José

    2012-10-01

    Full Text Available Abstract Background Living with HIV makes considerable demands on a person in terms of self-management, especially as regards adherence to treatment and coping with adverse side-effects. The online HIV Treatment, Virtual Nursing Assistance and Education (Virus de I’immunodéficience Humaine–Traitement Assistance Virtuelle Infirmière et Enseignement; VIH-TAVIE™ intervention was developed to provide persons living with HIV (PLHIV with personalized follow-up and real-time support in managing their medication intake on a daily basis. An online randomized controlled trial (RCT will be conducted to evaluate the efficacy of this intervention primarily in optimizing adherence to combination anti-retroviral therapy (ART among PLHIV. Methods/design A convenience sample of 232 PLHIV will be split evenly and randomly between an experimental group that will use the web application, and a control group that will be handed a list of websites of interest. Participants must be aged 18 years or older, have been on ART for at least 6 months, and have internet access. The intervention is composed of four interactive computer sessions of 20 to 30 minutes hosted by a virtual nurse who engages the PLHIV in a skills-learning process aimed at improving self-management of medication intake. Adherence constitutes the principal outcome, and is defined as the intake of at least 95% of the prescribed tablets. The following intermediary measures will be assessed: self-efficacy and attitude towards antiretroviral medication, symptom-related discomfort, and emotional support. There will be three measurement times: baseline (T0, after 3 months (T3 and 6 months (T6 of baseline measurement. The principal analyses will focus on comparing the two groups in terms of treatment adherence at the end of follow-up at T6. An intention-to-treat (ITT analysis will be carried out to evaluate the true value of the intervention in a real context. Discussion Carrying out this online RCT

  18. Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.

    Science.gov (United States)

    Denburg, Avram; Rodriguez-Galindo, Carlos; Joffe, Steven

    2016-06-01

    Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a "trial effect," however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure-the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research-may function as a quality improvement lever, improving the quality of care and outcomes of all patients within an institution or region independent of their individual participation in trials. We further contend that this "infrastructure effect" can yield particular benefits for patients in low- and middle-income countries (LMICs). The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development. PMID:27216089

  19. Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

    Science.gov (United States)

    Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny

    2012-01-01

    Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

  20. Effect of dietary intervention on serum lignan levels in pregnant women - a controlled trial

    Directory of Open Access Journals (Sweden)

    Mäkelä Sari

    2010-10-01

    Full Text Available Abstract Background Mother's diet during pregnancy is important, since plant lignans and their metabolites, converted by the intestinal microflora to enterolignans, are proposed to possess multiple health benefits. Aim of our study was to investigate whether a dietary intervention affects lignan concentrations in the serum of pregnant women. Methods A controlled dietary intervention trial including 105 first-time pregnant women was conducted in three intervention and three control maternity health clinics. The intervention included individual counseling on diet and on physical activity, while the controls received conventional care. Blood samples were collected on gestation weeks 8-9 (baseline and 36-37 (end of intervention. The serum levels of the plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and of the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone, were measured using a validated method. Results The baseline levels of enterolactone, enterodiol and the sum of lignans were higher in the control group, whereas at the end of the trial their levels were higher in the intervention group. The adjusted mean differences between the baseline and end of the intervention for enterolactone and the total lignan intake were 1.6 ng/ml (p = 0.018, 95% CI 1.1-2.3 and 1.4 ng/mg (p = 0.08, 95% CI 1.0-1.9 higher in the intervention group than in the controls. Further adjustment for dietary components did not change these associations. Conclusion The dietary intervention was successful in increasing the intake of lignan-rich food products, the fiber consumption and consequently the plasma levels of lignans in pregnant women. Trial registration ISRCTN21512277, http://www.isrctn.org

  1. Measurement of serum haptoglobin as an indicator of the efficacy of malaria intervention trials.

    Science.gov (United States)

    Sisay, F; Byass, P; Snow, R W; Greenwood, B M; Perrin, L H; Yerly, S

    1992-01-01

    Serum haptoglobin levels were measured by an enzyme-linked immunosorbent assay in Gambian children who participated in 3 malaria intervention trials with untreated or impregnated bed nets. In one study, in which a significant effect on clinical malaria was observed, the mean serum haptoglobin level was significantly higher in the intervention than in the control group. In the other 2 studies, in which no significant protection was observed, mean haptoglobin levels were similar in intervention and control groups. Measurement of serum haptoglobin may provide a useful indirect measure of the effectiveness of malaria control programmes. PMID:1566291

  2. Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

    Directory of Open Access Journals (Sweden)

    Thoke-Colberg Anette

    2010-03-01

    Full Text Available Abstract Background Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN program, a multi modular structured intervention to improve self management in cancer patients with pain. Methods 240 patients with diagnosed malignancy and pain > 3 days and average pain ≥ 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients from the intervention wards will receive, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, nonpharmacologic pain management and discharge management. The intervention will be conducted by specially trained oncology nurses and includes components of patient education, skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group will receive standard care. Primary endpoint is the group difference in patient related barriers to management of cancer pain (BQII, 7 days after discharge. Secondary endpoints are: pain intensity & interference, adherence, coping and HRQoL. Discussion The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital. It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain. Trial Registration ClinicalTrials NCT

  3. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    Science.gov (United States)

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  4. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.

    2015-01-01

    Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was

  5. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

    Science.gov (United States)

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2008-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  6. Positive Family Intervention for Severe Challenging Behavior I: A Multisite Randomized Clinical Trial

    Science.gov (United States)

    Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.

    2013-01-01

    The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…

  7. Randomized controlled trial of a family problem-solving intervention.

    Science.gov (United States)

    Drummond, Jane; Fleming, Darcy; McDonald, Linda; Kysela, Gerard M

    2005-02-01

    Adaptive problem solving contributes to individual and family health and development. In this article, the effect of the cooperative family learning approach (CFLA) on group family problem solving and on cooperative parenting communication is described. A pretest or posttest experimental design was used. Participant families were recruited from Head Start programs and exhibited two or more risk factors. Participant preschool children were screened to have two or more developmental delays. Direct behavioral observation measures were used to determine group family problem solving and cooperative parenting communication outcomes. Few group family problem-solving behaviors were coded, and they displayed little variability. However, intervention parents increased the length of time they played and extended the cooperative parent-child interactions. The evidence shows that CFLA has the potential to enhance parental-modeling of cooperative behavior while engaged in play activities with preschoolers. Direct measurement of group family problem solving was difficult. Solutions are suggested. PMID:15604228

  8. Belonging to a peer support group enhance the quality of life and adherence rate in patients affected by breast cancer: A non-randomized controlled clinical trialFNx01

    Directory of Open Access Journals (Sweden)

    Afsaneh Malekpour Tehrani

    2011-01-01

    Full Text Available Background: Breast cancer is the most common cancer in women. It seems that breast cancer patients benefit from meeting someone who had a similar experience. This study evaluated the effect of two kinds of interventions (peer support and educational program on quality of life in breast cancer patients. Methods: This study was a controlled clinical trial on women with non-metastatic breast cancer. The patients studied in two experimental and control groups. Experimental group took part in peer support program and control group passed a routine educational program during 3 months. The authors administered SF-36 for evaluating the quality of life pre-and post intervention. Also, patient′s adherence was assessed by means of a simple checklist. Results: Two groups were similar with respect of age, age of onset of the disease, duration of having breast cancer, marital status, type of the treatment receiving now, and type of the received surgery. In the control group, there were statistically significant improvements in body pain, role-physical, role-emotional and social functioning. In experimental group, role-physical, vitality, social functioning, role-emotional and mental health showed significant improvement. Vitality score and mental health score in experimental group was significantly higher than that of the control group, both with p < 0.001. Also, it was shown that adherence was in high levels in both groups and no significant difference was seen after the study was done. Conclusions: According to the results of this study, supporting the patients with breast cancer by forming peer groups or by means of educational sessions could improve their life qualities.

  9. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  10. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention

  11. A randomized lifestyle intervention with 5-year follow-up in subjects with impaired glucose tolerance: pronounced short-term impact but long-term adherence problems

    DEFF Research Database (Denmark)

    Lindahl, Bernt; Nilssön, Torbjörn K; Borch-Johnsen, Knut;

    2009-01-01

    AIMS: To compare data on cardiovascular risk factor changes in lipids, insulin, proinsulin, fibrinolysis, leptin and C-reactive protein, and on diabetes incidence, in relation to changes in lifestyle. METHODS: The study was a randomized lifestyle intervention trial conducted in northern Sweden be...

  12. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial.

    Directory of Open Access Journals (Sweden)

    2005-11-01

    Full Text Available BACKGROUND: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis. METHODS AND FINDINGS: A total of 3,274 uncircumcised men, aged 18-24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 - RR. The trial was stopped at the interim analysis, and the mean (interquartile range follow-up was 18.1 mo (13.0-21.0 when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years in the intervention group and 49 (2.1 per 100 person-years in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%-0.68%; p < 0.001. This RR corresponds to a protection of 60% (95% CI: 32%-76%. When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%-77%. CONCLUSION: Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil..

  13. Postgraduate education to increase adherence to a Dutch physiotherapy practice guideline for hip and knee OA: a randomized controlled trial

    NARCIS (Netherlands)

    Peter, W.F.; Wees, P.J. van der; Verhoef, J.; Jong, Z. de; Bodegom-Vos, L. van; Hilberdink, W.K.H.A.; Fiocco, M.; Vliet Vlieland, T.P.M.

    2013-01-01

    OBJECTIVE: To compare the effectiveness of two educational courses aiming to improve adherence to recommendations in a Dutch physiotherapy practice guideline for hip and knee OA. METHODS: Physiotherapists (PTs) from three regions in The Netherlands were invited to participate in a study comparing an

  14. Pharmacokinetically and Clinician-Determined Adherence to an Antidepressant Regimen and Clinical Outcome in the TORDIA Trial

    Science.gov (United States)

    Woldu, Hiwot; Porta, Giovanna; Goldstein, Tina; Sakolsky, Dara; Perel, James; Emslie, Graham; Mayes, Taryn; Clarke, Greg; Ryan, Neal D.; Birmaher, Boris; Wagner, Karen Dineen; Asarnow, Joan Rosenbaum; Keller, Martin B.; Brent, David

    2011-01-01

    Objective: Nonadherence to antidepressant treatment may contribute to poor outcome and to suicidal adverse events in adolescent depression. We examine the relationship between adherence and both clinical response and suicidal events in participants in the Treatment of Resistant Depression in Adolescents (TORDIA) study. Method: The relationship…

  15. A simplified combination antiretroviral therapy regimen enhances adherence, treatment satisfaction and quality of life : results of a randomized clinical trial

    NARCIS (Netherlands)

    Langebeek, N.; Sprenger, H. G.; Gisolf, E. H.; Reiss, P.; Sprangers, M. A. G.; Legrand, J. C.; Richter, C.; Nieuwkerk, P. T.

    2014-01-01

    Objectives The aim of the study was to investigate the effect of a simplified regimen, in terms of reducing pill burden, dietary requirements and possible adverse effects, on patients' adherence, treatment satisfaction and quality of life (QoL). Methods Antiretroviral-naive patients who achieved a v

  16. Evaluating an intervention to reduce fear of falling and associated activity restriction in elderly persons: design of a randomised controlled trial [ISRCTN43792817

    Directory of Open Access Journals (Sweden)

    van Eijk JThM

    2005-03-01

    Full Text Available Abstract Background Fear of falling and associated activity restriction is common in older persons living in the community. Adverse consequences of fear of falling and associated activity restriction, like functional decline and falls, may have a major impact on physical, mental and social functioning of these persons. This paper presents the design of a trial evaluating a cognitive behavioural group intervention to reduce fear of falling and associated activity restriction in older persons living in the community. Methods/design A two-group randomised controlled trial was developed to evaluate the intervention. Persons 70 years of age or over and still living in the community were eligible for study if they experienced at least some fear of falling and associated activity restriction. A random community sample of elderly people was screened for eligibility; those eligible for study were measured at baseline and were subsequently allocated to the intervention or control group. Follow-up measurements were carried out directly after the intervention period, and then at six months and 12 months after the intervention. People allocated to the intervention group were invited to participate in eight weekly sessions of two hours each and a booster session. This booster session was conducted before the follow-up measurement at six months after the intervention. People allocated to the control group received no intervention as a result of this trial. Both an effect evaluation and a process evaluation were performed. The primary outcome measures of the effect evaluation are fear of falling, avoidance of activity due to fear of falling, and daily activity. The secondary outcome measures are perceived general health, self-rated life satisfaction, activities of daily life, feelings of anxiety, symptoms of depression, social support interactions, feelings of loneliness, falls, perceived consequences of falling, and perceived risk of falling. The outcomes of

  17. Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention

    DEFF Research Database (Denmark)

    Krogsbøll, Lasse Theis; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

    2009-01-01

    were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95...... from baseline, and we aimed at quantifying these contributions. METHODS: Systematic review and meta-analysis, based on a Cochrane review of the effect of placebo interventions for all clinical conditions. We selected all trials that had randomised the patients to three arms: no treatment, placebo...

  18. Falls Assessment Clinical Trial (FACT: design, interventions, recruitment strategies and participant characteristics

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    Lawton Beverley

    2007-07-01

    Full Text Available Abstract Background Guidelines recommend multifactorial intervention programmes to prevent falls in older adults but there are few randomised controlled trials in a real life health care setting. We describe the rationale, intervention, study design, recruitment strategies and baseline characteristics of participants in a randomised controlled trial of a multifactorial falls prevention programme in primary health care. Methods Participants are patients from 19 primary care practices in Hutt Valley, New Zealand aged 75 years and over who have fallen in the past year and live independently. Two recruitment strategies were used – waiting room screening and practice mail-out. Intervention participants receive a community based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme. Control participants receive usual care and social visits. Outcome measures include number of falls and injuries over 12 months, balance, strength, falls efficacy, activities of daily living, quality of life, and physical activity levels. Results 312 participants were recruited (69% women. Of those who had fallen, 58% of people screened in the practice waiting rooms and 40% when screened by practice letter were willing to participate. Characteristics of participants recruited using the two methods are similar (p > 0.05. Mean age of all participants was 81 years (SD 5. On average participants have 7 medical conditions, take 5.5 medications (29% on psychotropics with a median of 2 falls (interquartile range 1, 3 in the previous year. Conclusion The two recruitment strategies and the community based intervention delivery were feasible and successful, identifying a high risk group with multiple falls. Recruitment in the waiting room gave higher response rates but was less efficient than practice mail-out. Testing the effectiveness of an evidence based intervention in a

  19. Participant adherence to the Internet-based prevention program StudentBodies™ for eating disorders — A review

    Directory of Open Access Journals (Sweden)

    Ina Beintner

    2014-03-01

    Adherence to StudentBodies™ proved to be high across a number of trials, settings and countries. These findings are promising, but it is likely that adherence will be distinctly lower in the general public than in research settings, and intervention effects will turn out smaller. However, the intervention is readily available at minimal cost per participant, and the public health impact may still be notable.

  20. Knowledge and adherence to antihypertensive therapy in primary care: results of a randomized trial Conocimiento y adherencia a la terapia antihipertensiva en atención primaria: resultados de un ensayo clínico

    Directory of Open Access Journals (Sweden)

    Ester Amado Guirado

    2011-02-01

    Full Text Available Objectives: To evaluate the efficacy of a healthcare education program for patients with hypertension. Methods: A multicenter, prospective, cluster-randomized trial was conducted. Randomization was by primary care center; 18 of 36 urban primary care centers in Barcelona and its metropolitan area were randomized to the intervention group (IG and 18 to the control group (CG. The study sample consisted of patients with hypertension (n=996; 515 in the IG and 481 in the CG receiving outpatient treatment with antihypertensive drugs. The intervention consisted of personalized information by a trained nurse and written leaflets. Questionnaires on knowledge and awareness of hypertension and its medication, treatment adherence, healthy lifestyle habits, systolic and diastolic blood pressure, and body mass index were assessed at each visit, with a 12-month follow-up. An intention-to-treat analysis was applied. Results: Knowledge of hypertension increased by 27.8% in the IG and by 18.5% in the CG, while that of medication increased by 10.1% in the IG and 5.5% in the CG. Treatment adherence measured by the Morisky-Green test increased by 9.6% (95% CI: 5.5-13.6 in the IG and 8.8% (95% CI: 4.9-12.6 in the CG. There were no differences in adherence on the other tests used. No differences were observed between the IG and CG in clinical variables such as blood pressure or BMI at the end of the trial. Conclusions: The educational intervention had no significant impact on patients´ adherence to the medication.Objetivos: Evaluar la eficacia de un programa de educación sanitaria en pacientes con hipertensión. Métodos: Se diseñó un estudio multicéntrico prospectivo y aleatorizado de conglomerados. La unidad de aleatorización fueron los centros de atención primaria (CAP situados en Barcelona y su área metropolitana, con 18 CAPs urbanos asignados al grupo intervención (GI y 18 al grupo control (GC. La muestra de pacientes hipertensos que recibían tratamiento

  1. The IMEA project: an intervention based on microfinance, entrepreneurship, and adherence to treatment for women with HIV/AIDS living in poverty.

    Science.gov (United States)

    Arrivillaga, Marcela; Salcedo, Juan Pablo; Pérez, Mauricio

    2014-10-01

    A number of issues affect adherence to treatment and quality of life among women living with HIV/AIDS. In particular, women living in poverty have a higher risk of mortality due to their vulnerable conditions and socioeconomic exclusion. The objective of this study was to evaluate the effectiveness of an intervention that combines microfinance, entrepreneurship and adherence to treatment (IMEA) for women with HIV/AIDS and living in poverty in Cali, Colombia. A pre-post research design without a control was utilized, and 48 women were included in the study. The evaluation showed effectiveness of the program in the majority of the results (knowledge of HIV and treatment, adherence to treatment, self-efficacy, and the formation of a microenterprise) (p global indicator increased from 28.3% to 85.5% (p business. It is concluded that the IMEA project should be tested in other contexts and that its consequent results should be analyzed; so it could be converted into a large scale public health program. PMID:25299805

  2. Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

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    van Balkom Anton

    2008-11-01

    Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an

  3. Intervention strategies for improving patient adherence to follow-up in the era of mobile information technology: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Haotian Lin

    Full Text Available Patient adherence to follow-up plays a key role in the medical surveillance of chronic diseases and affects the implementation of clinical research by influencing cost and validity. We previously reported a randomized controlled trial (RCT on short message service (SMS reminders, which significantly improved follow-up adherence in pediatric cataract treatment.RCTs published in English that reported the impact of SMS or telephone reminders on increasing or decreasing the follow-up rate (FUR were selected from Medline, EMBASE, PubMed, and the Cochrane Library through February 2014. The impacts of SMS and telephone reminders on the FUR of patients were systematically evaluated by meta-analysis and bias was assessed.We identified 13 RCTs reporting on 3276 patients with and 3402 patients without SMS reminders and 8 RCTs reporting on 2666 patients with and 3439 patients without telephone reminders. For the SMS reminders, the majority of the studies (>50% were at low risk of bias, considering adequate sequence generation, allocation concealment, blinding, evaluation of incomplete outcome data, and lack of selective reporting. For the studies on the telephone reminders, only the evaluation of incomplete outcome data accounted for more than 50% of studies being at low risk of bias. The pooled odds ratio (OR for the improvement of follow-up adherence in the SMS group compared with the control group was 1.76 (95% CI [1.37, 2.26]; P<0.01, and the pooled OR for the improvement of follow-up adherence in the telephone group compared with the control group was 2.09 (95% CI [1.85, 2.36]; P<0.01; both sets showed no evidence of publication bias.SMS and telephone reminders could both significantly improve the FUR. Telephone reminders were more effective but had a higher risk of bias than SMS reminders.

  4. Implementation of physical coordination training and cognitive behavioural training interventions at cleaning workplaces - secondary analyses of a randomised controlled trial

    DEFF Research Database (Denmark)

    Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias;

    2012-01-01

    This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12...... intervention effects, more research on implementation is needed. Trial registration: ISRCTN96241850. Practitioner summary: Both physical coordination training and cognitive behavioural training are potential effective workplace interventions among low educated job groups with high physical work demands...

  5. Application of Balanced Scorecard in the Evaluation of a Complex Health System Intervention: 12 Months Post Intervention Findings from the BHOMA Intervention: A Cluster Randomised Trial in Zambia

    Science.gov (United States)

    Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

    2014-01-01

    Introduction In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. Methods The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. Results The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. Conclusion This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful

  6. The effect on survival of a multidimensional intervention project (SEAD in HIV/AIDS patients with follow-up and adherence (FUP/ADH barriers

    Directory of Open Access Journals (Sweden)

    M Pérez Elías

    2012-11-01

    Full Text Available Purpose of the study: Irregular FUP/ADH were associated with higher mortality and resource use [1]. SEAD was a multidimensional intervention project, designed from the patient's perspective, to specifically attend patients with poor FUP/ADH in an HIV/AIDS outpatient clinic. Methods: From Jan 2006 to May 2010, patients with poor FUP/ADH were offered SEAD inclusion, all were evaluated by a nurse or a psychologist (adherence collaborators who assessed all the reasons and barriers precluding a correct FUP/ADH. For each identified problem, different interventions were planned, using our own resources or coordinating others. Follow-up was censored in Nov 2011. Time to death after being admitted to SEAD and the effect of SEAD program intervention were assessed with Kaplan-Meier curves, log-Rank test and a Cox regression model. Summary of results: Overall, 215 patients were assessed: mean age 45 years, 24% women, IDU 75%, with baseline ADH >90% in only 23%; median HIV-RNA and CD4 cell count were 377 copies/ml and 326 cell/mcL. Patients entered in SEAD due to poor ADH in 17%, FUP problems in 23%, and both 60%. Main reasons driving poor FUP/ADH were severe bio-psycho-social problems 28%, severe drug and/or alcohol abuse 26%, logistic problems 18%, other psychiatric disorders 13%, oversights 9%, unknown 4% and antiretroviral intolerance 2%. Only 54% of patients received;>50% of planned interventions, due to population complexity. Cocaine/heroin and alcohol abuse were reported by 34% and 17% respectively. Afer a median follow-up of 3.7 [3.31–4.4] years 193 patients received a mean of 8 (2.5–12 interventions/year, achieving virological control in 64%. Probability of survival was 92%, 89% and 86% after 1, 2 and 3 years respectively. In Cox regression model an intervention of SEAD project higher than 50% of planned was an independent predictor of survival HR 0.336 (95% CI 0.156–0.725; p=0.005, after adjusting for age, alcohol or cocaine abuse

  7. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence

    OpenAIRE

    Hark, Lisa A.; Johnson, Deiana M; Berardi,Giuliana; Patel, Neal S.; Zeng, Lichuan; Dai, Yang; Mayro, Eileen L; Waisbourd, Michael; Katz, L Jay

    2016-01-01

    Purpose Patients with glaucoma who do not keep their follow-up eye care appointments are at risk for developing more severe ocular disease. The primary aim of the current study was to evaluate whether the use of a patient navigator altered adherence to follow-up eye care appointments in community-versus office-based settings. Patients and methods Patients diagnosed with a glaucoma-related condition following a comprehensive eye examination at 43 community sites in Philadelphia, PA, USA, were ...

  8. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence

    OpenAIRE

    Zeng, Lichuan; Hark, Lisa A.; Johnson,Deiana; Berardi,Giuliana; Patel, Neal; Dai, Yang; Mayro,Eileen; Waisbourd, Michael; Katz, L Jay

    2016-01-01

    Lisa A Hark, Deiana M Johnson, Giuliana Berardi, Neal S Patel, Lichuan Zeng, Yang Dai, Eileen L Mayro, Michael Waisbourd, L Jay Katz On behalf of the Glaucoma Research Group Wills Eye Hospital Glaucoma Research Center, Philadelphia, PA, USA Purpose: Patients with glaucoma who do not keep their follow-up eye care appointments are at risk for developing more severe ocular disease. The primary aim of the current study was to evaluate whether the use of a patient navigator altered adherence to...

  9. A trial of an iPad™ intervention targeting social communication skills in children with autism.

    Science.gov (United States)

    Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen

    2016-10-01

    This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of developmental level, and was rated highly by parents. There were no significant group differences in parent-report measures post-intervention, nor in a measure of parent-child play at follow-up. Therefore, this intervention did not have an observable impact on real-world social communication skills and caution is recommended about the potential usefulness of iPad(™) apps for amelioration of difficulties in interaction. However, positive attitudes among participants, lack of harms and the potential of apps to deliver therapeutic content at low economic cost suggest this approach is worth pursuing further, perhaps targeting other skill domains.

  10. Measures of clinical malaria in field trials of interventions against Plasmodium falciparum

    Directory of Open Access Journals (Sweden)

    Smith Thomas A

    2007-05-01

    Full Text Available Abstract Background Standard methods for defining clinical malaria in intervention trials in endemic areas do not guarantee that efficacy estimates will be unbiased, and do not indicate whether the intervention has its effect by modifying the force of infection, the parasite density, or the risk of pathology at given parasite density. Methods Three different sets, each of 500 Phase IIb or III malaria vaccine trials were simulated corresponding to each of a pre-erythrocytic, blood stage, and anti-disease vaccine, each in a population with 80% prevalence of patent malaria infection. Simulations considered only the primary effects of vaccination in a homogeneous trial population. The relationships between morbidity and parasite density and the performance of different case definitions for clinical malaria were analysed using conventional likelihood ratio tests to compare incidence of episodes defined using parasite density cut-offs. Bayesian latent class models were used to compare the overall frequencies of clinical malaria episodes in analyses that did not use diagnostic cut-offs. Results The different simulated interventions led to different relationships between clinical symptoms and parasite densities. Consequently, the operating characteristics of parasitaemia cut-offs in general differ between vaccine and placebo arms of the simulated trials, leading to different patterns of bias in efficacy estimates depending on the type of intervention effect. Efficacy was underestimated when low parasitaemia cut-offs were used but the efficacy of an asexual blood stage vaccine was overestimated when a high parasitaemia cut-off was used. The power of a trial may be maximal using case definitions that are associated with substantial bias in efficacy. Conclusion Secondary analyses of the data of malaria intervention trials should consider the relationship between clinical symptoms and parasite density, and attempt to estimate overall numbers of clinical

  11. Effect of Three Interventions on Contact Lens Comfort in Symptomatic Wearers: A Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Maria Navascues-Cornago

    Full Text Available To investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD contact lens wearers.A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 h on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a 'scleral swish'; and no action (control. Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain to 100 (excellent comfort scale. Comfort scores before lens application, at 6 mins post-application, and at 6 mins post-intervention were also recorded.There was a significant reduction in comfort from pre-lens application to 6 mins post-application for all groups (all p0.05. After the intervention, comfort continued to decline (p<0.0001 with slightly lower mean scores for the control group compared to the new lens group (p = 0.003. Change in comfort relative to pre-intervention (5 h was similar for all groups (p = 0.81. There was no difference in comfort at 12 h between groups (p = 0.83.This work has confirmed that comfort shows a continual and significant decline over a 12-h wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather than to the lens itself.Controlled-Trials.com ISRCTN10419752 http://www.controlled-trials.com/ISRCTN10419752.

  12. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Ravaud Philippe

    2009-05-01

    Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P

  13. Evaluation of a pharmacist intervention on patients initiating pharmacological treatment for depression: a randomized controlled superiority trial

    OpenAIRE

    Rubio Valera, Maria; March Pujol, Marian; Fernández Sánchez, Ana; Peñarrubia María, María Teresa; Travé i Mercadé, Pere; López del Hoyo, Yolanda; Serrano Blanco, Antoni

    2013-01-01

    Major depression is associated with high burden, disability and costs. Non-adherence limits the effectiveness of antidepressants. Community pharmacists (CP) are in a privileged position to help patients cope with antidepressant treatment. The aim of the study was to evaluate the impact of a CP intervention on primary care patients who had initiated antidepressant treatment. Newly diagnosed primary care patients were randomised to usual care (UC) (92) or pharmacist intervention (87). Patients ...

  14. Process and effects of a community intervention on malaria in rural Burkina Faso: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gustafsson Lars

    2008-03-01

    Full Text Available Abstract Background In the rural areas of sub-Saharan Africa, the majority of young children affected by malaria have no access to formal health services. Home treatment through mothers of febrile children supported by mother groups and local health workers has the potential to reduce malaria morbidity and mortality. Methods A cluster-randomized controlled effectiveness trial was implemented from 2002–2004 in a malaria endemic area of rural Burkina Faso. Six and seven villages were randomly assigned to the intervention and control arms respectively. Febrile children from intervention villages were treated with chloroquine (CQ by their mothers, supported by local women group leaders. CQ was regularly supplied through a revolving fund from local health centres. The trial was evaluated through two cross-sectional surveys at baseline and after two years of intervention. The primary endpoint of the study was the proportion of moderate to severe anaemia in children aged 6–59 months. For assessment of the development of drug efficacy over time, an in vivo CQ efficacy study was nested into the trial. The study is registered under http://www.controlled-trials.com (ISRCTN 34104704. Results The intervention was shown to be feasible under program conditions and a total of 1.076 children and 999 children were evaluated at baseline and follow-up time points respectively. Self-reported CQ treatment of fever episodes at home as well as referrals to health centres increased over the study period. At follow-up, CQ was detected in the blood of high proportions of intervention and control children. Compared to baseline findings, the prevalence of anaemia (29% vs 16%, p P. falciparum parasitaemia, fever and palpable spleens was lower at follow-up but there were no differences between the intervention and control group. CQ efficacy decreased over the study period but this was not associated with the intervention. Discussion The decreasing prevalence of malaria

  15. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    Science.gov (United States)

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto

    2014-03-01

    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety. PMID:23362335

  16. Implementation of the Dutch low back pain guideline for general practitioners: a cluster randomized controlled trial.

    NARCIS (Netherlands)

    Engers, A.J.; Wensing, M.J.P.; Tulder, M.W. van; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.

    2005-01-01

    STUDY DESIGN: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence to

  17. Preliminary Evidence for Feasibility, Use, and Acceptability of Individualized Texting for Adherence Building for Antiretroviral Adherence and Substance Use Assessment among HIV-Infected Methamphetamine Users

    Directory of Open Access Journals (Sweden)

    David J. Moore

    2013-01-01

    Full Text Available The feasibility, use, and acceptability of text messages to track methamphetamine use and promote antiretroviral treatment (ART adherence among HIV-infected methamphetamine users was examined. From an ongoing randomized controlled trial, 30-day text response rates of participants assigned to the intervention (individualized texting for adherence building (iTAB, n = 20 were compared to those in the active comparison condition (n = 9. Both groups received daily texts assessing methamphetamine use, and the iTAB group additionally received personalized daily ART adherence reminder texts. Response rate for methamphetamine use texts was 72.9% with methamphetamine use endorsed 14.7% of the time. Text-derived methamphetamine use data was correlated with data from a structured substance use interview covering the same time period (P<0.05. The iTAB group responded to 69.0% of adherence reminder texts; among those responses, 81.8% endorsed taking ART medication. Standardized feedback questionnaire responses indicated little difficulty with the texts, satisfaction with the study, and beliefs that future text-based interventions would be helpful. Moreover, most participants believed the intervention reduced methamphetamine use and improved adherence. Qualitative feedback regarding the intervention was positive. Future studies will refine and improve iTAB for optimal acceptability and efficacy. This trial is registered with ClinicalTrials.gov NCT01317277.

  18. Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

    Science.gov (United States)

    Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

    2014-01-01

    Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress. PMID:23969994

  19. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K. M; Hunink, M. G. Myriam; van Dijk, Monique

    2016-01-01

    Objective Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants’ well-being. Methods We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. Results After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Conclusions Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants. PMID

  20. Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Simon D French

    Full Text Available INTRODUCTION: This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP in general practice. METHODS: General practices were randomised to either access to a guideline for acute LBP (control or facilitated interactive workshops (intervention. We measured behavioural predictors (e.g. knowledge, attitudes and intentions and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP level: behavioural simulation (clinical decision about vignettes and rates of x-ray and CT-scan (medical administrative data. All those not involved in the delivery of the intervention were blinded to allocation. RESULTS: 47 practices (53 GPs were randomised to the control and 45 practices (59 GPs to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05 and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60. Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10 for x-ray or CT-scan. CONCLUSIONS: The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant

  1. Behavior Intervention Planning and Implementation of Positive Behavioral Support Plans: An Examination of States' Adherence to Standards for Practice

    Science.gov (United States)

    Killu, Kim; Weber, Kimberly P.; Derby, K. Mark; Barretto, Anjali

    2006-01-01

    To address the behavioral needs of students with disabilities in school settings, the Individuals with Disabilities Education Improvement Act of 2004 (IDEIA) requires the development and implementation of a behavior intervention plan/positive behavioral support plan (BIP/PBSP) based on positive behavioral interventions and supports (PBIS). Despite…

  2. Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

    Science.gov (United States)

    Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk

    2016-10-01

    Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies. PMID:26848872

  3. Statistical design of personalized medicine interventions: The Clarification of Optimal Anticoagulation through Genetics (COAG trial

    Directory of Open Access Journals (Sweden)

    Gage Brian F

    2010-11-01

    Full Text Available Abstract Background There is currently much interest in pharmacogenetics: determining variation in genes that regulate drug effects, with a particular emphasis on improving drug safety and efficacy. The ability to determine such variation motivates the application of personalized drug therapies that utilize a patient's genetic makeup to determine a safe and effective drug at the correct dose. To ascertain whether a genotype-guided drug therapy improves patient care, a personalized medicine intervention may be evaluated within the framework of a randomized controlled trial. The statistical design of this type of personalized medicine intervention requires special considerations: the distribution of relevant allelic variants in the study population; and whether the pharmacogenetic intervention is equally effective across subpopulations defined by allelic variants. Methods The statistical design of the Clarification of Optimal Anticoagulation through Genetics (COAG trial serves as an illustrative example of a personalized medicine intervention that uses each subject's genotype information. The COAG trial is a multicenter, double blind, randomized clinical trial that will compare two approaches to initiation of warfarin therapy: genotype-guided dosing, the initiation of warfarin therapy based on algorithms using clinical information and genotypes for polymorphisms in CYP2C9 and VKORC1; and clinical-guided dosing, the initiation of warfarin therapy based on algorithms using only clinical information. Results We determine an absolute minimum detectable difference of 5.49% based on an assumed 60% population prevalence of zero or multiple genetic variants in either CYP2C9 or VKORC1 and an assumed 15% relative effectiveness of genotype-guided warfarin initiation for those with zero or multiple genetic variants. Thus we calculate a sample size of 1238 to achieve a power level of 80% for the primary outcome. We show that reasonable departures from these

  4. Randomized, Controlled Trial of an Intervention for Toddlers With Autism: The Early Start Denver Model

    Science.gov (United States)

    Dawson, Geraldine; Rogers, Sally; Munson, Jeffrey; Smith, Milani; Winter, Jamie; Greenson, Jessica; Donaldson, Amy; Varley, Jennifer

    2016-01-01

    OBJECTIVE To conduct a randomized, controlled trial to evaluate the efficacy of the Early Start Denver Model (ESDM), a comprehensive developmental behavioral intervention, for improving outcomes of toddlers diagnosed with autism spectrum disorder (ASD). METHODS Forty-eight children diagnosed with ASD between 18 and 30 months of age were randomly assigned to 1 of 2 groups: (1) ESDM intervention, which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years; or (2) referral to community providers for intervention commonly available in the community. RESULTS Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD:15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of grow thin adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group. CONCLUSIONS This is the first randomized, controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis. Results of this study underscore the importance of early detection of and intervention in autism. PMID:19948568

  5. Preventing College Women's Sexual Victimization Through Parent Based Intervention: A Randomized Controlled Trial

    OpenAIRE

    Testa, Maria; Hoffman, Joseph H.; Livingston, Jennifer A.; Turrisi, Rob

    2010-01-01

    A randomized controlled trial, using parent-based intervention (PBI) was designed to reduce the incidence of alcohol-involved sexual victimization among first-year college students. The PBI, adapted from Turrisi et al. (2001), was designed to increase alcohol-specific and general communication between mother and daughter. Female graduating high school seniors and their mothers were recruited from the community and randomly assigned to one of four conditions: Alcohol PBI (n=305), Enhanced Alco...

  6. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials

    OpenAIRE

    Bradley, Clare

    1993-01-01

    The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partial...

  7. Improving the Dictation in Attention Deficit Hyperactivity Disorder by Using Computer Based Interventions: A Clinical Trial

    OpenAIRE

    Mahdi Tehranidoost; Anahita Basirnia; Shervin Assari; Mohammad Reza Mohammadi; Mostafa Najafi; Javad Alaghband-rad

    2006-01-01

    Objective: The aim of the current study was to assess the impact of computer games and computer-assisted type instruction on dictation scores of elementary school children with attention deficit – hyperactivity disorder (ADHD). Method: In this single-blind clinical trial, 37 elementary school children with ADHD, selected by convenience sampling and divided into group I (n=17) and group II (n=20), underwent eight one-hour sessions (3 sessions per week) of intervention by computer games versus ...

  8. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.

    OpenAIRE

    Thomson, NC; Rubin, AS; Niven, RM; Corris, PA; Siersted, HC; Olivenstein, R.; Pavord, ID; McCormack, D.; Laviolette, M.; Shargill, NS; Cox, G.

    2011-01-01

    BACKGROUND: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. METHODS: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial...

  9. Long term (5 Year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

    OpenAIRE

    Thomson, N C; Rubin, A.S.; Niven, R. M.; Corris, P A; Siersted, H. C.; Olivenstein, R.; Pavord, I.D.; McCormick, D.; Laviolette, M.; Shargill, N.S.; Cox, G.

    2011-01-01

    Background: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. Methods: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. ...

  10. Accounting for expected attrition in the planning of community intervention trials.

    Science.gov (United States)

    Taljaard, Monica; Donner, Allan; Klar, Neil

    2007-06-15

    Trials in which intact communities are the units of randomization are increasingly being used to evaluate interventions which are more naturally administered at the community level, or when there is a substantial risk of treatment contamination. In this article we focus on the planning of community intervention trials in which k communities (for example, medical practices, worksites, or villages) are to be randomly allocated to each of an intervention and a control group, and fixed cohorts of m individuals enrolled in each community prior to randomization. Formulas to determine k or m may be obtained by adjusting standard sample size formulas to account for the intracluster correlation coefficient rho. In the presence of individual-level attrition however, observed cohort sizes are likely to vary. We show that conventional approaches of accounting for potential attrition, such as dividing standard sample size formulas by the anticipated follow-up rate pi or using the average anticipated cohort size m pi, may, respectively, overestimate or underestimate the required sample size when cluster follow-up rates are highly variable, and m or rho are large. We present new sample size estimation formulas for the comparison of two means or two proportions, which appropriately account for variation among cluster follow-up rates. These formulas are derived by specifying a model for the binary missingness indicators under the population-averaged approach, assuming an exchangeable intracluster correlation coefficient, denoted by tau. To aid in the planning of future trials, we recommend that estimates for tau be reported in published community intervention trials. PMID:17068842

  11. Validation of Green Tea Polyphenol Biomarkers in a Phase II Human Intervention Trial

    OpenAIRE

    Wang, Jia-Sheng; Luo, Haitao; Wang, Piwen; Tang, Lili; YU, JIAHUA; Huang, Tianren; Cox, Stephen; Gao, Weimin

    2007-01-01

    Health benefits of green tea polyphenols (GTPs) have been reported in many animal models, but human studies are inconclusive. This is partly due to a lack of biomarkers representing green tea consumption. In this study, GTP components and metabolites were analyzed in plasma and urine samples collected from a phase II intervention trial carried out in 124 healthy adults who received 500- or 1,000-mg GTPs or placebo for 3 months. A significant dose-dependent elevation was found for (-)-epicatec...

  12. Intervention impact on depression product appraisal and purchasing behavior by employers: a randomized trial

    OpenAIRE

    Rost, Kathryn M.; Marshall, Donna; Xu, Stanley

    2014-01-01

    Background Employers can purchase high quality depression products that provide the type, intensity and duration of depression care management shown to improve work outcomes sufficiently for many employers to achieve a return on investment. The purpose of this randomized controlled trial was to test an intervention to encourage employers to purchase a high quality depression product for their workforce. Methods Twenty nine organizations recruited senior health benefit professional members rep...

  13. The Effect of Educational and Modifying Intervention on Asthma Control among Adolescents: a Randomized Clinical Trial

    OpenAIRE

    Zarei, Soheila; Valizadeh, Leila; BILAN, Nemat

    2013-01-01

    Introduction: Controlling over allergens and environmental irritants is one of the essential elements of controlling asthma. Asthma control in adolescents is a challenge. The current study was performed with the goal of investigating the effect of an educational and modifying intervention about asthma triggers on asthma control among adolescents. Methods: The current study was a randomized clinical trial. 60 adolescents of 12-18 years of age participated in this study. The p...

  14. Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

    OpenAIRE

    Quinn, Charlene C.; Shardell, Michelle D; Terrin, Michael L.; Barr, Erik A.; Ballew, Shoshana H.; Gruber-Baldini, Ann L.

    2011-01-01

    OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled...

  15. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    OpenAIRE

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; HARDCASTLE, EMILY; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole

    2009-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9–15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; ...

  16. Belonging to a peer support group enhance the quality of life and adherence rate in patients affected by breast cancer: A non-randomized controlled clinical trial*

    OpenAIRE

    Tehrani, Afsaneh Malekpour; Farajzadegan, Ziba; Rajabi, Fariborz Mokarian; Zamani, Ahmad Reza

    2011-01-01

    BACKGROUND: Breast cancer is the most common cancer in women. It seems that breast cancer patients benefit from meeting someone who had a similar experience. This study evaluated the effect of two kinds of interventions (peer support and educational program) on quality of life in breast cancer patients. METHODS: This study was a controlled clinical trial on women with non-metastatic breast cancer. The patients studied in two experimental and control groups. Experimental group took part in pee...

  17. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.

    Science.gov (United States)

    Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

    2009-10-01

    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

  18. A controlled trial of an internet-based intervention program for cannabis users.

    Science.gov (United States)

    Tossmann, Hans-Peter; Jonas, Benjamin; Tensil, Marc-Dennan; Lang, Peter; Strüber, Evelin

    2011-11-01

    In the last decade, several programs for the treatment of cannabis-related disorders were developed. Until now, no information is available on the efficacy of Internet-based counseling approaches for this target group. This article describes the evaluation of "quit the shit," a web-based intervention developed to help young people to quit or reduce their cannabis use significantly. Cannabis users seeking web-based treatment were included in a two-arm controlled trial conducted on a website for drug-related information and prevention. After the baseline assessment, members of the treatment condition were randomized to a 50-day intervention program. Other trial participants were put on a waiting list. A post-test was conducted 3 months after randomization. Of all 1,292 subjects included in the trial, a total of 206 participants took part at the post-test. Per-protocol- and intention-to-treat analyses were conducted. Members of the treatment condition showed a significantly stronger reduction in cannabis use (primary outcome) than the control group. In the per-protocol analyses, moderate-to-strong effects were found for the reduction of the frequency and the reduction of the quantity of consumed cannabis. Small-to-moderate effects were observed on the secondary outcomes (use-related self-efficacy, anxiety, depression, and life satisfaction). Despite limitations concerning the interpretation of the results, the intervention seems to offer an effective treatment option for persons with cannabis-related problems. PMID:21651419

  19. Effectiveness and cost-effectiveness of a very brief physical activity intervention delivered in NHS Health Checks (VBI Trial): study protocol for a randomised controlled trial

    OpenAIRE

    Mitchell, Joanna; Hardeman, Wendy; Pears, Sally; Vasconcelos, Joana C.; Prevost, A. Toby; Wilson, Ed; Sutton, Stephen

    2016-01-01

    Background: Physical activity interventions that are targeted at individuals can be effective in encouraging people to be more physically active. However, most such interventions are too long or complex and not scalable to the general population. This trial will test the effectiveness and cost-effectiveness of a very brief physical activity intervention when delivered as part of preventative health checks in primary care (National Health Service (NHS) Health Check). Methods/design: The Very B...

  20. Novel Three-Day, Community-Based, Nonpharmacological Group Intervention for Chronic Musculoskeletal Pain (COPERS): A Randomised Clinical Trial

    Science.gov (United States)

    Taylor, Stephanie J. C.; Carnes, Dawn; Homer, Kate; Kahan, Brennan C.; Hounsome, Natalia; Eldridge, Sandra; Spencer, Anne; Pincus, Tamar; Underwood, Martin

    2016-01-01

    Background Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain. Methods and Findings We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost–utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle

  1. Characteristics of control group participants who increased their physical activity in a cluster-randomized lifestyle intervention trial

    Directory of Open Access Journals (Sweden)

    Fjeldsoe Brianna S

    2011-01-01

    Full Text Available Abstract Background Meaningful improvement in physical activity among control group participants in lifestyle intervention trials is not an uncommon finding, and may be partly explained by participant characteristics. This study investigated which baseline demographic, health and behavioural characteristics were predictive of successful improvement in physical activity in usual care group participants recruited into a telephone-delivered physical activity and diet intervention trial, and descriptively compared these characteristics with those that were predictive of improvement among intervention group participants. Methods Data come from the Logan Healthy Living Program, a primary care-based, cluster-randomized controlled trial of a physical activity and diet intervention. Multivariable logistic regression models examined variables predictive of an improvement of at least 60 minutes per week of moderate-to-vigorous intensity physical activity among usual care (n = 166 and intervention group (n = 175 participants. Results Baseline variables predictive of a meaningful change in physical activity were different for the usual care and intervention groups. Being retired and completing secondary school (but no further education were predictive of physical activity improvement for usual care group participants, whereas only baseline level of physical activity was predictive of improvement for intervention group participants. Higher body mass index and being unmarried may also be predictors of physical activity improvement for usual care participants. Conclusion This is the first study to examine differences in predictors of physical activity improvement between intervention group and control group participants enrolled in a physical activity intervention trial. While further empirical research is necessary to confirm findings, results suggest that participants with certain socio-demographic characteristics may respond favourably to minimal intensity

  2. Guiding the design and selection of interventions to influence the implementation of evidence-based practice: an experimental simulation of a complex intervention trial.

    Science.gov (United States)

    Bonetti, Debbie; Eccles, Martin; Johnston, Marie; Steen, Nick; Grimshaw, Jeremy; Baker, Rachel; Walker, Anne; Pitts, Nigel

    2005-05-01

    A consistent finding in health services research is the report of uneven uptake of research findings. Implementation trials have a variable record of success in effectively influencing clinicians' behaviour. A more systematic approach may be to conduct Intervention Modelling Experiments before service-level trials, examining intervention effects on 'interim endpoints' representing clinical behaviour, derived from empirically supported psychological theories. The objectives were to: (1) Design Intervention Modelling Experiments by backward engineering a 'real-world' randomised controlled trial (NEXUS); (2) examine the applicability of psychological theories to clinical decision-making; (3) explore whether psychological theories can illuminate how interventions achieve their effects. A 2 x 2 factorial randomised controlled trial was designed with pre- and post-intervention data collection by postal questionnaire surveys. The first survey was used to generate feedback data and the interventions were delivered in the second survey. General medical practitioners (GPs) in England and Scotland participated. First survey respondents were randomised twice to receive or not audit and feedback and educational reminder messages. The main outcome measures included behavioural intention (general plan to refer for lumbar X-rays) and simulated behaviour (specific, scenario-based, decisions to refer for lumbar X-ray). Predictors were attitude, subjective norm, perceived behavioural control (theory of planned behaviour), self-efficacy (social cognitive theory) and decision difficulty. Both interventions significantly influenced simulated behaviour, but neither influenced behavioural intention. There were no interaction effects. All theoretically derived cognitions significantly predicted simulated behaviour. Only subjective norm was not predictive of behavioural intention. The effect of audit and feedback on simulated behaviour was mediated through perceived behavioural control. The

  3. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials

    Science.gov (United States)

    Doyle, Orla; McGlanaghy, Edel; O’Farrelly, Christine; Tremblay, Richard E.

    2016-01-01

    This study examined the impact of a targeted Irish early intervention program on children’s emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally. Trial Registration: ISRCTN Registry ISRCTN04631728 PMID:27253184

  4. An Intervention To Reduce Postpartum Depressive Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Howell, Elizabeth A; Bodnar-Deren, Susan; Balbierz, Amy; Loudon, Holly; Mora, Pablo A.; Zlotnick, Caron; Wang, Jason; Leventhal, Howard

    2013-01-01

    Depressive symptoms and depression are a common complication of childbirth and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high income mothers in a second randomized trial. Mothers in the intervention arm received a 2-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3-weeks, 3-months, and 6-months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum were unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention vs. enhanced usual care post hospitalization: 3-weeks (6.0 % vs. 5.6%, p=.83), 3-months (5.1% vs. 6.5%, p=.53) and 6-months (3.6% vs. 4.6%, p=.53). PMID:24019052

  5. A randomized controlled trial of a videoconferencing smoking cessation intervention for Korean American women: preliminary findings

    Science.gov (United States)

    Kim, Sun S; Sitthisongkram, Somporn; Bernstein, Kunsook; Fang, Hua; Choi, Won S; Ziedonis, Douglas

    2016-01-01

    Introduction Korean women are reluctant to pursue in-person smoking cessation treatment due to stigma attached to women smokers and prefer treatment such as telephone and online smoking cessation programs that they can access secretively at home. However, there is some evidence that face-to-face interaction is the most helpful intervention component for them to quit smoking. Methods This study is a pilot clinical trial that examined the acceptability and feasibility of a videoconferencing smoking cessation intervention for Korean American women and compared its preliminary efficacy with a telephone-based intervention. Women of Korean ethnicity were recruited nationwide in the United States and randomly assigned at a ratio of 1:1 to either a video arm or a telephone arm. Both arms received eight 30-minute weekly individualized counseling sessions of a deep cultural smoking cessation intervention and nicotine patches for 8 weeks. Participants were followed over 3 months from the quit day. Results The videoconferencing intervention was acceptable and feasible for Korean women aged effective, and personal preference is likely an important factor in treatment matching. The deep cultural smoking cessation intervention may account for the outcomes of telephone counseling being better than prior studies in the literature for Korean women.

  6. A behavioural intervention increases physical activity in people with subacute spinal cord injury: a randomised trial

    Directory of Open Access Journals (Sweden)

    Carla FJ Nooijen

    2016-01-01

    Full Text Available Questions: For people with subacute spinal cord injury, does rehabilitation that is reinforced with the addition of a behavioural intervention to promote physical activity lead to a more active lifestyle than rehabilitation alone? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis, and blinded assessors. Participants: Forty-five adults with subacute spinal cord injury who were undergoing inpatient rehabilitation and were dependent on a manual wheelchair. The spinal cord injuries were characterised as: tetraplegia 33%; motor complete 62%; mean time since injury 150 days (SD 74. Intervention: All participants received regular rehabilitation, including handcycle training. Only the experimental group received a behavioural intervention promoting an active lifestyle after discharge. This intervention involved 13 individual sessions delivered by a coach who was trained in motivational interviewing; it began 2 months before and ended 6 months after discharge from inpatient rehabilitation. Outcome measures: The primary outcome was physical activity, which was objectively measured with an accelerometer-based activity monitor 2 months before discharge, at discharge, and 6 and 12 months after discharge from inpatient rehabilitation. The accelerometry data were analysed as total wheeled physical activity, sedentary time and motility. Self-reported physical activity was a secondary outcome. Results: The behavioural intervention significantly increased wheeled physical activity (overall between-group difference from generalised estimating equation 21 minutes per day, 95% CI 8 to 35. This difference was evident 6 months after discharge (28 minutes per day, 95% CI 8 to 48 and maintained at 12 months after discharge (25 minutes per day, 95% CI 1 to 50. No significant intervention effect was found for sedentary time or motility. Self-reported physical activity also significantly improved. Conclusion: The behavioural

  7. A randomised controlled trial of a smoking cessation intervention delivered by dental hygienists: a feasibility study

    Directory of Open Access Journals (Sweden)

    Jenkins William

    2007-05-01

    Full Text Available Abstract Background Tobacco use continues to be a global public health problem. Helping patients to quit is part of the preventive role of all health professionals. There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking. The aim of this study was to determine the feasibility of undertaking a randomised controlled smoking cessation intervention, utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients. Methods One hundred and eighteen patients who attended consultant clinics in an outpatient dental hospital department (Periodontology were recruited into a trial. Data were available for 116 participants, 59 intervention and 57 control, and were analysed on an intention-to-treat basis. The intervention group received smoking cessation advice based on the 5As (ask, advise, assess, assist, arrange follow-up and were offered nicotine replacement therapy (NRT, whereas the control group received 'usual care'. Outcome measures included self-reported smoking cessation, verified by salivary cotinine measurement and CO measurements. Self-reported measures in those trial participants who did not quit included number and length of quit attempts and reduction in smoking. Results At 3 months, 9/59 (15% of the intervention group had quit compared to 5/57 (9% of the controls. At 6 months, 6/59 (10% of the intervention group quit compared to 3/57 (5% of the controls. At one year, there were 4/59 (7% intervention quitters, compared to 2/59 (4% control quitters. In participants who described themselves as smokers, at 3 and 6 months, a statistically higher percentage of intervention participants reported that they had had a quit attempt of at least one week in the preceding 3 months (37% and 47%, for the intervention group respectively, compared with 18% and 16% for the control group. Conclusion This study has shown the potential that trained dental hygienists

  8. The role of interventional radiology in reducing haemorrhage and hysterectomy following caesarean section for morbidly adherent placenta

    International Nuclear Information System (INIS)

    Aim: To report experience of prophylactic occlusion balloon catheters (POBCs) in both internal iliac arteries before caesarean section, with or without embolization, to preserve the uterus and reduce haemorrhage. Methods and materials: Twenty-seven women diagnosed with morbidly adherent placenta (MAP) and with suspected placenta percreta underwent POBC placement before caesarean section. The balloons were inflated immediately after delivery of the baby. The patients' case notes were reviewed retrospectively for histological grading of MAP, blood loss, transfusion, requirement of uterine artery embolization (UAE), or hysterectomy, radiation dose, and infant or maternal morbidity and mortality. Results: MAP was confirmed histologically as percreta in 17, accreta in eight, and increta in two women. Mean blood loss was 1.92 l (range 0.5–12 l). Postpartum haemorrhage (PPH) occurred in nine patients. Eight were referred for UAE, which was successful in six. Immediate peri-partum hysterectomy was performed in one patient. Three women in total required hysterectomy, two after recurrent haemorrhage after UAE. No foetal morbidity or mortality occurred. No maternal mortality occurred. There was one case of iliac artery thrombosis, which resolved with conservative therapy. Conclusion: POBC, with or without UAE, contributes to reduction of blood loss and preservation of the uterus in women with MAP. - Highlights: • Management of morbidly adherent placenta requires a multidisciplinary team approach. • Prophylactic occlusion balloon catheters reduce blood loss and help avoid hysterectomy. • Protocols ensure correct management of placenta percreta patients and minimise risk

  9. Context by treatment interactions as the primary object of study in cluster randomized controlled trials of population health interventions.

    Science.gov (United States)

    Fuller, Daniel; Potvin, Louise

    2012-06-01

    Cluster randomized controlled trials are increasingly used in population health intervention research. Through randomization, researchers attempt to isolate the treatment effect and remove all other effects, including any effects of social context. In many cases, the constant effect assumption cannot be satisfied in cluster randomized controlled trials. We argue that when studying population health interventions, the effective mechanism of intervention lies in the interaction between the treatment and social context. Researchers should be cognizant that attempts to remove the effect of social context using CRTC may fail. The interaction between the treatment and social context should be the primary object of study in population health intervention research.

  10. Programming generality into a performance feedback writing intervention: A randomized controlled trial.

    Science.gov (United States)

    Hier, Bridget O; Eckert, Tanya L

    2016-06-01

    Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone.

  11. A randomized controlled intervention trial to relieve and prevent neck/shoulder pain

    DEFF Research Database (Denmark)

    Andersen, Lars; Jørgensen, Marie Birk; Blangsted, Anne;

    2008-01-01

    PURPOSE:: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS:: A 1-yr randomized controlled intervention trial was done with three groups: specific...... in maximal muscle strength, and changes in intensity of neck/shoulder pain (scale 0-9) in those with and without pain at baseline. RESULTS:: Regular participation was achieved by 54%, 31%, and 16% of those of the participants who answered the questionnaire in SRT (78%), APE (81%), and REF (80%), respectively......, during the first half of the intervention period, and decreased to 35%, 28% and 9%, respectively, during the second half. Shoulder elevation strength increased 9-11% in SRT and APE (P

  12. Expanding the scope and relevance of health interventions: Moving beyond clinical trials and behavior change models

    Directory of Open Access Journals (Sweden)

    Khary K. Rigg

    2014-07-01

    Full Text Available An overemphasis on clinical trials and behavior change models has narrowed the knowledge base that can be used to design interventions. The overarching point is that the process of overanalyzing variables is impeding the process of gaining insight into the everyday experiences that shape how people define health and seek treatment. This claim is especially important to health decision-making and behavior change because subtle interpretations often influence the decisions that people make. This manuscript provides a critique of traditional approaches to developing health interventions, and theoretically justifies what and why changes are warranted. The limited scope of these models is also discussed, and an argument is made to adopt a strategy that includes the perceptions of people as necessary for understanding health and health-related decision-making. Three practical strategies are suggested to be used with the more standard approaches to assessing the effectiveness and relevance of health interventions.

  13. Economic Evaluation of a Worksite Obesity Prevention and Intervention Trial among Hotel Workers in Hawaii

    Science.gov (United States)

    Meenan, Richard T.; Vogt, Thomas M.; Williams, Andrew E.; Stevens, Victor J.; Albright, Cheryl L.; Nigg, Claudio

    2010-01-01

    Objective Economic evaluation of Work, Weight, and Wellness (3W), a two-year randomized trial of a weight loss program delivered through Hawaii hotel worksites. Methods Business case analysis from hotel perspective. Program resources were micro-costed (2008 dollars). Program benefits were reduced medical costs, fewer absences, and higher productivity. Primary outcome was discounted 24-month net present value (NPV). Results Control program cost $222K to implement over 24 months ($61 per participant), intervention program cost $1.12M ($334). Including overweight participants (body mass index > 25), discounted control NPV was −$217K; −$1.1M for intervention program. Presenteeism improvement of 50% combined with baseline 10% productivity shortfall required to generate positive 24-month intervention NPV. Conclusions 3W’s positive clinical outcomes did not translate into immediate economic benefit for participating hotels, although modest cost savings were observed in the trial’s second year. PMID:20061889

  14. Programming generality into a performance feedback writing intervention: A randomized controlled trial.

    Science.gov (United States)

    Hier, Bridget O; Eckert, Tanya L

    2016-06-01

    Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone. PMID:27268572

  15. An adaptive physical activity intervention for overweight adults: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Marc A Adams

    intervention outperformed the static intervention for increasing PA. The adaptive goal and feedback algorithm is a "behavior change technology" that could be incorporated into mHealth technologies and scaled to reach large populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT01793064.

  16. The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Directory of Open Access Journals (Sweden)

    Parsons Suzanne

    2011-02-01

    Full Text Available Abstract Background The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale. Methods/design Quantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control. Discussion Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation. Trial Registration ISRCTN No: ISRCTN43769277

  17. Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Smith Sunyata

    2011-04-01

    Full Text Available Abstract Background Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH. High intakes of the omega-6 (n-6 polyunsaturated fatty acids (PUFAs, linoleic acid (LA and arachidonic acid (AA may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity. Methods Adults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks. Results Subject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence. Trial Registration ClinicalTrials.gov (NCT01157208

  18. A novel school-based intervention to improve nutrition knowledge in children: cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ong Ken K

    2010-03-01

    Full Text Available Abstract Background Improving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a novel educational intervention to increase nutrition knowledge among primary school children. Methods We developed a card game 'Top Grub' and a 'healthy eating' curriculum for use in primary schools. Thirty-eight state primary schools comprising 2519 children in years 5 and 6 (aged 9-11 years were recruited in a pragmatic cluster randomised controlled trial. The main outcome measures were change in nutrition knowledge scores, attitudes to healthy eating and acceptability of the intervention by children and teachers. Results Twelve intervention and 13 control schools (comprising 1133 children completed the trial. The main reason for non-completion was time pressure of the school curriculum. Mean total nutrition knowledge score increased by 1.1 in intervention (baseline to follow-up: 28.3 to 29.2 and 0.3 in control schools (27.3 to 27.6. Total nutrition knowledge score at follow-up, adjusted for baseline score, deprivation, and school size, was higher in intervention than in control schools (mean difference = 1.1; 95% CI: 0.05 to 2.16; p = 0.042. At follow-up, more children in the intervention schools said they 'are currently eating a healthy diet' (39.6% or 'would try to eat a healthy diet' (35.7% than in control schools (34.4% and 31.7% respectively; chi-square test p Conclusions The 'Top Grub' card game facilitated the enjoyable delivery of nutrition education in a sample of UK primary school age children. Further studies should determine whether improvements in nutrition knowledge are sustained and lead to changes in dietary behaviour.

  19. The Breathe Easier through Weight Loss Lifestyle (BE WELL Intervention: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Buist A

    2010-03-01

    Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical

  20. PARTICIPANT BLINDING AND GASTROINTESTINAL ILLNESS IN A RANDOMIZED, CONTROLLED TRIAL OF AN IN-HOME DRINKING WATER INTERVENTION

    Science.gov (United States)

    Background. There is no consensus about the level of risk of gastrointestinal illness posed by consumption of drinking water that meets all regulatory requirements. Earlier drinking water intervention trials from Canada suggested that 14% - 40% of such gastrointestinal il...

  1. Effects of a stepwise multidisciplinary intervention for challenging behavior in advanced dementia: a cluster randomized controlled trial.

    NARCIS (Netherlands)

    Pieper, M.J.C.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.A.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    Objectives: To assess whether implementation of a stepwise multicomponent intervention (STA OP!) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia. Design: Cluster randomized controlled trial. Setting: Twenty-one clusters (single independe

  2. Effect of a Community-Based Nursing Intervention on Mortality in Chronically Ill Older Adults: A Randomized, Controlled Trial

    OpenAIRE

    Bierman, Arlene S

    2012-01-01

    Arlene Bierman discusses new research findings from a randomized trial evaluating community-based nursing interventions in older adults, and and comments on how we need to to re-engineer health systems to provide greater quality of care.

  3. A physiotherapist-delivered integrated exercise and pain coping skills training intervention for individuals with knee osteoarthritis: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Bennell Kim L

    2012-07-01

    the Western Ontario and McMaster Universities Osteoarthritis Index subscale. Secondary outcomes include global rating of change, muscle strength, functional performance, physical activity levels, health related quality of life and psychological factors. Measurements will be taken at baseline and immediately following the intervention (12 weeks as well as at 32 weeks and 52 weeks to examine maintenance of any intervention effects. Specific assessment of adherence to the treatment program will also be made at weeks 22 and 42. Relative cost-effectiveness will be determined from health service usage and outcome data. Discussion The findings from this randomised controlled trial will provide evidence for the efficacy of an integrated PCST and exercise program delivered by physiotherapists in the management of painful and functionally limiting knee OA compared to either program alone. Trial registration Australian New Zealand Clinical Trials Registry reference number: ACTRN12610000533099

  4. A Behavioral Intervention for War-Affected Youth in Sierra Leone: A Randomized Controlled Trial

    Science.gov (United States)

    Betancourt, Theresa S.; McBain, Ryan; Newnham, Elizabeth A.; Akinsulure-Smith, Adeyinka M.; Brennan, Robert T.; Weisz, John R.; Hansen, Nathan B.

    2016-01-01

    Objective Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)–based group mental health intervention for multisymptomatic war-affected youth (aged 15–24 years) in Sierra Leone. Method War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. Results The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. Conclusion YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI

  5. Motivational brief intervention for the prevention of sexually transmitted infections in travelers: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Berdoz Didier

    2011-11-01

    Full Text Available Abstract Background Sexually transmitted infections (STIs are among the frequent risks encountered by travelers. Efficient interventions are needed to improve the understanding of the risks of STIs. We investigated the potential benefits of a motivational brief intervention (BI and the provision of condoms on the engagement in unprotected casual sex. Methods 3-arm randomized controlled trial performed among single travelers aged 18-44 years visiting a travel clinic in Switzerland. The main outcomes were the prevalence of casual unprotected sexual intercourse and their predictors. Results 5148 eligible travelers were seen from 2006 to 2008. 1681 agreed to participate and 1115 subjects (66% completed the study. 184/1115 (17% had a casual sexual relationship abroad and overall 46/1115 (4.1% had inconsistently protected sexual relations. Women (adjusted OR 2.7 [95%CI 1.4-5.6] and travelers with a history of past STI (adjusted OR 2.8 [95%CI 1.1-7.4] had more frequent casual sexual relationships without consistent protection. Regarding the effect of our intervention, the prevalence of subjects using condoms inconsistently was 28% (95%CI16-40 in the motivational BI group, 24% (95%CI10-37 in the condoms group and 24% (95%CI14-33 in the control group (p = 0.7. Conclusion This study showed that a motivational brief intervention and/or the provision of free condoms did not modify risky sexual behavior of young travelers. The rate of inconsistently protected sexual relationships during travel was however lower than expected Trial Registration Number ClinicalTrials.gov: NCT01056536

  6. Family nurture intervention (FNI: methods and treatment protocol of a randomized controlled trial in the NICU

    Directory of Open Access Journals (Sweden)

    Welch Martha G

    2012-02-01

    Full Text Available Abstract Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT with blinded assessment comparing Standard Care (SC with a novel Family Nurture Intervention (FNI. FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1 In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2 Outside the isolette during holding and feeding via the Calming Cycle; and 3 through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA, maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group. Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally

  7. Safe and effective use of medicines for patients with type 2 diabetes - A randomized controlled trial of two interventions delivered by local pharmacies

    DEFF Research Database (Denmark)

    Kjeldsen, Lene Juel; Bjerrum, Lars; Dam, Pernille;

    2015-01-01

    Poor management of chronic medical treatments may result in severe health consequences for patients as well as costs for society. Non-adherence is common among patients with type 2 diabetes. Interventions by community pharmacists may assist in improving adherence and consequently health outcomes ...

  8. Matching social support to individual needs: a community-based intervention to improve HIV treatment adherence in a resource-poor setting.

    Science.gov (United States)

    Muñoz, Maribel; Bayona, Jaime; Sanchez, Eduardo; Arevalo, Jorge; Sebastian, Jose Luis; Arteaga, Fernando; Guerra, Dalia; Zeladita, Jhon; Espiritu, Betty; Wong, Milagros; Caldas, Adolfo; Shin, Sonya

    2011-10-01

    From December 2005 to April 2007, we enrolled 60 adults starting antiretroviral therapy (ART) in Lima, Peru to receive community-based accompaniment with supervised antiretrovirals (CASA), consisting of 12 months of DOT-HAART, as well as microfinance assistance and/or psychosocial support group according to individuals' need. We matched 60 controls from a neighboring district, and assessed final clinical and psychosocial outcomes at 24 months. CASA support was associated with higher rates of virologic suppression and lower mortality. A comprehensive, tailored adherence intervention in the form of community-based DOT-HAART and matched economic and psychosocial support is both feasible and effective for certain individuals in resource-poor settings. PMID:20383572

  9. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

    Directory of Open Access Journals (Sweden)

    López-García-Franco Alberto

    2012-05-01

    Full Text Available Abstract Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain. The number of patients required is 242 (121 in each arm, all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity

  10. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Science.gov (United States)

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  11. Short-term effects of an educational intervention on physical restraint use: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Gulpers Math JM

    2006-10-01

    Full Text Available Abstract Background Physical restraints are still frequently used in nursing home residents despite growing evidence for the ineffectiveness and negative consequences of these methods. Therefore, reduction in the use of physical restraints in psycho-geriatric nursing home residents is very important. The aim of this study was to investigate the short-term effects of an educational intervention on the use of physical restraints in psycho-geriatric nursing home residents. Methods A cluster randomized trial was applied to 5 psycho-geriatric nursing home wards (n = 167 residents with dementia. The wards were assigned at random to either educational intervention (3 wards or control status (2 wards. The restraint status was observed and residents' characteristics, such as cognitive status, were determined by using the Minimum Data Set (MDS at baseline and 1 month after intervention. Results Restraint use did not change significantly over time in the experimental group (55%–56%, compared to a significant increased use (P Conclusion An educational programme for nurses combined with consultation with a nurse specialist did not decrease the use of physical restraints in psycho-geriatric nursing home residents in the short term. However, the residents in the control group experienced more restraint use during the study period compared to the residents in the experimental group. Whether the intervention will reduce restraint use in the long term could not be inferred from these results. Further research is necessary to gain insight into the long-term effects of this educational intervention.

  12. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    International Nuclear Information System (INIS)

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators

  13. Impact of a Social Work Care Coordination Intervention on Hospital Readmission: A Randomized Controlled Trial.

    Science.gov (United States)

    Bronstein, Laura R; Gould, Paul; Berkowitz, Shawn A; James, Gary D; Marks, Kris

    2015-07-01

    This study assessed how a social work-led care coordination intervention would reduce the within-30-day hospital readmission rate among moderate- and high-risk patients age 50 years or older. Authors ran a randomized controlled trial to determine whether there was a significant difference in within-30-day readmission rates between patients receiving usual care post-discharge and those receiving intervention from an MSW intern (one home visit and one to two phone calls). Results were obtained using a sample of hospitalized patients with a LACE index score of 7 or higher (N = 89). Analysis suggests that the intervention improved the likelihood of not being readmitted by some 22 percent (RR = 1.222; 95% CI = 1.063-1.405). The risk improvement with the intervention was highly statistically significant (p = .003). This study shows that a time-efficient care coordination intervention by MSW interns may decrease hospital readmission rates. Replications of this study in other communities, with more diverse populations, and with larger numbers of patients will indicate whether results are generalizable.

  14. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Science.gov (United States)

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. PMID:26121535

  15. What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

    Science.gov (United States)

    Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

    2015-11-01

    Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions.

  16. INFERENCES DRAWN FROM A RISK ASSESSMENT COMPARED DIRECTLY TO A RANDOMIZED TRIAL OF A HOME DRINKING WATER INTERVENTION

    Science.gov (United States)

    Risk assessments and intervention trials have been used to inform the EPA on drinking water risks. Seldom are both methods used concurrently. Between 2001 and 2003, illness data from a trial were collected simultaneously with exposure data, providing a unique opportunity to com...

  17. Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: a randomized controlled trial.

    Science.gov (United States)

    Trompetter, Hester R; Bohlmeijer, Ernst T; Veehof, Martine M; Schreurs, Karlein M G

    2015-02-01

    Acceptance-based psychological interventions can potentially minimize the burden of chronic pain. This randomized controlled trial evaluated an internet-delivered, guided self-help intervention based on Acceptance and Commitment Therapy (ACT). A total of 238 chronic pain sufferers from the general population were randomly allocated to either ACT (n = 82), an internet-based control condition Expressive Writing (n = 79) or a waiting list condition (n = 77). Participants completed measures at baseline, posttreatment (3 months) and at a 3-month follow-up. At follow-up, ACT participants had improved in pain interference in daily life (primary outcome) compared to participants in Expressive Writing (Cohen's d = .47), but not compared to waiting list participants (p value = .11). Those who adhered to the ACT-intervention (48%) did improve significantly compared to waiting list participants (d = .49). ACT-participants also showed superior improvement on depression, pain intensity, psychological inflexibility and pain catastrophizing (d: .28-.60). Significant clinical improvement was present. Especially, 28% of ACT-participants showed general clinically relevant improvement in pain interference, as well as in pain intensity and depression (vs. Expressive Writing and waiting list 5%). Given these findings, internet-based ACT programs may be a promising treatment modality for chronic pain.

  18. “Smart” RCTs: Development of a Smartphone App for Fully Automated Nutrition-Labeling Intervention Trials

    OpenAIRE

    Volkova, Ekaterina; Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona

    2016-01-01

    Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled...

  19. A community intervention trial of multimodal suicide prevention program in Japan: A Novel multimodal Community Intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J

    Directory of Open Access Journals (Sweden)

    Suzuki Yuriko

    2008-09-01

    Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.

  20. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

    Directory of Open Access Journals (Sweden)

    Chisholm Katharine

    2012-03-01

    Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors

  1. Mathematics Learned by Young Children in An Intervention Based on Learning Trajectories: A Large-Scale Cluster Randomized Trial

    Science.gov (United States)

    Clements, Douglas H.; Sarama, Julie; Spitler, Mary Elaine; Lange, Alissa A.; Wolfe, Christopher B.

    2011-01-01

    This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the "Building Blocks" mathematics curriculum, which is structured in research-based learning trajectories, and congruous professional…

  2. “Smart” RCTs: Development of a Smartphone App for Fully Automated Nutrition-Labeling Intervention Trials

    Science.gov (United States)

    Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona

    2016-01-01

    Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Methods Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. Results In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. Conclusions The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for

  3. Clinical trials to estimate the efficacy of preventive interventions against malaria in paediatric populations: a methodological review

    Directory of Open Access Journals (Sweden)

    Reed Zarifah

    2009-02-01

    Full Text Available Abstract Background Recent years have seen publication of a considerable number of clinical trials of preventive interventions against clinical malaria in children. There has been variability in the specification of end-points, case definitions, analysis methods and reporting and the relative lack of standardization complicates the ability to make comparative evaluations between trials. Methods To prepare for a WHO consultation on design issues in malaria vaccine trials, controlled trials of preventive interventions against malaria in children in endemic countries were identified in which clinical malaria, or death, had been one of the main end-points. Trials were included that evaluated the impact of vaccines, insecticide-treated bed nets (ITN, intermittent presumptive or preventive therapy in infants (IPTi or, in one instance, vitamin A supplementation. Methods that had been used in these trials were summarized and compared in order to identify issues that were directly relevant to the design of malaria vaccine trials. Results 29 controlled trials of preventive malaria interventions were identified, of which eight were vaccine trials. Vaccine trials that were designed to detect an effect on clinical malaria all reported the incidence rate of first episodes of clinical malaria as their primary endpoint. Only one trial of a preventive intervention (of ITN was identified that was designed to detect an effect on severe malaria. A group of larger trials were designed to detect an effect of impregnated bed nets or curtains on all-cause mortality as the primary end-point. Key methodological and reporting differences between trials are noted in the text. Two issues have been identified that are of some concern. Firstly, the choice of primary endpoint is not stated in the reports of a number of the trials and, secondly, the relationship between pre-specified analysis plans and trial reports is rarely made clear. Conclusion This article reports an

  4. Randomised controlled trial of behavioural infant sleep intervention to improve infant sleep and maternal mood

    Science.gov (United States)

    Hiscock, H; Wake, M

    2002-01-01

    Objective To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression. Design Randomised controlled trial. Setting Well child clinics, Melbourne, Australia Participants 156 mothers of infants aged 6-12 months with severe sleep problems according to the parents. Main outcome measures Maternal report of infant sleep problem; scores on Edinburgh postnatal depression scale at two and four months. Intervention Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations. Results At two months more sleep problems had resolved in the intervention group than in the control group (53/76 v 36/76, P=0.005). Overall depression scores fell further in the intervention group than in the control group (mean change −3.7, 95% confidence interval −4.7 to −2.7, v −2.5, −1.7 to −3.4, P=0.06). For the subgroup of mothers with depression scores of 10 and over more sleep problems had resolved in the intervention group than in the control group (26/33 v 13/33, P=0.001). In this subgroup depression scores also fell further for intervention mothers than control mothers at two months (−6.0, −7.5 to −4.0, v −3.7, −4.9 to −2.6, P=0.01) and at four months (−6.5, −7.9 to 5.1 v –4.2, –5.9 to −2.5, P=0.04). By four months, changes in sleep problems and depression scores were similar. Conclusions Behavioural intervention significantly reduces infant sleep problems at two but not four months. Maternal report of symptoms of depression decreased significantly at two months, and this was sustained at four months for mothers with high depression scores. What is already known on this topicInfant sleep problems and postnatal depression are both common potentially serious problemsWomen whose infants have sleep problems are more likely to report symptoms of depressionUncontrolled studies in clinical populations suggest that reducing infant

  5. Evidence of Physiotherapy Interventions for Patients with Chronic Neck Pain: A Systematic Review of Randomised Controlled Trials

    OpenAIRE

    Damgaard, Pia; Bartels, Else Marie; Ris, Inge; Christensen, Robin; Juul-Kristensen, Birgit

    2013-01-01

    Chronic neck pain (CNP) is common and costly, and the effect of physiotherapeutic interventions on the condition is unclear. We reviewed the literature for evidence of effect of physiotherapy interventions on patients with CNP. Five bibliographic databases (MEDLINE, EMBASE, CINAHL, Cochrane Library, and PEDro) were systematically searched. Randomised, placebo and active-treatment-controlled trials including physiotherapy interventions for adults with CNP were selected. Data were extracted pri...

  6. Barriers to and facilitators of implementing complex workplace dietary interventions: process evaluation results of a cluster controlled trial

    OpenAIRE

    Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J

    2016-01-01

    Background Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees’ dietary intakes, nutri...

  7. Physical activity and nutrition behavioural outcomes of a home-based intervention program for seniors: a randomized controlled trial

    OpenAIRE

    Burke Linda; Lee Andy H; Jancey Jonine; Xiang Liming; Kerr Deborah A; Howat Peter A; Hills Andrew P; Anderson Annie S

    2013-01-01

    Abstract Background This intervention aimed to ascertain whether a low-cost, accessible, physical activity and nutrition program could improve physical activity and nutrition behaviours of insufficiently active 60–70 year olds residing in Perth, Australia. Methods A 6-month home-based randomised controlled trial was conducted on 478 older adults (intervention, n = 248; control, n = 230) of low to medium socioeconomic status. Both intervention and control groups completed postal questionnaires...

  8. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Farah Jindani

    2015-01-01

    Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  9. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    Science.gov (United States)

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

  10. Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

    Science.gov (United States)

    Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan

    2014-11-01

    Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may

  11. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Orla Doyle

    Full Text Available This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally.ISRCTN Registry ISRCTN04631728.

  12. Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD. TECEPOC: study protocol for a partially randomized controlled trial (preference trial

    Directory of Open Access Journals (Sweden)

    Leiva-Fernández Francisca

    2012-05-01

    Full Text Available Abstract Background Drugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD. Methods This study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1 the patients´ preference group with two arms and 2 the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques. Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center. Discussion Our hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice. Trial registration Current Controlled Trials ISRTCTN15106246

  13. The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

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    Dunkley David

    2008-09-01

    Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will

  14. Protocol for a pilot randomised controlled trial of an online intervention for post-treatment cancer survivors with persistent fatigue

    Science.gov (United States)

    Corbett, Teresa; Walsh, Jane C; Groarke, AnnMarie; Moss-Morris, Rona; McGuire, Brian E

    2016-01-01

    Introduction Many post-treatment cancer survivors experience persistent fatigue that can disrupt attempts to resume normal everyday activities after treatment. Theoretical models that aim to explain contributory factors that initiate and sustain fatigue symptoms, or that influence the efficacy of interventions for cancer-related fatigue (CrF) require testing. Adjustment to fatigue is likely to be influenced by coping behaviours that are guided by the representations of the symptom. Objectives This paper describes the protocol for a pilot trial of a systematically and theoretically designed online intervention to enable self-management of CrF after cancer treatment. Methods and analysis This 2-armed randomised controlled pilot trial will study the feasibility and potential effectiveness of an online intervention. Participants will be allocated to either the online intervention (REFRESH (Recovery from Cancer-Related Fatigue)), or a leaflet comparator. Participants 80 post-treatment cancer survivors will be recruited for the study. Interventions An 8-week online intervention based on cognitive–behavioural therapy. Primary and secondary outcome measures The primary outcome is a change in fatigue as measured by the Piper Fatigue Scale (revised). Quality of life will be measured using the Quality of Life in Adult Survivors of Cancer Scale. Outcome measures will be collected at baseline, and at completion of intervention. Results The feasibility of trial procedures will be tested, as well as the effect of the intervention on the outcomes. Conclusions This study may lead to the development of a supportive resource to target representations and coping strategies of cancer survivors with CrF post-treatment. Setting Recruitment from general public in Ireland. Ethics and dissemination This trial was approved by the Research Ethics Committee at National University of Ireland Galway in January 2013. Trial results will be communicated in a peer-reviewed journal. Trial

  15. Randomized controlled trial of a self-management intervention in persons with spinal cord injury: design of the HABITS (Healthy Active Behavioural IntervenTion in SCI) study

    OpenAIRE

    Kooijmans, H.; Post, M.W.M.; van der Woude, L H V; Groot, S.; Stam, H. J.; Bussmann, J.B.J

    2013-01-01

    Purpose: To evaluate the effectiveness of a 16-week self-management intervention on physical activity level and self-management skills (self-efficacy, proactive coping and problem solving skills) in persons with chronic SCI. Method and design: Multicenter randomized controlled trial (RCT). Eighty persons with a SCI for at least 10 years and aged 18 to 65 will randomly be assigned to the intervention (self-management) or the control group (information provision). During the 16-week self-manage...

  16. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

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    Arija Victoria

    2012-05-01

    view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers’ education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Trial Registration number Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775

  17. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial.

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    Anne N Thorndike

    Full Text Available BACKGROUND: Physicians are expected to serve as role models for healthy lifestyles, but long work hours reduce time for healthy behaviors. A hospital-based physical activity intervention could improve physician health and increase counseling about exercise. METHODS: We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston, Massachusetts. Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed (intervention or to a blinded monitor (control. Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback. Phase 1 outcomes were: 1 median steps/day and 2 proportion of days activity monitor worn. The Phase 2 outcome was mean steps/day on days monitor worn (≥500 steps/day. Physiologic measurements were collected at baseline and study end. Median steps/day were compared using Wilcoxon rank-sum tests. Mean steps were compared using repeated measures regression analyses. RESULTS: In Phase 1, intervention and control groups had similar activity (6369 vs. 6063 steps/day, p = 0.16 and compliance with wearing the monitor (77% vs. 77% of days, p = 0.73. In Phase 2 (team competition, residents recorded more steps/day than during Phase 1 (CONTROL: 7,971 vs. 7,567, p = 0.002; INTERVENTION: 7,832 vs. 7,739, p = 0.13. Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 (60% vs. 77%, p<0.001. Mean systolic blood pressure decreased (p = 0.004 and HDL cholesterol increased (p<0.001 among all participants at end of study compared to baseline. CONCLUSIONS: Although the activity monitor intervention did not have a major impact on activity or health, the high participation rates of busy residents and modest changes in steps, blood pressure, and HDL suggest that more

  18. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial

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    Montero-Marín, Jesús; Araya, Ricardo; Mayoral, Fermín; Gili, Margalida; Botella, Cristina; Baños, Rosa; Castro, Adoración; Romero-Sanchiz, Pablo; López-Del-Hoyo, Yolanda; Nogueira-Arjona, Raquel; Vives, Margarita; Riera, Antoni; García-Campayo, Javier

    2016-01-01

    Background Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain. Objective Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression. Methods Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken. Results There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings. Conclusions An Internet

  19. Efficacy of musical interventions in dementia: methodological requirements of nonpharmacological trials.

    Science.gov (United States)

    Samson, Séverine; Clément, Sylvain; Narme, Pauline; Schiaratura, Loris; Ehrlé, Nathalie

    2015-03-01

    The management of patients with Alzheimer's disease is a significant public health problem given the limited effectiveness of pharmacological therapies combined with iatrogenic effects of drug treatments in dementia. Consequently, the development of nondrug care, such as musical interventions, has become a necessity. The experimental rigor of studies in this area, however, is often lacking. It is therefore difficult to determine the impact of musical interventions on patients with dementia. As part of a series of studies, we carried out randomized controlled trials to compare the effectiveness of musical activities to other pleasant activities on various functions in patients with severe Alzheimer's disease. The data obtained in these trials are discussed in light of the methodological constraints and requirements specific to these clinical studies. Although the results demonstrate the power of music on the emotional and behavioral status of patients, they also suggest that other pleasant activities (e.g., cooking) are also effective, leaving open the question about the specific benefits of music in patients with dementia. All these findings highlight the promising potential for nonpharmacological treatments to improve the well-being of patients living in residential care and to reduce caregiver burden. PMID:25773641

  20. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Emerson, John F; Welch, Madelyn; Rossman, Whitney E; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2016-01-01

    median of nine total documented contacts with PCMH providers compared to four in the control group. Three intervention and two control participants had controlled diabetes (hemoglobin A1C <9%). Multidisciplinary care that utilizes health coach-facilitated virtual visits is an intervention that could increase access to intensive primary care services in a vulnerable population. The methods tested are feasible and should be tested in a pragmatic randomized controlled trial to evaluate the impact on patient-relevant outcomes across multiple chronic diseases. PMID:26703661

  1. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    John F. Emerson

    2015-12-01

    , participants had a median of nine total documented contacts with PCMH providers compared to four in the control group. Three intervention and two control participants had controlled diabetes (hemoglobin A1C <9%. Multidisciplinary care that utilizes health coach-facilitated virtual visits is an intervention that could increase access to intensive primary care services in a vulnerable population. The methods tested are feasible and should be tested in a pragmatic randomized controlled trial to evaluate the impact on patient-relevant outcomes across multiple chronic diseases.

  2. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

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    Morris David W

    2011-09-01

    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  3. A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: Study protocol

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    Szczepura Ala

    2011-06-01

    Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in

  4. Treatment Protocols for Eating Disorders: Clinicians' Attitudes, Concerns, Adherence and Difficulties Delivering Evidence-Based Psychological Interventions.

    Science.gov (United States)

    Waller, Glenn

    2016-04-01

    There are several protocols in existence that guide clinicians in the implementation of effective, evidence-based psychological interventions for eating disorders. These have been made accessible in the form of treatment manuals. However, relatively few clinicians use those protocols, preferring to offer more eclectic or integrative approaches. Following a summary of the research that shows that these evidence-based approaches can be used successfully in routine clinical settings, this review considers why there is such poor uptake of these therapies in such settings. This review focuses on the role of service culture and on clinicians' own attitudes, beliefs and emotions. Possible means of enhancing uptake are considered, but these cannot be considered to be ideal solutions at present. PMID:26893234

  5. Personalizing Behavioral Interventions Through Single-Patient (N-of-1) Trials.

    Science.gov (United States)

    Davidson, Karina W; Peacock, James; Kronish, Ian M; Edmondson, Donald

    2014-08-01

    Behavioral interventions are typically studied with the use of a conventional between-subject randomized controlled trial (RCT) design. In this design, the effect of an intervention on one group of patients is compared with the effect of a control condition on another group of patients, such that a between-subject change is tested. A between-subject design has an underlying assumption that there is a homogenous treatment effect for a behavioral intervention, drug or psychotherapy, and that the way the intervention operates in the study that will tend to operate in the same way in many other patients. We review some of the philosophical and practical problems with the use of this design when a clinician is attempting to decide on a course of behavioral treatment aimed at within-subject change in patients who are likely to have heterogeneous or unique responses to behavioral treatment. We also review the biases inherent in our current clinical practice model, which does not use any empirical data collection or design for testing if a treatment is useful, and also in the conventional between-subject personalized medicine RCT designs. We propose increased use of single-patient (also known as N-of-1) trials that employ within-subject designs, in cases where treatment response is heterogeneous-as is the case for most psychological and behavioral treatments. Limitations of such designs include that they can only be used when the treatment is potentially reversible, the patient can act as their own control, and the outcome can be measured repeatedly. Increased use of within-subject trials may address in many more instances the more clinically relevant question of how a specific patient will respond to a specific treatment, and could introduce a more harmonious scientific approach into the way we treat our patients. We have incorporated a case presentation that illustrates the complexities of applying evidence drawn from these different designs to selecting and evaluating

  6. Outcomes of a randomised controlled trial of a complex genetic counselling intervention to improve family communication.

    Science.gov (United States)

    Hodgson, Jan; Metcalfe, Sylvia; Gaff, Clara; Donath, Susan; Delatycki, Martin B; Winship, Ingrid; Skene, Loane; Aitken, MaryAnne; Halliday, Jane

    2016-03-01

    When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information.

  7. Helicobacter pylori, cyclooxygenase-2 and evolution of gastric lesions: results from an intervention trial in China.

    Science.gov (United States)

    Zhang, Yang; Pan, Kai-Feng; Zhang, Lian; Ma, Jun-Ling; Zhou, Tong; Li, Ji-You; Shen, Lin; You, Wei-Cheng

    2015-12-01

    To investigate the role of cyclooxygenase (COX)-2/prostaglandin E2 (PGE2) in the process of Helicobacter pylori-induced gastric carcinogenesis, a prospective study based on an intervention trial was conducted in Linqu County, China. A total of 1401 subjects with histopathologic diagnosis were investigated at baseline, among those, 919 completed subsequent interventions (anti-H.pylori and/or celecoxib treatment). Expressions of COX-2 and Ki-67 were assessed by immunohistochemistry, and PGE2 levels were measured by enzyme immunoassay before and after interventions, respectively. We found a grade-response relationship between COX-2 expression level and risk of advanced gastric lesions at baseline. Stratified analysis indicated an additive interaction between COX-2 expression and H.pylori infection on the elevated risk of advanced gastric lesions. The odds ratios (ORs) for both factors combined were 9.31 [95% confidence interval (CI): 4.13-20.95] for chronic atrophic gastritis, 16.26 (95% CI: 7.29-36.24) for intestinal metaplasia and 21.13 (95% CI: 7.87-56.75) for dysplasia, respectively. After interventions, COX-2 expression and Ki-67 labeling index (LI) were decreased in anti-H.pylori group (OR: 1.65, 95% CI: 1.36-1.99 for COX-2; OR: 1.78, 95% CI: 1.49-2.12 for Ki-67) or anti-H.pylori followed by celecoxib group (OR: 1.41, 95% CI: 1.17-1.70 for COX-2; OR: 1.63, 95% CI: 1.37-1.94 for Ki-67). PGE2 levels were decreased in all treatment groups. Furthermore, the regression of gastric lesions was associated with the decrease of COX-2 expression or Ki-67 LI after interventions. Our findings indicate that H.pylori-induced COX-2/PGE2 pathways play an important role on the progression of precancerous gastric lesions in a Chinese population. PMID:26449252

  8. Outcomes of a randomised controlled trial of a complex genetic counselling intervention to improve family communication.

    Science.gov (United States)

    Hodgson, Jan; Metcalfe, Sylvia; Gaff, Clara; Donath, Susan; Delatycki, Martin B; Winship, Ingrid; Skene, Loane; Aitken, MaryAnne; Halliday, Jane

    2016-03-01

    When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information. PMID:26130486

  9. The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC: a randomised cluster controlled trial

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    Xu Guifa

    2010-05-01

    Full Text Available Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. Methods/Design The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook and physical activity intervention (Happy 10 program will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device, physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Discussion Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the

  10. Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care

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    Fanshawe Tom

    2011-04-01

    Full Text Available Abstract Background The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year. Methods/Design ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i intensive treatment alone (n = 239, or (ii intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239. Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking, including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing, change in objectively measured dietary intake (plasma vitamin C, medication adherence (plasma drug levels, and smoking status (plasma cotinine levels at

  11. Adherence to a Mediterranean-style diet and effects on cognition in adults: A qualitative evaluation of the systematic review of longitudinal and prospective trials

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    Roy J Hardman

    2016-07-01

    Full Text Available The Mediterranean-style diet (MedDiet involves substantial intake of fruits, vegetables, and fish, and a lower consumption of dairy, red meat, and sugars. Over the past 15 years much empirical evidence supports the suggestion that a MedDiet may be beneficial with respect to reducing the incidence of cardiovascular disease, cancer, metabolic syndrome, and dementia. A number of cross-sectional studies that have examined the impact of MedDiet on cognition have yielded largely positive results. The objective of this review is to evaluate longitudinal and prospective trials to gain an understanding of how a MedDiet may impact cognitive processes over time. The included studies were aimed at improving cognition or minimizing of cognitive decline. Studies reviewed included assessments of dietary status using either a food frequency questionnaire or a food diary assessment. Eighteen articles meeting our inclusion criteria were subjected to systematic review. These revealed that higher adherence to a MedDiet is associated with slower rates of cognitive decline, reduced conversion to Alzheimer’s disease (AD and improvements in cognitive function. The specific cognitive domains that were found to benefit with improved Mediterranean Diet Score (MedDietS were memory (delayed recognition, long-term and working memory executive function, and visual constructs. The current review has also considered a number of methodological issues in making recommendations for future research. The utilisation of a dietary pattern such as the Mediterranean style diet will be essential as part of the armamentarium to maintain quality of life and reduce the potential social and economic burden of dementia. Key Words: Nutrition, cognition, Mediterranean diet, clinical trials

  12. Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial

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    DeWalt Darren A

    2009-06-01

    Full Text Available Abstract Background Heart failure (HF is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. Methods/Design In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success. The primary outcome is the combined incidence of all cause hospitalization and death

  13. Enhancing Father Engagement and Interparental Teamwork in an Evidence-Based Parenting Intervention: A Randomized-Controlled Trial of Outcomes and Processes.

    Science.gov (United States)

    Frank, Tenille J; Keown, Louise J; Sanders, Matthew R

    2015-11-01

    This study examined the outcomes and process in a positive parenting program adapted to enhance father engagement and teamwork. A randomized control trial of the Group Triple P Program with additional father-relevant content was conducted with 42 families of children with conduct problems aged between 3 to 8years. Families were allocated to either the intervention or waitlist condition. Assessments of child behavior, self- and partner-reported parenting, and the interparental relationship were conducted at T1 (pre), T2 (post), and T3 (6-month follow-up). Observations were used to examine fathers' and mothers' unique and shared contributions to group process during participation in parenting group sessions. Following program completion (T2) intervention group fathers and mothers reported significantly fewer child behavior problems, dysfunctional parenting practices, and interparental conflict about child-rearing than waitlist parents. Intervention group mothers also reported increased parenting confidence and rated their partners as showing significantly fewer dysfunctional parenting practices. Intervention effects were maintained at 6-month follow-up. Observational data showed that fathers and mothers made similar contributions during the group sessions. The most frequent types of contributions were asking questions and sharing information with other parents about implementing parenting strategies. The key differences between parents were fathers' more frequent use of humor and mothers' more frequent sharing of personal stories and reporting co-parenting cooperation. The levels of session attendance and program satisfaction were high for both fathers and mothers. Findings highlight the potential benefits of efforts to engage both fathers and mothers for program adherence, satisfaction, and effectiveness. PMID:26520218

  14. The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411

    Directory of Open Access Journals (Sweden)

    Dale Jeremy

    2006-07-01

    Full Text Available Abstract Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months and following an agreed protocol change over 7% (months 13 to 18. Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

  15. A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Schuengel Carlo

    2011-07-01

    Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

  16. Land- and water-based exercise intervention in women with fibromyalgia: the al-andalus physical activity randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Carbonell-Baeza Ana

    2012-02-01

    Full Text Available Abstract Background The al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome, and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes in women with fibromyalgia. Methods/Design One hundred eighty women with fibromyalgia (age range: 35-65 years will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain. Patients will be randomly assigned to a usual care (control group (n = 60, a water-based exercise intervention group (n = 60 or a land-based exercise intervention group (n = 60. Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 min each per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises. We will also study the effect of a detraining period (i.e., 12 weeks with no exercise intervention on the studied variables. Discussion Our study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia. Trial registration ClinicalTrials

  17. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

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    Prchal Alice

    2012-01-01

    Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907

  18. Study protocol: a randomised controlled trial of a theory-based online intervention to improve sun safety among Australian adults

    International Nuclear Information System (INIS)

    The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants’ attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults’ sun-protective behaviour. Australian and New Zealand Trials

  19. A theory-based online health behaviour intervention for new university students (U@Uni:LifeGuide): results from a repeat randomized controlled trial

    OpenAIRE

    Cameron, David; Epton, Tracy; Norman, Paul; Sheeran, Paschal; Harris, Peter R; Webb, Thomas L.; Julious, Steven A.; Brennan, Alan; Thomas, Chloe; Petroczi, Andrea; Naughton, Declan; Shah, Iltaf

    2015-01-01

    Background This paper reports the results of a repeat trial assessing the effectiveness of an online theory-based intervention to promote healthy lifestyle behaviours in new university students. The original trial found that the intervention reduced the number of smokers at 6-month follow-up compared with the control condition, but had non-significant effects on the other targeted health behaviours. However, the original trial suffered from low levels of engagement, which the repeat trial sou...

  20. Guided self-help concreteness training as an intervention for major depression in primary care: a Phase II randomized controlled trial

    DEFF Research Database (Denmark)

    Watkins, E R; Taylor, R S; Baeyens, C;

    2012-01-01

    Background The development of widely accessible, effective psychological interventions for depression is a priority. This randomized trial provides the first controlled data on an innovative cognitive bias modification (CBM) training guided self-help intervention for depression. Method One hundred...

  1. Randomized controlled trial of a family intervention for children bullied by peers.

    Science.gov (United States)

    Healy, Karyn L; Sanders, Matthew R

    2014-11-01

    This study examined the effects of a family intervention on victimization and emotional distress of children bullied by peers. The intervention, Resilience Triple P, combined facilitative parenting and teaching children social and emotional skills relevant to developing strong peer relationships and addressing problems with peers. Facilitative parenting is parenting that supports the development of children's peer relationship skills. A randomized controlled trial was conducted with 111 families who reported chronic bullying of children aged 6 to 12 years. Families were randomly allocated to either an immediate start to Resilience Triple P (RTP) or an assessment control (AC) condition. Assessments involving children, parents, teachers, and observational measures were conducted at 0 (pre), 3 (post) and 9 months follow-up. RTP families had significantly greater improvements than AC families on measures of victimization, child distress, child peer and family relationships, including teacher reports of overt victimization (d=0.56), child internalizing feelings (d=0.59), depressive symptoms (d=0.56), child overt aggression towards peers (d=0.51), acceptance by same sex and opposite sex peers (d=0.46/ 0.60), and child liking school (d=0.65). Families in both conditions showed significant improvements on most variables over time including child reports of bullying in the last week reducing to a near zero and indistinguishable from the normative sample. The intervention combining facilitative parenting and social and emotional skills training for children produced better results than the comparison assessment control condition. This study demonstrated that family interventions can reduce victimization and distress and strengthen school efforts to address bullying. PMID:25311286

  2. Improving the Dictation in Attention Deficit Hyperactivity Disorder by Using Computer Based Interventions: A Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mahdi Tehranidoost

    2006-07-01

    Full Text Available Objective: The aim of the current study was to assess the impact of computer games and computer-assisted type instruction on dictation scores of elementary school children with attention deficit – hyperactivity disorder (ADHD. Method: In this single-blind clinical trial, 37 elementary school children with ADHD, selected by convenience sampling and divided into group I (n=17 and group II (n=20, underwent eight one-hour sessions (3 sessions per week of intervention by computer games versus computer-assisted type instruction, respectively. 12 school dictation scores were considered: 4 scores preintervention, 4 scores during interventions, and 4 scores post-intervention. Dictation test was taken during each session. Data was analyzed using repeated measure ANOVA. Results: Two groups were matched for age, gender, school grade, medication, IQ, parent’s and teacher’s Conners’ scale scores, having computer at home, history of working with computer, and mean dictation scores. There was no significant difference in dictation scores before and after interventions and also between the study groups. The improvement in school dictation scores had no significant correlation with age, gender, Ritalin use, owning a computer at home and past history of computer work, baseline dictation scores, Ritalin dose, educational status, IQ, and the total score of parent’s and teacher’s Conners’ rating scale. Conclusion: Absence of significant improvement in dictation scores in study groups may be due to the confounding effect of other variables with known impact on dictation scores. Further studies in this field should also assess the change of attention and memory.

  3. On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption.

    Directory of Open Access Journals (Sweden)

    Paul Wallace

    Full Text Available BACKGROUND: Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347. METHODOLOGY/PRINCIPAL FINDINGS: A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2 units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3 units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10 or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention. CONCLUSIONS/SIGNIFICANCE: Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption

  4. The working mechanisms of an environmentally tailored physical activity intervention for older adults: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mudde Aart N

    2009-12-01

    Full Text Available Abstract Background The aim of this study was to explore the working mechanisms of a computer tailored physical activity intervention for older adults with environmental information compared to a basic tailored intervention without environmental information. Method A clustered randomized controlled trial with two computer tailored interventions and a no-intervention control group was conducted among 1971 adults aged ≥ 50. The two tailored interventions were developed using Intervention Mapping and consisted of three tailored letters delivered over a four-month period. The basic tailored intervention targeted psychosocial determinants alone, while the environmentally tailored intervention additionally targeted environmental determinants, by providing tailored environmental information. Study outcomes were collected with questionnaires at baseline, three and six months and comprised total physical activity (days/week, walking (min/week, cycling (min/week, sports (min/week, environmental perceptions and use and appreciation of the interventions. Results Mediation analyses showed that changes in cycling, sports and total physical activity behaviour induced by the environmentally tailored intervention were mediated by changes in environmental perceptions. Changes in environmental perceptions did not mediate the effect of the basic tailored intervention on behaviour. Compared with the basic tailored intervention, the environmentally tailored intervention significantly improved cycling behaviour (τ = 30.2. Additionally, the tailored letters of the environmentally tailored intervention were better appreciated and used, although these differences did not mediate the intervention effect. Discussion This study gave some first indications of the relevance of environmental perceptions as a determinant of changing physical activity behaviours and the potential effectiveness of providing environmental information as an intervention strategy aimed at

  5. Prevention through Activity in Kindergarten Trial (PAKT: A cluster randomised controlled trial to assess the effects of an activity intervention in preschool children

    Directory of Open Access Journals (Sweden)

    Lenz Dorothea

    2010-07-01

    Full Text Available Abstract Background Physical activity and motor skills acquisition are of high importance for health-related prevention and a normal development in childhood. However, few intervention studies exist in preschool children focussing on an increase in physical activity and motor skills. Proof of positive effects is available but not consistent. Methods/Design The design, curriculum, and evaluation strategy of a cluster randomised intervention study in preschool children are described in this manuscript. In the Prevention through Activity in Kindergarten Trial (PAKT, 41 of 131 kindergartens of Wuerzburg and Kitzingen, Germany, were randomised into an intervention and a control group by a random number table stratified for the location of the kindergarten in an urban (more than 20.000 inhabitants or rural area. The aims of the intervention were to increase physical activity and motor skills in the participating children, and to reduce health risk factors as well as media use. The intervention was designed to involve children, parents and teachers, and lasted one academic year. It contained daily 30-min sessions of physical education in kindergarten based on a holistic pedagogic approach termed the "early psychomotor education". The sessions were instructed by kindergarten teachers under regular supervision by the research team. Parents were actively involved by physical activity homework cards. The kindergarten teachers were trained in workshops and during the supervision. Assessments were performed at baseline, 3-5 months into the intervention, at the end of the intervention and 2-4 months after the intervention. The primary outcomes of the study are increases in physical activity (accelerometry and in motor skills performance (composite score of obstacle course, standing long jump, balancing on one foot, jumping sidewise to and fro between baseline and the two assessments during the intervention. Secondary outcomes include decreases in body

  6. Secondary analysis of electronically monitored medication adherence data for a cohort of hypertensive African-Americans

    Directory of Open Access Journals (Sweden)

    Knafl GJ

    2012-03-01

    Full Text Available George J Knafl1, Antoinette Schoenthaler2, Gbenga Ogedegbe21School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 2Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USABackground: Electronic monitoring devices (EMDs are regarded as the “gold standard” for assessing medication adherence in research. Although EMD data provide rich longitudinal information, they are typically not used to their maximum potential. Instead, EMD data are usually combined into summary measures, which lack sufficient detail for describing complex medication-taking patterns. This paper uses recently developed methods for analyzing EMD data that capitalize more fully on their richness.Methods: Recently developed adaptive statistical modeling methods were used to analyze EMD data collected with medication event monitoring system (MEMS™ caps in a clinical trial testing the effects of motivational interviewing on adherence to antihypertensive medications in a cohort of hypertensive African-Americans followed for 12 months in primary care practices. This was a secondary analysis of EMD data for 141 of the 190 patients from this study for whom MEMS data were available.Results: Nonlinear adherence patterns for 141 patients were generated, clustered into seven adherence types, categorized into acceptable (for example, high or improving versus unacceptable (for example, low or deteriorating adherence, and related to adherence self-efficacy and blood pressure. Mean adherence self-efficacy was higher across all time points for patients with acceptable adherence in the intervention group than for other patients. By 12 months, there was a greater drop in mean post-baseline blood pressure for patients in the intervention group, with higher baseline blood pressure values than those in the usual care group.Conclusion: Adaptive statistical modeling methods can provide novel insights into patients’ medication

  7. Interventions for the prevention of overweight and obesity in preschool children: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Monasta, L; Batty, G D; Macaluso, A; Ronfani, L; Lutje, V; Bavcar, A; van Lenthe, F J; Brug, J; Cattaneo, A

    2011-05-01

    The objective of this study was to analyse interventions for the prevention of overweight and obesity in children under 5 years of age. We carried out a systematic review focusing exclusively on randomized controlled trials (RCTs). Data sources include Medline, Cochrane Library, EMBASE, CINHAL, PsychInfo and Web of Science. Data were extracted from seventeen articles describing seven RCTs identified through electronic search, screening of references in systematic reviews, own files and contact with authors. RCTs were assessed with the Jadad scale. Four trials were carried out in preschool settings, one with an exclusive educational component, two with an exclusive physical activity component and one with both. Two trials were family-based, with education and counselling for parents and children. The remaining trial was carried out in maternity hospitals, with a training intervention on breastfeeding. None of the interventions had an effect in preventing overweight and obesity. The failure to show an effect may be due to the choice of outcomes, the quality of the RCTs, the suboptimal implementation of the interventions, the lack of focus on social and environmental determinants. More rigorous research is needed on interventions and on social and environmental factors that could impact on lifestyle.

  8. The effectiveness of behavioural interventions in the primary prevention of Hepatitis C amongst injecting drug users: a randomised controlled trial and lessons learned

    Directory of Open Access Journals (Sweden)

    Tibbs Christopher

    2008-07-01

    Full Text Available Abstract Aim To develop and evaluate the comparative effectiveness of behavioural interventions of enhanced prevention counselling (EPC and simple educational counselling (SEC in reducing hepatitis C viral (HCV infection in sero-negative injecting drug users (IDU. Design Randomised controlled trial (RCT of EPC intervention in comparison with simple educational counselling (SEC. Setting Specialised Drug services in London and Surrey, United Kingdom. Participants and Measurements Ninety five IDUs were recruited and randomised to receive EPC (n = 43 or SEC (n = 52. Subjects were assessed at baseline using the Addiction Severity Index (ASI, the Injecting Risk Questionnaire (IRQ, and Drug Injecting Confidence Questionnaire (DICQ. The primary outcome was measured by the rate of sero-conversion at 6 months and 12 months from baseline and by the ASI, IRQ and DICQ at 6 months from baseline. Hepatitis C testing was undertaken by the innovative test of the dried blood spot (DBS test which increased the rate of testing by 4 fold compared to routine blood testing. Findings Seventy Eighty two subjects (82% out of the 95 recruited were followed up at 6 months and 62 (65% were followed up at 12 months. On the primary outcome measure of the rate of seroconversion, 8 out of 62 patients followed-up at twelve months seroconverted, three in the EPC group and five in the SEC group, indicating incidence rates of 9.1 per 100 person years for the EPC group, 17.2 per 100 person years for the SEC group, and 12.9 per 100 person years for the cohort as a whole. Analysis of the secondary outcome measures on alcohol use, risk behaviour, psychological measures, quality of life, showed no significant differences between the EPC and the SEC groups. However, there were significant changes on a number of measures from baseline values indicating positive change for both groups. Conclusion We were not able to prove the efficacy of EPC in comparison with SEC in the prevention of

  9. Group mindfulness-based intervention for distressing voices: A pragmatic randomised controlled trial.

    Science.gov (United States)

    Chadwick, Paul; Strauss, Clara; Jones, Anna-Marie; Kingdon, David; Ellett, Lyn; Dannahy, Laura; Hayward, Mark

    2016-08-01

    Group Person-Based Cognitive Therapy (PBCT) integrates cognitive therapy and mindfulness to target distinct sources of distress in psychosis. The present study presents data from the first randomised controlled trial investigating group PBCT in people distressed by hearing voices. One-hundred and eight participants were randomised to receive either group PBCT and Treatment As Usual (TAU) or TAU only. While there was no significant effect on the primary outcome, a measure of general psychological distress, results showed significant between-group post-intervention benefits in voice-related distress, perceived controllability of voices and recovery. Participants in the PBCT group reported significantly lower post-treatment levels of depression, with this effect maintained at six-month follow-up. Findings suggest PBCT delivered over 12weeks effectively impacts key dimensions of the voice hearing experience, supports meaningful behaviour change, and has lasting effects on mood. PMID:27146475

  10. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial

    DEFF Research Database (Denmark)

    Adamsen, Lis; Quist, Morten; Andersen, Christina;

    2009-01-01

    OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced...... disease. DESIGN: Randomised controlled trial. SETTING: Two university hospitals in Copenhagen, Denmark. PARTICIPANTS: 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing 21 diagnoses. Main exclusion criteria were brain or bone metastases. 235 patients completed follow...... and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Medical Outcomes Study Short Form (MOS SF-36), Leisure Time Physical Activity Questionnaire, muscular strength (one repetition maximum), maximum oxygen consumption (Vo(2)max). Statistical methods The general linear model was used...

  11. Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

    Directory of Open Access Journals (Sweden)

    Usherwood Tim

    2010-08-01

    Full Text Available Abstract Background The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. Methods/Design The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. Discussion The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. Trial Registration This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

  12. Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial

    Directory of Open Access Journals (Sweden)

    Rajalakshmi Lakshman

    2014-01-01

    Full Text Available Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients and healthcare professionals (intervention deliverers to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

  13. Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized controlled trial

    OpenAIRE

    Gaete, Jorge; Martinez, Vania; Fritsch, Rosemarie; Rojas, Graciela; Montgomery, Alan A.; Araya, Ricardo

    2016-01-01

    Background Depression is a disabling condition affecting people of all ages, but generally starting during adolescence. Schools seem to be an excellent setting where preventive interventions may be delivered. This study aimed to test the effectiveness of an indicated school-based intervention to reduce depressive symptoms among at-risk adolescents from low-income families. Methods A two-arm, parallel, randomized controlled trial was conducted in 11 secondary schools in vulnerable socioeconomi...

  14. Efficacy of brief alcohol screening intervention for college students (BASICS): a meta-analysis of randomized controlled trials

    OpenAIRE

    Fachini Alexandre; Aliane Poliana P; Martinez Edson Z; Furtado Erikson F

    2012-01-01

    Abstract Background Many studies reported that brief interventions are effective in reducing excessive drinking. This study aimed to assess the efficacy of a protocol of brief intervention for college students (BASICS), delivered face-to-face, to reduce risky alcohol consumption and negative consequences. Methods A systematic review with meta-analysis was performed by searching for randomized controlled trials (RCTs) in Medline, PsycInfo, Web of Science and Cochrane Library databases. A quali...

  15. Randomized trials of alcohol-use interventions with college students and their parents: lessons from the Transitions Project

    OpenAIRE

    Fernandez, AC; Wood, MD; Laforge, R; Black, JT

    2011-01-01

    Background Matriculation from high school to college is typified by an increase in alcohol use and related harm for many students. Therefore, this transition period is an ideal time for preventive interventions to target alcohol use and related problems. Purpose The purpose of this report is to describe the design and methods used in the Transitions Project, a randomized controlled trial of two interventions designed to prevent and reduce heavy episodic drinking and alcohol-related negative c...

  16. Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial

    OpenAIRE

    Kim, Min-Ji; Han, Chang-Wan; Min, Kyoung-Youn; CHO, Chae-Yoon; Lee, Chae-Won; Ogawa, Yoshiko; Mori, Etsuro; Kohzuki, Masahiro

    2016-01-01

    Aims This study aimed to investigate the effect of 6-month physical exercise with a multicomponent cognitive program (MCP) on the cognitive function of older adults with moderate to severe Alzheimer's disease (AD). Methods We included 33 participants with AD in a 6-month randomized controlled trial. The intervention group participated in physical exercise and received a MCP. The control group received only the MCP. Before and after the intervention, cognitive outcomes were assessed using the ...

  17. Effects of a Psychosocial Intervention on Caregivers of Recently Placed Nursing Home Residents: A Randomized Controlled Trial

    OpenAIRE

    Schulz, Richard; Rosen, Jules; KLINGER, JULIE; Musa, Donald; Castle, Nicholas G; KANE, APRIL; Lustig, Amy

    2014-01-01

    Many caregivers continue to provide care and support to their care recipients after institutional placement. A two-group randomized controlled trial was carried out to test the efficacy of a psychosocial intervention for informal caregivers whose care recipients resided in a long-term care facility. The intervention was delivered during the 6 month period following baseline assessment. Follow-up assessments were carried out at 6, 12, and 18 months. Primary outcomes were caregiver depression, ...

  18. The effect of intensive nutrition interventions on weight gain after kidney transplantation: protocol of a randomised controlled trial

    OpenAIRE

    Ryan, Kristin J; Casas, Jessie M Segedin; Mash, Laura E; McLellan, Sandra L; Lloyd, Lyn E; Stinear, James W.; Plank, Lindsay D; Collins, Michael G.

    2014-01-01

    Background Weight gain and obesity are common after kidney transplantation, particularly during the first year. Obesity is a risk factor for the development of new-onset diabetes after transplantation, and is associated with reduced graft survival. There is a lack of evidence for effective interventions to prevent weight gain after kidney transplantation. Methods/Design The effect of INTEnsive Nutrition interventions on weight gain after kidney Transplantation (INTENT) trial is a single-blind...

  19. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    OpenAIRE

    van der Heijden, Marianne J.E.; Sadaf Oliai Araghi; Monique van Dijk; Johannes Jeekel; M G Myriam Hunink

    2015-01-01

    Objective Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery. Data Sources We searched 25 electronic databases from their first available date until October 2014. Study Selection Included were all randomized controlled trials with a parallel group, crossove...

  20. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials.

    Directory of Open Access Journals (Sweden)

    Jim McCambridge

    Full Text Available BACKGROUND: Participant reports of their own behaviour are critical for the provision and evaluation of behavioural interventions. Recent developments in brief alcohol intervention trials provide an opportunity to evaluate longstanding concerns that answering questions on behaviour as part of research assessments may inadvertently influence it and produce bias. The study objective was to evaluate the size and nature of effects observed in randomized manipulations of the effects of answering questions on drinking behaviour in brief intervention trials. METHODOLOGY/PRINCIPAL FINDINGS: Multiple methods were used to identify primary studies. Between-group differences in total weekly alcohol consumption, quantity per drinking day and AUDIT scores were evaluated in random effects meta-analyses. Ten trials were included in this review, of which two did not provide findings for quantitative study, in which three outcomes were evaluated. Between-group differences were of the magnitude of 13.7 (-0.17 to 27.6 grams of alcohol per week (approximately 1.5 U.K. units or 1 standard U.S. drink and 1 point (0.1 to 1.9 in AUDIT score. There was no difference in quantity per drinking day. CONCLUSIONS/SIGNIFICANCE: Answering questions on drinking in brief intervention trials appears to alter subsequent self-reported behaviour. This potentially generates bias by exposing non-intervention control groups to an integral component of the intervention. The effects of brief alcohol interventions may thus have been consistently under-estimated. These findings are relevant to evaluations of any interventions to alter behaviours which involve participant self-report.

  1. Land- and water-based exercise intervention in women with fibromyalgia: The al-Andalus physical activity randomised controlled trial

    OpenAIRE

    Carbonell-Baeza Ana; Ruiz Jonatan R; Aparicio Virginia A; Ortega Francisco B; Munguía-Izquierdo Diego; Álvarez-Gallardo Inmaculada C; Segura-Jiménez Víctor; Camiletti-Moirón Daniel; Romero Alejandro; Estévez-López Fernando; Samos Blanca; Casimiro Antonio J; Sierra Ángela; Latorre Pedro A; Pulido-Martos Manuel

    2012-01-01

    Abstract Background The al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes) in women...

  2. Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence

    OpenAIRE

    Butow, Phyllis N.; Bell, Melanie L; Smith, Allan B; Fardell, Joanna E.; Thewes, Belinda; Turner, Jane; Gilchrist, Jemma; Beith, Jane; Girgis, Afaf; Sharpe, Louise; Shih, Sophy; Mihalopoulos, Cathrine

    2013-01-01

    Background Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR). Despite the known negative impact of FCR on psychological wellbeing and quality of life, little research has investigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear) based on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer Fear in a randomised controlled trial (RCT). We aim to...

  3. Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial

    Directory of Open Access Journals (Sweden)

    Byamugisha Robert

    2011-09-01

    Full Text Available Abstract Background The objective of the study was to evaluate the effect of a written invitation letter to the spouses of new antenatal clinic attendees on attendance by couples and on male partner acceptance of HIV testing at subsequent antenatal clinic visits. Methods The trial was conducted with 1060 new attendees from October 2009 to February 2010 in an antenatal clinic at Mbale Regional Referral Hospital, Mbale District, eastern Uganda. The intervention comprised an invitation letter delivered to the spouses of new antenatal attendees, while the control group received an information letter, a leaflet, concerning antenatal care. The primary outcome measure was the proportion of pregnant women who attended antenatal care with their male partners during a follow-up period of four weeks. Eligible pregnant women were randomly assigned to the intervention or non-intervention groups using a randomization sequence, which was computer generated utilizing a random sequence generator (RANDOM ORG that employed a simple randomization procedure. Respondents, health workers and research assistants were masked to group assignments. Results The trial was completed with 530 women enrolled in each group. Participants were analyzed as originally assigned (intention to treat. For the primary outcome, the percentage of trial participants who attended the antenatal clinic with their partners were 16.2% (86/530 and 14.2% (75/530 in the intervention and non-intervention groups, respectively (OR = 1.2; 95% CI: 0.8, 1.6. For the secondary outcome, most of the 161 male partners attended the antenatal clinic; 82 of 86 (95% in the intervention group and 68 of 75 (91% in the non-intervention group were tested for HIV (OR = 2.1; 95% CI: 0.6 to 7.5. Conclusions The effect of the intervention and the control on couple antenatal attendance was similar. In addition, the trial demonstrated that a simple intervention, such as a letter to the spouse, could increase couple

  4. Randomized controlled trial of dietary intervention: association between level of urinary phenolics and anti-mutagenicity.

    Science.gov (United States)

    Malaveille, Christian; Fiorini, Laura; Bianchini, Monica; Davico, Laura; Bertinetti, Sabrina; Allegro, Giovanni; Hautefeuille, Agnès; Sacerdote, Carlotta; Vineis, Paolo

    2004-07-11

    We have undertaken a randomized trial to confirm the ability of a class of phenolics, flavonoids, to increase urinary anti-mutagenicity in smokers. Ninety heavy smokers were recruited and randomly assigned to three groups, who were given three different diets. One diet was rich in flavonoids, but not based on supplementation ('flavonoid'), one was a normal iso-caloric diet with an adequate administration of fruit and vegetables ('normal'), and one was based on supplementation of flavonoids in the form of green tea and soy products ('supplement'). The urinary anti-mutagenicity-as inhibiting effect of the urinary extracts on the mutations induced by MeIQx-was measured in Salmonella typhimurium YG1024 in the presence of liver S9 from male Sprague-Dawley rats treated with Aroclor 1254. The amount of total phenolics in the urinary extracts was measured by use of spectrometric analysis. We found that important dietary modifications can be achieved through special recipes and instructions given by a cook during an intensive course. The intervention was focused on increasing the flavonoid intake, and it was successful in that respect. In fact, differences in flavonoid intake were appreciated mainly between the first group (normal diet) and the other two (flavonoid-rich and supplemented diet), suggesting that dietary modification can be as effective as supplementation. However, both urinary anti-mutagenicity and the amounts of urinary phenolics did not change as a consequence of the trial. These results suggest that only a small fraction of urinary phenolics is influenced by dietary changes in the intake of flavonoids, and that most urinary anti-mutagens and phenolics are metabolites of dietary flavonoids, whose formation is more affected by the activity and diversity of bacterial flora in the colon than by the quantity and type of intake. A strong correlation was found between urinary phenolics and anti-mutagenicity in all the groups involved in the trial. Such correlation

  5. Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma.

    Science.gov (United States)

    Ma, Jun; Strub, Peg; Lv, Nan; Xiao, Lan; Camargo, Carlos A; Buist, A Sonia; Lavori, Philip W; Wilson, Sandra R; Nadeau, Kari C; Rosas, Lisa G

    2016-01-01

    Rigorous research on the benefit of healthy eating patterns for asthma control is lacking.We randomised 90 adults with objectively confirmed uncontrolled asthma and a low-quality diet (Dietary Approaches to Stop Hypertension (DASH) scores Asthma Control Questionnaire scores (-0.2 (-0.5, 0) versus 0 (-0.3, 0.3); difference -0.2 (-0.5, 0.1)) at 6 months. The mean group differences in changes in Mini Asthma Quality of Life Questionnaire overall and subdomain scores consistently favoured the intervention over the control group: overall 0.4 (95% CI 0, 0.8), symptoms 0.5 (0, 0.9), environment 0.4 (-0.1, 1.0), emotions 0.4 (-0.2, 0.9) and activities 0.3 (0, 0.7). These differences were modest, but potentially clinical significant.The DASH behavioural intervention improved diet quality with promising clinical benefits for better asthma control and functional status among adults with uncontrolled asthma. A full-scale efficacy trial is warranted.

  6. Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Patricia Bourgault

    Full Text Available This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.A mixed-methods randomized controlled trial (intervention (INT vs. waitlist (WL was conducted with patients suffering from FMS. Data were collected at baseline (T0, at the end of the intervention (T1, and 3 months later (T2. The primary outcome was change in pain intensity (0-10. Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC, and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively than in the WL Group (8%, 12%, 20%. The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%. The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12% and 3 months post-intervention (33% vs 4%. Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.International Standard Randomized Controlled Trial Number

  7. Effectiveness of a single-session early psychological intervention for children after road traffic accidents: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meuli Martin

    2010-02-01

    approaches for children and adolescents. Also, the intervention evaluated here needs to be studied in other groups of traumatised children. Trial Registration Clinical Trial Registry: ClinicalTrials.gov: NCT00296842.

  8. Time-Based Physical Activity Interventions for Weight Loss: A Randomized Trial

    Science.gov (United States)

    Jakicic, John M.; Rickman, Amy D.; Lang, Wei; Davis, Kelliann K.; Gibbs, Bethany Barone; Neiberg, Rebecca; Marcus, Marsha D.

    2014-01-01

    Purpose To examine whether enhancing standard behavior weight loss interventions (SBWP) with additional strategies at the initiation of the intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18 month weight loss. Methods This was a clinical trial with participants (n=195; age= 43.2±8.6 yrs; BMI= 33.0±3.4 kg/m2) randomized to SBWP, ADOPT, or MAINTAIN. All were prescribed an energy restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT received additional phone contact (months 1–3), supervised exercise (months 1–6), and behavior campaigns (months 4–9). MAINTAIN received additional phone contact (months 4–6), supervised exercise (months 7–12), and behavior campaigns (months 13–18). Results There was a significant Group X Time interaction for weight loss (p=0.0032). SBWP lost 9.3±0.9, 7.8±1.1, and 5.9±1.2 kg at 6, 12, and 18 months, respectively. ADOPT lost 8.9±0.9, 7.6±1.2, and 5.8±1.2 kg, and MAINTAIN lost 9.7±0.9, 11.0±1.2, and 9.0±1.2 kg at 6, 12, and 18 months, respectively. The Group X Time interaction for SBWP vs. MAINTAIN (p=0.0033) and ADOPT vs. MAINTAIN (p=0.0075) was significant. There was a significant Group X Time interaction for change in fitness (p=0.0060). The Group X Time interaction for MAINTAIN vs. ADOPT (p=0.0018) was significant with a trend for MAINTAIN vs. SBWP (p=0.0525). Conclusions MAINTAIN improved 18-month weight loss compared to SBWP and ADOPT, with statistical trends that MAINTAIN resulted in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity conferred greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies to improve long-term weight loss and fitness in overweight and obese adults. PMID:25160843

  9. A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol

    Directory of Open Access Journals (Sweden)

    Bunker Jeremy M

    2012-09-01

    Full Text Available Abstract Background Chronic Obstructive Pulmonary Disease (COPD is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care. Design A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD. The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate, smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities. The primary outcome measure is health-related quality of life, assessed with the St George’s Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related

  10. Adherence: a review of education, research, practice, and policy in the United States

    Directory of Open Access Journals (Sweden)

    Brown TA

    2010-03-01

    Full Text Available Objective: To describe the education, research, practice, and policy related to pharmacist interventions to improve medication adherence in community settings in the United States.Methods: Authors used MEDLINE and International Pharmaceutical Abstracts (since 1990 to identify community and ambulatory pharmacy intervention studies which aimed to improve medication adherence. The authors also searched the primary literature using Ovid to identify studies related to the pharmacy teaching of medication adherence. The bibliographies of relevant studies were reviewed in order to identify additional literature. We searched the tables of content of three US pharmacy education journals and reviewed the American Association of Colleges of Pharmacy website for materials on teaching adherence principles. Policies related to medication adherence were identified based on what was commonly known to the authors from professional experience, attendance at professional meetings, and pharmacy journals.Results: Research and Practice: 29 studies were identified: 18 randomized controlled trials; 3 prospective cohort studies; 2 retrospective cohort studies; 5 case-controlled studies; and one other study. There was considerable variability in types of interventions and use of adherence measures. Many of the interventions were completed by pharmacists with advanced clinical backgrounds and not typical of pharmacists in community settings. The positive intervention effects had either decreased or not been sustained after interventions were removed. Although not formally assessed, in general, the average community pharmacy did not routinely assess and/or intervene on medication adherence. Education: National pharmacy education groups support the need for pharmacists to learn and use adherence-related skills. Educational efforts involving adherence have focused on students’ awareness of adherence barriers and communication skills needed to engage patients in behavioral

  11. Adherence to a Mediterranean-Style Diet and Effects on Cognition in Adults: A Qualitative Evaluation and Systematic Review of Longitudinal and Prospective Trials.

    Science.gov (United States)

    Hardman, Roy J; Kennedy, Greg; Macpherson, Helen; Scholey, Andrew B; Pipingas, Andrew

    2016-01-01

    The Mediterranean-style diet (MedDiet) involves substantial intake of fruits, vegetables, and fish, and a lower consumption of dairy, red meat, and sugars. Over the past 15 years, much empirical evidence supports the suggestion that a MedDiet may be beneficial with respect to reducing the incidence of cardiovascular disease, cancer, metabolic syndrome, and dementia. A number of cross-sectional studies that have examined the impact of MedDiet on cognition have yielded largely positive results. The objective of this review is to evaluate longitudinal and prospective trials to gain an understanding of how a MedDiet may impact cognitive processes over time. The included studies were aimed at improving cognition or minimizing of cognitive decline. Studies reviewed included assessments of dietary status using either a food frequency questionnaire or a food diary assessment. Eighteen articles meeting our inclusion criteria were subjected to systematic review. These revealed that higher adherence to a MedDiet is associated with slower rates of cognitive decline, reduced conversion to Alzheimer's disease, and improvements in cognitive function. The specific cognitive domains that were found to benefit with improved Mediterranean Diet Score were memory (delayed recognition, long-term, and working memory), executive function, and visual constructs. The current review has also considered a number of methodological issues in making recommendations for future research. The utilization of a dietary pattern, such as the MedDiet, will be essential as part of the armamentarium to maintain quality of life and reduce the potential social and economic burden of dementia. PMID:27500135

  12. Adherence to a Mediterranean-Style Diet and Effects on Cognition in Adults: A Qualitative Evaluation and Systematic Review of Longitudinal and Prospective Trials

    Science.gov (United States)

    Hardman, Roy J.; Kennedy, Greg; Macpherson, Helen; Scholey, Andrew B.; Pipingas, Andrew

    2016-01-01

    The Mediterranean-style diet (MedDiet) involves substantial intake of fruits, vegetables, and fish, and a lower consumption of dairy, red meat, and sugars. Over the past 15 years, much empirical evidence supports the suggestion that a MedDiet may be beneficial with respect to reducing the incidence of cardiovascular disease, cancer, metabolic syndrome, and dementia. A number of cross-sectional studies that have examined the impact of MedDiet on cognition have yielded largely positive results. The objective of this review is to evaluate longitudinal and prospective trials to gain an understanding of how a MedDiet may impact cognitive processes over time. The included studies were aimed at improving cognition or minimizing of cognitive decline. Studies reviewed included assessments of dietary status using either a food frequency questionnaire or a food diary assessment. Eighteen articles meeting our inclusion criteria were subjected to systematic review. These revealed that higher adherence to a MedDiet is associated with slower rates of cognitive decline, reduced conversion to Alzheimer’s disease, and improvements in cognitive function. The specific cognitive domains that were found to benefit with improved Mediterranean Diet Score were memory (delayed recognition, long-term, and working memory), executive function, and visual constructs. The current review has also considered a number of methodological issues in making recommendations for future research. The utilization of a dietary pattern, such as the MedDiet, will be essential as part of the armamentarium to maintain quality of life and reduce the potential social and economic burden of dementia. PMID:27500135

  13. Mindfulness Training Improves Attentional Task Performance in Incarcerated Youth: A Group Randomized Controlled Intervention Trial

    Directory of Open Access Journals (Sweden)

    Noelle R Leonard

    2013-11-01

    Full Text Available We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16 to 18, to a CBT/MT intervention (youth n = 147 or an active control intervention (youth n = 117. Both arms received approximately 750 minutes of intervention in a small-group setting over a 3-5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. Keywords: adolescent development, incarcerated adolescents, detained adolescents, stress, attention, mindfulness meditation.

  14. Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in HIV-Infected Injection Drug Users: A Randomized Controlled Trial

    Science.gov (United States)

    Safren, Steven A.; O'Cleirigh, Conall M.; Bullis, Jacqueline R.; Otto, Michael W.; Stein, Michael D.; Pollack, Mark H.

    2012-01-01

    Objective: Depression and substance use, the most common comorbidities with HIV, are both associated with poor treatment adherence. Injection drug users comprise a substantial portion of individuals with HIV in the United States and globally. The present study tested cognitive behavioral therapy for adherence and depression (CBT-AD) in patients…

  15. Effects of self-management intervention on health outcomes of patients with heart failure: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Holroyd-Leduc Jayna M

    2006-11-01

    Full Text Available Abstract Background Heart failure is the most common cause of hospitalization among adults over 65. Over 60% of patients die within 10 years of first onset of symptoms. The objective of this study is to determine the effectiveness of self-management interventions on hospital readmission rates, mortality, and health-related quality of life in patients diagnosed with heart failure. Methods The study is a systematic review of randomized controlled trials. The following data sources were used: MEDLINE (1966-11/2005, EMBASE (1980-11/2005, CINAHL (1982-11/2005, the ACP Journal Club database (to 11/2005, the Cochrane Central Trial Registry and the Cochrane Database of Systematic Reviews (to 11/2005; article reference lists; and experts in the field. We included randomized controlled trials of self-management interventions that enrolled patients 18 years of age or older who were diagnosed with heart failure. The primary outcomes of interest were all-cause hospital readmissions, hospital readmissions due to heart failure, and mortality. Secondary outcomes were compliance with treatment and quality of life scores. Three reviewers independently assessed the quality of each study and abstracted the results. For each included study, we computed the pooled odds ratios (OR for all-cause hospital readmission, hospital readmission due to heart failure, and death. We used a fixed effects model to quantitatively synthesize results. We were not able to pool effects on health-related quality of life and measures of compliance with treatment, but we summarized the findings from the relevant studies. We also summarized the reported cost savings. Results From 671 citations that were identified, 6 randomized trials with 857 patients were included in the review. Self-management decreased all-cause hospital readmissions (OR 0.59; 95% confidence interval (CI 0.44 to 0.80, P = 0.001 and heart failure readmissions (OR 0.44; 95% CI 0.27 to 0.71, P = 0.001. The effect on

  16. Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial

    Science.gov (United States)

    Downing Jr, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

    2016-01-01

    Background Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. Objective To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Methods Sex Positive![+] is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Results Participant recruitment began in June 2015 and ended in December 2015. Conclusions This protocol

  17. Evaluation of benefit to patients of training mental health professionals in suicide guidelines: cluster randomised trial.

    OpenAIRE

    Beurs, D.P. de; Groot, M.H. de; Keijser, J. de; Duijn, E. van; Winter, R.F.P. de; Kerkhof, A.J.F.M.

    2015-01-01

    Background: Randomised studies examining the effect on patients of training professionals in adherence to suicide guidelines are scarce. Aims: To assess whether patients benefited from the training of professionals in adherence to suicide guidelines. Method: In total 45 psychiatric departments were randomised (Dutch trial register: NTR3092). In the intervention condition, all staff in the departments were trained with an e-learning supported train-the-trainer programme. After the intervention...

  18. An intervention to promote physical activity and self-management in people with stable chronic heart failure The Home-Heart-Walk study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Currow David C

    2011-03-01

    Full Text Available Abstract Background Chronic heart failure (CHF is a chronic debilitating condition with economic consequences, mostly because of frequent hospitalisations. Physical activity and adequate self-management capacity are important risk reduction strategies in the management of CHF. The Home-Heart-Walk is a self-monitoring intervention. This model of intervention has adapted the 6-minute walk test as a home-based activity that is self-administered and can be used for monitoring physical functional capacity in people with CHF. The aim of the Home-Heart-Walk program is to promote adherence to physical activity recommendations and improving self-management in people with CHF. Methods/Design A randomised controlled trial is being conducted in English speaking people with CHF in four hospitals in Sydney, Australia. Individuals diagnosed with CHF, in New York Heart Association Functional Class II or III, with a previous admission to hospital for CHF are eligible to participate. Based on a previous CHF study and a loss to follow-up of 10%, 166 participants are required to be able to detect a 12-point difference in the study primary endpoint (SF-36 physical function domain. All enrolled participant receive an information session with a cardiovascular nurse. This information session covers key self-management components of CHF: daily weight; diet (salt reduction; medication adherence; and physical activity. Participants are randomised to either intervention or control group through the study randomisation centre after baseline questionnaires and assessment are completed. For people in the intervention group, the research nurse also explains the weekly Home-Heart-Walk protocol. All participants receive monthly phone calls from a research coordinator for six months, and outcome measures are conducted at one, three and six months. The primary outcome of the trial is the physical functioning domain of quality of life, measured by the physical functioning subscale

  19. Randomized Trial Outcomes of a TTM-Tailored Condom Use and Smoking Intervention in Urban Adolescent Females

    Science.gov (United States)

    Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.

    2015-01-01

    Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females…

  20. Outcomes of a Telehealth Intervention for Homebound Older Adults with Heart or Chronic Respiratory Failure: A Randomized Controlled Trial

    Science.gov (United States)

    Gellis, Zvi D.; Kenaley, Bonnie; McGinty, Jean; Bardelli, Ellen; Davitt, Joan; Ten Have, Thomas

    2012-01-01

    Purpose: Telehealth care is emerging as a viable intervention model to treat complex chronic conditions, such as heart failure (HF) and chronic obstructive pulmonary disease (COPD), and to engage older adults in self-care disease management. Design and Methods: We report on a randomized controlled trial examining the impact of a multifaceted…

  1. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial

    NARCIS (Netherlands)

    Hoogendam, A.; Vries Robbé, P.F. de; Overbeke, A.J.P.M.

    2012-01-01

    BACKGROUND: Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick s

  2. Pre-trial Intervention: The Manhattan Court Employment Project of the Vera Institute of Justice. Final Report.

    Science.gov (United States)

    Vera Inst. of Justice, New York, NY.

    The final report of an experimental pre-trial intervention program of intensive manpower services (individual and group counseling and job, training, or academic placement with the help of career developers) for selected defendants in Manhattan covers the period November 1967 through October 1970. After three years and 1,300 participants,…

  3. Progression to type 1 diabetes in islet cell antibody-positive relatives in the European Nicotinamide Diabetes Intervention Trial

    DEFF Research Database (Denmark)

    Bingley, P J; Gale, E A M; Reimers, Jesper Irving

    2006-01-01

    AIMS/HYPOTHESIS: To examine the role of additional immune, genetic and metabolic risk markers in determining risk of diabetes in islet cell antibody (ICA)-positive individuals with a family history of type 1 diabetes recruited into the European Nicotinamide Diabetes Intervention Trial. METHODS...

  4. An Open Trial of the Anxiety Action Plan ("AxAP"): A Brief Pediatrician-Delivered Intervention for Anxious Youth

    Science.gov (United States)

    Ginsburg, Golda S.; Drake, Kelly L.; Winegrad, Heather; Fothergill, Kate; Wissow, Lawrence S.

    2016-01-01

    Background: Anxiety disorders in youth are among the most common psychiatric disorders, yet the majority of affected youth do not receive treatment. One approach to improving access to care is identification and intervention within the primary care setting. Objective: This manuscript presents data from a single group pre-post open trial of the…

  5. Who Benefits and How Does It Work? Moderators and Mediators of Outcome in an Effectiveness Trial of a Parenting Intervention

    Science.gov (United States)

    Gardner, Frances; Hutchings, Judy; Bywater, Tracey; Whitaker, Chris

    2010-01-01

    We examined mediators and moderators of change in conduct problems, in a multiagency randomized trial of the Incredible Years parenting program. Preschoolers (n = 153) at risk for conduct problems were randomly assigned to intervention (n = 104) and wait-list (n = 49) groups. Boys and younger children, and those with more depressed mothers, tended…

  6. A cluster randomized control field trial of the ABRACADABRA web-based literacy intervention: Replication and extension of basic findings.

    Directory of Open Access Journals (Sweden)

    Noella Angele Piquette

    2014-12-01

    Full Text Available The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA, an evidence-based and web-based literacy intervention (http://abralite.concordia.ca with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10-12 hours of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d = +.66, phonological blending (d = +.52, and word reading (d = +.52, over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years.

  7. The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial

    Science.gov (United States)

    Nugent, Chris D; McClean, Sally I; Cleland, Ian; Tschanz, JoAnn T; Clark, Christine J; Norton, Maria C

    2016-01-01

    Background Health education and behavior change programs targeting specific risk factors have demonstrated their effectiveness in reducing the development of future diseases. Alzheimer disease (AD) shares many of the same risk factors, most of which can be addressed via behavior change. It is therefore theorized that a behavior change intervention targeting these risk factors would likely result in favorable rates of AD prevention. Objective The objective of this study was to reduce the future risk of developing AD, while in the short term promoting vascular health, through behavior change. Methods The study was an interventional randomized controlled trial consisting of subjects who were randomly assigned into either treatment (n=102) or control group (n=42). Outcome measures included various blood-based biomarkers, anthropometric measures, and behaviors related to AD risk. The treatment group was provided with a bespoke “Gray Matters” mobile phone app designed to encourage and facilitate behavior change. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviors across 6 behavioral domains, and presented feedback on the user’s performance, calculated from reported behaviors against recommended guidelines. Results This paper explores the rationale for a mobile phone–led intervention and details the app’s effect on behavior change and subsequent clinical outcomes. Via the app, the average participant submitted 7.3 (SD 3.2) behavioral logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their high-density lipoprotein cholesterol levels during the study duration answered a statistically significant higher number of questions per day (mean 8.30, SD 2.29) than those with no improvement (mean 6.52, SD 3.612), t97.74=−3.051, P=.003. Participants who decreased their body mass index (BMI) performed significantly

  8. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)