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Sample records for adherence intervention trial

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

    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

    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. The Team Education and Adherence Monitoring (TEAM) trial: pharmacy interventions to improve hypertension control in blacks.

    Svarstad, Bonnie L; Kotchen, Jane Morley; Shireman, Theresa I; Crawford, Stephanie Y; Palmer, Pamela A; Vivian, Eva M; Brown, Roger L

    2009-05-01

    Recent studies suggest that involving pharmacists is an effective strategy for improving patient adherence and blood pressure (BP) control. To date, few controlled studies have tested the cost-effectiveness of specific models for improving patient adherence and BP control in community pharmacies, where most Americans obtain prescriptions. We hypothesized that a team model of adherence monitoring and intervention in corporately owned community pharmacies can improve patient adherence, prescribing, and BP control among hypertensive black patients. The Team Education and Adherence Monitoring (TEAM) Trial is a randomized controlled trial testing a multistep intervention for improving adherence monitoring and intervention in 28 corporately owned community pharmacies. Patients in the 14 control pharmacies received "usual care," and patients in the 14 intervention pharmacies received TEAM Care by trained pharmacists and pharmacy technicians working with patients and physicians. Data collectors screened 1250 patients and enrolled 597 hypertensive black patients. The primary end points were the proportion of patients achieving BP control and reductions in systolic and diastolic BP measured after 6 and 12 months. Secondary end points were changes in adherence monitoring and intervention, patient adherence and barriers to adherence, prescribing, and cost-effectiveness. Researchers also will examine potential covariates and barriers to change. Involving pharmacists is a potentially powerful means of improving BP control in blacks. Pharmacists are in an excellent position to monitor patients between clinic visits and to provide useful information to patients and physicians. PMID:20031847

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

    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...

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

    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...

  6. Enhancing Adherence in Clinical Exercise Trials.

    O'Neal, Heather A.; Blair, Steven N.

    2001-01-01

    Discusses exercise adherence from the perspective of adhering to an exercise treatment in a controlled trial, focusing on: adherence (to intervention and measurement); the development of randomized clinical trials; exemplary randomized clinical trials in exercise science (exercise training studies and physical activity interventions); and study…

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

    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.

  8. Effects of a Phone Call Intervention to Promote Adherence to Antiretroviral Therapy and Quality of Life of HIV/AIDS Patients in Baoshan, China: A Randomized Controlled Trial

    Weibin Zheng; Virasakdi Chongsuvivatwong; Edward McNeil; Rassamee Sangthong; Dongsheng Huang; Xuemei Yang

    2013-01-01

    Background. Suboptimal adherence to antiretroviral therapy (ART) is still pervasive. The effect of using a mobile phone call intervention to improve patient adherence is currently not known. Objective. This study aims to investigate the effects of a phone call intervention on adherence to ART and quality of life (QOL) of treatment-naive and treatment-experienced patients. Methods. A randomized controlled trial was conducted in the three largest public hospitals. Adherence was measured by self...

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

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

    Shojaeizadeh, Davoud; Tol, Azar; Garmaroudi, Gholamreza; Yekaninejad, Mir Saeed; Kebede, Abebaw; Ejeta, Luche Tadesse; Kassa, Desta; Klinkenberg, Eveline

    2016-01-01

    Background 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). Methodology 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. Results 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)). Conclusion Psychological counseling and educational interventions

  11. 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

    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

  12. 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

    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

  13. A systematic review of techniques and interventions for improving adherence to inclusion and exclusion criteria during enrolment into randomised controlled trials

    Sweetman Elizabeth A

    2010-02-01

    Full Text Available Abstract Background Enrolment of patients into a randomised controlled trial (RCT in violation of key inclusion or exclusion criteria, may lead to excess avoidable harm. The purpose of this paper was to systematically identify and review techniques and interventions proven to prevent or avoid inappropriate enrolment of patients into RCTs. Methods EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Methodology Register, online abstract repositories, and conference websites were searched. Experts were contacted and bibliographies of retrieved papers hand-searched. The search cut-off date was 31 August 2009. Results No primary publications were found. We identified one study in the grey literature (conference abstracts and presentations reporting the results of an evaluation of the effectiveness of an intervention designed to prevent or avoid inappropriate enrolment of patients into an RCT. In the context of a multicentre trial, use of a dummy enrolment run-in phase was shown to reduce enrolment errors significantly (P Conclusions Our systematic search yielded only one technique or intervention shown to improve adherence to eligibility criteria during enrolment into RCTs. Given the potential harm involved in recruiting patients into a clinical trial in violation of key eligibility criteria, future research is needed to better inform those conducting clinical trials of how best to prevent enrolment errors

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

    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

  15. Psychosocial interventions and medication adherence in bipolar disorder

    Depp, Colin A.; Moore, David J.; Thomas L. Patterson; Lebowitz, Barry D.; Jeste, Dilip V.

    2008-01-01

    Recent research has indicated that psychosocial interventions can have a valuable role in reducing the substantial psychosocial disability associated with bipolar disorder. Randomized controlled trials of these interventions indicate that improvements are seen in symptoms, psychosocial functioning, and treatment adherence. These interventions systematically presented in the form of standardized treatment manuals, vary in format, duration, and theoretical basis. All are meant to augment pharma...

  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.

    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

    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. Mobile Assessment and Treatment for Schizophrenia (MATS): A Pilot Trial of An Interactive Text-Messaging Intervention for Medication Adherence, Socialization, and Auditory Hallucinations

    Granholm, Eric; Ben-Zeev, Dror; Link, Peter C.; Bradshaw, Kristen R.; Holden, Jason L.

    2011-01-01

    Mobile Assessment and Treatment for Schizophrenia (MATS) employs ambulatory monitoring methods and cognitive behavioral therapy interventions to assess and improve outcomes in consumers with schizophrenia through mobile phone text messaging. Three MATS interventions were developed to target medication adherence, socialization, and auditory hallucinations. Participants received up to 840 text messages over a 12-week intervention period. Fifty-five consumers with schizophrenia or schizoaffectiv...

  19. Comparison of Trial Participants and Open Access Users of a Web-Based Physical Activity Intervention Regarding Adherence, Attrition, and Repeated Participation

    Wanner, Miriam; Martin-Diener, Eva; Bauer, Georg; Braun-Fahrländer, Charlotte; Martin, Brian W

    2010-01-01

    Background Web-based interventions are popular for promoting healthy lifestyles such as physical activity. However, little is known about user characteristics, adherence, attrition, and predictors of repeated participation on open access physical activity websites. Objective The focus of this study was Active-online, a Web-based individually tailored physical activity intervention. The aims were (1) to assess and compare user characteristics and adherence to the website (a) in the open access...

  20. Comparison of Trial Participants and Open Access Users of a Web-Based Physical Activity Intervention Regarding Adherence, Attrition, and Repeated Participation

    Wanner, M.; Martin-Diener, E; Bauer, G; Braun-Fahrländer, C.; De Martin, B W

    2010-01-01

    Background: Web-based interventions are popular for promoting healthy lifestyles such as physical activity. However, little is known about user characteristics, adherence, attrition, and predictors of repeated participation on open access physical activity websites. Objective: The focus of this study was Active-online, a Web-based individually tailored physical activity intervention. The aims were (1) to assess and compare user characteristics and adherence to the website (a) in the open a...

  1. Microbicide clinical trial adherence: insights for introduction.

    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

  2. Microbicide clinical trial adherence: insights for introduction

    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.

  3. Efficacy of an alcohol-focused intervention for improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes – a randomised controlled trial protocol

    Parry, Charles DH; Morojele, Neo K.; Myers, Bronwyn J.; Kekwaletswe, Connie T; Manda, Samuel OM; Sorsdahl, Katherine; Ramjee, Gita; Hahn, Judith A.; Rehm, Jürgen; Shuper, Paul A.

    2014-01-01

    Background Little research has examined whether alcohol reduction interventions improve antiretroviral therapy (ART) adherence and HIV treatment outcomes. This study assesses the efficacy of an intervention for reducing alcohol use among HIV patients on ART who are hazardous/harmful drinkers. Specific aims include adapting a blended Motivational Interviewing (MI) and Problem Solving Therapy (PST) intervention for use with HIV patients; evaluating the efficacy of the intervention for reducing ...

  4. Improving pneumonia case-management in Benin: a randomized trial of a multi-faceted intervention to support health worker adherence to Integrated Management of Childhood Illness guidelines

    Lama Marcel

    2009-08-01

    Full Text Available Abstract Background Pneumonia is a leading cause of death among children under five years of age. The Integrated Management of Childhood Illness strategy can improve the quality of care for pneumonia and other common illnesses in developing countries, but adherence to these guidelines could be improved. We evaluated an intervention in Benin to support health worker adherence to the guidelines after training, focusing on pneumonia case management. Methods We conducted a randomized trial. After a health facility survey in 1999 to assess health care quality before Integrated Management of Childhood Illness training, health workers received training plus either study supports (job aids, non-financial incentives and supervision of workers and supervisors or "usual" supports. Follow-up surveys were conducted in 2001, 2002 and 2004. Outcomes were indicators of health care quality for Integrated Management-defined pneumonia. Further analyses included a graphical pathway analysis and multivariable logistic regression modelling to identify factors influencing case-management quality. Results We observed 301 consultations of children with non-severe pneumonia that were performed by 128 health workers in 88 public and private health facilities. Although outcomes improved in both intervention and control groups, we found no statistically significant difference between groups. However, training proceeded slowly, and low-quality care from untrained health workers diluted intervention effects. Per-protocol analyses suggested that health workers with training plus study supports performed better than those with training plus usual supports (20.4 and 19.2 percentage-point improvements for recommended treatment [p = 0.08] and "recommended or adequate" treatment [p = 0.01], respectively. Both groups tended to perform better than untrained health workers. Analyses of treatment errors revealed that incomplete assessment and difficulties processing clinical findings

  5. A Randomized Trial Comparing In Person and Electronic Interventions for Improving Adherence to Oral Medications in Schizophrenia

    Velligan, Dawn; Mintz, Jim; Maples, Natalie; Xueying, Li; Gajewski, Stephanie; Carr, Heather; Sierra, Cynthia

    2012-01-01

    Poor adherence to medication leads to symptom exacerbation and interferes with the recovery process for patients with schizophrenia. Following baseline assessment, 142 patients in medication maintenance at a community mental health center were randomized to one of 3 treatments for 9 months: (1) PharmCAT, supports including pill containers, signs, alarms, checklists and the organization of belongings established in weekly home visits from a PharmCAT therapist; (2) Med-eMonitor (MM), an electro...

  6. Understanding adherence to web-based interventions

    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

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

    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.

  8. A randomized controlled trial of interventions to enhance patient-physician partnership, patient adherence and high blood pressure control among ethnic minorities and poor persons: study protocol NCT00123045

    Larson Susan M

    2009-02-01

    Full Text Available Abstract Background Disparities in health and healthcare are extensively documented across clinical conditions, settings, and dimensions of healthcare quality. In particular, studies show that ethnic minorities and persons with low socioeconomic status receive poorer quality of interpersonal or patient-centered care than whites and persons with higher socioeconomic status. Strong evidence links patient-centered care to improvements in patient adherence and health outcomes; therefore, interventions that enhance this dimension of care are promising strategies to improve adherence and overcome disparities in outcomes for ethnic minorities and poor persons. Objective This paper describes the design of the Patient-Physician Partnership (Triple P Study. The goal of the study is to compare the relative effectiveness of the patient and physician intensive interventions, separately, and in combination with one another, with the effectiveness of minimal interventions. The main hypothesis is that patients in the intensive intervention groups will have better adherence to appointments, medication, and lifestyle recommendations at three and twelve months than patients in minimal intervention groups. The study also examines other process and outcome measures, including patient-physician communication behaviors, patient ratings of care, health service utilization, and blood pressure control. Methods A total of 50 primary care physicians and 279 of their ethnic minority or poor patients with hypertension were recruited into a randomized controlled trial with a two by two factorial design. The study used a patient-centered, culturally tailored, education and activation intervention for patients with active follow-up delivered by a community health worker in the clinic. It also included a computerized, self-study communication skills training program for physicians, delivered via an interactive CD-ROM, with tailored feedback to address their individual

  9. Clinical pharmacist interventions to support adherence to thrombopreventive therapy

    Hedegaard, Ulla

    The three papers in the thesis were based on two randomised controlled trials (RCTs) on in-hospital clinical pharmacist interventions for improvement of adherence to thrombopreventive therapy in two different populations: outpatients with hypertension and patients with acute stroke/transient isch......The three papers in the thesis were based on two randomised controlled trials (RCTs) on in-hospital clinical pharmacist interventions for improvement of adherence to thrombopreventive therapy in two different populations: outpatients with hypertension and patients with acute stroke...... targeted patients with hypertension or stroke in a hospital care setting. Thus, the aim of this thesis was to develop and evaluate in-hospital pharmacist interventions including MI to improve adherence to primary and secondary thrombopreventive therapy. The first study was a RCT, which investigated the...... persistence to specific thrombopreventive medications and a combined clinical endpoint of cardiovascular death, stroke or acute myocardial infarction. The second RCT included 532 patients with hypertension from three hospital outpatient clinics. The study examined the effectiveness of an intervention very...

  10. Interventions to Increase Treatment Adherence in Pediatric Atopic Dermatitis: A Systematic Review

    Alexandria M. Bass

    2015-01-01

    Full Text Available Poor adherence to treatment is a major factor limiting treatment outcomes in patients with atopic dermatitis. The purpose of our systematic review is to identify techniques that have been tested to increase treatment adherence in atopic dermatitis. A MEDLINE search was performed for clinical trials focusing on interventions used to increase adherence in atopic dermatitis. Four articles were retrieved. References of these studies were analyzed yielding three more trials. The seven results were evaluated by comparing the intervention used to improve adherence, how adherence was assessed, and the outcome of the intervention tested. Different approaches to increase adherence such as written eczema action plans, educational workshops, extra office visits, and use of an atopic dermatitis educator were evaluated. All interventions increased adherence rates or decreased severity in patients, except for two. The MEDLINE search yielded limited results due to a lack of studies conducted specifically for atopic dermatitis and adherence was measured using different methods making the studies difficult to compare. Interventions including patient education, eczema action plans, and a quick return for a follow-up visit improve adherence, but based on the lack of clinical trials, developing new techniques to improve adherence could be as valuable as developing new treatments.

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

    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

  12. 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

    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

  13. Improving diabetes medication adherence: successful, scalable interventions

    Zullig LL

    2015-01-01

    Full Text Available Leah L Zullig,1,2 Walid F Gellad,3,4 Jivan Moaddeb,2,5 Matthew J Crowley,1,2 William Shrank,6 Bradi B Granger,7 Christopher B Granger,8 Troy Trygstad,9 Larry Z Liu,10 Hayden B Bosworth1,2,7,11 1Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA; 2Department of Medicine, Duke University, Durham, NC, USA; 3Center for Health Equity Research and Promotion, Pittsburgh Veterans Affairs Medical Center, Pittsburgh, PA, USA; 4Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA; 5Institute for Genome Sciences and Policy, Duke University, Durham, NC, USA; 6CVS Caremark Corporation; 7School of Nursing, Duke University, Durham, NC, USA; 8Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC, USA; 9North Carolina Community Care Networks, Raleigh, NC, USA; 10Pfizer, Inc., and Weill Medical College of Cornell University, New York, NY, USA; 11Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA Abstract: Effective medications are a cornerstone of prevention and disease treatment, yet only about half of patients take their medications as prescribed, resulting in a common and costly public health challenge for the US healthcare system. Since poor medication adherence is a complex problem with many contributing causes, there is no one universal solution. This paper describes interventions that were not only effective in improving medication adherence among patients with diabetes, but were also potentially scalable (ie, easy to implement to a large population. We identify key characteristics that make these interventions effective and scalable. This information is intended to inform healthcare systems seeking proven, low resource, cost-effective solutions to improve medication adherence. Keywords: medication adherence, diabetes mellitus, chronic disease, dissemination research

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

    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...

  15. A Systematic Review of Antiretroviral Adherence Interventions for HIV-Infected People Who Use Drugs

    CampBinford, Meredith; Kahana, Shoshana Y.; Altice, Frederick L.

    2012-01-01

    HIV-infected persons who use drugs (PWUDs) are particularly vulnerable for suboptimal combination antiretroviral therapy (cART) adherence. A systematic review of interventions to improve cART adherence and virologic outcomes among HIV-infected PWUDs was conducted. Among the 45 eligible studies, randomized controlled trials suggested directly administered antiretroviral therapy, medication-assisted therapy (MAT), contingency management, and multi-component, nurse-delivered interventions provid...

  16. Frailty Intervention Trial (FIT

    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

  17. Predictors of Low Clopidogrel Adherence Following Percutaneous Coronary Intervention

    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

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

    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 ...

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

    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 ...

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

    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...

  1. Interventions for enhancing adherence with physiotherapy: a systematic review

    McLean, S.; Burton, M.; L. Bradley(a); Littlewood, C

    2010-01-01

    Poor adherence to treatment is commonplace and may adversely affect outcomes, efficiency and healthcare cost. The aim of this systematic review was to identify strategies to improve adherence with musculoskeletal outpatient treatment. Five suitable studies were identified which provided moderate evidence that a motivational cognitive-behavioural programme can improve attendance at exercise-based clinic sessions. There was conflicting evidence that adherence interventions increase short-ter...

  2. Interventions for enhancing adherence to treatment in adults with bronchiectasis

    McCullough, Amanda; Ryan, Cristin; Bradley, Judy M.; O'Neill, Brenda; Elborn, Stuart; Hughes, Carmel

    2014-01-01

    Background: Bronchiectasis is characterised by a widening of the airways, leading to excess mucus production and recurrent infection. It is more prevalent in women and those in middle age. Many patients with bronchiectasis do not adhere to treatments (medications, exercise and airway clearance) prescribed for their condition. The best methods to change these adherence behaviours have not been identified.Objectives: To assess the effects of interventions to enhance adherence to any aspect of tr...

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

    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

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

    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…

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

    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

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

    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

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

    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

  8. Internet-based adherence interventions for treatment of chronic disorders in adolescents

    Bass AM

    2015-05-01

    Full Text Available Alexandria M Bass,1 Michael E Farhangian,1 Steven R Feldman1–3 1Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC, USA; 2Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC, USA; 3Department of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA Background: Treatment adherence is a ubiquitous challenge in medicine, particularly in the adolescent population with chronic disorders. Web-based adherence interventions may be particularly useful in adolescents, due to their familiarity with and frequent use of the Internet. Objective: To review web-based interventions used to improve adherence to medication in adolescent patients with chronic disorders. Methods: A PubMed search was performed for full-text, English, clinical trials in adolescents using keywords “adherence” or “compliance”, “Internet” or “web”, and “treatment” from inception until November 2014. Articles were selected if they involved using the Internet to provide support to adolescents to help improve their adherence to treatment, excluding those focused on solely providing medical services through the Internet and articles focusing on preventative care, rather than treatment of an illness. Results: Fourteen studies were found concentrating on chronic adolescent disorders. Interventions included online surveys, physician chat lines, monitoring programs, and interactive programs. All interventions experienced either greater improvement in adherence or another disease control measure or no statistically significant difference compared with the control group (in-clinic visits. Limitations: Few clinical trials studying web-based interventions to improve adherence in adolescents were found. Due to not having one standard outcome measured in all of the studies, it was also difficult comparing the effectiveness of the interventions. Conclusion: Web

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

    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

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

    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.

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

    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.

  12. Interventional trials in atypical parkinsonism.

    Eschlböck, S; Krismer, F; Wenning, G K

    2016-01-01

    Atypical parkinson disorders (APD) are rapidly progressive neurodegenerative diseases with a variable clinical presentation that may even mimic Parkinson's disease. Multiple system atrophy (MSA), progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are commonly summarized under this umbrella term. Significant developments in research have expanded knowledge and have broadened available symptomatic treatments, particularly for the treatment of neurogenic orthostatic hypotension. Nonetheless, symptomatic support still remains limited in all of these disorders. Currently, there exists no effective treatment to delay disease progression and disease-modifying trials have failed to provide coherent and convincing results. Recent trials of rasagiline (in MSA), rifampicin (in MSA), tideglusib (in PSP) and davunetide (in PSP) reported negative results. Nevertheless, large cohorts of patients were recruited for interventional studies in the last few years which improved our understanding of trial methodology in APDs immensely. In addition, remarkable progress in basic research has been reported recently and will provide a solid foundation for future therapeutic trials. In this review, we will summarize published randomized, placebo-controlled clinical trials (RCTs) in APDs. Additionally, the design of ongoing and unpublished interventions will be presented. PMID:26421389

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

    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.

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

    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...

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

    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

  16. ‘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

    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...

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

    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

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

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

    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-led and......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...... evaluate process outcomes. Results In total, 240 patients with hypertension were invited to participate in the study. Among these, 156 patients (65%) accepted participation and received the intervention. The focused medication review revealed 91 drug-related problems categorized into eight types. According...

  19. A Systematic Review of CPAP Adherence Across Age Groups: Clinical and Empiric Insights for Developing CPAP Adherence Interventions

    Sawyer, A.M.; Gooneratne, N.; Marcus, C.L.; Ofer, D.; Richards, K.C.; Weaver, T E

    2011-01-01

    Continuous positive airway pressure (CPAP) is a highly efficacious treatment for obstructive sleep apnea (OSA) but adherence to the treatment limits its overall effectiveness across all age groups of patients. Factors that influence adherence to CPAP include disease and patient characteristics, treatment titration procedures, technological device factors and side effects, and psychological and social factors. These influential factors have guided the development of interventions to promote CP...

  20. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol

    Ball T Blake; Ngugi Elizabeth; Estambale Benson; Nguti Rosemary; Barasa Samson; Karanja Sarah; Habyarimana James; Jack William; Chung Michael; Ritvo Paul; Kariri Antony; Mills Edward J; Lester Richard T; Thabane Lehana; Kimani Joshua

    2009-01-01

    Abstract Background The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya. Methods and Design A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to ...

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

    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. Supporting patients : pharmacy based interventions to improve medication adherence

    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...

  3. Nutrition Intervention Trials in Linxian, China

    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

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

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

    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.

  6. Improving adherence to venous thromoembolism prophylaxis using multiple interventions

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

    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

  8. 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

    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...

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

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

    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...

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

    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 ...

  12. Component Analysis of Adherence in a Family Intervention

    Hill, Laura G.; Owens, Robert W.

    2013-01-01

    Purpose: Most studies of adherence use a single global measure to examine the relation of adherence to outcomes. These studies inform us about effects of overall implementation but not about importance of specific program elements. Previous research on the Strengthening Families Program 10-14 has shown that outcomes were unrelated to global…

  13. Development of adherence metrics for caloric restriction interventions

    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...

  14. Development of adherence metrics for caloric restriction interventions

    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...

  15. Getting inside acupuncture trials - Exploring intervention theory and rationale

    Godfrey Mary

    2011-03-01

    Full Text Available Abstract Background Acupuncture can be described as a complex intervention. In reports of clinical trials the mechanism of acupuncture (that is, the process by which change is effected is often left unstated or not known. This is problematic in assisting understanding of how acupuncture might work and in drawing together evidence on the potential benefits of acupuncture. Our aim was to aid the identification of the assumed mechanisms underlying the acupuncture interventions in clinical trials by developing an analytical framework to differentiate two contrasting approaches to acupuncture (traditional acupuncture and Western medical acupuncture. Methods Based on the principles of realist review, an analytical framework to differentiate these two contrasting approaches was developed. In order to see how useful the framework was in uncovering the theoretical rationale, it was applied to a set of trials of acupuncture for fatigue and vasomotor symptoms, identified from a wider literature review of acupuncture and early stage breast cancer. Results When examined for the degree to which a study demonstrated adherence to a theoretical model, two of the fourteen selected studies could be considered TA, five MA, with the remaining seven not fitting into any recognisable model. When examined by symptom, five of the nine vasomotor studies, all from one group of researchers, are arguably in the MA category, and two a TA model; in contrast, none of the five fatigue studies could be classed as either MA or TA and all studies had a weak rationale for the chosen treatment for fatigue. Conclusion Our application of the framework to the selected studies suggests that it is a useful tool to help uncover the therapeutic rationale of acupuncture interventions in clinical trials, for distinguishing between TA and MA approaches and for exploring issues of model validity. English language acupuncture trials frequently fail to report enough detail relating to the

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

    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 (Mage = 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. PMID:26693964

  17. Study of adherence to exercise in heart failure: the HEART camp trial protocol

    Pozehl, Bunny J; Duncan, Kathleen; Hertzog, Melody; McGuire, Rita; Norman, Joseph F.; Artinian, Nancy T.; Keteyian, Steven J.

    2014-01-01

    Background Adherence to the Heart Failure Society of America (HFSA) 2010 guidelines recommending 30 minutes of supervised moderate intensity exercise five days per week is difficult for patients with heart failure (HF). Innovative programs are needed to assist HF patients to adhere to long-term exercise. The objective of this prospective randomized two-group repeated measures experimental design is to determine the efficacy of a behavioral exercise training intervention on long-term adherence...

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

    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 ...

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

    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

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

    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...

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

    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…

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

    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...

  3. 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).

    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

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

    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.

  5. Cost-Effectiveness of Financial Incentives to Promote Adherence to Depot Antipsychotic Medication: Economic Evaluation of a Cluster-Randomised Controlled Trial.

    Catherine Henderson

    Full Text Available Offering a modest financial incentive to people with psychosis can promote adherence to depot antipsychotic medication, but the cost-effectiveness of this approach has not been examined.Economic evaluation within a pragmatic cluster-randomised controlled trial. 141 patients under the care of 73 teams (clusters were randomised to intervention or control; 138 patients with diagnoses of schizophrenia, schizo-affective disorder or bipolar disorder participated. Intervention participants received £15 per depot injection over 12 months, additional to usual acute, mental and community primary health services. The control group received usual health services. Main outcome measures: incremental cost per 20% increase in adherence to depot antipsychotic medication; incremental cost of 'good' adherence (defined as taking at least 95% of the prescribed number of depot medications over the intervention period.Economic and outcome data for baseline and 12-month follow-up were available for 117 participants. The adjusted difference in adherence between groups was 12.2% (73.4% control vs. 85.6% intervention; the adjusted costs difference was £598 (95% CI -£4,533, £5,730. The extra cost per patient to increase adherence to depot medications by 20% was £982 (95% CI -£8,020, £14,000. The extra cost per patient of achieving 'good' adherence was £2,950 (CI -£19,400, £27,800. Probability of cost-effectiveness exceeded 97.5% at willingness-to-pay values of £14,000 for a 20% increase in adherence and £27,800 for good adherence.Offering a modest financial incentive to people with psychosis is cost-effective in promoting adherence to depot antipsychotic medication. Direct healthcare costs (including costs of the financial incentive are unlikely to be increased by this intervention.ISRCTN.com 77769281.

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

    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

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

    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...

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

    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)...

  9. Implementation of physical coordination training and cognitive behavioural training interventions at cleaning workplaces - secondary analyses of a randomised controlled trial

    Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias;

    2012-01-01

    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......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......-week interventions were performed in groups guided by an instructor. Records were kept on intervention dose (adherence) unanticipated events at the work place (context) and quality of intervention delivery (fidelity). Participant adherence was 37% in the PCT and 49% in the CBTr interventions. Optimal...

  10. ‘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

    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...

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

    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...

  12. Intensive Quality Assurance of Therapist Adherence to Behavioral Interventions for Adolescent Substance Use Problems

    Holth, Per; Torsheim, Torbjørn; Sheidow, Ashli J.; Ogden, Terje; Henggeler, Scott W.

    2011-01-01

    This study was a crosscultural replication of a study that investigated therapist adherence to behavioral interventions as a result of an intensive quality assurance system which was integrated into Multisystemic Therapy. Thirty-three therapists and eight supervisors participated in the study and were block randomized to either an Intensive Quality Assurance or a Workshop Only condition. Twenty-one of these therapists treated 41 cannabis-abusing adolescents and their families. Therapist adher...

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

    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...

  14. Yoga Adherence in Older Women Six Months Post–Osteoarthritis Intervention

    Cheung, Corjena; Justice, Catherine; Peden-McAlpine, Cynthia

    2015-01-01

    Background/Objective: Osteoarthritis (OA) is a highly prevalent condition worldwide. Yoga is potentially a safe and feasible option for managing OA; however, the extent of long-term yoga adherence is unknown. The purpose of this study was to examine yoga adherence 6 months after participants completed an OA intervention program. Methods: This follow-up study employed a cross-sectional descriptive design using survey, interview, and video recordings to collect both quantitative and qualitative...

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

    Kyla L. Smith

    2015-06-01

    Full Text Available 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 trial with 12 months of follow up. Diet was assessed using three-day food records and a brief eating behavior questionnaire. Changes in dietary outcomes were assessed using linear mixed models, adjusted for underreporting. Food record data suggested reduced adherence to dietary intervention messages over time following the intervention, despite conflicting information from the brief eating behavior questionnaire. During the intervention, energy intake was stable but favorable nutrient changes occurred. During the 12 month maintenance period; self-reported eating behaviors improved, energy intake remained stable but dietary fat and saturated fat intake gradually returned to baseline levels. Discrepancies between outcomes from brief dietary assessment methods and three-day food records show differences between perceived and actual intake, highlighting the need for detailed dietary reporting. Further, adherence to dietary intervention principles reduces over time, indicating a need for better maintenance support.

  16. ‘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

    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

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

    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…

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

    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...

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

    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

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

    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

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

    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....

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

    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

  3. Intensive Quality Assurance of Therapist Adherence to Behavioral Interventions for Adolescent Substance Use Problems

    Holth, Per; Torsheim, Torbjorn; Sheidow, Ashli J.; Ogden, Terje; Henggeler, Scott W.

    2011-01-01

    This study was a cross-cultural replication of a study that investigated therapist adherence to behavioral interventions as a result of an intensive quality assurance system which was integrated into Multisystemic Therapy (MST). Thirty-three therapists and eight supervisors were block randomized to either an Intensive Quality Assurance or a…

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

    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.

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

    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...

  6. Helicobacter pylori eradication in dyspeptic primary care patients: a randomized controlled trial of a pharmacy intervention

    STEVENS, Victor J; Shneidman, Robert J; Johnson, Richard E; Boles, Myde; Steele, Paul E.; Lee, Nancy L

    2002-01-01

    Objective To determine the effectiveness of structured adherence counseling by pharmacists on the eradication of Helicobacter pylori when using a standard drug treatment regimen. Design Randomized controlled clinical trial. Setting Nonprofit group-practice health maintenance organization (HMO). Participants HMO primary care providers referred 1,393 adult dyspeptic patients for carbon 14 urea breath testing (UBT). Interventions Those whose tests were positive for H pylori (23.3%) were provided...

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

    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

  8. Delayed educational reminders for long-term medication adherence in ST-elevation myocardial infarction (DERLA-STEMI: Protocol for a pragmatic, cluster-randomized controlled trial

    Ivers Noah M

    2012-06-01

    Full Text Available Abstract Background Despite evidence-based recommendations supporting long-term use of cardiac medications in patients post ST-elevation myocardial infarction, adherence is known to decline over time. Discontinuation of cardiac medications in such patients is associated with increased mortality. Methods/design This is a pragmatic, cluster-randomized controlled trial with blinded outcome assessment and embedded qualitative process evaluation. Patients from one health region in Ontario, Canada who undergo a coronary angiogram during their admission for ST-elevation myocardial infarction and who survive their initial hospitalization will be included. Allocation of eligible patients to intervention or usual care will take place within one week after the angiogram using a computer-generated random sequence. To avoid treatment contamination, patients treated by the same family physician will be allocated to the same study arm. The intervention consists of recurrent, personalized, paper-based educational messages and reminders sent via post on behalf of the interventional cardiologist to the patient, family physician, and pharmacist urging long-term adherence to secondary prevention medications. The primary outcome is the proportion of patients who report in a phone interview taking all relevant classes of cardiac medications at twelve months. Secondary outcomes to be measured at three and twelve months include proportions of patients who report: actively taking each cardiac medication class of interest (item-by-item; stopping medications due to side effects; taking one or two or three medication classes concurrently; a perfect Morisky Medication Adherence Score for cardiac medication compliance; and having a discussion with their family physician about long-term adherence to cardiac medications. Self-reported measures of adherence will be validated using administrative data for prescriptions filled. Discussion This intervention is designed to be

  9. In-Depth Analysis of Patient-Clinician Cell Phone Communication during the WelTel Kenya1 Antiretroviral Adherence Trial

    van der Kop, Mia L; Karanja, Sarah; Thabane, Lehana; Marra, Carlo; Chung, Michael H.; Gelmon, Lawrence; Kimani, Joshua; Lester, Richard T.

    2012-01-01

    Background The WelTel Kenya1 trial demonstrated that text message support improved adherence to antiretroviral therapy (ART) and suppression of HIV-1 RNA load. The intervention involved sending weekly messages to patients inquiring how they were doing; participants were required to respond either that they were well or that there was a problem. Objectives 1) Describe problems participants identified through mobile phone support and reasons why participants did not respond to the messages; 2) ...

  10. 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.

    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...

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

    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

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

    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

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

    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

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

    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

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

    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

  16. 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

    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

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

    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

  18. High Adherence Is Necessary to Realize Health Gains from Water Quality Interventions

    Brown, J.; Clasen, T

    2012-01-01

    BACKGROUND: Safe drinking water is critical for health. Household water treatment (HWT) has been recommended for improving access to potable water where existing sources are unsafe. Reports of low adherence to HWT may limit the usefulness of this approach, however. METHODS AND FINDINGS: We constructed a quantitative microbial risk model to predict gains in health attributable to water quality interventions based on a range of assumptions about pre-treatment water quality; treatment effective...

  19. Cost-effectiveness of adherence therapy versus health education for people with schizophrenia: randomised controlled trial in four European countries

    Patel, Anita; McCRONE, PAUL; Leese, Morven; Amaddeo, Francesco; Tansella, Michele; Kilian, Reinhold; Angermeyer, Matthias; Kikkert, Martijn; SCHENE, AART; Knapp, Martin

    2013-01-01

    Background Non-adherence to anti-psychotics is common, expensive and affects recovery. We therefore examine the cost-effectiveness of adherence therapy for people with schizophrenia by multi-centre randomised trial in Amsterdam, London, Leipzig and Verona. Methods Participants received 8 sessions of adherence therapy or health education. We measured lost productivity and use of health/social care, criminal justice system and informal care at baseline and one year to estimate and compare mean ...

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

    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.

  1. Determining the Cost-Savings Threshold for HIV Adherence Intervention Studies for Persons with Serious Mental Illness and HIV.

    Wu, Evan S; Rothbard, Aileen; Holtgrave, David R; Blank, Michael B

    2016-05-01

    Persons with serious mental illnesses are at increased risk for contracting and transmitting HIV and often have poor adherence to medication regimens. Determining the economic feasibility of different HIV adherence interventions among individuals with HIV and serious mental illness is important for program planners who must make resource allocation decisions. The goal of this study was to provide a methodology to estimate potential cost savings from an HIV medication adherence intervention program for a new study population, using data from prior published studies. The novelty of this approach is the way CD4 count data was used as a biological marker to estimate costs averted by greater adherence to anti-retroviral treatment. Our approach is meant to be used in other adherence intervention studies requiring cost modeling. PMID:25535041

  2. 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

    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

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

    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 ...

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

    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

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

    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…

  6. Designing Clinical Trials of Intervention for Mobility Disability: Results from the Lifestyle Interventions and Independence for Elders (LIFE) Pilot Trial

    Clinical trials to assess interventions for mobility disability are critically needed, however data for efficiently designing such trials are lacking. Our results are described from the LIFE pilot clinical trial, in which 424 volunteers aged 70-89 years were randomly assigned to one of two intervent...

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

    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

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

    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

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

    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

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

    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

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

    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

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

    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...

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

    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

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

    Kekwaletswe CT; Morojele NK

    2014-01-01

    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...

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

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

    2015-01-01

    taken and time spent on the intervention. RESULTS: In total, 91 DRPs in 8 categories generated recommendations to the physicians; 56 recommendations were generated at the medication review and 35 at the patient interview. At the interview, 421 problems were identified, of which 60% were medication......-39% reported increased knowledge, confidence and skills in relation to their medication as well as better quality of life. The pharmacists found that the intervention elements were meaningful pharmacist tasks, and that the DRAW tool was easy to use and helped them focus on addressing reasons for non......-adherence. The mean total time spent by the pharmacist per patient was 2 h 14 min (SD 40 min). CONCLUSIONS: A pharmacist-led, multifaceted, tailored adherence intervention was feasible for identifying and addressing a wide range of potential adherence and lifestyle problems. Among the intervention procedures, MI...

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

    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

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

    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

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

    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

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

    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

  20. Choosing a control intervention for a randomised clinical trial

    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.

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

    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

    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

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

    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

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

    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

  6. Implications of the results of community intervention trials.

    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

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

    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…

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

    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

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

    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,…

  10. 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

    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....

  11. European Nicotinamide Diabetes Intervention Trial (ENDIT)

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

    2004-01-01

    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...... Juvenile Diabetes Federation (JDF) units or more, and a non-diabetic oral glucose tolerance test. Participants were recruited from 18 European countries, Canada, and the USA, and were randomly allocated oral modified release nicotinamide (1.2 g/m2) or placebo for 5 years. Random allocation was done with a...... pseudorandom number generator and we used size balanced blocks of four and stratified by age and national group. Primary outcome was development of diabetes, as defined by WHO criteria. Analysis was done on an intention-to-treat basis. FINDINGS: There was no difference in the development of diabetes between...

  12. Protocol for a randomised controlled trial to estimate the effects and costs of a patient centred educational intervention in glaucoma management

    Cate Heidi

    2012-11-01

    Full Text Available Abstract Background Poor glaucoma education is thought to be a causative factor of non-adherence to glaucoma therapy. However, the multi-factorial nature of non-adherent behaviour may explain the failure of purely educational interventions to achieve significant improvement in adherence. Behaviour Change Counselling (BCC allows both the imparting of information and assessment of patient ambivalence to medication use and may elicit behaviour change in order to achieve better adherence. The chronic and complex nature of glaucoma means that patient non-adherence to glaucoma therapy does not easily correlate with measureable objective clinical endpoints. However, electronic medication monitoring offers an objective method of measuring adherence without reliance on clinical endpoints. Methods/design The study is a randomised controlled trial (RCT with glaucoma (open angle or ocular hypertension patients attending a glaucoma clinic and prescribed travoprost. The study will determine whether additional glaucoma education using BCC is beneficial and cost effective in improving adherence with glaucoma therapy. An 8-month follow-up period, using an electronic adherence monitoring device (Travalert® dosing aid, TDA, will indicate if the intervention is likely to be sustained in the longer term. Additionally, a cost-effectiveness framework will be used to estimate the cost benefit of improving adherence. The development of a novel intervention to deliver glaucoma education using BCC required practitioner training and fidelity testing. Five practitioners were successfully trained to become Glaucoma Support Assistants able to deliver the BCC intervention. The research group had prior clinical and investigative experience in this setting, and used multiple strategies to design a method to address the study objectives. Discussion This RCT, using BCC to improve adherence to ocular hypotensive therapy, to our knowledge is the first within this disease area

  13. Adherence to Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea: Implications for Future Interventions

    Weaver, Terri E; Sawyer, Amy M.

    2010-01-01

    Adherence to continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA) is a critical problem with adherence rates ranging from 30–60%. Poor adherence to CPAP is widely recognized as a significant limiting factor in treating OSA, reducing the overall effectiveness of the treatment and leaving many OSA patients at heightened risk for comorbid conditions, impaired function and quality of life. The extant literature examining adherence to CPAP provides critical insigh...

  14. Adherence to WHO breastfeeding guidelines among HIV positive mothers in Southern Ethiopia: implication for intervention

    Haile D

    2015-06-01

    mothers. Seventy-one percent (70.9% of HIV positive mothers practiced “on demand” breastfeeding. Twenty nine percent of infants aged 6–11 months and 47.8% of infants aged ≥12 months were no longer breastfed. The mean (± standard deviation duration of breastfeeding was 7.8 (±3.1 months (95% confidence interval: 6.9–8.7. Conclusion: The 2010 WHO guidelines and recommendations on breastfeeding duration for HIV positive mothers was not adhered to after 6 months of age. Promotion and counseling of optimal breastfeeding practice for HIV positive mothers based on the updated WHO guideline is an appropriate intervention. However, further research is recommended to evaluate the acceptance of the new 2010 WHO guideline by the health professionals and HIV positive mothers. Keywords: HIV-exposed, infants, breastfeeding, initiation

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

    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. 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

    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...

  17. 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

    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...

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

    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.

  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

    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. Rethinking adherence.

    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

  1. Community based intervention to optimize osteoporosis management: randomized controlled trial

    Ciaschini Patricia M

    2010-08-01

    Full Text Available Abstract Background Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis are underutilized. This pragmatic randomised study was done to evaluate the impact of a multifaceted community-based care program aimed at optimizing evidence-based management in patients at risk for osteoporosis and fractures. Methods This was a 12-month randomized trial performed in Ontario, Canada. Eligible patients were community-dwelling, aged ≥55 years, and identified to be at risk for osteoporosis-related fractures. Two hundred and one patients were allocated to the intervention group or to usual care. Components of the intervention were directed towards primary care physicians and patients and included facilitated bone mineral density testing, patient education and patient-specific recommendations for osteoporosis treatment. The primary outcome was the implementation of appropriate osteoporosis management. Results 101 patients were allocated to intervention and 100 to control. Mean age of participants was 71.9 ± 7.2 years and 94% were women. Pharmacological treatment (alendronate, risedronate, or raloxifene for osteoporosis was increased by 29% compared to usual care (56% [29/52] vs. 27% [16/60]; relative risk [RR] 2.09, 95% confidence interval [CI] 1.29 to 3.40. More individuals in the intervention group were taking calcium (54% [54/101] vs. 20% [20/100]; RR 2.67, 95% CI 1.74 to 4.12 and vitamin D (33% [33/101] vs. 20% [20/100]; RR 1.63, 95% CI 1.01 to 2.65. Conclusions A multi-faceted community-based intervention improved management of osteoporosis in high risk patients compared with usual care. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00465387

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

    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. Our application of intervention mapping strategies used existing literature, formative research and multidisciplinary team input to...

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

    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

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

    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.

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

    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

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

    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

  7. Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

    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

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

    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...

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

    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.

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

    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...

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

    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,...

  12. 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

    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

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

    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 (P<.05). Expectation of care and social support are important factors for developing interventions to increase medication adherence among blacks. PMID:26593105

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

    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,...

  15. 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

    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...

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

    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

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

    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

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

    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

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

    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

  20. A pragmatic cluster randomised trial evaluating three implementation interventions

    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

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

    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

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

    Keeling Sally; Peri Kathy; Hatcher Simon; Elley C Raina; Dowell Tony; Kolt Gregory S; Hayman Karen J; Moyes Simon A; Falloon Karen; Kerse Ngaire; Robinson Elizabeth; Parsons John; Wiles Janine; Arroll Bruce

    2008-01-01

    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 a...

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

    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 ...

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

    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

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

    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

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

    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

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

    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…

  8. Overcoming Psychosocial Barriers to Maternal Exercise: Intervention Strategies to Improve Participation and Adherence

    Schoenfeld, Brad; Tiryaki-Sonmez, Gul

    2011-01-01

    Poor adherence to physical activity programmes during pregnancy is a serious national issue, one that has detrimental effects on a large percentage of the population. Not only does a lack of activity result in a decrease in quality of life for women during term, but the effects can carry over well after pregnancy, potentially leading to increased…

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

    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

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

    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

  11. A Randomized Controlled Trial of a Mobile Health Intervention to Promote Self-Management After Lung Transplantation.

    DeVito Dabbs, A; Song, M K; Myers, B A; Li, R; Hawkins, R P; Pilewski, J M; Bermudez, C A; Aubrecht, J; Begey, A; Connolly, M; Alrawashdeh, M; Dew, M A

    2016-07-01

    Lung transplant recipients are encouraged to perform self-management behaviors, including (i) monitoring health indicators, (ii) adhering to their regimen, and (iii) reporting abnormal health indicators to the transplant coordinator, yet performance is suboptimal. When hospital discharge was imminent, this two-group trial randomized 201 recipients to use either the mobile health (mHealth) intervention (n = 99) or usual care (n = 102), to compare efficacy for promoting self-management behaviors (primary outcomes) and self-care agency, rehospitalization, and mortality (secondary outcomes) at home during the first year after transplantation. The mHealth intervention group performed self-monitoring (odds ratio [OR] 5.11, 95% confidence interval [CI] 2.95-8.87, p testing. PMID:26729617

  12. Measuring the quality of life of the elderly in health promotion intervention clinical trials.

    Kutner, N G; Ory, M G; Baker, D. I.; Schechtman, K B; Hornbrook, M C; Mulrow, C D

    1992-01-01

    The Multicenter Trials of Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT) is a series of clinical trials of biomedical, behavioral, and environmental interventions to reduce the risks of frailty and injury among the elderly. Reliable assessment of the quality of life reported by the subjects is a central issue in evaluating the interventions. An intervention may have a significant impact on an elderly person's sense of well-being, even though significant improvem...

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

    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...

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

    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...

  15. Adherence to Antidepressant Medication

    Åkerblad, Ann-Charlotte

    2007-01-01

    Non-adherence to medication is a major obstacle in the treatment of depression. The objectives of the present study were to explore the effect of two interventions aiming to increase antidepressant treatment adherence, and to examine long-term consequences and costs of depression in adherent and non-adherent primary care patients. A randomised controlled design was used to assess the respective effects of a written educational adherence enhancing programme and therapeutic drug monitoring in ...

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

    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...

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

    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...

  18. Specifying active components of educational interventions to promote adherence to treatment in glaucoma patients: application of a taxonomy of behavior change techniques

    Berzins KM

    2015-07-01

    Full Text Available Kathryn M Berzins,1 Trish A Gray,1 Heather Waterman,1 Jill J Francis2 1School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK; 2School of Health Sciences, City University London, London, UK Purpose: In response to recent calls for clearer specification of behavior change interventions, the purpose of this study was to apply a system of taxonomy for behavior change techniques (BCTs to two educational interventions to improve adherence to glaucoma eye drops. Clarification of constituent BCTs will promote easy and reliable application of the interventions in clinical settings and research. Methods: A published taxonomy of BCTs was used to code two interventions (group and individual to increase adherence to eye drops. Intervention materials were coded by assigning a BCT label to each text unit. We noted the frequency with which each BCT occurred, compared the interventions in terms of the BCTs that were delivered, and identified whether the taxonomy was sufficient to describe the intervention components. Results: The individual intervention consisted of 94 text units. Fifty-seven were identified as targeting behavior change and coded using 18 BCTs, many coded more than once. In the group intervention, 165 units of text were identified, and 125 were coded using 22 BCTs. The most frequently coded BCT was “provide information about behavior–health link” in the group intervention and “prompt barrier identification” in the individual intervention. The interventions included similar BCTs. All text units targeting behavior change were codable into BCTs. Conclusion: The similarity of the two interventions may have implications for the cost-effectiveness of the interventions. The taxonomy was found sufficient to describe both interventions. This level of specification can be used to ensure that precisely the same intervention that has been pilot tested is reproducible in the clinical setting and in any further

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

    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.

  20. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults

    Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

    2015-01-01

    Background Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Objective Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inact...

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

    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…

  2. 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

    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

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

    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...

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

    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.

  5. Women with pregnancies had lower adherence to 1% tenofovir vaginal gel as HIV preexposure prophylaxis in CAPRISA 004, a phase IIB randomized-controlled trial.

    Lynn T Matthews

    Full Text Available BACKGROUND: Antiretroviral prophylaxis may be a critical strategy to reduce periconception HIV transmission. Maximizing the benefit of periconception pharmacologic HIV risk-reduction requires an understanding of the links between pregnancy and adherence to this prevention strategy. METHODS: We assessed study gel adherence among women with pregnancies compared to women without pregnancies enrolled in the CAPRISA 004 phase IIB trial of 1% vaginal tenofovir gel. Pregnancy was assessed with monthly urine tests. Adherence was measured monthly and defined as proportion of sex acts covered by two returned, used applicators based on pre- and post-coital dosing. High adherence was defined as a median adherence score of >80%, that is, more than 80% of sex acts were covered by two applications of study gel. A multivariate generalized estimating equations (GEE model with a binomial distribution was used to assess covariates associated with high adherence (>80% over time. Median adherence before and after pregnancy was compared using Wilcoxon signed rank test. RESULTS: Among 868 women, 53 had at least 1 pregnancy (4.06 per 100 woman years, 95% CI: 3.04, 5.31. Women with pregnancies had lower median adherence compared to women without pregnancies (50% [IQR: 45-83] vs. 60% [IQR: 50-100], p = 0.02. Women with pregnancies also had a 48% lower odds of high adherence compared to women without pregnancies when adjusting for confounders (aOR 0.52, 95%CI: 0.41-0.66, p<0.0001. Among women with pregnancies, adherence before and after pregnancy was not different (50% [IQR: 46-83] vs. 55% [IQR: 20-100], p = 0.68. CONCLUSIONS: Women with pregnancies were less likely to have high adherence to study gel compared to women without pregnancies. Understanding these differences may inform findings from HIV prevention trials and future implementation of antiretroviral prophylaxis for at-risk women who choose to conceive. The protocol for the parent trial is registered on ClinicalTrials

  6. Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE: a randomized controlled trial

    Wilson Sandra R

    2009-11-01

    Full Text Available Abstract Background Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings. Design E-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240 recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided α level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up. Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level and moderators (e.g., age, gender, race/ethnicity, baseline mental status of the intervention's effect on weight change also will be examined. Discussion This study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care

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

    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.

  8. Intervention Efficacy in Trials Targeting Cannabis Use Disorders in Patients with Comorbid Psychosis

    Hjorthoj, Carsten Rygaard; Baker, Amanda; Fohlmann, Allan;

    2014-01-01

    observed on quantity of use and on positive symptoms of schizophrenia. Psychosocial intervention did not have an appreciable effect on negative symptoms. Longer interventions appear to be more efficacious, and efficacy may be better in trials with comparatively few women. Larger trials may be better at...... establishing effects on positive symptoms. Conclusion: Psychosocial interventions appear moderately efficacious in reducing quantity of cannabis-use and positive symptoms....

  9. 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.

    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

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

    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

  11. Promoting exercise on prescription: recruitment, motivation, barriers and adherence in a Danish community intervention study to reduce type 2 diabetes, dyslipidemia and hypertension

    Roessler, Kirsten Kaya; Ibsen, Bjarne

    2008-01-01

    Abstract Objective The aim of this study is to analyse recruitment, motivation, barriers and adherence to increasing physical activity in a community-based 1-year intervention. Research design and methods This study included a baseline investigation of 1,156 participants (67% female, 33% male), a post-intervention investigation after 4 months and a follow-up assessment after 1 year. All patients included i...

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

    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

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

    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.

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

    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…

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

    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

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

    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.

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

    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

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

    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

  19. Adherence to guidelines of pain assessment and intervention in internal medicine wards.

    Kerner, Yehudit; Plakht, Ygal; Shiyovich, Arthur; Schlaeffer, Pnina

    2013-12-01

    Proper management of pain reduces morbidity, assists in recovery, and increases patient satisfaction. The role of a nurse in an accurate pain evaluation is pivotal. It seems that pain evaluation guidelines are not fully adhered to by nurses. The aim of this study was to assess the performance of pain evaluation and management by nurses in patients admitted in internal medicine wards and to identify groups of patients in which pain evaluation was insufficient. In this cross-sectional study medical records of 59 randomly chosen patients were reviewed: age 64.5 ± 18.5 years, 55% women, and hopitalization length 3.9 ± 1.6 days. Data relating to pain evaluation and management were obtained for every patient-hospitalization day (total 213 patient-days) and compared with the guidelines. Pain was evaluated in 176 out of 213 encounters (66.2%): 84.3% upon admission and 72.7% daily routine evaluation in accordance with guidelines. In 23.7% of evaluations, pain level warranted alleviating treatment (visual analog scale ≥3). However, such treatment was administered in only 29.3% of these cases. Reevaluation after treatment and additional evaluations thereafter were performed in 33.3% and 22% of encounters, respectively. The independent factors associated with the reduced performance of pain evaluation were: widower (odds ratio [OR] 0.88, 95% confidence interval [CI] 0.78-0.98; p = .024), reduced level of consicousnness (OR 0.77, 95% CI 0.63-0.95; p = .013), mental disorders as a cause of hospitalization (OR 0.81, 95% CI 0.71-0.94; p = .004), and isolation (OR 0.87, 95% CI 0.76-0.99; p = .03). Pain assessment and management in internal medicine wards is insufficient, especially in the above subgroups. Specific education programs targeted to the latter subgroups and to the unique pain assessment tools are warranted. PMID:23178103

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

    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...

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

    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

  2. Randomised controlled trial of tailored interventions to improve the management of anxiety and depressive disorders in primary care

    Terluin Berend

    2011-07-01

    Full Text Available Abstract Background Anxiety and depressive disorders are highly prevalent disorders and are mostly treated in primary care. The management of these disorders by general practitioners is not always consistent with prevailing guidelines because of a variety of factors. Designing implementation strategies tailored to prospectively identified barriers could lead to more guideline-recommended care. Although tailoring of implementation strategies is promoted in practice, little is known about the effect on improving the quality of care for the early recognition, diagnosis, and stepped care treatment allocation in patients with anxiety or depressive disorders in general practice. This study examines whether the tailored strategy supplemented with training and feedback is more effective than providing training and feedback alone. Methods In this cluster randomised controlled trial, a total of 22 general practices will be assigned to one of two conditions: (1 training, feedback, and tailored interventions and (2 training and feedback. The primary outcome measure is the proportion of patients who have been recognised to have anxiety and/or depressive disorder. The secondary outcome measures in patients are severity of anxiety and depressive symptoms, level of functioning, expectation towards and experience with care, quality of life, and economic costs. Measures are taken after the start of the intervention at baseline and at three- and six-month follow-ups. Secondary outcome measures in general practitioners are adherence to guideline-recommended care in care that has been delivered, the proportion of antidepressant prescriptions, and number of referrals to specialised mental healthcare facilities. Data will be gathered from the electronic medical patient records from the patients included in the study. In a process evaluation, the identification of barriers to change and the relations between prospectively identified barriers and improvement

  3. Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial.

    Steven A Safren

    Full Text Available PEARLS, a large scale trial of antiretroviral therapy (ART for HIV (n = 1,571, 9 countries, 4 continents, found that a once-daily protease inhibitor (PI based regimen (ATV+DDI+FTC, but not a once-daily non-nucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI regimen (EFV+FTC/TDF, had inferior efficacy compared to a standard of care twice-daily NNRTI/NRTI regimen (EFV+3TC/ZDV. The present study examined non-adherence in PEARLS.Outcomes: non-adherence assessed by pill count and by self-report, and time to treatment failure. Longitudinal predictors: regimen, quality of life (general health perceptions  =  QOL-health, mental health  =  QOL-mental health, social support, substance use, binge drinking, and sexual behaviors. "Life-Steps" adherence counseling was provided.In both pill-count and self-report multivariable models, both once-a-day regimens had lower levels of non-adherence than the twice-a-day standard of care regimen; although these associations attenuated with time in the self-report model. In both multivariable models, hard-drug use was associated with non-adherence, living in Africa and better QOL-health were associated with less non-adherence. According to pill-count, unprotected sex was associated with non-adherence. According to self-report, soft-drug use was associated with non-adherence and living in Asia was associated with less non-adherence. Both pill-count (HR = 1.55, 95% CI: 1.15, 2.09, p<.01 and self-report (HR = 1.13, 95% CI: 1.08, 1.13, p<.01 non-adherence were significant predictors of treatment failure over 72 weeks. In multivariable models (including pill-count or self-report nonadherence, worse QOL-health, age group (younger, and region were also significant predictors of treatment failure.In the context of a large, multi-national, multi-continent, clinical trial there were variations in adherence over time, with more simplified regimens generally being

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

    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...

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

    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 ...

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

    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 such......—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...... childhood obesity is low where observed differences with respect to country, age and gender call for targeted intervention....

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

    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

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

    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...

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

    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...

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

    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...... (rosiglitazone and pioglitazone) on cardiovascular outcomes and the effects of vitamin D (cholecalciferol) on cancers and mortality....

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

    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…

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

    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....

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

    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 to sys...

  14. A randomized controlled intervention trial to relieve and prevent neck/shoulder pain

    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...

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

    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…

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

    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-…

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

    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…

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

    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…

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

    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…

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

    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…

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

    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…

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

    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

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

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

    2007-01-01

    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 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...

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

    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

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

    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

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

    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

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

    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 ...

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

    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...

  9. A trial of an iPad intervention targeting social communication skills in children with autism

    Fletcher-Watson, Susan; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catriona; O'Hare, Anne; Pain, Helen; McConachie, Helen

    2015-01-01

    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 old 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 me...

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

    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...