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Sample records for adherence trial weltel

  1. In-depth analysis of patient-clinician cell phone communication during the WelTel Kenya1 antiretroviral adherence trial.

    Science.gov (United States)

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

    2012-01-01

    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. 1) Describe problems participants identified through mobile phone support and reasons why participants did not respond to the messages; 2) investigate factors associated with indicating a problem and not responding; and 3) examine participant perceptions of the intervention. Secondary analysis of WelTel Kenya1 trial data. Reasons participants indicated a problem or did not respond were extracted from the study log. Negative binomial regression was used to determine participant characteristics associated with indicating a problem and non-response. Data from follow-up questionnaires were used to describe participant perceptions of the intervention. Between 2007 and 2009, 271 participants generated 11,873 responses; 377 of which indicated a problem. Health issues were the primary reason for problem responses (72%). Rural residence (adjusted incidence rate ratio [IRR] 1.96; 95%CI 1.19-3.25; p=0.009 and age were associated with indicating a problem (adjusted IRR 0.63 per increase in age group category; 95%CI 0.50-0.80; pphone issues were the most common barrier. Benefits included reminding patients to take medication and promoting a feeling that "someone cares". The WelTel intervention enabled frequent communication between clinicians and patients during the WelTel Kenya1 trial. Many patients valued the service for the support it provided, with health-related concerns comprising the majority of problems identified by participants. Few sociodemographic characteristics were associated with participant engagement in the intervention.

  2. The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial.

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    Jongbloed, Kate; Friedman, Anton J; Pearce, Margo E; Van Der Kop, Mia L; Thomas, Vicky; Demerais, Lou; Pooyak, Sherri; Schechter, Martin T; Lester, Richard T; Spittal, Patricia M

    2016-03-09

    Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-way text messaging, and support from Cedar Case Managers. The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders, and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat. Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way m

  3. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

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

    2013-04-08

    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.

  4. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    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.

  5. Operationalizing mHealth to improve patient care: a qualitative implementation science evaluation of the WelTel texting intervention in Canada and Kenya.

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    Bardosh, Kevin Louis; Murray, Melanie; Khaemba, Antony M; Smillie, Kirsten; Lester, Richard

    2017-12-06

    Mobile health (mHealth) applications have proliferated across the globe with much enthusiasm, although few have reached scale and shown public health impact. In this study, we explored how different contextual factors influenced the implementation, effectiveness and potential for scale-up of WelTel, an easy-to-use and evidence-based mHealth intervention. WelTel uses two-way SMS communication to improve patient adherence to medication and engagement in care, and has been developed and tested in Canada and Kenya. We used a comparative qualitative case study design, which drew on 32 key informant interviews, conducted in 2016, with stakeholders involved in six WelTel projects. Our research was guided by the Consolidated Framework for Implementation Research (CFIR), a meta-theoretical framework, and our analysis relied on a modified approach to grounded theory, which allowed us to compare findings across these projects. We found that WelTel had positive influences on the "culture of care" at local clinics and hospitals in Canada and Kenya, many of which stretched beyond the immediate patient-client relationship to influence wider organizational systems. However, these were mediated by clinician norms and practices, the availability of local champion staff, the receptivity and capacity of local management, and the particular characteristics of the technology platform, including the ability for adaptation and co-design. We also found that scale-up was influenced by different forms of data and evidence, which played important roles in legitimization and partnership building. Even with robust research evidence, scale-up was viewed as a precarious and uncertain process, embedded within the wider politics and financing of Canadian and Kenyan health systems. Challenges included juggling different interests, determining appropriate financing pathways, maintaining network growth, and "packaging" the intervention for impact and relevance. Our comparative case study, of a unique

  6. Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review.

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    Swift, Robert; Oslin, David W; Alexander, Mark; Forman, Robert

    2011-11-01

    The efficacy of naltrexone (Revia, Vivitrol) for the treatment of alcohol dependence exhibits a high degree of heterogeneity. The aim of the current study was to evaluate the extent to which variability in patient adherence to treatment contributed to the range of clinical responses observed during naltrexone treatment. A systematic review was conducted of efficacy trials of naltrexone for the treatment of alcohol dependence to evaluate the level of adherence monitoring. Of 49 identified trials, 22 (49%) met the inclusion criteria of being randomized, double-blind, placebo-controlled trials that reported adherence. The "adherence-assurance score" of these trials was calculated as a function of the frequency with which "low," "moderate," or "high" confidence levels of adherence monitoring were used. Of these 22 randomized, controlled trials, only 3 (14%) met criteria for high levels of adherence assurance, 5 (23%) met medium adherenceassurance criteria, and 14 (64%) met low adherence criteria. Of the three high-assurance studies, one used direct supervision of thrice-weekly oral dosing of naltrexone, and two used extended-release injectable formulations of naltrexone administered once per month. The Spearman correlation between risk ratios for return to heavy drinking (for naltrexone vs. placebo) and the level of adherence assurance (low vs. medium vs. high) was significant (r = -.62, p = .025). These findings suggest that the modest effect sizes for naltrexone reported in systematic reviews and meta-analyses may be attributable, at least in part, to variability in naltrexone adherence rates. High-assurance adherence strategies should be standard practice in clinical trials of medications being evaluated for the treatment of alcohol dependence.

  7. Participation in a clinical trial enhances adherence and persistence to treatment: a retrospective cohort study.

    NARCIS (Netherlands)

    Onzenoort, H.A.W. van; Menger, F.E.; Neef, C.; Verberk, W.J.; Kroon, A.A.; Leeuw, P.W. de; Kuy, P.H. van der

    2011-01-01

    Poor adherence to treatment is one of the major determinants of an uncontrolled blood pressure. Participation in a clinical trial may increase patient's adherence to treatment. This prompted us to investigate adherence and persistence profiles in patients with hypertension who had participated in a

  8. Improving adherence to glaucoma medication: a randomised controlled trial of a patient-centred intervention (The Norwich Adherence Glaucoma Study)

    OpenAIRE

    Cate, Heidi; Bhattacharya, Debi; Clark, Allan; Fordham, Richard; Holland, Richard; David C Broadway

    2014-01-01

    Background Improving adherence to ocular hypertension (OH)/glaucoma therapy is highly likely to prevent or reduce progression of optic nerve damage. The present study used a behaviour change counselling intervention to determine whether education and support was beneficial and cost-effective in improving adherence with glaucoma therapy. Methods A randomised controlled trial with a 13-month recruitment and 8-month follow-up period was conducted. Patients with OH/glaucoma attending a glaucoma c...

  9. A comparison of measures used to describe adherence to glaucoma medication in a randomised controlled trial

    OpenAIRE

    Cate, Heidi; Bhattacharya, Debi; Clark, Allan; Holland, Richard; Broadway, David

    2015-01-01

    Background: Understanding the magnitude of non-adherence in pre-marketing clinical trials and clinical practice is essential. However, accurately measuring non-adherence to medication is problematic, and the variety of adherence measures and/or calculation methods has led to highly variable results. Purpose: To compare commonly used methods for measuring adherence to eye drop therapy in order to assess which methods achieve the most complete datasets over an 8-month monitoring period, to quan...

  10. Interventions to Improve Medication Adherence among Older Adults: Meta-Analysis of Adherence Outcomes among Randomized Controlled Trials

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    Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Ruppar, Todd M.; Mehr, David R.; Russell, Cynthia L.

    2009-01-01

    Purpose: This study investigated the effectiveness of interventions to improve medication adherence (MA) in older adults. Design and Methods: Meta-analysis was used to synthesize results of 33 published and unpublished randomized controlled trials. Random-effects models were used to estimate overall mean effect sizes (ESs) for MA, knowledge,…

  11. Predicting nursing home adherence to a clinical trial intervention: lessons for the conduct of cluster randomized trials.

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    Tjia, Jennifer; Mazor, Kathleen M; Field, Terry; Doherty, Peter; Spenard, Ann; Gurwitz, Jerry H

    2011-12-01

    To describe factors predictive of nursing home (NH) adherence to a clinical trial intervention. Post hoc analysis of a cluster randomized trial (CRT) evaluating a structured communication intervention to improve nurse-physician telephone communication in NHs. NH. All eligible licensed nursing staff in all participating NHs. Adherence was defined as active participation for at least 3 months of the 12-month trial. NH characteristics hypothesized to affect trial outcomes (profit status, bed size, nursing staff time, NH quality, and leadership turnover) were measured a priori. The association between intervention adherence, NH characteristics and preintervention questionnaire response rate was examined. Of 13 intervention NHs, seven adhered to the intervention. Three factors differentiated adherent from nonadherent NHs: director of nursing turnover (nonadherent NHs 50% vs adherent NHs 0%, P = .03); Centers for Medicare and Medicaid Services (CMS) nurse staffing rating (range: 1-5) (nonadherent NHs mean 3.7 ± 0.5 vs adherent NHs mean 4.3 ± 0.5), P = .048); and questionnaire response rate (nonadherent NHs 15.6 ± 10.0% vs adherent NHs 34.2 ± 12.1%, P = .02). Profit status, bed size, and number of NH deficiencies on state surveys were not significantly associated with intervention adherence. CMS nurse staffing rating, leadership turnover, and questionnaire response rate are associated with adherence to a CRT intervention. Pretrial evaluation of NH staffing rating by CMS and of response to a questionnaire can help investigators improve trial efficiency by screening for NHs likely to adhere to a CRT intervention. © 2011, Copyright the Authors Journal compilation © 2011, The American Geriatrics Society.

  12. The Relevance of Living Supports on Antiplatelet Adherence and Trial Participation: The SPS3 Trial

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    Lewis, Brandy L; Pearce, Lesly A; Field, Thalia S; White, Carole L; Benavente, Oscar R

    2014-01-01

    Background While living with others has been associated with improved functional outcome after acute stroke, it is unclear if this affects adherence to stroke prevention measures. We examined the relationship between living arrangement and adherence to antiplatelet therapy (AP) assignment and participation status in an international randomized trial for secondary stroke prevention. Methods AP therapy adherence, trial retention outcomes, and baseline characteristics for participants enrolled in the Secondary Prevention of Small Subcortical Strokes Study (SPS3) were compared between those who lived alone vs. with others (n=2374). Participant status at end-of-trial was categorized into (1)on assigned antiplatelet, (2)off assigned antiplatelet by participant request, or (3)participant withdrew consent/lost to follow-up. Multivariable multivariate logistic regression was used to identify patient features at entry predictive of participant status at trial end. Results Living arrangement, alone vs. with other(s), was not significantly associated with participant status. Participants enrolled in the US/Canada (OR 3.1, CI 2.0-5.0, vs. Latin America), taking more (7+) prescription medications (OR 1.7, CI 1.1-2.7, vs. 0-2 medications), and scoring lower on the Stroke Specific Quality of Life (SSQoL) scale (OR 1.3, CI 1.1-1.5, per 10 points) were more likely to withdraw or become lost-to-follow-up in the study versus completing the study on assigned AP. Participants enrolled in the US/Canada (OR 5.0, CI 2.4-10.0, vs. Latin America) and taking fewer (0-2) medications (OR 1.9, CI 1.2-3.1 vs. 3-6 medications) were more likely to request discontinuation of assigned antiplatelet medication vs. completing the study. Conclusions Living with others was not independently predictive of protocol adherence in this cohort. Number of medications and Stroke Specific Quality of Life (SSQoL) scale score may be more indicative of likelihood of trial participation and acceptance of long

  13. Increasing adherence to treatment in epilepsy: what do the strongest trials show?

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    da Mota Gomes, M; Navarro, T; Keepanasseril, A; Jeffery, R; Haynes, R B

    2017-03-01

    Patient non-adherence to prescribed anti-epileptic drugs (AEDs) remains a challenge to successful treatment of patients with epilepsy. However, the literature on epilepsy does not document a comprehensive review of interventions to improve adherence as a means to improve clinical outcomes. This study systematically reviews existing literature on interventions to enhance AED adherence and clinical outcomes, and the measures of adherence included in these studies. We selected randomized controlled trials (RCTs) of interventions to enhance adherence with AEDs, which also measured clinical outcomes, with at least 80% follow-up of participants for at least 6 months, from a comprehensive Cochrane review of adherence interventions for medications, complete to January 2013, and updated searches for additional AED studies in multiple bibliographic databases to January 2016. Two review authors independently extracted all data and a third author resolved disagreements. The present update included one trial from the Cochrane review and three RCTs published since, bringing the total number of RCTs on this topic to four. Two types of intervention were tested: educational (e.g., providing information to the patient or carer about treatment characteristics, duration, dosage regime, and how to use the AED) and behavioral (activity in order to remind the patient to take a medicine). Methods of measuring adherence included a combination of direct (plasma AED levels) and indirect measures (prescription refill frequency and appointment keeping) or use alone of self-report adherence on standardized scales. Despite the importance of the problem, evidence is limited concerning enhancement of adherence among people with epilepsy. However, the trials available to date show that medication adherence in epilepsy can be improved, leading to better seizure control. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Patient and Partner Feedback Reports to Improve Statin Medication Adherence: A Randomized Control Trial.

    Science.gov (United States)

    Reddy, Ashok; Huseman, Tiffany L; Canamucio, Anne; Marcus, Steven C; Asch, David A; Volpp, Kevin; Long, Judith A

    2017-03-01

    Simple nudges such as reminders and feedback reports to either a patient or a partner may facilitate improved medication adherence. To test the impact of a pill bottle used to monitor adherence, deliver a daily alarm, and generate weekly medication adherence feedback reports on statin adherence. Three-month, three-arm randomized clinical trial (ClinicalTrials.gov identifier: NCT02480530). One hundred and twenty-six veterans with known coronary artery disease and poor adherence (medication possession ratio medication adherence feedback report; and (3) a partner feedback group (n = 54) that received an alarm and a weekly feedback report that was shared with a friend, family member, or a peer. The intervention continued for 3 months, and participants were followed for an additional 3 months after the intervention period. Adherence as measured by pill bottle. Secondary outcomes included change in LDL (mg/dl), patient activation, and social support. During the 3-month intervention period, medication adherence was higher in both feedback arms than in the control arm (individual feedback group 89 %, partner feedback group 86 %, control group 67 %; p medication adherence between either of the feedback groups and the control (individual feedback 60 %, partner feedback 52 %, control group 54 %; p = 0.75 and 0.97). Daily alarms combined with individual or partner feedback reports improved statin medication adherence. While neither an individual feedback nor partner feedback strategy created a sustainable medication adherence habit, the intervention itself is relatively easy to implement and low cost.

  15. Personality and medication non-adherence among older adults enrolled in a six-year trial

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    Jerant, Anthony; Chapman, Benjamin; Duberstein, Paul; Robbins, John; Franks, Peter

    2011-01-01

    Objectives Personality factors parsimoniously capture the variation in dispositional characteristics that affect behaviours, but their value in predicting medication non-adherence is unclear. We investigated the relationship between five-factor model personality factors (Conscientiousness, Neuroticism, Agreeableness, Extraversion, and Openness) and medication non-adherence among older participants during a six-year randomized placebo-controlled trial (RCT). Design Observational cohort data from 771 subjects aged ≥72 years enrolled in the Ginkgo Evaluation of Memory study, a RCT of Ginkgo biloba for prevention of dementia. Methods Random effects logistic regression analyses examined effects of NEO Five-Factor Inventory scores on medication non-adherence, determined via pill counts every 6 months (median follow-up 6.1 years) and defined as taking personality factor associated with non-adherence: a 1 SD increase was associated with a 3.8% increase in the probability of non-adherence (95% CI [0.4, 7.2]). Lower cognitive function was also associated with non-adherence: a 1 SD decrease in mental status exam score was associated with a 3.0% increase in the probability of non-adherence (95% CI [0.2, 5.9]). Conclusions Neuroticism was associated with medication non-adherence over 6 years of follow-up in a large sample of older RCT participants. Personality measurement in clinical and research settings might help to identify and guide interventions for older adults at risk for medication non-adherence. PMID:21226789

  16. Cancer survivors' uptake and adherence in diet and exercise intervention trials: an integrative data analysis.

    Science.gov (United States)

    Adams, Rebecca N; Mosher, Catherine E; Blair, Cindy K; Snyder, Denise C; Sloane, Richard; Demark-Wahnefried, Wendy

    2015-01-01

    The health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors' willingness to participate in diet and exercise intervention trials, study enrollment, intervention adherence, and study completion. To assist in interpreting the generalizability of trial findings and to improve the design of future trials, this study examined predictors of these process measures. An integrative data analysis was performed on data from 3 of the largest home-based diet and exercise intervention trials for cancer survivors (n = 23,841). Demographic and medical factors (ie, sex, race, age, time since diagnosis, and cancer type) were examined as predictors of willingness to participate, study enrollment, intervention adherence, and study completion in the pooled sample. A 99% confidence interval was used to determine statistical significance. Across trials, 11.1% of contacted survivors were willing to participate, and 5.7% were eligible and enrolled. Among enrollees, 53.4% demonstrated ≥75% adherence to the intervention, and 91.1% completed the study. Race (Caucasian vs others), age, time since diagnosis, and cancer type predicted survivors' willingness to participate (P Cancer survivors' demographic and medical characteristics predicted their interest and participation in diet and exercise intervention trials. These findings have implications for the generalizability of results and can help to guide procedures used in future trials to enhance patient representation. © 2014 American Cancer Society.

  17. Cancer Survivors’ Uptake and Adherence in Diet and Exercise Intervention Trials: An Integrative Data Analysis

    Science.gov (United States)

    Adams, Rebecca N.; Mosher, Catherine E.; Blair, Cindy K.; Snyder, Denise C.; Sloane, Richard; Demark-Wahnefried, Wendy

    2014-01-01

    BACKGROUND The health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors’ willingness to participate in diet and exercise intervention trials, study enrollment, intervention adherence, and study completion. To assist in interpreting the generalizability of trial findings as well as to improve the design of future trials, we examined predictors of these process measures. METHODS An integrative data analysis was performed on data from three of the largest home-based diet and exercise intervention trials for cancer survivors (N=23,841). Demographic and medical factors (i.e., gender, race, age, time since diagnosis, and cancer type) were examined as predictors of willingness to participate, study enrollment, intervention adherence, and study completion in the pooled sample. A 99% confidence interval was used to determine statistical significance. RESULTS Across trials, 11.1% of contacted survivors were willing to participate and 5.7% were eligible and enrolled. Among enrollees, 53.4% demonstrated ≥75% adherence to the intervention and 91.1% completed the study. Race (Caucasian vs. others), age, time since diagnosis, and cancer type predicted survivors’ willingness to participate (p-valuesCancer survivors’ demographic and medical characteristics predicted their interest and participation in diet and exercise intervention trials. These findings have implications for the generalizability of results and can help guide procedures used in future trials to enhance patient representation. PMID:25155573

  18. Adherence to blood pressure telemonitoring in a cluster-randomized clinical trial

    Science.gov (United States)

    Kerby, Tessa J; Asche, Stephen E; Maciosek, Michael V; O’Connor, Patrick J; Sperl-Hillen, JoAnn M; Margolis, Karen L

    2012-01-01

    Background Hypertension is a leading cause of cardiovascular disease and death worldwide. Advances in technology have added telemedicine as a tool for managing hypertension. The effectiveness of telemedicine depends upon patients’ ability to adhere to schedules of home monitoring and case management. Methods Participants with uncontrolled hypertension in the intervention arm of a randomized trial who had completed 6 months of follow-up were included in this analysis. They were asked to measure their BP a minimum of 6 times per week using a telemonitor that transmitted the readings to their pharmacist case manager. Results Hypertensive patients in this study had high adherence to telemonitoring (73% took at least 6 BP readings per week) and phone visits (88% of expected visits were attended). In a multivariate analysis, older age, male gender, and some college education predicted better telemonitoring adherence. White non-hispanic race/ethnicity predicted better adherence to phone visits with pharmacist case managers. Telemonitoring adherence and phone adherence were highly correlated; participants who did not send readings on schedule were more likely to skip at least one phone visit with their pharmacist case manager. Conclusion The findings from this analysis indicate that hypertensive patients in this study were able to achieve and maintain high adherence to both the telemonitoring and the phone case management visits. PMID:23031143

  19. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial.

    Science.gov (United States)

    Sparrow, David; Aloia, Mark; Demolles, Deborah A; Gottlieb, Daniel J

    2010-12-01

    Continuous positive airway pressure (CPAP) is the most widely prescribed treatment for obstructive sleep apnoea syndrome (OSAS). Although it has been shown to improve the symptoms of OSAS, many patients have difficulty adhering to this treatment. The purpose of this study was to investigate the effectiveness of an automated telemedicine intervention to improve adherence to CPAP. A randomised clinical trial was undertaken in 250 patients being started on CPAP therapy for OSAS. Patients were randomly assigned to use a theory-driven interactive voice response system designed to improve CPAP adherence (telephone-linked communications for CPAP (TLC-CPAP), n=124) or to an attention placebo control (n=126) for 12 months. TLC-CPAP monitors patients' self-reported behaviour and CPAP-related symptoms and provides feedback and counselling through a structured dialogue to enhance motivation to use CPAP. A Sleep Symptoms Checklist, the Functional Outcomes of Sleep Questionnaire, the Center for Epidemiological Studies Depression Scale and the Psychomotor Vigilance Task were administered at study entry and at 6-month and 12-month follow-up. Hours of CPAP usage at effective mask pressure were measured by the CPAP device stored in its memory and retrieved at each visit. Median observed CPAP use in patients randomised to TLC-CPAP was approximately 1 h/night higher than in the control subjects at 6 months and 2 h/night higher at 12 months. Using generalised estimating equation modelling, the intervention had a significant effect on CPAP adherence. For secondary analysis, the effect of CPAP adherence on the secondary outcomes was analysed. CPAP adherence was significantly associated with a greater reduction in sleep apnoea symptoms and depressive symptoms and a greater improvement in functional status. No significant association was observed between CPAP adherence and reaction time. The TLC-CPAP intervention resulted in improved CPAP adherence, which was associated with improved

  20. Predictors of Medication Adherence in an AIDS Clinical Trial: Patient and Clinician Perceptions

    Science.gov (United States)

    Cox, Lisa E.

    2009-01-01

    This article presents data from an AIDS clinical trial that evaluated 238 (60 percent nonwhite) patients infected with HIV and their clinician's perceptions of medication adherence and visit attendance in relationship to lifestyle, psychosocial, and health belief model (HBM) variables. Twelve sites collected data via a prospective, multisite…

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

    Directory of Open Access Journals (Sweden)

    Kathleen M MacQueen

    2014-09-01

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

  2. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG).

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    Chesney, M A; Ickovics, J R; Chambers, D B; Gifford, A L; Neidig, J; Zwickl, B; Wu, A W

    2000-06-01

    This paper describes the AACTG Adherence Instruments, which are comprised of two self-report questionnaires for use in clinical trials conducted by the Adult AIDS Clinical Trials Group (AACTG). The questionnaires were administered to 75 patients at ten AACTG sites in the USA. All patients were taking combination antiretroviral therapy (ART), including at least one protease inhibitor. Eleven per cent of patients reported missing at least one dose the day before the interview, and 17% reported missing at least one dose during the two days prior. The most common reasons for missing medications included 'simply forgot' (66%) and a number of factors often associated with improved health, including being busy (53%), away from home (57%) and changes in routine (51%). Less adherent patients reported lower adherence self-efficacy (p = 0.006) and were less sure of the link between non-adherence and the development of drug resistance (p = 0.009). They were also more likely to consume alcohol, to be employed outside the home for pay and to have enrolled in clinical trials to gain access to drugs (all p USA and abroad.

  3. A randomized trial of lottery-based incentives and reminders to improve warfarin adherence: the Warfarin Incentives (WIN2) Trial.

    Science.gov (United States)

    Kimmel, Stephen E; Troxel, Andrea B; French, Benjamin; Loewenstein, George; Doshi, Jalpa A; Hecht, Todd E H; Laskin, Mitchell; Brensinger, Colleen M; Meussner, Chris; Volpp, Kevin

    2016-11-01

    Previous research has suggested that daily lottery incentives could improve medication adherence. Such daily incentives include implicit reminders. However, the comparative effectiveness of reminders alone versus daily incentives has not been tested. A total of 270 patients on warfarin were enrolled in a four-arm, multi-center, randomized controlled trial comparing a daily lottery-based incentive, a daily reminder, and a combination of the two against a control group (usual care). Participants in the reminder group had the lowest percentage of time out of target international normalized ratio (INR) range, the primary outcome, with an adjusted odds of an out-of-range INR 36% lower than among those in the control group, 95%CI [7%, 55%]. No other group had a statistically significant improvement in anticoagulation control relative to the control group or to each other. The only group that had significant improvement in incorrect adherence was the lottery group (incorrect adherence: 12.1% compared with 23.7% in the control group, difference of -7.4% 95%CI [-14%, -0.3%]). However, there was no relationship between changes in adherence and anticoagulation control in the lottery group. Automated reminders led to the largest improvements in anticoagulation control, although without impacting measured adherence. Lottery-based reminders improved measured adherence but did not lead to improved anticoagulation control. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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

    Directory of Open Access Journals (Sweden)

    Jessica E Haberer

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

  5. Understanding adherence to medications in type 2 diabetes care and clinical trials to overcome barriers: a narrative review.

    Science.gov (United States)

    Tiktin, Margaret; Celik, Selda; Berard, Lori

    2016-01-01

    To identify factors affecting adherence to medications in type 2 diabetes (T2D) care and clinical trials. Adherence to medication is associated with better patient outcomes, lower healthcare costs, and improved quality and robustness of trial data. In T2D, non-adherence to regimens may compromise glycemic, blood pressure and lipid control, which can, in turn, increase morbidity and mortality rates. A literature search was performed to identify studies reporting adherence to medications and highlighting specific adherence challenges/approaches in T2D. The search was limited to clinical trials, comparative studies or meta-analyses, reported in English with a freely available abstract. MEDLINE (31 December 2008 to 31 December 2013). Studies not reporting adherence to medications or highlighting adherence challenges/approaches in T2D, presenting only self-reported adherence or including fewer than 100 patients were excluded. Eligible reports are discussed narratively. Factors identified as having a detrimental impact on adherence were smoking, depression and polypharmacy. Conversely, increased convenience (e.g. pen compared with vial and syringe; medication supplied by mail order vs. retail pharmacy) was associated with better patient adherence, as were interventions that increased patient motivation (e.g. individualized, nurse-led consultation) and education. Medication adherence is influenced by complex and multifactorial issues, which can include smoking, depression, polypharmacy, convenience of obtaining and administering the medication, patient motivation and education. We recommend simplifying treatment regimens, where possible, improving provider-patient communication, and providing support and education to increase medication adherence, with a view to improving patient outcomes and clinical trial data quality.

  6. Evaluating adherence to the International Committee of Medical Journal Editors' policy of mandatory, timely clinical trial registration.

    Science.gov (United States)

    Huser, Vojtech; Cimino, James J

    2013-06-01

    To determine whether two specific criteria in Uniform Requirements for Manuscripts (URM) created by the International Committee of Medical Journal Editors (ICMJE)--namely, including the trial ID registration within manuscripts and timely registration of trials, are being followed. Observational study using computerized analysis of publicly available Medline article data and clinical trial registry data. We analyzed a purposive set of five ICMJE founding journals looking at all trial articles published in those journals during 2010-2011, and data from the ClinicalTrials.gov (CTG) trial registry. We measured adherence to trial ID inclusion policy as the percentage of trial journal articles that contained a valid trial ID within the article (journal-based sample). Adherence to timely registration was measured as the percentage of trials that registered the trial before enrolling the first participant within a 60-day grace period. We also examined timely registration rates by year of all phase II and higher interventional trials in CTG (registry-based sample). To determine trial ID inclusion, we analyzed 698 clinical trial articles in five journals. A total of 95.8% (661/690) of trial journal articles included the trial ID. In 88.3% the trial-article link is stored within a structured Medline field. To evaluate timely registration, we analyzed trials referenced by 451 articles from the selected five journals. A total of 60% (272/451) of articles were registered in a timely manner with an improving trend for trials initiated in later years (eg, 89% of trials that began in 2008 were registered in a timely manner). In the registry-based sample, the timely registration rates ranged from 56% for trials registered in 2006 to 72% for trials registered in 2011. Adherence to URM requirements for registration and trial ID inclusion increases the utility of PubMed and links it in an important way to clinical trial repositories. This new integrated knowledge source can facilitate

  7. Assessing Adherence in the CAPRISA 004 Tenofovir Gel HIV Prevention Trial: Results of a Nested Case–Control Study

    OpenAIRE

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

    2014-01-01

    Adherence undeniably impacts product effectiveness in microbicide trials, but the connection has proven challenging to quantify using routinely collected behavioral data. We explored this relationship using a nested case–control study in the CAPRISA 004 Tenofovir (TFV) gel HIV prevention trial. Detailed 3-month recall data on sex events, condom and gel use were collected from 72 incident cases and 205 uninfected controls. We then assessed how the relationship between self-reported adherence a...

  8. Tailored health messaging improves contraceptive continuation and adherence: results from a randomized controlled trial.

    Science.gov (United States)

    Garbers, Samantha; Meserve, Allison; Kottke, Melissa; Hatcher, Robert; Chiasson, Mary Ann

    2012-11-01

    Discontinuation and incorrect use of contraceptive methods may contribute to as many as 1 million unintended pregnancies annually in the United States. Interventions to improve contraceptive method continuation and adherence are needed. A three-arm randomized controlled trial was conducted at two family planning sites testing the efficacy of a computer-based contraceptive assessment module in increasing the proportion of patients who continued use of their chosen contraceptive method 4 months after the family planning visit (n=224). In analyses adjusting for clinical site of recruitment, family planning patients who used the module and received individually tailored health materials (n=78), compared to those in the control group (n=70), were significantly more likely to continue use of their chosen contraceptive method [95% compared to 77%; odds ratio (OR)=5.48; 95% confidence interval (CI): 1.72-17.42] and to adhere to their method (86% compared to 69%; OR=2.74; 95% CI: 1.21-6.21). No significant differences in these outcomes were found for participants who used the module but did not receive tailored materials (n=76), compared to the control group. Tailored health materials significantly improved contraceptive method continuation and adherence. Additional research on the impact of the intervention on continuation and adherence in a larger sample and over a longer follow-up period is merited. Copyright © 2012 Elsevier Inc. All rights reserved.

  9. Brief behavioral self-regulation counseling for HIV treatment adherence delivered by cell phone: an initial test of concept trial.

    Science.gov (United States)

    Kalichman, Seth C; Kalichman, Moira O; Cherry, Chauncey; Swetzes, Connie; Amaral, Christina M; White, Denise; Jones, Mich'l; Grebler, Tamar; Eaton, Lisa

    2011-05-01

    Affordable and effective antiretroviral therapy (ART) adherence interventions are needed for many patients to promote positive treatment outcomes and prevent viral resistance. We conducted a two-arm randomized trial (n = 40 men and women receiving and less than 95% adherent to ART) to test a single office session followed by four biweekly cell phone counseling sessions that were grounded in behavioral self-management model of medication adherence using data from phone-based unannounced pill counts to provide feedback-guided adherence strategies. The control condition received usual care and matched office and cell phone/pill count contacts. Participants were baseline assessed and followed with biweekly unannounced pill counts and 4-month from baseline computerized interviews (39/40 retained). Results showed that the self-regulation counseling delivered by cell phone demonstrated significant improvements in adherence compared to the control condition; adherence improved from 87% of pills taken at baseline to 94% adherence 4 months after baseline, p self-efficacy (p < 0.05) and use of behavioral strategies for ART adherence (p < 0.05). We conclude that the outcomes from this test of concept trial warrant further research on cell phone-delivered self-regulation counseling in a larger and more rigorous trial.

  10. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  11. Randomized trial of lottery-based incentives to improve warfarin adherence.

    Science.gov (United States)

    Kimmel, Stephen E; Troxel, Andrea B; Loewenstein, George; Brensinger, Colleen M; Jaskowiak, Jane; Doshi, Jalpa A; Laskin, Mitchell; Volpp, Kevin

    2012-08-01

    Poor adherence to medications is a major cause of morbidity and inadequate drug effectiveness. Efforts to improve adherence have typically been either ineffective or too complex to implement in clinical practice. Lottery-based incentive interventions could be a scalable approach to improving adherence. This was a randomized, controlled clinical trial of a daily lottery-based incentive in patients on warfarin stratified by baseline international normalized ratio (INR). The trial randomized 100 patients to either a lottery-based incentive or no lottery intervention. Main outcome was out-of-range INRs. Over 6 months, the overall percentage of out-of-range INRs did not differ between the 2 arms (mean 23.0% in lottery arm and 25.9% in control arm, adjusted odds ratio [OR] 0.93, 95% CI 0.62-1.41). However, among the a priori subgroup with a baseline INR below therapeutic range, there was a significant reduction in out-of-range INR in the lottery arm versus the control arm (adjusted OR 0.39, 95% CI 0.25-0.62), whereas there was no such effect among those with therapeutic INRs at baseline (adjusted OR 1.26, 95% CI, 0.76-2.09, P value for interaction = .0016). Among those with low INR at baseline, there was a nonsignificant 49% reduction in the odds of nonadherence with the intervention (OR 0.51, 95% CI 0.23-1.14). Although a lottery-based intervention was not associated with a significant improvement in anticoagulation control among all study participants, it improved control among an a priori group of patients at higher risk for poor adherence. Copyright © 2012 Mosby, Inc. All rights reserved.

  12. Using daily text-message reminders to improve adherence with oral contraceptives: a randomized controlled trial.

    Science.gov (United States)

    Hou, Melody Y; Hurwitz, Shelley; Kavanagh, Erin; Fortin, Jennifer; Goldberg, Alisa B

    2010-09-01

    To estimate whether women receiving daily text-message reminders have increased oral contraceptive pill adherence compared with women not receiving reminders. This randomized controlled trial estimated whether there was an effect of daily text-message reminders on oral contraceptive pill adherence of new oral contraceptive pill users. Pill-taking was tracked for 3 months by an electronic monitoring device with wireless data collection. During the study period, participants assigned the intervention received a daily reminder text message. Eighty-two women were assigned randomly to detect a 1.6+/-2.0 pill difference (90% power, 5% alpha, 15% dropout). Participants were 79% white, non-Hispanic, 99% high school graduates, and 99% nulliparous with a mean age of 22 years. Most reported condom use with past coital activity, and more than half reported prior emergency contraception use. The mean number of missed pills per cycle did not differ significantly between the groups: 4.9+/-3.0 for the text-message group and 4.6+/-3.5 for the control group (P=.60). The number of missed pills per cycle increased over the course of the study, but this pattern did not increase differentially between the groups. Adherence recorded by the electronic monitoring device indicated much poorer adherence than that recorded by patient diaries. Despite poor pill-taking, there were no pregnancies. Daily text-message reminders did not improve oral contraceptive pill adherence. Although the lack of benefit may be attributed to the frequent use of alternative reminder systems in the control group, the rate of missed pills when measured objectively was still very high in both groups. Clinicaltrials.gov, www.clinicaltrials.gov, NCT00733707. I.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    Goswami NJ

    2013-07-01

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

  15. Exposure to Latent Tuberculosis Treatment during Pregnancy: The PREVENT TB and the iAdhere Trials.

    Science.gov (United States)

    Moro, Ruth N; Scott, Nigel A; Vernon, Andrew; Tepper, Naomi K; Goldberg, Stefan V; Schwartzman, Kevin; Leung, Chi-Chiu; Schluger, Neil W; Belknap, Robert W; Chaisson, Richard E; Narita, Masahiro; Machado, Elizabeth S; Lopez, Marta; Sanchez, Jorge; Villarino, Margarita E; Sterling, Timothy R

    2018-02-02

    Data are limited regarding the safety of 12-dose once-weekly isoniazid (900 mg) plus rifapentine (900 mg) (3HP) for latent tuberculosis infection (LTBI) treatment during pregnancy. To assess safety and pregnancy outcomes among pregnant women who were inadvertently exposed to study medications in two LTBI trials (PREVENT TB or iAdhere) evaluating 3HP and 9 months of daily isoniazid (300 mg) (9H). Data from reproductive age (15-51 years) women who received ≥1 study dose of 3HP or 9H in either trial were analyzed. Drug exposure during pregnancy occurred if the estimated date of conception was on or before the last dose date. Of 126 pregnancies (125 participants) that occurred during treatment or follow-up, 87 were exposed to study drugs. Among these, fetal loss was reported for 4/31 (13%) and 8/56 (14%), 3HP and 9H, respectively (difference 13% - 14% = -1%; 95% CI -17% to +18%); and congenital anomalies in 0/20 and 2/41 (5%) live births, 3HP and 9H, respectively (difference 0 - 5% = -5%; 95% CI -18% to +16%). All fetal losses occurred in pregnancies trials, there was no unexpected fetal loss or congenital anomalies. These data offer some preliminary reassurance to clinicians and patients in circumstances when these drugs and regimens are the best option in pregnancy or in women of child-bearing potential. Clinical trial registered with clinicaltrials.gov (NCT00023452 and NCT01582711).

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

    Directory of Open Access Journals (Sweden)

    Sheridan Stacey L

    2011-12-01

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

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

    Science.gov (United States)

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

    2014-05-01

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

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

    Science.gov (United States)

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

    2016-10-06

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

  19. Determinants of exercise adherence and contamination in a randomized controlled trial in cancer patients during and after allogeneic HCT.

    Science.gov (United States)

    Kuehl, Rea; Schmidt, Martina E; Dreger, Peter; Steindorf, Karen; Bohus, Martin; Wiskemann, Joachim

    2016-10-01

    Evidence from randomized controlled trials is growing that exercise interventions are beneficial in cancer patients receiving allogeneic stem cell transplantation (allo-HCT). However, information about adherence to exercise interventions and exercise contamination in control groups is lacking. This information is crucial for the interpretation of study results. We therefore examined the determinants of exercise adherence and contamination in different treatment periods during (inpatient) and after (outpatient) allo-HCT. One hundred fifty-three patients scheduled for allo-HCT were randomized to a 1-year partly supervised exercise intervention (endurance and resistance exercise) or to a control group. Adherence was assessed via exercise logs and contamination via questionnaires. Adherence varied between 66 % (inpatient) and 78 % (outpatient) in different treatment periods. During (inpatient) transplantation period, higher adherence was significantly associated with lower fatigue (P = 0.004) and with having children at home (P = 0.049). Adherence after discharge was positively associated with endurance performance (P = 0.003); higher adherence after day 100 was associated with exercise activity prior allo-HCT (P = 0.010) and higher adherence after discharge (P = 0.001). Contamination among controls was high with 54 % and significantly associated with muscle strength (P = 0.025) and fatigue (P = 0.050). Exercise adherence in different treatment periods was determined by different variables, and contamination among controls was evident. These findings may have important implications for correct interpretation of randomized exercise intervention trials.

  20. Do Trials of Resistance Training to Improve Mobility After Stroke Adhere to the American College of Sports Medicine Guidelines? A Systematic Review.

    Science.gov (United States)

    Hendrey, Genevieve; Holland, Anne E; Mentiplay, Benjamin F; Clark, Ross A; Williams, Gavin

    2017-07-26

    To determine whether resistance training to improve mobility outcomes after stroke adheres to the American College of Sports Medicine (ACSM) guidelines, and whether adherence was associated with better outcomes. Online databases searched from 1975 to October 30, 2016. Randomized controlled trials examining the effectiveness of lower limb strength training on mobility outcomes in adult participants with stroke. Two independent reviewers completed data extraction. Quality of trials was determined using the Cochrane Risk of Bias Tool. Trials were scored based on their protocol's adherence to 8 ACSM recommendations. To determine if a relation existed between total adherence score and effect size, Spearman ρ was calculated, and between individual recommendations and effect size, Mann-Whitney U or Kruskal-Wallis tests were used. Thirty-nine trials met the inclusion criteria, and 34 were scored on their adherence to the guidelines. Adherence was high for frequency of training (100% of studies), but few trials adhered to the guidelines for intensity (32%), specificity (24%), and training pattern (3%). Based on the small number of studies that could be included in pooled analysis (n=12), there was no relation between overall adherence and effect size (Spearman ρ=-.39, P=.21). Adherence to the ACSM guidelines for resistance training after stroke varied widely. Future trials should ensure strength training protocols adhere more closely to the guidelines, to ensure their effectiveness in stroke can be accurately determined. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  1. Simulation improves procedural protocol adherence during central venous catheter placement: a randomized-controlled trial

    Science.gov (United States)

    Peltan, Ithan D.; Shiga, Takashi; Gordon, James A.; Currier, Paul F.

    2015-01-01

    Background Simulation training may improve proficiency at and reduces complications from central venous catheter (CVC) placement, but the scope of simulation’s effect remains unclear. This randomized controlled trial evaluated the effects of a pragmatic CVC simulation program on procedural protocol adherence, technical skill, and patient outcomes. Methods Internal medicine interns were randomized to standard training for CVC insertion or standard training plus simulation-based mastery training. Standard training involved a lecture, a video-based online module, and instruction by the supervising physician during actual CVC insertions. Intervention-group subjects additionally underwent supervised training on a venous access simulator until they demonstrated procedural competence. Raters evaluated interns’ performance during internal jugular CVC placement on actual patients in the medical intensive care unit. Generalized estimating equations were used to account for outcome clustering within trainees. Results We observed 52 interns place 87 CVCs. Simulation-trained interns exhibited better adherence to prescribed procedural technique than interns who received only standard training (p=0.024). There were no significant differences detected in first-attempt or overall cannulation success rates, mean needle passes, global assessment scores or complication rates. Conclusions Simulation training added to standard training improved protocol adherence during CVC insertion by novice practitioners. This study may have been too small to detect meaningful differences in venous cannulation proficiency and other clinical outcomes, highlighting the difficulty of patient-centered simulation research in settings where poor outcomes are rare. For high-performing systems, where protocol deviations may provide an important proxy for rare procedural complications, simulation may improve CVC insertion quality and safety. PMID:26154250

  2. Predictors of adherence to pharmacological and behavioral treatment in a cessation trial among smokers in Aleppo, Syria.

    Science.gov (United States)

    Ben Taleb, Ziyad; Ward, Kenneth D; Asfar, Taghrid; Bahelah, Raed; Maziak, Wasim

    2015-08-01

    The development of evidence-based smoking cessation programs is in its infancy in developing countries, which continue to bear the main brunt of the tobacco epidemic. Adherence to treatment recommendations is an important determinant of the success of smoking cessation programs, but little is known about factors influencing adherence to either pharmacological or behavioral treatment in developing countries settings. Our study represents the first attempt to examine the predictors of adherence to cessation treatment in a low-income developing country. Predictors of adherence to pharmacological and behavioral treatment were identified by analyzing data from a multi-site, two-group, parallel-arm, double-blind, randomized, placebo-controlled smoking cessation trial in primary care clinics in Aleppo, Syria. Participants received 3 in-person behavioral counseling sessions plus 5 brief follow-up phone counseling sessions, and were randomized to either 6 weeks of nicotine or placebo patch. Of the 269 participants, 68% adhered to pharmacological treatment, while 70% adhered to behavioral counseling. In logistic regression modeling, lower adherence to pharmacological and behavioral treatment was associated with higher daily smoking at baseline, greater withdrawal symptoms, and perception of receiving placebo instead of active nicotine patch. Women showed lower adherence than men to behavioral treatment, while being assigned to placebo condition and baseline waterpipe use were associated with lower adherence to pharmacological treatment. Adherence to cessation treatment for cigarette smokers in low-income countries such as Syria may benefit from integrated cessation components that provide intensive treatment for subjects with higher nicotine dependence, and address concurrent waterpipe use at all stages. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  3. Model-Based Approach to Predict Adherence to Protocol During Antiobesity Trials.

    Science.gov (United States)

    Sharma, Vishnu D; Combes, François P; Vakilynejad, Majid; Lahu, Gezim; Lesko, Lawrence J; Trame, Mirjam N

    2018-02-01

    Development of antiobesity drugs is continuously challenged by high dropout rates during clinical trials. The objective was to develop a population pharmacodynamic model that describes the temporal changes in body weight, considering disease progression, lifestyle intervention, and drug effects. Markov modeling (MM) was applied for quantification and characterization of responder and nonresponder as key drivers of dropout rates, to ultimately support the clinical trial simulations and the outcome in terms of trial adherence. Subjects (n = 4591) from 6 Contrave® trials were included in this analysis. An indirect-response model developed by van Wart et al was used as a starting point. Inclusion of drug effect was dose driven using a population dose- and time-dependent pharmacodynamic (DTPD) model. Additionally, a population-pharmacokinetic parameter- and data (PPPD)-driven model was developed using the final DTPD model structure and final parameter estimates from a previously developed population pharmacokinetic model based on available Contrave® pharmacokinetic concentrations. Last, MM was developed to predict transition rate probabilities among responder, nonresponder, and dropout states driven by the pharmacodynamic effect resulting from the DTPD or PPPD model. Covariates included in the models and parameters were diabetes mellitus and race. The linked DTPD-MM and PPPD-MM was able to predict transition rates among responder, nonresponder, and dropout states well. The analysis concluded that body-weight change is an important factor influencing dropout rates, and the MM depicted that overall a DTPD model-driven approach provides a reasonable prediction of clinical trial outcome probabilities similar to a pharmacokinetic-driven approach. © 2017, The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

  4. An educational intervention to improve adherence to high-dosage patching regimen for amblyopia: a randomised controlled trial.

    Science.gov (United States)

    Pradeep, Archana; Proudlock, Frank Antony; Awan, Musarat; Bush, Glen; Collier, Jacqueline; Gottlob, Irene

    2014-07-01

    Previous reports suggest that adherence to patching is a major issue in amblyopia treatment. We tested with an unmasked randomised controlled clinical trial whether an intense educational/motivational intervention improves adherence when a high-dose regime is prescribed. 62 children with newly diagnosed amblyopia were randomly allocated into two treatment arms with and without educational/motivational intervention material. Both were prescribed patching 10 h/day, 6 days/week for a fixed period of 12 weeks. The intervention arm received an educational/motivational intervention before patching which included information booklets, video, a cartoon story book, sticker charts and a dedicated session with a researcher. The control arm received the usual clinical information. The primary outcome measure was adherence measured using electronic occlusion dose monitors where a success/failure binary outcome was used to account for participants who dropped out of the study defined as patching >4 h/day. Visual outcome, expressed as percentage visual deficit, was measured as secondary outcome. The intervention increased adherence success rate from 45.2% in the control group to 80.6% in the intervention group (p=0.0027). However, visual outcome was not significantly better in the intervention group (p=0.190). Our study shows that an intense educational/motivational intervention can improve adherence to patching to high prescribed doses although no significant improvement in visual outcome was observed. TRIALS REGISTRATION NUMBER: ISRCTN05346737 (International Standard Randomised Controlled Trial Number Register).

  5. The Effect of Group Psychoeducation Program on Medication Adherence in Patients with Bipolar Mood Disorders: a Randomized Controlled Trial.

    Science.gov (United States)

    Rahmani, Farnaz; Ebrahimi, Hossein; Ranjbar, Fatemeh; Razavi, Seyed Sajjad; Asghari, Elnaz

    2016-12-01

    Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS) before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.

  6. The Effect of Group Psychoeducation Program on Medication Adherence in Patients with Bipolar Mood Disorders: a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Farnaz Rahmani

    2016-12-01

    Full Text Available Introduction: Medication nonadherence is highly prevalent in patients with bipolar disorders and often results in worsening disease prognosis. The purpose of this study was to investigate the effect of group psychoeducation on medication adherence in female patients with bipolar mood disorder type I. Methods: This randomized controlled trial was conducted on 76 patients with bipolar mood disorder admitted in female psychiatric wards of Razi teaching hospital, Tabriz, Iran. The participants were selected by convenience sampling method and were randomly assigned to experimental and control groups. Patients in experimental group received 10 continuous 90 minutes sessions of psychoeducation, two times a week. Medication adherence was measured using the medicine check list and medication adherence rating scale (MARS before and after intervention. Data analysis was performed with SPSS ver.13. Results: There was no significant difference between two groups regarding medication adherence before the intervention. After the study intervention, the mean scores of medication adherence check list and medication adherence rating scale in the experimental group were significantly higher than the control group. Conclusion: Since group psychoeducation was effective in improving patients' medication adherence, it could be recommended for psychiatric nurses to apply this intervention in the clinical setting.

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

    Science.gov (United States)

    Richardson, Cliff; Brunton, Lisa; Olleveant, Nicola; Henson, David B; Pilling, Mark; Mottershead, Jane; Fenerty, Cecilia H; Spencer, Anne Fiona; Waterman, Heather

    2013-01-01

    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. 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. 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. All questionnaires other than the Short Form-12 were considered to be valuable measures and use of a Medical Events Monitoring System device was considered to be an objective surrogate measure for adherence with eye drops. A multicenter, randomized, controlled equivalence trial of group versus individualized education using adherence as the primary outcome is the next step.

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

    Directory of Open Access Journals (Sweden)

    Julia R G Raifman

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

  9. Financial Incentives for Adherence to Hepatitis C Virus Clinical Care and Treatment: A Randomized Trial of Two Strategies

    Science.gov (United States)

    Allmon, Andrew G.; Evon, Donna; Hurt, Christopher; Reifeis, Sarah Ailleen; Thirumurthy, Harsha; Straub, Becky; Edwards, Angela; Mollan, Katie R.

    2017-01-01

    Abstract Background. Although rates of sustained virologic response (SVR) after hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) surpass 90% in trials and some more “real world” settings, some patients, such as those with substance use disorders, will be challenged to adhere to HCV care. Methods. To assess the feasibility of 2 strategies for financially incentivizing adherence to HCV care, patients with a substance use history prescribed 12 weeks of a sofosbuvir-containing regimen were randomized to either fixed or lottery-based monetary incentives for attending clinic appointments, pill count adherence >90%, and SVR achievement. Electronic medication monitoring provided an objective measure of DAA adherence. Results. Fifty-nine participants were randomized to the lottery (n = 31) or fixed-incentive (n = 28) arms. All 31 (100%) in the lottery arm and 24 of 28 (86%) in the fixed arm completed 12 weeks of therapy. By intent-to-treat, 93% in the lottery arm and 92% in the fixed arm achieved SVR (estimated difference: 0.5%; 95% confidence interval, −17.5 to 18.8). Overall, 92% of scheduled visits were attended without significant differences between arms. The mean adherence ratio (days with ≥1 bottle opening:monitored days) was 0.91 for lottery and 0.92 for fixed arms. Conclusions. In this pilot, fixed- and lottery-based financial incentives were successfully implemented and accepted by patients with a substance use history. High levels of HCV therapy and care adherence, as well as rates of SVR, were observed. Financial incentives may be useful to support treatment adherence in patients with substance use disorders and should be tested in a larger, randomized, controlled trial. PMID:28695144

  10. Increasing adherence to obstructive sleep apnea treatment with a group social cognitive therapy treatment intervention: a randomized trial.

    Science.gov (United States)

    Bartlett, Delwyn; Wong, Keith; Richards, Dianne; Moy, Emma; Espie, Colin A; Cistulli, Peter A; Grunstein, Ronald

    2013-11-01

    To examine whether a social cognitive therapy (SCT) intervention increases continuous positive airway pressure (CPAP) use compared to equivalent social interaction (SI) time. Individuals with obstructive sleep apnea (OSA) referred for CPAP therapy. Participants received a 30-min group education session regarding OSA and CPAP. Groups of three to four participants were then randomly assigned to an SCT session or social interaction. CPAP usage was assessed at 7 nights, then 1, 3, and 6 months. The two primary outcomes were adherence, usage ≥ 4 h per night at 6 months, and uptake of CPAP. Questionnaires were given pretreatment and posttreatment. Two hundred six individuals were randomized to SI (n = 97) or SCT (n = 109). CPAP uptake was not different between groups (82% in SI, 88% in SCT groups, P = 0.35). There were no differences between groups in adherence: 63-66% at 1 week, and at 6 months 55-47% (P = 0.36). Higher pretreatment apnea-hypopnea index, higher baseline self-efficacy, and use of CPAP (≥ 4 h) at 1 week were independent predictors of CPAP adherence at 6 months. CPAP adherence increased by a factor of 1.8 (odds ratio = 1.8, 95% confidence interval 1.1-3.0) for every one-unit increase in self-efficacy. There was no difference between groups postintervention in self-efficacy scores, sleepiness, mood, or sleep quality. In this randomized trial, a single SCT application did not increase adherence when compared with SI time. Although self-efficacy scores prior to CPAP predicted adherence, self-efficacy was not increased by the interventions. Increasing intensity and understanding of SCT interventions may be needed to improve CPAP adherence. Australian New Zealand Clinical Trials Registry, ACTRN12607000424404.

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

    Science.gov (United States)

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

    2014-07-07

    Oral medication for patients with type 2 diabetes mellitus plays an important role in diabetes care and is associated with a high level self-care behavior and self-management. However, poor adherence to diabetes treatment is common which causes severe health complications and increased mortality. Barriers to adherence may consist of complex treatment regimens often along with long-term multi-therapies, side effects due to the medication as well as insufficient, incomprehensible or confusing information or instructions provided by the health care provider. Multidisciplinary approaches can support adherence success and can enable a more effective management of diabetes care. One approach in diabetes care can be the involvement of a pharmacist. The aim was to analyze the effectiveness of adherence-enhancing pharmacist interventions for oral medication in type 2 diabetes mellitus. A systematic review of randomized controlled trials. The study quality was assessed with the Cochrane risk of bias tool. Of 491 hits, six publications were included. Two studies mainly examining educational interventions showed a significant improvement in adherence. Moreover, the quality of the included studies was deficient. Although pharmacist interventions might potentially improve adherence to type 2 diabetes mellitus medication, high-quality studies are needed to assess effectiveness.

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

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    Madelon Novato Ribeiro

    2014-07-01

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

  13. Rationale and design of the Medication adherence Improvement Support App For Engagement-Blood Pressure (MedISAFE-BP) trial.

    Science.gov (United States)

    Morawski, Kyle; Ghazinouri, Roya; Krumme, Alexis; McDonough, Julianne; Durfee, Erin; Oley, Leslie; Mohta, Namita; Juusola, Jessie; Choudhry, Niteesh K

    2017-04-01

    Hypertension is a major contributor to the health and economic burden imposed by stroke, heart disease, and renal insufficiency. Antihypertensives can prevent many of the harmful effects of elevated blood pressure, but medication nonadherence is a known barrier to the effectiveness of these treatments. Smartphone-based applications that remind patients to take their medications, provide education, and allow for social interactions between individuals with similar health concerns have been widely advocated as a strategy to improve adherence but have not been subject to rigorous testing. The MedISAFE-BP study is a prospective, randomized control trial designed to evaluate the impact on blood pressure and medication adherence of an mhealth application (Medisafe). Four hundred thirteen patients with uncontrolled hypertension have been enrolled and randomized in a 1:1 fashion to usual care or to the use of the Medisafe mhealth platform. Patients will be followed up for 12 weeks and the trial's co-primary outcomes will be change in systolic blood pressure and self-reported medication adherence. The MedISAFE-BP trial is the first study to rigorously evaluate an mhealth application's effect on blood pressure and medication adherence. The results will inform the potential effectiveness of this simple system in improving cardiovascular disease risk factors and clinical outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Richardson C

    2013-10-01

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

  15. The patient education - Learning and Coping Strategies - improves adherence in cardiac rehabilitation (LC-REHAB): A randomised controlled trial.

    Science.gov (United States)

    Lynggaard, Vibeke; Nielsen, Claus Vinther; Zwisler, Ann-Dorthe; Taylor, Rod S; May, Ole

    2017-06-01

    Despite proven benefits of cardiac rehabilitation (CR), adherence to CR remains suboptimal. This trial aimed to assess the impact of the patient education 'Learning and Coping Strategies' (LC) on patient adherence to an eight-week CR program. 825 patients with ischaemic heart disease or heart failure were open label randomised to either the LC arm (LC plus CR) or the control arm (CR alone) across three hospital units in Denmark. Both arms received same amount of training and education hours. LC consisted of individual clarifying interviews, participation of experienced patients as co-educators, situational, reflective and inductive teaching. The control arm received structured deductive teaching. The primary outcomes were patient adherence to at least 75% of the exercise training or education sessions. We tested for subgroup effects on the primary outcomes using interaction terms. The primary outcomes were compared across arms using logistic regression. More patients in the LC arm adhered to at least 75% of the exercise training sessions than control (80% versus 73%, adjusted odds ratio (OR):1.48; 95% CI:1.07 to 2.05, P=0.018) and 75% of education sessions (79% versus 70%, adjusted OR:1.61, 1.17 to 2.22, P=0.003). Some evidence of larger effects of LC on adherence was seen for patients with heart failure, low education and household income. Addition of LC strategies improved adherence in rehabilitation both in terms of exercise training and education. Patients with heart failure, low levels of education and household income appear to benefit most from this adherence promoting intervention. www.clinicaltrials.gov identifier NCT01668394. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Exploring ART intake scenes in a human rights-based intervention to improve adherence: a randomized controlled trial.

    Science.gov (United States)

    Basso, Cáritas Relva; Helena, Ernani Tiaraju Santa; Caraciolo, Joselita Maria Magalhães; Paiva, Vera; Nemes, Maria Ines Battistela

    2013-01-01

    To assess the effectiveness of a psychosocial individual intervention to improve adherence to ART in a Brazilian reference-center, consenting PLHIV with viral load >50 copies/ml were selected. After 4 weeks of MEMS cap use, participants were randomized into an intervention group (IG) (n = 64) or control group (CG) (n = 57). CG received usual care only. The IG participated in a human rights-based intervention approach entailing four dialogical meetings focused on medication intake scenes. Comparison between IG and CG revealed no statistically significant difference in adherence measured at weeks 8, 12, 16, 20 and 24. Viral load (VL) decreased in both groups (p < 0.0001) with no significant difference between study groups. The lower number of eligible patients than expected underpowered the study. Ongoing qualitative analysis should provide deeper understanding of the trial results. NIH Clinical Trials: NCT00716040.

  17. Telemonitoring Adherence to Medications in Heart Failure Patients (TEAM-HF): A Pilot Randomized Clinical Trial.

    Science.gov (United States)

    Gallagher, Benjamin D; Moise, Nathalie; Haerizadeh, Mytra; Ye, Siqin; Medina, Vivian; Kronish, Ian M

    2017-04-01

    Medication nonadherence contributes to hospitalizations in recently discharged patients with heart failure (HF). We aimed to test the feasibility of telemonitoring medication adherence in patients with HF. We randomized 40 patients (1:1) hospitalized for HF to 30 days of loop diuretic adherence monitoring with telephonic support or to passive adherence monitoring alone. Eighty-three percent of eligible patients agreed to participate. The median age of patients was 64 years, 25% were female, and 45% were Hispanic. Overall, 67% of patients were nonadherent (percentage of days that the correct number of doses were taken patients, respectively, in adherence (median correct dosing adherence 82% vs 73%; P = .41) or in the proportion readmitted within 30 days (30% vs 20%; P = .72). Eighty-eight percent of patients rated the wireless electronic adherence device as somewhat or very easy to use, and 88% agreed to use it again. Adherence telemonitoring was acceptable to most patients with HF. Diuretic nonadherence was common even when patients knew they were being monitored. Future studies should assess whether adherence telemonitoring can improve adherence and reduce readmissions among patients with HF. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study.

    Science.gov (United States)

    Scianni, Aline; Teixeira-Salmela, Luci F; Ada, Louise

    2012-01-01

    There is a high demand for stroke rehabilitation in the Brazilian public health system which should make undertaking clinical trials straightforward. The aims of this study were to 1) determine the rate of recruitment of community-dwelling stroke survivors into a randomized trial of the effects of strength training in addition to task-specific gait training, 2) compare the effectiveness of various recruitment strategies on accrual rates, and 3) determine the attendance at training sessions and adherence to the intervention protocol. Participants within six months of a stroke were screened for eligibility and invited to participate. Recruitment strategies were classified as advertisement or referral. The number of people who were screened, eligible and recruited for each strategy was recorded. Attendance at training sessions and adherence to the intervention protocol were recorded. Over the first 14 months, 150 stroke survivors were screened, 10 were recruited, and 35 (23%) were eligible. Twenty-five of these patients (71%) were unable to participate with lack of transport given as the most common reason. The most successful strategy was referral via hospital-based physical therapists (50%). Overall attendance was 72% with lack of transport being the most common reason for non-attendance. Overall adherence to the protocol was 97% with feeling unwell being the most common reason for non-adherence. Recruitment of stroke survivors was inefficient. Lack of transport was the most common barrier to participate in and attend training sessions. Funding for transport is essential to make carrying out trials in Brazil feasible. Trial Registration ACTRN12609000803291.

  19. A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial

    Science.gov (United States)

    Koufopoulos, Justin T; Conner, Mark T; Gardner, Peter H

    2016-01-01

    Background Online communities hold great potential as interventions for health, particularly for the management of chronic illness. The social support that online communities can provide has been associated with positive treatment outcomes, including medication adherence. There are few studies that have attempted to assess whether membership of an online community improves health outcomes using rigorous designs. Objective Our objective was to conduct a rigorous proof-of-concept randomized controlled trial of an online community intervention for improving adherence to asthma medicine. Methods This 9-week intervention included a sample of asthmatic adults from the United Kingdom who were prescribed an inhaled corticosteroid preventer. Participants were recruited via email and randomized to either an “online community” or “no online community” (diary) condition. After each instance of preventer use, participants (N=216) were required to report the number of doses of medication taken in a short post. Those randomized to the online community condition (n=99) could read the posts of other community members, reply, and create their own posts. Participants randomized to the no online community condition (n=117) also posted their medication use, but could not read others’ posts. The main outcome measures were self-reported medication adherence at baseline and follow-up (9 weeks postbaseline) and an objective measure of adherence to the intervention (visits to site). Results In all, 103 participants completed the study (intervention: 37.8%, 39/99; control: 62.2%, 64/117). MANCOVA of self-reported adherence to asthma preventer medicine at follow-up was not significantly different between conditions in either intention-to-treat (P=.92) or per-protocol (P=.68) analysis. Site use was generally higher in the control compared to intervention conditions. Conclusions Joining an online community did not improve adherence to preventer medication for asthma patients. Without

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

    Directory of Open Access Journals (Sweden)

    Alfredo D. Oliveira-Filho

    2014-12-01

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

  1. A Pharmaceutical Care Program to Improve Adherence to Statin Therapy : A Randomized Controlled Trial

    NARCIS (Netherlands)

    Eussen, Simone R. B. M.; van der Elst, Menno E.; Klungel, Olaf H.; Rompelberg, Cathy J. M.; Garssen, Johan; Oosterveld, Marco H.; de Boer, Anthonius; de Gier, Johan J.; Bouvy, Marcel L.

    2010-01-01

    BACKGROUND: Despite the well-known beneficial effects of statins, many patients do not adhere to chronic medication regimens. OBJECTIVE: To implement and assess the effectiveness of a community pharmacy based pharmaceutical care program developed to improve patients' adherence to statin therapy.

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

    Science.gov (United States)

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

    2012-01-01

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

  3. Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol.

    Science.gov (United States)

    Ivers, Noah; Schwalm, J-D; Witteman, Holly O; Presseau, Justin; Taljaard, Monica; McCready, Tara; Bosiak, Beth; Cunningham, Jennifer; Smarz, Shelley; Desveaux, Laura; Tu, Jack V; Atzema, Clare; Oakes, Garth; Isaranuwatchai, Wanrudee; Grace, Sherry L; Bhatia, R Sacha; Natarajan, Madhu; Grimshaw, Jeremy M

    2017-08-01

    Guidelines recommend cardiac rehabilitation and long-term use of cardiac medications for most patients who have had a myocardial infarction (MI), but adherence to these secondary prevention treatments is suboptimal. This is a multicenter, pragmatic, 3-arm randomized trial. Eligible patients (n = 2,742) with obstructive coronary artery disease are randomized post-MI to usual care or 1 of 2 intervention arms. Patients in the first intervention arm receive mail-outs sent on behalf of their cardiologist at 4, 8, 20, 32, and 44 weeks post-MI; content is designed to address determinants of adherence and facilitate discussion between the patient and their health care team. Patients in the second intervention arm receive mail-outs plus automated interactive voice response system telephone calls 2 weeks after each letter, as well as a telephone call by trained lay health workers if the interactive voice response system identifies challenges with adherence. Outcomes are assessed 12 months post-MI via patient self-report and administrative data sources. Co-primary outcomes are adherence to cardiac medications and completion of cardiac rehabilitation. Secondary outcomes include cardiovascular events and mortality. An embedded, theory-informed process evaluation will explore the mechanism of action; an economic evaluation is also planned. We describe a complete program evaluation of a highly pragmatic, health-system intervention to support adherence to recommended treatments. Research ethics boards approved waiver of consent for patients enrolled in the trial with provision of multiple opportunities to opt out and a debrief at the time of outcome assessment. The methods used here may provide a model for similar interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. Medication Adherence and Treatment Success in the NICHD-Reproductive Medicine Network’s “Pregnancy in Polycystic Ovary Syndrome” (PPCOS) Trial

    Science.gov (United States)

    McGovern, Peter G.; Carson, Sandra A.; Barnhart, Huiman X.; Myers, Evan R.; Legro, Richard S.; Diamond, Michael P.; Carr, Bruce R.; Schlaff, William D.; Coutifaris, Christos; Cataldo, Nicholas A.; Steinkampf, Michael P.; Nestler, John E.; Gosman, Gabey; Leppert, Phyllis C.; Giudice, Linda C.

    2008-01-01

    We investigated whether poor adherence with metformin tablets may have contributed to the poor success rates seen in the metformin-containing arms of the PPCOS Trial. Median adherence for both metformin and clomiphene citrate tablets were within acceptable limits and unrelated to ovulation: thus, failure to comply with physician recommendations for metformin dosing was not the reason for low ovulation and pregnancy rates in the PPCOS Trial. PMID:18082737

  5. PrEP Adherence Patterns Strongly Affect Individual HIV Risk and Observed Efficacy in Randomized Clinical Trials.

    Science.gov (United States)

    Dimitrov, Dobromir T; Mâsse, Benoît R; Donnell, Deborah

    2016-08-01

    Randomized controlled trials (RCTs) suggest that the efficacy of tenofovir-based preexposure prophylaxis (PrEP) strongly depends on the consistency of PrEP use. We explore how the patterns of pill taking and waning of PrEP protection may affect PrEP efficacy for HIV prevention. A 2-arm RCT was simulated by mathematical models assuming that the prescribed daily doses were skipped periodically, randomly, or in large blocks. Risk-driven adherence, in which PrEP was taken when sex was expected, was also investigated. Three temporal PrEP protection profiles were explored: long (5 days), intermediate (3 days), and short (24 hours). Modeling results were compared to the efficacy observed in completed RCTs. The expected PrEP efficacy was 60% with periodic, 50% with random, and 34% with block adherence when PrEP had a long protection profile and pills were taken only 50% of the days. Risk-driven pill taking resulted in 29% and 37% daily pills taken and efficacy of 43% and 51%, respectively, for long protection. High PrEP efficacy comparable with that observed in Partners PrEP and Centers for Disease Control and Prevention Botswana trials was simulated under long protection, high overall adherence, and limited block pill taking; the moderate efficacy observed in iPrEx and Bangkok trials was comparable with the 50% adherence scenarios under random pill taking and long protection. Pill-taking patterns may have a substantial impact on the protection provided by PrEP even when the same numbers of pills are taken. When PrEP retains protection for longer than a day, pill-taking patterns can explain a broad range of efficacies observed in PrEP RCTs.

  6. Trials and tribulations with electronic medication adherence monitoring in kidney transplantation.

    Science.gov (United States)

    Williams, Allison; Low, Jac Kee; Manias, Elizabeth; Dooley, Michael; Crawford, Kimberley

    2016-01-01

    Medication adherence in kidney transplantation is critical to prevent graft rejection. Testing interventions designed to support patients to take their prescribed medications following a kidney transplant require an accurate measure of medication adherence. In research, the available methods for measuring medication adherence include self-report, pill counts, prescription refill records, surrogate measures of medication adherence and medication bottles with a microchip-embedded cap to record bottle openings. Medication bottles with a microchip-embedded cap are currently regarded as the gold standard measure. This commentary outlines the challenges in measuring medication adherence using electronic medication monitoring of kidney transplant patients recruited from five sites. The challenges included obtaining unanimous stakeholder support for using this method, agreement on an index medication to measure, adequate preparation of the patient and training of pharmacy staff, and how to analyze data when periods of time were not recorded using the electronic adherence measure. Provision of this information will enable hospital and community pharmacists to implement approaches that promote the effective use of this adherence measure for optimal patient outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. The clinical utility of the Medication Adherence Questionnaire (MAQ) in an alcohol pharmacotherapy trial.

    Science.gov (United States)

    Zweben, A; Piepmeier, M E; Fucito, L; O'Malley, S S

    2017-06-01

    Medication nonadherence is a ubiquitous problem in pharmacology treatment for alcohol use disorders. Unintentional and purposeful nonadherence as measured by the Medication Adherence Questionnaire (MAQ) has been shown to predict problems with medication adherence; however, feedback from the MAQ has never been incorporated into a behavioral intervention to facilitate medication adherence. We assessed the integration of the MAQ into medical management (MM), a counseling approach frequently employed in conjunction with alcohol pharmacotherapy, to determine whether prior patterns of nonadherence could be addressed effectively to promote medication adherence. We conducted a post-hoc analysis of data from 131 alcohol dependent smokers who participated in a double blind, placebo controlled study of varenicline for the treatment of alcohol dependence. At baseline, participants completed a single administration of the MAQ, which asks 2 questions about unintentional nonadherence (e.g., forgetting) and 2 questions about purposeful nonadherence (e.g., stopping because feeling good or feeling bad). Based on these responses, participants were divided into 1 of 3 three categories. Adherent (n=60), Unintentional or Purposeful Nonadherent (n=50) and Unintentional and Purposeful Nonadherent (n=21). Over the course of the 16-week treatment period, patients were expected to participate in 12 medical management (MM) sessions; a brief psychosocial treatment. Feedback based on the MAQ responses was integrated into the MM sessions to facilitate medication and treatment adherence. The 3 adherence groups were compared on baseline characteristics, medication adherence, treatment attendance and end-of-treatment patient ratings of treatment helpfulness. Baseline demographics and characteristics were not significantly different among the three categories. We found no statistically significant differences among the three groups with respect to pill adherence, treatment attendance, and treatment

  8. Video chat technology to remotely quantify dietary, supplement and medication adherence in clinical trials.

    Science.gov (United States)

    Peterson, Courtney M; Apolzan, John W; Wright, Courtney; Martin, Corby K

    2016-11-01

    We conducted two studies to test the validity, reliability, feasibility and acceptability of using video chat technology to quantify dietary and pill-taking (i.e. supplement and medication) adherence. In study 1, we investigated whether video chat technology can accurately quantify adherence to dietary and pill-taking interventions. Mock study participants ate food items and swallowed pills, while performing randomised scripted 'cheating' behaviours to mimic non-adherence. Monitoring was conducted in a cross-over design, with two monitors watching in-person and two watching remotely by Skype on a smartphone. For study 2, a twenty-two-item online survey was sent to a listserv with more than 20 000 unique email addresses of past and present study participants to assess the feasibility and acceptability of the technology. For the dietary adherence tests, monitors detected 86 % of non-adherent events (sensitivity) in-person v. 78 % of events via video chat monitoring (P=0·12), with comparable inter-rater agreement (0·88 v. 0·85; P=0·62). However, for pill-taking, non-adherence trended towards being more easily detected in-person than by video chat (77 v. 60 %; P=0·08), with non-significantly higher inter-rater agreement (0·85 v. 0·69; P=0·21). Survey results from study 2 (n 1076 respondents; ≥5 % response rate) indicated that 86·4 % of study participants had video chatting hardware, 73·3 % were comfortable using the technology and 79·8 % were willing to use it for clinical research. Given the capability of video chat technology to reduce participant burden and outperform other adherence monitoring methods such as dietary self-report and pill counts, video chatting is a novel and promising platform to quantify dietary and pill-taking adherence.

  9. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial.

    Science.gov (United States)

    Lai, Agnes Y K; Fong, Daniel Y T; Lam, Jamie C M; Weaver, Terri E; Ip, Mary S M

    2014-09-01

    Poor adherence to CPAP treatment in OSA adversely affects the effectiveness of this therapy. This randomized controlled trial (RCT) examined the efficacy of a brief motivational enhancement education program in improving adherence to CPAP treatment in subjects with OSA. Subjects with newly diagnosed OSA were recruited into this RCT. The control group received usual advice on the importance of CPAP therapy and its care. The intervention group received usual care plus a brief motivational enhancement education program directed at enhancing the subjects' knowledge, motivation, and self-efficacy to use CPAP through the use of a 25-min video, a 20-min patient-centered interview, and a 10-min telephone follow-up. Self-reported daytime sleepiness adherence-related cognitions and quality of life were assessed at 1 month and 3 months. CPAP usage data were downloaded at the completion of this 3-month study. One hundred subjects with OSA (mean ± SD, age 52 ± 10 years; Epworth Sleepiness Scales [ESS], 9 ± 5; median [interquartile range] apnea-hypopnea index, 29 [20, 53] events/h) prescribed CPAP treatment were recruited. The intervention group had better CPAP use (higher daily CPAP usage by 2 h/d [Cohen d = 1.33, P CPAP for ≥ 70% of days with ≥ 4 h/d [P motivational enhancement education in addition to usual care were more likely to show better adherence to CPAP treatment, with greater improvements in treatment self-efficacy and daytime sleepiness. ClinicalTrials.gov; No.: NCT01173406; URL: www.clinicaltrials.gov.

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

    National Research Council Canada - National Science Library

    Lonsdale, Chris; Hall, Amanda M; Williams, Geoffrey C; McDonough, Suzanne M; Ntoumanis, Nikos; Murray, Aileen; Hurley, Deirdre A

    2012-01-01

    ...., adherence to physiotherapists' recommendations). The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists' autonomy-supportive communication on low back pain patients' adherence to physical activity...

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

    Directory of Open Access Journals (Sweden)

    Prevost A Toby

    2010-11-01

    Full Text Available Abstract Background The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows: IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype, compared to one tailored to nicotine dependence questionnaire score (phenotype. II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype. Methods/Design An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily using National Health Service (NHS stop smoking services in primary care are randomly allocated to one of two groups: i. NRT oral dose tailored by DNA analysis (OPRM1 gene (genotype, or ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples t-test and by estimating the 95

  12. Simplifying regimens promotes greater adherence and outcomes with topical acne medications: a randomized controlled trial.

    Science.gov (United States)

    Yentzer, Brad A; Ade, Rachel A; Fountain, Julie M; Clark, Adele R; Taylor, Sarah L; Fleischer, Alan B; Feldman, Steven R

    2010-08-01

    New combination topical formulations for the treatment of acne may improve outcomes by increasing adherence. We assessed adherence to and efficacy of a combination topical medication for acne applied once daily compared with daily applications of 2 separate generic subcomponents. Twenty-six participants with mild to moderate acne vulgaris were randomized to 12 weeks of once daily application of clindamycin phosphate 7.2%-tretinoin 0.025% gel (CTG) combination product or separate daily applications of clindamycin phosphate gel 1% and tretinoin cream 0.025% (C gel + T cream) for a total of 2 applications daily. Disease severity was measured at baseline and weeks 4, 8, and 12. Adherence was monitored using electronic monitoring caps on the medication tubes. Of the 26 participants enrolled, 21 completed the 12-week study. Median adherence in the CTG group was 88% compared with 61% in the C gel + T cream group. There was a 51% mean reduction in total lesions for the CTG group versus a 32% mean reduction for the C gel + T cream group by the end of the study. Both CTG and separate applications of C gel + T cream improved mild to moderate acne. The use of a once daily combination product has the advantage of promoting better adherence and clinical outcomes.

  13. Predicting the effect of interactive video bikes on exercise adherence: An efficacy trial.

    Science.gov (United States)

    Rhodes, Ryan E; Warburton, Darren E R; Bredin, Shannon S D

    2009-12-01

    Exercise games that employ video game technology are increasing in the marketplace but have received scant research attention despite their popularity. The purpose of this study was to evaluate the effect of videobike gaming on the constructs of the theory of planned behavior (TPB) and adherence in comparison to a cycling condition where participants listen to self-selected music. Participants were 29 inactive young men assigned randomly to experimental (n = 16) or comparison (n = 13) conditions. The recommended training regime consisted of moderate intensity activity (60-75% heart rate reserve), 3 days/week for 30 min/day for 6 weeks. At the end of the first session, participants were asked to complete TPB measures and these were subsequently measured 6 weeks later. Attendance was used as the measure of adherence. Results showed that affective attitude and adherence across the 6 weeks significantly favored the videobike condition over the comparison condition. Regression analyses suggested partial mediation of the effect of the videobike condition on adherence via affective attitude. This is the first study to provide evidence that interactive videobikes may improve adherence over traditional cycling because the activity produces higher affective attitudes. The results are promising for expanding to community-based evaluation.

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

    Directory of Open Access Journals (Sweden)

    Sachin Satpute

    2016-01-01

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

  15. Design of a randomized trial to evaluate the influence of mobile phone reminders on adherence to first line antiretroviral treatment in South India - the HIVIND study protocol

    Directory of Open Access Journals (Sweden)

    Kumarasamy Nagalingeswaran

    2010-03-01

    Full Text Available Abstract Background Poor adherence to antiretroviral treatment has been a public health challenge associated with the treatment of HIV. Although different adherence-supporting interventions have been reported, their long term feasibility in low income settings remains uncertain. Thus, there is a need to explore sustainable contextual adherence aids in such settings, and to test these using rigorous scientific designs. The current ubiquity of mobile phones in many resource-constrained settings, make it a contextually appropriate and relatively low cost means of supporting adherence. In India, mobile phones have wide usage and acceptability and are potentially feasible tools for enhancing adherence to medications. This paper presents the study protocol for a trial, to evaluate the influence of mobile phone reminders on adherence to first-line antiretroviral treatment in South India. Methods/Design 600 treatment naïve patients eligible for first-line treatment as per the national antiretroviral treatment guidelines will be recruited into the trial at two clinics in South India. Patients will be randomized into control and intervention arms. The control arm will receive the standard of care; the intervention arm will receive the standard of care plus mobile phone reminders. Each reminder will take the form of an automated call and a picture message. Reminders will be delivered once a week, at a time chosen by the patient. Patients will be followed up for 24 months or till the primary outcome i.e. virological failure, is reached, whichever is earlier. Self-reported adherence is a secondary outcome. Analysis is by intention-to-treat. A cost-effectiveness study of the intervention will also be carried out. Discussion Stepping up telecommunications technology in resource-limited healthcare settings is a priority of the World Health Organization. The trial will evaluate if the use of mobile phone reminders can influence adherence to first

  16. Adherence to the CONSORT Statement in the Reporting of Randomized Controlled Trials on Pharmacological Interventions Published in Iranian Medical Journals

    Directory of Open Access Journals (Sweden)

    Pooneh Sarveravan

    2017-11-01

    Full Text Available Background: Among manuscripts submitted to biomedical journals, randomized controlled trials (RCTs form the backbone of evidence-based medicine. Hence, their protocol should be designed rigorously and their results should be reported clearly. To improve the quality of RCT reporting, researchers developed the CONSORT Statement in 1996 and updated it in 2010. This study was designed to assess the quality of RCT reporting vis-à-vis adherence to CONSORT among articles published in Iranian medical journals (English, Persian, CONSORT-endorsing, and non-CONSORT-endorsing. Methods: In this cross-sectional study, all RCTs published in all Iranian medical journals from September 2012 to September 2013 were retrieved to evaluate their adherence to CONSORT. The journals’ instructions for authors were also reviewed to find out whether or not they endorsed CONSORT. The CONSORT 2010 Checklist was used. Microsoft Excel 2007 was applied to analyze the data, and MedCalc was employed to compare the groups. Results: Totally, 492 pharmacological RCTs that met our inclusion criteria were identified. Twenty-five items were reported in fewer than 50% of the articles. The differences between the articles published in Persian and English language journals were statistically significant in 17 items. The differences between the articles published in the CONSORT-endorsing and non-CONSORT-endorsing journals were significant in 8 items. Conclusion: Our findings showed very weak adherence to CONSORT. Authors, reviewers, and editors should be trained to use standards expressed by the CONSORT Group in reporting RCTs.

  17. Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial.

    Science.gov (United States)

    Hwang, Dennis; Chang, Jeremiah W; Benjafield, Adam V; Crocker, Maureen E; Kelly, Colleen; Becker, Kendra A; Kim, Joseph B; Woodrum, Rosa R; Liang, Joanne; Derose, Stephen F

    2018-01-01

    Automated telemedicine interventions could potentially improve adherence to continuous positive airway pressure (CPAP) therapy. Examining the effects of telemedicine-delivered obstructive sleep apnea (OSA) education and CPAP telemonitoring with automated patient feedback messaging on CPAP adherence. This four-arm, randomized, factorial design clinical trial enrolled 1,455 patients (51.0% women; age, 49.1 ± 12.5 yr [mean ± SD]) referred for suspected OSA. Nine hundred and fifty-six underwent home sleep apnea testing, and 556 were prescribed CPAP. Two telemedicine interventions were implemented: 1) web-based OSA education (Tel-Ed) and 2) CPAP telemonitoring with automated patient feedback (Tel-TM). Patients were randomized to 1) usual care, 2) Tel-Ed added, 3) Tel-TM added, or 4) Tel-Ed and Tel-TM added (Tel-both). The primary endpoint was 90-day CPAP usage. Secondary endpoints included attendance to OSA evaluation, and change in Epworth Sleepiness Scale score. CPAP average daily use at 90 days was 3.8 ± 2.5, 4.0 ± 2.4, 4.4 ± 2.2, and 4.8 ± 2.3 hours in usual care, Tel-Ed, Tel-TM, and Tel-both groups. Usage was significantly higher in the Tel-TM and Tel-both groups versus usual care (P = 0.0002 for both) but not for Tel-Ed (P = 0.10). Medicare adherence rates were 53.5, 61.0, 65.6, and 73.2% in usual care, Tel-Ed, Tel-TM, and Tel-both groups (Tel-both vs. usual care, P = 0.001; Tel-TM vs. usual care, P = 0.003; Tel-Ed vs. usual care, P = 0.07), respectively. Telemedicine education improved clinic attendance compared with no telemedicine education (show rate, 68.5 vs. 62.7%; P = 0.02). The use of CPAP telemonitoring with automated feedback messaging improved 90-day adherence in patients with OSA. Telemedicine-based education did not significantly improve CPAP adherence but did increase clinic attendance for OSA evaluation. Clinical trial registered with www.clinicaltrials.gov (NCT02279901).

  18. The impact of peer support and mp3 messaging on adherence to inhaled corticosteroids in minority adolescents with asthma: a randomized, controlled trial.

    Science.gov (United States)

    Mosnaim, Giselle; Li, Hong; Martin, Molly; Richardson, DeJuran; Belice, Paula Jo; Avery, Elizabeth; Ryan, Norman; Bender, Bruce; Powell, Lynda

    2013-01-01

    Poor adherence to inhaled corticosteroids (ICS) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents. This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS. Low-income African American and/or Hispanic adolescents, ages 11-16 years old, with persistent asthma, and poor (≤ 48%) adherence to prescription ICS during the 3-week run-in were randomized to intervention or attention control groups (ATG) for the 10-week treatment. During treatment, the intervention arm subjects participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages that promoted adherence. The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 physician-recorded asthma messages. Adherence was measured by using self-report and the Doser CT, an electronic dose counter. The primary outcome was the difference in adherence at 10 weeks between the 2 arms. Thirty-four subjects were randomized to each arm. At 10 weeks, no statistical difference in objectively measured adherence could be detected between the 2 arms when adjusting for baseline adherence (P = .929). Adherence declined in both groups over the course of the active treatment period. In both study arms, self-reported adherence by participants was significantly higher than their objectively measured adherence at week 10 (P < .0001). Improving medication adherence in longitudinal studies is challenging. Peer support and mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

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

    NARCIS (Netherlands)

    Hilbink-Smolders, M.; Lacroix, J.; Bremer-van der Heiden, L.; Halteren, A. van; Teichert, M.; Lieshout, J. van

    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

  20. Exercise motivation and adherence in cancer survivors after participation in a randomized controlled trial: an attribution theory perspective.

    Science.gov (United States)

    Courneya, Kerry S; Friedenreich, Christine M; Sela, Rami A; Quinney, H Arthur; Rhodes, Ryan E; Jones, Lee W

    2004-01-01

    The purpose of this study was to examine postprogram exercise motivation and adherence in cancer survivors who participated in the Group Psychotherapy and Home-Based Physical Exercise (GROUP-HOPE; Courneya, Friedenreich, Sela, Quinney, & Rhodes, 2002) trial. At the completion of the GROUP-HOPE trial, 46 of 51 (90%) participants in the exercise group completed measures of attribution theory constructs. A 5-week follow-up self-report of exercise was then completed by 30 (65%) participants. Correlational analyses indicated that program exercise, perceived success, expected success, and affective reactions were strong predictors of postprogram exercise. In multivariate stepwise regression analyses, program exercise and perceived success were the strongest predictors of postprogram exercise. Additionally, perceived success was more important than objective success in understanding the attribution process, and it interacted with personal control to influence expected success and negative affect. Finally, postprogram quality of life and changes in physical fitness were correlates of perceived success. We concluded that attribution theory may have utility for understanding postprogram exercise motivation and adherence in cancer survivors.

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

    Directory of Open Access Journals (Sweden)

    Widdershoven Jos

    2011-10-01

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

  2. Improving treatment adherence for blood pressure lowering via mobile phone SMS-messages in South Africa: a qualitative evaluation of the SMS-text Adherence SuppoRt (StAR) trial.

    Science.gov (United States)

    Leon, Natalie; Surender, Rebecca; Bobrow, Kirsty; Muller, Jocelyn; Farmer, Andrew

    2015-07-03

    Effective use of proven treatments for high blood pressure, a preventable health risk, is challenging for many patients. Prompts via mobile phone SMS-text messaging may improve adherence to clinic visits and treatment, though more research is needed on impact and patient perceptions of such support interventions, especially in low-resource settings. An individually-randomised controlled trial in a primary care clinic in Cape Town (2012-14), tested the effect of an adherence support intervention delivered via SMS-texts, on blood pressure control and adherence to medication, for hypertensive patients. ( ClinicalTrials.gov NCT02019823). We report on a qualitative evaluation that explored the trial participants' experiences and responses to the SMS-text messages, and identified barriers and facilitators to delivering adherence support via patients' own mobile phones. Two focus groups and fifteen individual interviews were conducted. We used comparative and thematic analysis approaches to identify themes and triangulated our analysis amongst three researchers. Most participants were comfortable with the technology of using SMS-text messages. Messages were experienced as acceptable, relevant and useful to a broad range of participants. The SMS-content, the respectful tone and the delivery (timing of reminders and frequency) and the relational aspect of trial participation (feeling cared for) were all highly valued. A subgroup who benefitted the most, were those who had been struggling with adherence due to high levels of personal stress. The intervention appeared to coincide with their readiness for change, and provided practical and emotional support for improving adherence behaviour. Change may have been facilitated through increased acknowledgement of their health status and attitudinal change towards greater self-responsibility. Complex interaction of psycho-social stressors and health service problems were reported as broader challenges to adherence behaviours

  3. Medication adherence and visit-to-visit variability of systolic blood pressure in African Americans with chronic kidney disease in the AASK trial.

    Science.gov (United States)

    Hong, K; Muntner, P; Kronish, I; Shilane, D; Chang, T I

    2016-01-01

    Lower adherence to antihypertensive medications may increase visit-to-visit variability of blood pressure (VVV of BP), a risk factor for cardiovascular events and death. We used data from the African American Study of Kidney Disease and Hypertension (AASK) trial to examine whether lower medication adherence is associated with higher systolic VVV of BP in African Americans with hypertensive chronic kidney disease (CKD). Determinants of VVV of BP were also explored. AASK participants (n=988) were categorized by self-report or pill count as having perfect (100%), moderately high (75-99%), moderately low (50-74%) or low (medication adherence over a 1-year follow-up period. We used multinomial logistic regression to examine determinants of medication adherence, and multivariable-adjusted linear regression to examine the association between medication adherence and systolic VVV of BP, defined as the coefficient of variation or the average real variability (ARV). Participants with lower self-reported adherence were generally younger and had a higher prevalence of comorbid conditions. Compared with perfect adherence, moderately high, moderately low and low adherence was associated with 0.65% (±0.31%), 0.99% (±0.31%) and 1.29% (±0.32%) higher systolic VVV of BP (defined as the coefficient of variation) in fully adjusted models. Results were qualitatively similar when using ARV or when using pill counts as the measure of adherence. Lower medication adherence is associated with higher systolic VVV of BP in African Americans with hypertensive CKD; efforts to improve medication adherence in this population may reduce systolic VVV of BP.

  4. Educational video to improve CPAP use in patients with obstructive sleep apnoea at risk for poor adherence: a randomised controlled trial.

    Science.gov (United States)

    Guralnick, Amy S; Balachandran, Jay S; Szutenbach, Shane; Adley, Kevin; Emami, Leila; Mohammadi, Meelad; Farnan, Jeanne M; Arora, Vineet M; Mokhlesi, Babak

    2017-12-01

    Suboptimal adherence to CPAP limits its clinical effectiveness in patients with obstructive sleep apnoea (OSA). Although rigorous behavioural interventions improve CPAP adherence, their labour-intensive nature has limited widespread implementation. Moreover, these interventions have not been tested in patients at risk of poor CPAP adherence. Our objective was to determine whether an educational video will improve CPAP adherence in patients at risk of poor CPAP adherence. Patients referred by clinicians without sleep medicine expertise to an urban sleep laboratory that serves predominantly minority population were randomised to view an educational video about OSA and CPAP therapy before the polysomnogram, or to usual care. The primary outcome was CPAP adherence during the first 30 days of therapy. Secondary outcomes were show rates to sleep clinic (attended appointment) and 30-day CPAP adherence after the sleep clinic visit date. A total of 212 patients met the eligibility criteria and were randomised to video education (n=99) or to usual care (n=113). There were no differences in CPAP adherence at 30 days (3.3, 95% CI 2.8 to 3.8 hours/day video education; vs 3.5, 95% CI 3.1 to 4.0 hours/day usual care; p=0.44) or during the 30 days after sleep clinic visit. Sleep clinic show rate was 54% in the video education group and 59% in the usual care group (p=0.41). CPAP adherence, however, significantly worsened in patients who did not show up to the sleep clinic. In patients at risk for poor CPAP adherence, an educational video did not improve CPAP adherence or show rates to sleep clinic compared with usual care. ClinicalTrials.gov Identifier: NCT02553694. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  5. Adherence to AHA Guidelines When Adapted for Augmented Reality Glasses for Assisted Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial.

    Science.gov (United States)

    Siebert, Johan N; Ehrler, Frederic; Gervaix, Alain; Haddad, Kevin; Lacroix, Laurence; Schrurs, Philippe; Sahin, Ayhan; Lovis, Christian; Manzano, Sergio

    2017-05-29

    The American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) are nowadays recognized as the world's most authoritative resuscitation guidelines. Adherence to these guidelines optimizes the management of critically ill patients and increases their chances of survival after cardiac arrest. Despite their availability, suboptimal quality of CPR is still common. Currently, the median hospital survival rate after pediatric in-hospital cardiac arrest is 36%, whereas it falls below 10% for out-of-hospital cardiac arrest. Among emerging information technologies and devices able to support caregivers during resuscitation and increase adherence to AHA guidelines, augmented reality (AR) glasses have not yet been assessed. In order to assess their potential, we adapted AHA Pediatric Advanced Life Support (PALS) guidelines for AR glasses. The study aimed to determine whether adapting AHA guidelines for AR glasses increased adherence by reducing deviation and time to initiation of critical life-saving maneuvers during pediatric CPR when compared with the use of PALS pocket reference cards. We conducted a randomized controlled trial with two parallel groups of voluntary pediatric residents, comparing AR glasses to PALS pocket reference cards during a simulation-based pediatric cardiac arrest scenario-pulseless ventricular tachycardia (pVT). The primary outcome was the elapsed time in seconds in each allocation group, from onset of pVT to the first defibrillation attempt. Secondary outcomes were time elapsed to (1) initiation of chest compression, (2) subsequent defibrillation attempts, and (3) administration of drugs, as well as the time intervals between defibrillation attempts and drug doses, shock doses, and number of shocks. All these outcomes were assessed for deviation from AHA guidelines. Twenty residents were randomized into 2 groups. Time to first defibrillation attempt (mean: 146 s) and adherence to AHA guidelines in terms of time to other

  6. Effects of interventions promoting monitoring of medication use and brief messaging on medication adherence for people with Type 2 diabetes: a systematic review of randomized trials.

    Science.gov (United States)

    Farmer, A J; McSharry, J; Rowbotham, S; McGowan, L; Ricci-Cabello, I; French, D P

    2016-05-01

    To assess the impact of interventions promoting the monitoring of medication use and brief messaging to support medication adherence in patients with Type 2 diabetes mellitus, and to investigate the extent of theory use to guide intervention development. We systematically searched for controlled trials, published from 1990 onwards in Medline, Embase, CINAHL, PsycINFO and the Cochrane library, that evaluated interventions based on monitoring and brief messaging to support medication adherence in patients with Type 2 diabetes, to examine the effectiveness of such interventions. A total of 11 trials, comparing 15 interventions, were identified. Only a small minority presented a low risk of bias. Three interventions were based on delivering brief messages, six were based on monitoring medication adherence, and six used both strategies. Messaging interventions included the use of short message service text messages, web-based feedback, and messages delivered through monitoring devices. Monitoring interventions included remote self-reporting of medication and telephone calls with healthcare staff. Improvements in medication adherence were observed in six interventions, although effect sizes were generally moderate. Only two interventions improved both adherence and clinical outcomes. A meta-analysis of five trials (eight interventions) combining monitoring and messaging strategies showed that the pooled difference in medication adherence between intervention and control was moderate and not statistically significant [standardized mean difference = 0.22 (95% CI -0.05; 0.49)]. Only four trials were based on explicit theoretical frameworks. Although interventions based on messaging and monitoring have the potential to improve medication adherence in patients with Type 2 diabetes, evidence of their efficacy is limited and additional high-quality, theory-based research is needed. © 2015 Diabetes UK.

  7. Adherence to dietary recommendations for preschoolers: clinical trial with teenage mothers.

    Science.gov (United States)

    Soldateli, Betina; Vigo, Alvaro; Giugliani, Elsa Regina Justo

    2016-12-22

    To assess the effect of educational dietary intervention offered in the child's first year of life, as well as teenage mothers and grandmothers in carrying out the dietary recommendations at four to seven years. Randomized clinical trial initiated in 2006, in Porto Alegre, RS, involving 323 teenage mothers and grandmothers who cohabited. The intervention consisted of six counseling sessions on breastfeeding and healthy complementary feeding. The first session occurred in the maternity ward and the other ones in the households of mothers at seven, 15, 30, 60, and 120 days of the child's life. The information about the child's diet were obtained on a monthly basis in the first six months, every two months in the second half-year, and at four to seven years, using a food frequency questionnaire. To assess the adequacy of food consumption to the recommendations from the Ministry of Health, we elaborated a score system that would reflect the compliance with the Ten Steps for Healthy Toddlers from 2 to 10 Years. The average scores of intervention and control groups were compared using the t-test. Low adherence to recommendations on child nutrition was found in the study population, with no difference in implementation the steps between the groups. The score on the compliance with the steps was similar in both groups (9.6 [SD = 1.63] and 9.3 [SD = 1.60] in the intervention and control groups, respectively) and no influence of the cohabitation with the grandmother was found. Educational dietary intervention in the first four months of the child's life for teenage mothers and grandmothers had no effect on the compliance with the recommendations at four to seven years of the child's life. Avaliar o efeito de intervenção alimentar educativa oferecida, no primeiro ano de vida da criança, a mães adolescentes e avós maternas, no cumprimento das recomendações alimentares aos quatro a sete anos. Ensaio clínico randomizado iniciado em 2006, em Porto Alegre, RS, envolvendo

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

    Directory of Open Access Journals (Sweden)

    Leiva A

    2014-12-01

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

  9. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population.

    Science.gov (United States)

    Hutton, John S; Gupta, Resmi; Gruber, Rachel; Berndsen, Jennifer; DeWitt, Thomas; Ollberding, Nicholas J; Van Ginkel, Judith B; Ammerman, Robert T

    2017-04-24

    Sleep-related infant deaths have plateaued in the past decade, disproportionately affecting low socioeconomic status (SES) families. Printed materials are widely used for anticipatory guidance, yet none for safe sleep has been studied. We tested the efficacy of a specially designed children's book compared to brochures for safe sleep knowledge and adherence, which we hypothesized would be greater due to superior readability and engagement. This randomized controlled trial involved low-SES mothers (n = 282) enrolled in a home visiting program. Home visitors (n = 56) were randomly assigned to perform safe sleep teaching and assessments during 3 visits: third trimester, 1 week old, and 2 months old, exclusively utilizing a specially designed children's book or brochures, and surveys incorporating the American Academy of Pediatrics' safe sleep recommendations. Outcomes were safe sleep knowledge, adherence, and usefulness of materials, controlling for maternal health literacy. Safe sleep knowledge increased across all time points with no overall group difference, though gains for sleep-evocative and general health items varied. Odds of bed sharing were higher and exclusive crib use lower for the brochure group (P book and mothers in the book group reported more book sharing with their baby. While a specially designed children's book and brochures were equally effective conveying aggregate safe sleep knowledge in low-SES mothers, adherence to exclusive crib use and avoiding bed sharing were greater in the book group, attributable to enhanced dialogue, readability and emotional engagement. Children's books are a promising mode of anticipatory guidance, warranting further investigation. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    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.

  11. Event-level relationship between methamphetamine use significantly associated with non-adherence to pharmacologic trial medications in event-level analyses.

    Science.gov (United States)

    Hermanstyne, Keith A; Santos, Glenn-Milo; Vittinghoff, Eric; Santos, Deirdre; Colfax, Grant; Coffin, Phillip

    2014-10-01

    Methamphetamine use has been previously associated with poor medication adherence, but, to date, there have been no studies that have conducted event-level analyses on correlates of medication adherence in studies of pharmacologic agents for methamphetamine dependence. We pooled data from two previous, randomized controlled trials (using bupropion and mirtazapine, respectively) for methamphetamine dependence and used a mixed effects logistic model to examine correlates of daily opening of the medication event monitoring system (MEMS) cap as a repeated measure. We explored whether periods of observed methamphetamine use via urine testing were associated with study medication adherence based on MEMS cap openings. We found a significant negative association between methamphetamine-urine positivity and event-level study medication adherence as measured by MEMS cap openings (AOR: 0.69; 95% CI: 0.49-0.98). In addition, age (AOR: 1.07; 95% CI: 1.02-1.11) and depressive symptoms (AOR: 0.78; 95% CI: 0.64-0.90) were significantly associated with adherence. Finally, participants were more likely to open their study medication bottles on days when they presented for in-person urine testing. Our event-level analysis shows that methamphetamine use can be associated with reduced medication adherence as measured by MEMS cap openings in pharmacologic trials, which corroborates prior research. These findings may suggest that medication adherence support in pharmacologic trials among methamphetamine users may be needed to improve study compliance and could be targeted towards periods of time when there are more likely to not open their study medication pill bottles. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  12. A group randomized trial using an appointment system to improve adherence to ART at reproductive and child health clinics implementing Option B+ in Tanzania.

    OpenAIRE

    Ross-Degnan, Dennis; Chalker, John; Liana, Jafary; Kajoka, Mwikemo Deborah; Valimba, Richard; Kimatta, Suleiman; Dillip, Angel; Vialle-Valentin, Catherine; Embrey, Martha; Lieber, Rachel; Johnson, Keith

    2017-01-01

    Introduction: In October 2013, Tanzania adopted Option B+ under which HIV-positive pregnant women are initiated on antiretroviral therapy in reproductive and child health clinics at diagnosis. Studies have shown that adherence and retention to antiretroviral treatment can be problematic. Methods: We implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. The trial tested the impact of implementing paper-based appointment ...

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

    NARCIS (Netherlands)

    Effing, T.W.; Krabbenbos, M.; Pieterse, Marcel E.; van der Valk, P.; Zielhuis, G.A.; Kerstjens, H.A.M.; van der Palen, J.; van der Palen, J.

    2012-01-01

    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,

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

    NARCIS (Netherlands)

    Effing, Tanja W.; Krabbenbos, Manon; Pieterse, Marcel E.; van der Valk, Paul D. L. P. M.; Zielhuis, Gerhard A.; Kerstjens, Huib A. M.; van der Palen, Job

    2012-01-01

    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,

  15. Correction to: Impact of an electronic monitoring device and behavioural feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.

    Science.gov (United States)

    Yeh, E Ann; Grover, Stephanie A; Powell, Victoria E; Alper, Gulay; Banwell, Brenda L; Edwards, Kim; Gorman, Mark; Graves, Jennifer; Lotze, Timothy E; Mah, Jean K; Mednick, Lauren; Ness, Jayne; Obadia, Maya; Slater, Ruth; Waldman, Amy; Waubant, Emmanuelle; Schwartz, Carolyn E

    2017-12-23

    The clinicaltrials.gov identifying number for the article titled "Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial" is NCT02234713 (https://clinicaltrials.gov/ct2/show/NCT02234713).

  16. A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents

    NARCIS (Netherlands)

    Van der Wurff, Inge; Meyer, Barbara; De Groot, Renate

    2017-01-01

    Introduction: The influence of n-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation on health outcomes has been studied extensively with randomized controlled trials (RCT). In many research fields, difficulties with recruitment, adherence and high drop-out rates have been

  17. A Randomized Controlled Trial of Real-Time Electronic Adherence Monitoring With Text Message Dosing Reminders in People Starting First-Line Antiretroviral Therapy.

    Science.gov (United States)

    Orrell, Catherine; Cohen, Karen; Mauff, Katya; Bangsberg, David R; Maartens, Gary; Wood, Robin

    2015-12-15

    There are conflicting findings about whether mobile phone text message reminders impact on antiretroviral adherence. We hypothesized that text reminders sent when dosing was late would improve adherence and HIV viral suppression. Antiretroviral therapy (ART)-naive participants, from a South African outpatient ART clinic, were randomized to standard of care (SoC, 3 pretreatment education sessions), or intervention (SoC and automated text reminders if dosing >30 minutes late). Dosing time was recorded by real-time electronic adherence monitoring devices, given to participants at ART start. CD4 cell count and HIV RNA were determined at baseline, 16 and 48 weeks. Primary outcome was cumulative adherence execution by electronic adherence monitoring device. HIV-1 viral suppression (TIs) >72 hours were secondary outcomes. Analysis was by intention to treat (missing = failure). Registration was with the Pan-African Clinical Trials Registry: PACTR201311000641402. A total of 230 participants were randomly assigned to control (n = 115) or intervention (n = 115) arms. Median adherence was 82.1% (interquartile range, 56.6%-94.6%) in the intervention arm, compared with 80.4% (interquartile range, 52.8%-93.8%) for SoC [adjusted odds ratio for adherence 1.08; 95% confidence interval (CI): 0.77 to 1.52]. Suppressed HIV RNA (TIs of >72 hours was reduced (adjusted incident rate ratio, 0.84; 95% CI: 0.75 to 0.94). Text message reminders linked to late doses detected by real-time adherence monitoring reduced the number of prolonged TIs, but did not significantly improve adherence or viral suppression.

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

    Directory of Open Access Journals (Sweden)

    Mayer JM

    2013-03-01

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

  19. A randomized clinical pharmacokinetic trial of Tenofovir in blood, plasma and urine in adults with perfect, moderate and low PrEP adherence: the TARGET study.

    Science.gov (United States)

    Cressey, Tim R; Siriprakaisil, Oraphan; Klinbuayaem, Virat; Quame-Amaglo, Justice; Kubiak, Rachel W; Sukrakanchana, Pra-Ornsuda; Than-In-At, Kanchana; Baeten, Jared; Sirirungsi, Wasna; Cressey, Ratchada; Drain, Paul K

    2017-07-14

    Tenofovir disoproxil fumarate (TDF) is key component of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) for HIV, but existing tools to monitor drug adherence are often inaccurate. Detection of tenofovir (TFV) in accessible biological samples, such as fingerprick blood, urine or oral fluid samples could be a novel objective measure of recent TDF adherence. To measure TFV concentrations associated with different levels of TDF adherence, we designed a randomized clinical trial to assess the blood, urine and oral fluid concentrations of TFV in adults with perfect, moderate and low drug adherence. A randomized, open-label, clinical pharmacokinetic study of tenofovir in healthy adult volunteers without HIV or Hepatitis B infection in Thailand. Consenting, eligible participants are randomized (1:1:1) among three groups to receive a controlled number of TDF (300 mg) doses in a combination pill with emtricitabine (FTC, 200 mg) for six weeks. Participants in Group 1 receive a single TDF/FTC tablet once daily (Perfect adherence); Group 2 receive a single TDF/FTC tablet 4 times/week (Moderate adherence); and Group 3 receive a single TDF/FTC tablet 2 times/week (Low adherence). Blood, plasma, urine and oral fluid samples are collected for drug measurement during three study phases: (i) initial 6-week treatment phase; (ii) intensive 24-h blood sampling phase after 6 weeks; (iii) 4-week washout phase. Thirty adults with evaluable pharmacokinetic samples (10 per group) will be enrolled [based on ensuring 25% precision in pharmacokinetic parameter estimates]. Pre-dose drug concentrations during the treatment phase will be descriptive and comparisons between groups performed using a Kruskal-Wallis test. A non-compartmental pharmacokinetic analysis will be performed on the intensive sampling data at Week 7 and the time course of TFV washout in the difference biological matrices will be reported based on the detected concentrations following drug cessation. The

  20. Post-Discharge Adherence With Venous Thromboembolism Prophylaxis After Orthopedic Trauma: Results From a Randomized Controlled Trial of Aspirin vs. Low Molecular Weight Heparin.

    Science.gov (United States)

    Haac, Bryce E; Van Besien, Richard; OʼHara, Nathan N; Slobogean, Gerard P; Manson, Theodore T; OʼToole, Robert V; Johal, Herman; Berger, Peter Z; Reahl, George B; Marinos, Dimitrius; Degani, Yasmin; Mascarenhas, Daniel; Connelly, Daniel; Scalea, Thomas M; Stein, Deborah M

    2017-12-14

    Orthopedic trauma patients are often treated with venous thromboembolism (VTE) chemoprophylaxis with aspirin or low molecular weight heparin (LMWH) after discharge from their index admission, but adherence patterns are not known. We hypothesized that overall adherence would be moderate and greater with aspirin compared to LMWH. We conducted a randomized controlled trial of adult trauma patients with an operative extremity fracture or any pelvic/acetabular fracture requiring VTE prophylaxis. Patients were randomized to receive either LMWH 30mg BID or aspirin 81mg BID. Patients prescribed outpatient prophylaxis were contacted between 10 to 21 days after discharge to assess adherence measured by the validated Morisky Medication Adherence Scale (MMAS-8). Adherence scores were compared between the two treatment arms with similar results for intention-to-treat and as-treated analyses. As-treated multivariable logistic regression was performed to determine factors associated with low-medium adherence scores. 150 patients (64 on LMWH, 86 on aspirin) on chemoprophylaxis at time of follow-up completed the questionnaire. As-treated analysis showed that adherence was high overall (mean MMAS 7.2 out of 8, SD 1.5) and similar for the two regimens (LMWH: 7.4 vs. aspirin: 7.0, p=0.13). However, patients on LMWH were more likely to feel hassled by their regimen (23% vs. 9%, p=0.02). In a multivariable model, low-medium adherence was associated with taking LMWH as the prophylaxis medication (aOR 2.34, CI 1.06 - 5.18, p=0.04), having to self-administer the prophylaxis (aOR 4.44, CI 1.45 - 13.61, p<0.01), being of male sex (aOR 2.46, CI 1.10 - 5.49, p=0.03) and of younger age (aOR 0.72 per additional 10 years of age, CI 0.57-0.91, p<0.01). Overall post-discharge adherence with VTE prophylaxis was high. Several factors, including prophylaxis by LMWH, were associated with decreased adherence. These factors should be considered when managing patients and designing efficacy trials. Level

  1. Comparison of trial participants and open access users of a web-based physical activity intervention regarding adherence, attrition, and repeated participation.

    Science.gov (United States)

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

    2010-02-10

    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. 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 context over time from 2003 to 2009, and (b) between trial participants and open access users; and (2) to analyze attrition and predictors of repeated use among participants in a randomized controlled trial compared with registered open access users. Data routinely recorded in the Active-online user database were used. Adherence was defined as: the number of pages viewed, the proportion of visits during which a tailored module was begun, the proportion of visits during which tailored feedback was received, and the time spent in the tailored modules. Adherence was analyzed according to six one-year periods (2003-2009) and according to the context (trial or open access) based on first visits and longest visits. Attrition and predictors of repeated participation were compared between trial participants and open access users. The number of recorded visits per year on Active-online decreased from 42,626 in 2003-2004 to 8343 in 2008-2009 (each of six one-year time periods ran from April 23 to April 22 of the following year). The mean age of users was between 38.4 and 43.1 years in all time periods and both contexts. The proportion of women increased from 49.5% in 2003-2004 to 61.3% in 2008-2009 (Ptrends in adherence to Active-online. The mean age of trial participants was 43.1 years, and 74.9% were women. Comparing contexts, adherence was highest for registered open access users. For open access users, adherence was similar during the first and the longest visits; for trial participants, adherence was

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

    Directory of Open Access Journals (Sweden)

    Habteyes Hailu Tola

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Sutton Stephen

    2008-04-01

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

  5. Prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder.

    Science.gov (United States)

    Sajatovic, Martha; Levin, Jennifer; Ramirez, Luis F; Hahn, David Y; Tatsuoka, Curtis; Bialko, Christopher S; Cassidy, Kristin A; Fuentes-Casiano, Edna; Williams, Tiffany D

    2013-12-01

    Treatment nonadherence in people with schizophrenia is associated with relapse and homelessness. Building on the usefulness of long-acting medication and our work in psychosocial interventions to enhance adherence, we conducted a prospective uncontrolled trial of customized adherence enhancement (CAE) plus long-acting injectable antipsychotic (LAI) using haloperidol decanoate in 30 homeless or recently homeless individuals with DSM-IV-defined schizophrenia or schizoaffective disorder. Participants received monthly CAE and LAI (CAE-L) for 6 months. Primary outcomes were adherence, as measured by the Tablets Routine Questionnaire, and housing status. Secondary outcomes included psychiatric symptoms, functioning, side effects, and hospitalizations. The study was conducted from July 2010 to December 2012. The mean age of participants was 41.8 years (SD = 8.6); they were mainly minorities (90%, n = 27 African-American) and mainly single/never married (70%, n = 21). Most (97%, n = 29) had past or current substance abuse and had been incarcerated (97%, n = 29). Ten individuals (33%) terminated the study prematurely. CAE-L was associated with good adherence to LAI (at 6 months, 76%) and dramatic improvement in oral medication adherence, which changed from missing 46% of medication at study enrollment to missing only 10% at study end (P = .03). There were significant improvements in psychiatric symptoms (P health outcomes for homeless people with serious mental illness. ClinicalTrials.gov identifier: NCT01152697. © Copyright 2013 Physicians Postgraduate Press, Inc.

  6. A prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder

    Science.gov (United States)

    Sajatovic, Martha; Levin, Jennifer; Ramirez, Luis F.; Hahn, David Y.; Tatsuoka, Curtis; Bialko, Christopher S.; Cassidy, Kristin A.; Fuentes-Casiano, Edna; Williams, Tiffany D.

    2014-01-01

    Background Treatment non-adherence in people with schizophrenia is associated with relapse and homelessness. Building upon the usefulness of long-acting medication, and our work in psychosocial interventions to enhance adherence, we conducted a prospective uncontrolled trial of customized adherence enhancement (CAE) plus long-acting injectable antipsychotic (LAI) using haloperidol decanoate in 30 homeless or recently homeless individuals with schizophrenia and schizoaffective disorder. Methods Participants received monthly CAE and LAI (CAE-L) for 6 months. Primary outcomes were adherence as measured by the Tablets Routine Questionnaire (TRQ) and housing status. Secondary outcomes included psychiatric symptoms, functioning, side effects, and hospitalizations. Results Mean age of participants was 41.8 years (SD 8.6), mainly minorities (90% African-American) and mainly single/never married (70%). Most (97%) had past or current substance abuse, and had been incarcerated (97%). Ten individuals (33%) terminated the study prematurely. CAE-L was associated with good adherence to LAI (76% at 6 months) and dramatic improvement in oral medication adherence, which changed from missing 46% of medication at study enrollment to missing only 10% at study end (p = 0.03). There were significant improvements in psychiatric symptoms (pschizoaffective disorder. Additional research is needed on effective and practical approaches to improving health outcomes for homeless people with serious mental illness. PMID:24434094

  7. Adherence to a Depression Self-Care Intervention among Primary Care Patients with Chronic Physical Conditions: A Randomised Controlled Trial

    Science.gov (United States)

    McCusker, Jane; Cole, Martin G.; Yaffe, Mark; Strumpf, Erin; Sewitch, Maida; Sussman, Tamara; Ciampi, Antonio; Lavoie, Kim; Belzile, Eric

    2016-01-01

    Objective: Among primary care patients with chronic physical conditions and comorbid depressive symptoms, to assess (1) the effect of lay telephone coaching on adherence to a psycho-educational intervention for depression, (2) demographic characteristics that predict adherence and (3) the association between adherence and 6-month outcomes. Design:…

  8. 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.

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    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

  9. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa

    Science.gov (United States)

    Nel, Annalene; Bekker, Linda-Gail; Bukusi, Elizabeth; Hellstrӧm, Elizabeth; Kotze, Philip; Louw, Cheryl; Martinson, Francis; Masenga, Gileard; Montgomery, Elizabeth; Ndaba, Nelisiwe; van der Straten, Ariane; van Niekerk, Neliëtte; Woodsong, Cynthia

    2016-01-01

    Background This was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containing vaginal ring as an HIV prevention technology for women. Objectives The trial assessed and compared the safety, acceptability and adherence to product use of a 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine, with a matching placebo ring among women from four countries in sub-Saharan Africa. Methods 280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with 140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matching placebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated by pelvic examination, colposcopy, clinical laboratory assessments, and adverse events. Blood samples for determination of plasma concentrations of dapivirine were collected at Weeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring users were determined post-trial. Participant acceptability and adherence to ring use were assessed by self-reports. Results No safety concerns or clinically relevant differences were observed between the dapivirine and placebo ring groups. Plasma dapivirine concentrations immediately prior to ring removal were similar after removal of the first and third ring, suggesting consistent ring use over the 12-week period. No clear relationship was observed between the residual amount of dapivirine in used rings and corresponding plasma concentrations. Self-reported adherence to daily use of the vaginal rings over the 12-week trial period was very high. At the end of the trial, 96% of participants reported that the ring was usually comfortable to wear, and 97% reported that they would be willing to use it in the future if proven effective. Conclusions The dapivirine vaginal ring has a favourable safety and acceptability profile. If proven safe and effective in large-scale trials, it will be an important component of

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

    Directory of Open Access Journals (Sweden)

    Mba Robert

    2011-01-01

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

  11. HIV Medication Adherence

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Treatment Home Understanding HIV/AIDS Fact Sheets HIV ... 4 p.m. ET) Send us an email HIV Medication Adherence Last Reviewed: January 17, 2018 Key ...

  12. ‘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

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    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

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

    Science.gov (United States)

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

    2016-07-01

    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). 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 (Ptele-nursing on improvement of adherence to dietary and medication regimen in the patients with MI. IRCT201409148505N8.

  14. Adherence to Hunger Training over 6 Months and the Effect on Weight and Eating Behaviour: Secondary Analysis of a Randomised Controlled Trial.

    Science.gov (United States)

    Jospe, Michelle R; Taylor, Rachael W; Athens, Josie; Roy, Melyssa; Brown, Rachel C

    2017-11-17

    Monitoring blood glucose prior to eating can teach individuals to eat only when truly hungry, but how adherence to 'hunger training' influences weight loss and eating behaviour is uncertain. This exploratory, secondary analysis from a larger randomized controlled trial examined five indices of adherence to 'hunger training', chosen a priori, to examine which adherence measure best predicted weight loss over 6 months. We subsequently explored how the best measure of adherence influenced eating behavior in terms of intuitive and emotional eating. Retention was 72% ( n = 36/50) at 6 months. Frequency of hunger training booklet entry most strongly predicted weight loss, followed by frequency of blood glucose measurements. Participants who completed at least 60 days of booklet entry (of recommended 63 days) lost 6.8 kg (95% CI: 2.6, 11.0; p eating scores than those who completed 30 days or less of booklet entry; a difference (95% CI) of 0.73 (0.12, 1.35) in body-food choice congruence and 0.79 (0.06, 1.51) for eating for physical rather than emotional reasons. Adherent participants also reported significantly lower scores for emotional eating of -0.70 (-1.13, -0.27). Following hunger training and focusing on simply recording ratings of hunger on a regular basis can produce clinically significant weight loss and clinically relevant improvements in eating behaviour.

  15. Improving adherence to surveillance and screening recommendations for people with colorectal cancer and their first degree relatives: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Carey Mariko

    2012-02-01

    Full Text Available Abstract Background Colorectal cancer (CRC is among the leading causes of cancer-related morbidity and mortality worldwide. Despite clinical practice guidelines to guide surveillance care for those who have completed treatment for this disease as well as screening for first degree relatives of people with CRC, the level of uptake of these recommendations remains uncertain. If outcomes for both patients and their families are to be improved, it is important to establish systematic and cost-effective interventions to improve adherence to guideline recommendations for CRC surveillance and screening. Methods/Design A randomized controlled trial will be used to test the effectiveness of a print-based intervention to improve adherence to colonoscopy surveillance among people with CRC and adherence to CRC screening recommendations among their first degree relatives (FDRs. People diagnosed with CRC in the past 10 months will be recruited through a population-based cancer registry. Consenting participants will be asked if their first degree relatives might also be willing to participate in the trial. Information on family history of CRC will be obtained from patients at baseline. Patients and their families will be randomized to either minimal ethical care or the print-based intervention. The print-based intervention for FDRs will be tailored to the participant's level of risk of CRC as determined by the self-reported family history assessment. Follow up data on surveillance and screening participation will be collected from patients and their FDRs respectively at 12, 24 and 36 months' post recruitment. The primary analyses will relate to comparing levels of guideline adherence in usual care group versus print-based group in the patient sample and the FDR sample respectively. Discussion Results of this study will provide contribute to the evidence base about effective strategies to a improve adherence to surveillance recommendation for people with CRC

  16. Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial.

    Science.gov (United States)

    Himes, Katherine Park; Donovan, Heidi; Wang, Stephanie; Weaver, Carrie; Grove, Jillian Rae; Facco, Francesca Lucia

    2017-10-10

    During the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit. The primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention. We used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception. The median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users' experience and

  17. The effect of dental health education on pregnant women's adherence with toothbrushing and flossing - A randomized control trial.

    Science.gov (United States)

    Al Khamis, Suad; Asimakopoulou, Koula; Newton, Tim; Daly, Blanaid

    2017-10-01

    In a three-arm randomized control trial, this study compared the efficacy of dental health education (DHE) with or without a planning intervention on adherence to oral health-related behaviours. Women (N=154) in their second trimester of pregnancy attending three maternal healthcare clinics in Kuwait completed an assessment of social cognitions and oral health behaviours before a debris and gingival assessment (Plaque Index [PI], Gingival Index [GI]) was undertaken; this was repeated at 1 month. In addition to treatment as usual (TAU), which was a demonstration of OH practices, intervention participants received one of two interventions: (i) DHE, which targeted social cognitions; or (ii) DHE and planning (DHE&P), which targeted social cognitions and intentions to undertake oral health behaviours. The TAU group was given a standard oral hygiene leaflet. At Time one (T1) 154 women were eligible and randomly allocated to the three groups, respectively: treatment as usual (TAU)=53; DHE=53; DHE and planning=48. At Time two (T2), the number of women in each group completing the intervention (N=90) was, respectively, as follows TAU=28; DHE=30; DHE&P=32. There were no demographic differences between the groups at baseline. The mean age of women was 27.80±SD 5.40; 43% (n=38) had a high school level education. A mixed factor ANOVA analysis demonstrated that all women improved their PI (F=94.343 df=1 P=.001) and GI (F=73.138 df=1 P=.001) scores. There were no differences in self-reported oral hygiene and PI and GI by intervention group. The social cognition models (SCM) constructs changed over time in all women (N=90) except barriers to attendance (F=1.067 df=1 P=.305). There were no statistically significant differences in SCM constructs by intervention group at T2. All women reported increasing the frequency of toothbrushing and flossing. The provision of information using a simple leaflet improved the adherence of Kuwaiti pregnant with toothbrushing and flossing advice

  18. Randomized trial of 'intelligent' autotitrating ventilation versus standard pressure support non-invasive ventilation: impact on adherence and physiological outcomes.

    Science.gov (United States)

    Kelly, Julia L; Jaye, Jay; Pickersgill, Rachel E; Chatwin, Michelle; Morrell, Mary J; Simonds, Anita K

    2014-05-01

    Effective non-invasive ventilation (NIV) therapy is dependent on optimal ventilator settings to maximize clinical benefit and patient tolerance. Intelligent volume-assured pressure support (iVAPS) is a hybrid mode of servoventilation, providing constant automatic adjustment of pressure support (PS) to achieve a target ventilation determined by the patient's requirements. In a randomized crossover trial, we tested the hypothesis that iVAPS, with automated selection of ventilator settings, was non-inferior to standard PS ventilation, with settings determined by an experienced health-care professional, for controlling nocturnal hypoventilation in patients naive to NIV. Eighteen patients referred to a ventilator clinic with chronic obstructive or restrictive lung disease and newly diagnosed nocturnal hypoventilation (10 male, median (interquartile range): age 54(41-61) years, mean daytime PaO2 9.25(8.59-10.31) kPa, -PaCO2 6.38(5.93-6.65) kPa were randomized to iVAPS and standard PS. Polysomnography with transcutaneous CO2 monitoring was performed at baseline and 1 month after each treatment period. Nightly hours of therapy were recorded by the ventilator. iVAPS delivered a lower median PS compared with standard PS (8.3(5.6-10.4) vs 10.0(9.0-11.4) cmH2 O; P = 0.001) for the same ventilatory outcome (mean overnight: SpO2 96(95-98) vs 96(93-97)%; P = 0.13 and PtcCO2 6.5(5.8-6.8) vs 6.2(5.8-6.9); P = 0.54). There was no difference in outcome between ventilator modes for spirometry, respiratory muscle strength, sleep quality, arousals or O2 desaturation index. Adherence was greater with iVAPS (5:40(4:42-6:49) vs 4:20(2:27-6:17) hh:mm/night; P = 0.004). iVAPS servoventilation with automation of ventilation settings is as effective as PS ventilation initiated by a skilled health-care professional in controlling nocturnal hypoventilation and produced better overnight adherence in patients naive to NIV. © 2014 Asian Pacific Society of Respirology.

  19. An app with remote support achieves better adherence to home exercise programs than paper handouts in people with musculoskeletal conditions: a randomised trial.

    Science.gov (United States)

    Lambert, Tara E; Harvey, Lisa A; Avdalis, Christos; Chen, Lydia W; Jeyalingam, Sayanthinie; Pratt, Carin A; Tatum, Holly J; Bowden, Jocelyn L; Lucas, Barbara R

    2017-07-01

    Do people with musculoskeletal conditions better adhere to their home exercise programs when these are provided to them on an app with remote support compared to paper handouts? Randomised, parallel-group trial with intention-to-treat analysis. Eighty participants with upper or lower limb musculoskeletal conditions were recruited to the trial. Each participant was prescribed a 4-week home exercise program by a physiotherapist at a tertiary teaching hospital in Australia. Participants were randomly assigned via a computer-generated concealed block randomisation procedure to either intervention (n=40) or control (n=40) groups. Participants in the intervention group received their home exercise programs on an app linked to the freely available website www.physiotherapyexercises.com. They also received supplementary phone calls and motivational text messages. Participants in the control group received their home exercise programs as a paper handout. Blinded assessors collected outcome measures at baseline and 4 weeks. The primary outcome was self-reported exercise adherence. There were five secondary outcomes, which captured functional performance, disability, patient satisfaction, perceptions of treatment effectiveness, and different aspects of adherence. Outcomes were available on 77 participants. The mean between-group difference for self-reported exercise adherence at 4 weeks was 1.3/11 points (95% CI 0.2 to 2.3), favouring the intervention group. The mean between-group difference for function was 0.9/11 points (95% CI 0.1 to 1.7) on the Patient-Specific Functional Scale, also favouring the intervention group. There were no significant between-group differences for the remaining outcomes. People with musculoskeletal conditions adhere better to their home exercise programs when the programs are provided on an app with remote support compared to paper handouts; however, the clinical importance of this added adherence is unclear. ACTRN12616000066482. [Lambert TE

  20. Assessing treatment-as-usual provided to control groups in adherence trials: Exploring the use of an open-ended questionnaire for identifying behaviour change techniques.

    Science.gov (United States)

    Oberjé, Edwin J M; Dima, Alexandra L; Pijnappel, Frank J; Prins, Jan M; de Bruin, Marijn

    2015-01-01

    Reporting guidelines call for descriptions of control group support in equal detail as for interventions. However, how to assess the active content (behaviour change techniques (BCTs)) of treatment-as-usual (TAU) delivered to control groups in trials remains unclear. The objective of this study is to pre-test a method of assessing TAU in a multicentre cost-effectiveness trial of an HIV-treatment adherence intervention. HIV-nurses (N = 21) completed a semi-structured open-ended questionnaire enquiring about TAU adherence counselling. Two coders independently coded BCTs. Completeness and clarity of nurse responses, inter-coder reliabilities and the type of BCTs reported were examined. The clarity and completeness of nurse responses were adequate. Twenty-three of the 26 identified BCTs could be reliably coded (mean κ = .79; mean agreement rate = 96%) and three BCTs scored below κ = .60. Total number of BCTs reported per nurse ranged between 7 and 19 (M = 13.86, SD = 3.35). This study suggests that the TAU open-ended questionnaire is a feasible and reliable tool to capture active content of support provided to control participants in a multicentre adherence intervention trial. Considerable variability in the number of BCTs provided to control patients was observed, illustrating the importance of reliably collecting and accurately reporting control group support.

  1. Mobile phone reminders and peer counseling improve adherence and treatment outcomes of patients on ART in Malaysia: A randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Surajudeen Abiola Abdulrahman

    Full Text Available Adherence to treatment remains the cornerstone of long term viral suppression and successful treatment outcomes among patients receiving Antiretroviral Therapy (ART.Evaluate the effectiveness of mobile phone reminders and peer counseling in improving adherence and treatment outcomes among HIV positive patients on ART in Malaysia.A single-blind, parallel group RCT conducted in Hospital Sungai Buloh, Malaysia in which 242 adult Malaysian patients were randomized to intervention or control groups. Intervention consisted of a reminder module delivered through SMS and telephone call reminders by trained research assistants for 24 consecutive weeks (starting from date of ART initiation, in addition to adherence counseling at every clinic visit. The length of intended follow up for each patient was 6 months. Data on adherence behavior of patients was collected using specialized, pre-validated Adult AIDS Clinical Trial Group (AACTG adherence questionnaires. Data on weight, clinical symptoms, CD4 count and viral load tests were also collected. Data was analyzed using SPSS version 22 and R software. Repeated measures ANOVA, Friedman's ANOVA and Multivariate regression models were used to evaluate efficacy of the intervention.The response rate after 6 months follow up was 93%. There were no significant differences at baseline in gender, employment status, income distribution and residential location of respondents between the intervention and control group. After 6 months follow up, the mean adherence was significantly higher in the intervention group (95.7; 95% CI: 94.39-96.97 as compared to the control group (87.5; 95% CI: 86.14-88.81. The proportion of respondents who had Good (>95% adherence was significantly higher in the intervention group (92.2% compared to the control group (54.6%. A significantly lower frequency in missed appointments (14.0% vs 35.5% (p = 0.001, lower viral load (p = 0.001, higher rise in CD4 count (p = 0.017, lower incidence of

  2. Exercise adherence in a randomized trial of exercise on aromatase inhibitor arthralgias in breast cancer survivors: the Hormones and Physical Exercise (HOPE) study.

    Science.gov (United States)

    Arem, Hannah; Sorkin, Mia; Cartmel, Brenda; Fiellin, Martha; Capozza, Scott; Harrigan, Maura; Ercolano, Elizabeth; Zhou, Yang; Sanft, Tara; Gross, Cary; Schmitz, Kathryn; Neogi, Tuhina; Hershman, Dawn; Ligibel, Jennifer; Irwin, Melinda L

    2016-08-01

    Up to 50 % of postmenopausal breast cancer survivors taking aromatase inhibitors (AIs) experience AI-associated arthralgias, or joint pain, which causes many to stop taking AIs and may inhibit exercise, despite known health benefits. We thus evaluated exercise adherence and factors associated with better exercise adherence in breast cancer survivors experiencing AI-induced arthralgia in the (HOPE) year long randomized controlled trial. We included 61 HOPE women randomized to exercise (150 min/week of moderate-intensity aerobic exercise and twice-weekly supervised strength training). Our main outcomes were aerobic exercise measured with daily activity logs, attendance at supervised exercise sessions, and changes in cardiorespiratory fitness, measured maximal oxygen consumption (VO2max). We examined means and standard deviations (SDs) for exercise adherence by demographic and medical characteristics and used the t test for mean differences. We also examined predictors of adherence using linear regression. On average, at the end of the year long trial, women reported 119 (SD 78) min/week of moderate-intensity aerobic exercise and participated in 70 % of supervised exercise training sessions. After adjustment for other factors that influence adherence, at 6 months postrandomization, only baseline VO2max was associated with higher aerobic exercise levels and at 12 months, only older age predicted better supervised exercise training attendance. Breast cancer survivors taking AIs and experiencing arthralgia are able to initiate and maintain a year long exercise program, regardless of other factors that influence activity levels. Breast cancer survivors can exercise at levels that have been shown to improve AI-associated arthralgia.

  3. Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial.

    Science.gov (United States)

    Spoelstra, Sandra L; Given, Charles W; Sikorskii, Alla; Coursaris, Constantinos K; Majumder, Atreyee; DeKoekkoek, Tracy; Schueller, Monica; Given, Barbara A

    2016-06-01

    This multisite, randomized controlled trial assigned 75 adult cancer patients prescribed an oral anticancer agent to either an experimental group that received daily text messages for adherence for 21 days plus usual care or a control group that received usual care. Measures were administered at baseline, weekly (Weeks 1-8), and at exit (Week 9). A satisfaction survey was conducted following the intervention. Acceptability, feasibility, and satisfaction were examined. Primary outcomes were adherence and symptoms. Secondary outcomes were depressive symptoms, self-efficacy, cognition, physical function, and social support. Mixed or general linear models were used for the analyses comparing trial groups. Effect sizes (ES) were estimated to gauge clinical significance. Regarding acceptability, 57.2% (83 of 145) of eligible patients consented, 88% (n = 37 of 42) receiving text messages read them most or all of the time, and 90% (n = 38) were satisfied. The differences between experimental and control groups' ES were 0.29 for adherence, 0.21 for symptom severity, and 0.21 for symptom interference, and differences were not statistically significant. Furthermore, perceived social support was higher (p = 0.04; ES = 0.54) in the experimental group. Proof of concept and preliminary efficacy of a mobile health intervention using text messages to promote adherence for patients prescribed oral anticancer agents were demonstrated. Patients accepted and had high satisfaction with the intervention, and adherence improved after the intervention. Text messages show promise. Additional research is needed prior to use in practice.

  4. A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents.

    Science.gov (United States)

    van der Wurff, Inge S M; Meyer, Barbara J; de Groot, Renate H M

    2017-05-10

    The influence of n -3 long-chain polyunsaturated fatty acids ( n -3 LCPUFA) supplementation on health outcomes has been studied extensively with randomized controlled trials (RCT). In many research fields, difficulties with recruitment, adherence and high drop-out rates have been reported. However, what is unknown is how common these problems are in n -3 LCPUFA supplementation studies in children and adolescents. Therefore, this paper will review n -3 LCPUFA supplementation studies in children and adolescents with regard to recruitment, adherence and drop-out rates. The Web of Science, PubMed and Ovid databases were searched for papers reporting on RCT supplementing children and adolescents (2-18 years) with a form of n -3 LCPUFA (or placebo) for at least four weeks. As a proxy for abiding to CONSORT guidelines, we noted whether manuscripts provided a flow-chart and provided dates defining the period of recruitment and follow-up. Ninety manuscripts (reporting on 75 studies) met the inclusion criteria. The majority of the studies did not abide by the CONSORT guidelines: 55% did not provide a flow-chart, while 70% did not provide dates. The majority of studies provided minimal details about the recruitment process. Only 25 of the 75 studies reported an adherence rate which was on average 85%. Sixty-five of the 75 studies included drop-out rates which were on average 17%. Less than half of the included studies abided by the CONSORT guidelines (45% included a flow chart, while 30% reported dates). Problems with recruitment and drop-out seem to be common in n -3 LCPUFA supplementation trials in children and adolescents. However, reporting about recruitment, adherence and dropout rates was very heterogeneous and minimal in the included studies. Some techniques to improve recruitment, adherence and dropout rates were identified from the literature, however these techniques may need to be tailored to n -3 LCPUFA supplementation studies in children and adolescents.

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

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    Seyed Saeed Najafi

    2016-07-01

    Full Text Available 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.

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

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    Williams NJ

    2014-03-01

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

  7. Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV.

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    Louise Balfour

    Full Text Available The MAINTAIN study is an on-going RCT comparing high-dose micronutrient and anti-oxidant supplementation versus recommended daily allowance (RDA vitamins in slowing HIV immune deficiency progression in ART-naïve people with HIV infection.We planned analysis of the first 127 participants to determine the baseline prevalence of serum micronutrient deficiencies and correlates, as well as tolerance and adherence to study interventions.Participants receive eight capsules twice daily of 1 high-dose or 2 RDA supplements for two years and are followed-up quarterly for measures of immune deficiency progression, safety and tolerability. Regression analysis was used to identify correlates of micronutrient levels at baseline. Adherence was measured by residual pill count, self-report using the General Treatment Scale (GTS and short-term recall HIV Adherence Treatment Scale (HATS.Prior micronutrient supplementation (within 30 days was 27% at screening and 10% of study population, and was not correlated with baseline micronutrient levels. Low levels were frequent for carotene (24%80% in 75% of participants.Micronutrient levels in asymptomatic HIV+ persons are in keeping with population norms, but micronutrient deficiencies are frequent. Adherence levels are high, and will permit a valid evaluation of treatment effects.ClinicalTrials.gov NCT00798772.

  8. Adherence to Hunger Training over 6 Months and the Effect on Weight and Eating Behaviour: Secondary Analysis of a Randomised Controlled Trial

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    Taylor, Rachael W.; Athens, Josie; Brown, Rachel C.

    2017-01-01

    Monitoring blood glucose prior to eating can teach individuals to eat only when truly hungry, but how adherence to ‘hunger training’ influences weight loss and eating behaviour is uncertain. This exploratory, secondary analysis from a larger randomized controlled trial examined five indices of adherence to ‘hunger training’, chosen a priori, to examine which adherence measure best predicted weight loss over 6 months. We subsequently explored how the best measure of adherence influenced eating behavior in terms of intuitive and emotional eating. Retention was 72% (n = 36/50) at 6 months. Frequency of hunger training booklet entry most strongly predicted weight loss, followed by frequency of blood glucose measurements. Participants who completed at least 60 days of booklet entry (of recommended 63 days) lost 6.8 kg (95% CI: 2.6, 11.0; p hunger training and focusing on simply recording ratings of hunger on a regular basis can produce clinically significant weight loss and clinically relevant improvements in eating behaviour. PMID:29149038

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

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    Natalie E. Allen

    2012-01-01

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

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

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

    2014-01-01

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

  11. A Randomised Controlled Trial to Test the Effectiveness of Planning Strategies to Improve Medication Adherence in Patients with Cardiovascular Disease.

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    Meslot, Carine; Gauchet, Aurélie; Hagger, Martin S; Chatzisarantis, Nikos; Lehmann, Audrey; Allenet, Benoît

    2017-03-01

    Low levels of adherence to medication prescribed to treat and manage chronic disease may lead to maladaptive health outcomes. Theory-based, easy-to-administer interventions that promote patients' effective self-regulation of their medication-taking behaviour are needed if adherence is to be maximised. We tested the effectiveness of an intervention adopting planning techniques to promote medication adherence. Outpatients with cardiovascular disease (N = 71) were allocated to either an experimental condition, in which participants were asked to form implementation intentions and coping plans related to their treatment, or to a no-planning control condition, in which participants received no treatment. Patients also completed self-report measures of medication adherence, self-efficacy, and beliefs in medication necessity and concerns. Measures were administered at baseline and at 6-week follow-up. Results revealed no overall main effect for the intervention on medication adherence. Post-hoc moderator analyses revealed that the intervention was effective in patients with lower necessity beliefs compared to those with higher necessity beliefs. While current findings have promise in demonstrating the conditional effects of planning interventions, there is a need to replicate these findings by manipulating planning and beliefs independently and testing their direct and interactive effects on medication adherence. © 2016 The International Association of Applied Psychology.

  12. Would older adults with mild cognitive impairment adhere to and benefit from a structured lifestyle activity intervention to enhance cognition?: a cluster randomized controlled trial.

    Science.gov (United States)

    Lam, Linda Chiu-Wa; Chan, Wai Chi; Leung, Tony; Fung, Ada Wai-Tung; Leung, Edward Man-Fuk

    2015-01-01

    Epidemiologic evidence suggests that cognitive and physical activities are associated with better cognition in late life. The present study was conducted to examine the possible benefits of four structured lifestyle activity interventions and compare their effectiveness in optimizing cognition for older adults with mild cognitive impairment (MCI). This was a 12-month cluster randomized controlled trial. 555 community-dwelling Chinese older adults with MCI (295 with multiple-domain deficits (mdMCI), 260 with single-domain deficit (sdMCI)) were recruited. Participants were randomized into physical exercise (P), cognitive activity (C), integrated cognitive and physical exercise (CP), and social activity (S, active control) groups. Interventions comprised of one-hour structured activities three times per week. Primary outcome was Clinical Dementia Rating sum of boxes (CDR-SOB) scores. Secondary outcomes included Chinese versions of Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog), delayed recall, Mini-Mental State Examination, Category Verbal Fluency Test (CVFT) and Disability Assessment for Dementia - Instrumental Activities of Daily Living (DAD-IADL). Percentage adherence to programs and factors affecting adherence were also examined. At 12th month, 423 (76.2%) completed final assessment. There was no change in CDR-SOB and DAD-IADL scores across time and intervention groups. Multilevel normal model and linear link function showed improvement in ADAS-Cog, delayed recall and CVFT with time (peveryday functioning, albeit with some improvements in cognitive scores across time. Higher adherence was associated with greater improvement in cognitive scores. Factors to enhance adherence should be specially considered in the design of psychosocial interventions for older adults with cognitive decline. ClinicalTrials.gov ChiCTR-TRC-11001359.

  13. Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial.

    Science.gov (United States)

    Muckelbauer, Rebecca; Englert, Heike; Rieckmann, Nina; Chen, Chih-Mei; Wegscheider, Karl; Völler, Heinz; Katus, Hugo A; Willich, Stefan N; Müller-Nordhorn, Jacqueline

    2015-08-01

    We evaluated the long-term effect of a smoking intervention embedded in an adherence program in patients with an increased risk for cardiovascular disease. Secondary analysis of a randomized controlled trial: In 2002-2004, 8108 patients with hypercholesterolemia were enrolled from general practices in Germany. Patients received a 12-month adherence program and statin medication (intervention) or statin medication only (control). The program aimed to improve adherence to medication and lifestyle by educational material, mailings, and phone calls. Smoking was self-reported at baseline and every 6months during the 3-year follow-up. In total, 7640 patients were analyzed. At baseline, smoking prevalence was 21.7% in the intervention and 21.5% in the control group. Prevalence decreased in both groups to 16.6% vs. 19.5%, 15.3% vs. 16.8%, and 14.2% vs. 15.6% at the 12-, 24-, and 36-month follow-up. The intervention had a beneficial effect on smoking differing over time (group×time: P=0.005). The effect was largest after 6 and 12months [odds ratios (95% confidence intervals): 0.67 (0.54-0.82) and 0.63 (0.51-0.78)]. The effect decreased until the 18-month follow-up [0.72 (0.58-0.90)] and was not significant after 24months. A low-intensity smoking intervention embedded in an adherence program can contribute to smoking cessation although the intervention effect diminished over time. ClinicalTrials.gov (www.clinicaltrials.gov): NCT00379249. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. Web-based computer-tailoring for practice nurses aimed to improve smoking cessation guideline adherence: A study protocol for a randomized controlled effectiveness trial.

    Science.gov (United States)

    de Ruijter, D; Smit, E S; de Vries, H; Hoving, C

    2016-05-01

    Dutch practice nurses sub-optimally adhere to evidence-based smoking cessation guidelines. Web-based computer-tailoring could be effective in improving their guideline adherence. Therefore, this paper aims to describe the development of a web-based computer-tailored program and the design of a randomized controlled trial testing its (cost-)effectiveness. Theoretically grounded in the I-Change Model and Self-Determination Theory, and based on the results of a qualitative needs assessment among practice nurses, a web-based computer-tailored program was developed including three modules with tailored advice, an online forum, modules with up-to-date information about smoking cessation, Frequently Asked Questions (FAQs) and project information, and a counseling checklist. The program's effects are assessed by comparing an intervention group (access to all modules) with a control group (access to FAQs, project information and counseling checklist only). Smoking cessation guideline adherence and behavioral predictors (i.e. intention, knowledge, attitude, self-efficacy, social influence, action and coping planning) are measured at baseline and at 6- and 12-month follow-up. Additionally, the program's indirect effects on smokers' quit rates and the number of quit attempts are assessed after 6 and 12months. This paper describes the development of a web-based computer-tailored adherence support program for practice nurses and the study design of a randomized controlled trial testing its (cost-)effectiveness. This program potentially contributes to improving the quality of smoking cessation care in Dutch general practices. If proven effective, the program could be adapted for use by other healthcare professionals, increasing the public health benefits of improved smoking cessation counseling for smokers. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Adherence to Hunger Training over 6 Months and the Effect on Weight and Eating Behaviour: Secondary Analysis of a Randomised Controlled Trial

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    Michelle R. Jospe

    2017-11-01

    Full Text Available Monitoring blood glucose prior to eating can teach individuals to eat only when truly hungry, but how adherence to ‘hunger training’ influences weight loss and eating behaviour is uncertain. This exploratory, secondary analysis from a larger randomized controlled trial examined five indices of adherence to ‘hunger training’, chosen a priori, to examine which adherence measure best predicted weight loss over 6 months. We subsequently explored how the best measure of adherence influenced eating behavior in terms of intuitive and emotional eating. Retention was 72% (n = 36/50 at 6 months. Frequency of hunger training booklet entry most strongly predicted weight loss, followed by frequency of blood glucose measurements. Participants who completed at least 60 days of booklet entry (of recommended 63 days lost 6.8 kg (95% CI: 2.6, 11.0; p < 0.001 more weight than those who completed fewer days. They also had significantly higher intuitive eating scores than those who completed 30 days or less of booklet entry; a difference (95% CI of 0.73 (0.12, 1.35 in body-food choice congruence and 0.79 (0.06, 1.51 for eating for physical rather than emotional reasons. Adherent participants also reported significantly lower scores for emotional eating of −0.70 (−1.13, −0.27. Following hunger training and focusing on simply recording ratings of hunger on a regular basis can produce clinically significant weight loss and clinically relevant improvements in eating behaviour.

  16. Evaluating counseling outcome on adherence to prophylaxis and follow-up after sexual HIV-risk exposure: a randomized controlled trial.

    Science.gov (United States)

    Bentz, L; Enel, P; Dunais, B; Durant, J; Poizot-Martin, I; Tourette-Turgis, C; Rebillon, M; Le Duff, F; Dellamonica, P; Pradier, C

    2010-12-01

    Post-exposure prophylaxis (PEP) is recommended for the management of sexual HIV-risk exposure. However, a high percentage of exposed patients discontinue both their 28-day prophylaxis course before 15 days and HIV testing follow-up before M3. The objective of this study is to assess the efficacy of a counseling intervention in enhancing both adherence to PEP and HIV testing follow-up. Between 1 June 2004 and 31 December 2005, 54 patients exposed to sexual HIV-risk exposure were included in a multicenter, prospective, controlled, randomized trial, comparing a group receiving a counseling intervention in addition to traditional medical management (intervention group (IG), n=28) vs. a control group (CG, n=26). Patients in the IG received interactive counseling interventions focused on adherence to PEP and to HIV testing follow-up, led by specially trained nurses. The main outcome measures were proportion of patients achieving 100% adherence to PEP as evaluated on D15 by a self-completed patient questionnaire and on HIV testing on D45 and M3. Groups were well balanced at baseline for age, sex, and circumstances of exposure. The proportion of 100% adherent patients to PEP was significantly higher in the IG compared to the CG (54% vs. 23%, p=0.036). Patients in the IG were more likely to complete the HIV testing follow-up at D45 (86% vs. 54%, p=0.023) and M3 (68% vs. 38%, p=0.056). This study suggests the effectiveness of a counseling program to enhance adherence to both PEP and HIV testing follow-up after sexual exposure.

  17. Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among Black women: randomized controlled trial.

    Science.gov (United States)

    Steinberg, Dori M; Levine, Erica L; Lane, Ilana; Askew, Sandy; Foley, Perry B; Puleo, Elaine; Bennett, Gary G

    2014-04-29

    eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =-.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate self-monitoring. Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability. Clinicaltrials.gov NCT00938535; http://www.clinicaltrials.gov/ct2/show/NCT00938535.

  18. Would older adults with mild cognitive impairment adhere to and benefit from a structured lifestyle activity intervention to enhance cognition?: a cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Linda Chiu-Wa Lam

    Full Text Available Epidemiologic evidence suggests that cognitive and physical activities are associated with better cognition in late life. The present study was conducted to examine the possible benefits of four structured lifestyle activity interventions and compare their effectiveness in optimizing cognition for older adults with mild cognitive impairment (MCI.This was a 12-month cluster randomized controlled trial. 555 community-dwelling Chinese older adults with MCI (295 with multiple-domain deficits (mdMCI, 260 with single-domain deficit (sdMCI were recruited. Participants were randomized into physical exercise (P, cognitive activity (C, integrated cognitive and physical exercise (CP, and social activity (S, active control groups. Interventions comprised of one-hour structured activities three times per week. Primary outcome was Clinical Dementia Rating sum of boxes (CDR-SOB scores. Secondary outcomes included Chinese versions of Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog, delayed recall, Mini-Mental State Examination, Category Verbal Fluency Test (CVFT and Disability Assessment for Dementia - Instrumental Activities of Daily Living (DAD-IADL. Percentage adherence to programs and factors affecting adherence were also examined. At 12th month, 423 (76.2% completed final assessment. There was no change in CDR-SOB and DAD-IADL scores across time and intervention groups. Multilevel normal model and linear link function showed improvement in ADAS-Cog, delayed recall and CVFT with time (p<0.05. Post-hoc subgroup analyses showed that the CP group, compared with other intervention groups, had more significant improvements of ADAS-Cog, delayed recall and CVFT performance with sdMCI participants (p<0.05. Overall adherence rate was 73.3%. Improvements in ADAS-Cog and delayed recall scores were associated with adherence after controlling for age, education, and intervention groups (univariate analyses.Structured lifestyle activity interventions

  19. A feasible method to improve adherence of Hawley retainer in adolescent orthodontic patients: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lin FO

    2015-10-01

    Full Text Available Feiou Lin,1 Hao Sun,1 Zhenyu Ni,1 Minling Zheng,1 Linjie Yao2 1Orthodontic Department, 2Pedodontic Department, School of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China Background: Retention is an important component of orthodontic treatment; however, poor compliance with retainer use is often encountered, especially in adolescents. The purpose of this study was to prove the hypothesis that verbal instructions combined with images showing the severe consequences of poor compliance can increase retainer use. Methods: This study was a randomized controlled trial. The sample was recruited from Wenzhou, People’s Republic of China, between February 2013 and May 2014, and 326 participants were randomized into three groups. Patients and parents in Group A (n=106 were given routine retainer wear instructions only; in Group B (n=111, images illustrating the severe consequences of poor compliance with Hawley retainer use were shown to patients, combined with routine instructions; and in Group C (n=109, images illustrating the severe consequences of poor compliance with Hawley retainer use were shown to patients and parents, combined with routine instructions. Three months after debonding, questionnaires were used to investigate daily wear time and the reasons for poor compliance. Differences in means between the groups were tested by one-way analysis of variance. Results: The mean daily wear time in Group C (15.09±4.13 hours was significantly greater than in Group A (12.37±4.58 hours, P<0.01 or Group B (13.50±4.22 hours, P<0.05; the mean daily wear time in Group B was greater than in Group A, but was not significant (P=0.67. Reasons for nonusage were forgetting to wear the retainer (51% and finding the retainer bothersome to frequently insert and remove (42%. Conclusion: Verbal instructions combined with images showing the severe consequences of poor compliance can increase retainer use. Parents play an

  20. Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.

    Science.gov (United States)

    Yeh, E Ann; Grover, Stephanie A; Powell, Victoria E; Alper, Gulay; Banwell, Brenda L; Edwards, Kim; Gorman, Mark; Graves, Jennifer; Lotze, Timothy E; Mah, Jean K; Mednick, Lauren; Ness, Jayne; Obadia, Maya; Slater, Ruth; Waldman, Amy; Waubant, Emmanuelle; Schwartz, Carolyn E

    2017-09-01

    To report the results of a randomized controlled trial using an electronic monitoring device (EM) plus a motivational interviewing (MI) intervention to enhance adherence to disease-modifying therapies (DMT) in pediatric MS. Fifty-two youth with MS (16.03 ± 2.2 years) were randomized to receive either MI (n = 25) (target intervention) or a MS medication video (n = 27) (attention control). Primary endpoint was change in adherence. Secondary outcomes included changes in quality of life, well-being and self-efficacy. Random effects modeling and Cohen's effect size computation evaluated intervention impact. Longitudinal random effect models revealed that the MI group decreased their EM adherence (GroupxTime interaction = -0.19), while increasing frequency of parental DMT reminder (26.01)/administration (11.69). We found decreased EM use in the MI group at 6 months (Cohen's d = -0.61), but increased pharmacy refill adherence (d = 0.23). Parental reminders about medication increased in MI subjects vs controls (d = 0.59 at 3 months; d = 0.70 at 6 months). We found increases in self-reported adherence (d = 0.21) at 3 but not 6 months, fewer barriers to adherence at three (d = -0.58) and six months (d = -0.31), better physical (d = 0.23 at 3 months; d = 0.45 at 6 months), emotional (d = 0.25 at 3 months) and self-efficacy function (d = 0.55 at 3 months; 0.48 at 6 months), but worse well-being, including self-acceptance (d = -0.53 at 6 months) and environmental mastery (d = -0.42 at 3 and 6 months) in intervention as compared to control patients. Participants receiving MI + EM experienced worsening on objective measures of adherence and increased parental involvement, but improved on some self- and parent-reported measures. MI participants reported improvements in quality of life and self-efficacy, but worsened well-being.

  1. The influence of wearing schemes and supportive telephone calls on adherence in accelerometry measurement: results of a randomized controlled trial

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    van den Berg N

    2017-03-01

    Full Text Available Neeltje van den Berg,1,2 Sabina Ulbricht,2,3 Thea Schwaneberg,1,2 Kerstin Weitmann,1,2 Franziska Weymar,1–3 Stefan Groß,2,4 Marcus Dörr,2,4 Wolfgang Hoffmann1,2 1Institute for Community Medicine, University Medicine Greifswald, 2German Centre for Cardiovascular Research (DZHK, Partner Site Greifswald, 3Institute of Social Medicine and Prevention, University Medicine Greifswald, 4Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany Background: Physical activity (PA can be assessed by accelerometer monitors. However, a high adherence to wearing this device is essential to obtain valid data. In this study, the influence of different wearing schemes and additional supportive phone calls (SPCs on adherence was examined. Methods: A randomized study with four groups was conducted in the context of a health examination program among participants aged 40–75 years without a history of cardiovascular diseases. Participants were recruited in different settings (general medical practices, job center, and health insurance. The participants were asked to wear an accelerometer for 7 consecutive days according to the wearing scheme “day and night” or “day only” and received or did not receive SPCs. Full adherence was defined as a total wearing time of 98 hours (between 8 am and 10 pm during 7 days. A generalized linear model was used to calculate the difference between the maximum possible and the observed adherence. Results: Adherence could be assessed for 249 participants (mean age: 56.40 years; standard deviation [SD] 9.83, 40% males. The mean wearing time was 84.04 hours (SD 20.75. Participants with the wearing scheme day and night were significantly more adherent than participants with the wearing scheme day only (incidence rate ratio [IRR] 0.63; P=0.005. SPCs had no additional effect on adherence (IRR 0.80; P=0.168. Conclusion: To assess PA, the wearing scheme day and night provides the best possible

  2. A randomized trial comparing in person and electronic interventions for improving adherence to oral medications in schizophrenia.

    Science.gov (United States)

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

    2013-09-01

    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 electronic medication monitor that prompts use of medication, cues the taking of medication, warns patients when they are taking the wrong medication or taking it at the wrong time, record complaints, and, through modem hookup, alerts treatment staff of failures to take medication as prescribed; (3) Treatment as Usual (TAU). All patients received the Med-eMonitor device to record medication adherence. The device was programmed for intervention only in the MM group. Data on symptoms, global functioning, and contact with emergency services and police were obtained every 3 months. Repeated measures analyses of variance for mixed models indicated that adherence to medication was significantly better in both active conditions than in TAU (both p<0.0001). Adherence in active treatments ranged from 90-92% compared to 73% in TAU based on electronic monitoring. In-person and electronic interventions significantly improved adherence to medication, but that did not translate to improved clinical outcomes. Implications for treatment and health care costs are discussed.

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

    Directory of Open Access Journals (Sweden)

    Puig-Ribera Anna

    2009-01-01

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

  4. A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Schoenthaler, Antoinette; De La Calle, Franzenith; Barrios-Barrios, Miguel; Garcia, Aury; Pitaro, Maria; Lum, Audrey; Rosal, Milagros

    2015-07-02

    Latinos experience disproportionately higher rates of uncontrolled hypertension as compared to Blacks and Whites. While poor adherence is a major contributor to disparities in blood pressure control, data in Latino patients are scant. More importantly, translation of interventions to improve medication adherence in community-based primary care practices, where the majority of Latino patients receive their care is non-existent. Using a randomized controlled design, this study evaluates the effectiveness of a culturally tailored, practice-based intervention compared to usual care on medication adherence, among 148 Latino patients with uncontrolled hypertension who are non-adherent to their antihypertensive medications. Bilingual medical assistants trained as Health Coaches deliver the intervention using an electronic medical record system-embedded adherence script. Patients randomized to the intervention group receive patient-centered counseling with a Health Coach to develop individualized self-monitoring strategies to overcome barriers and improve adherence behaviors. Health Coach sessions are held biweekly for the first 3 months (6 sessions total) and then monthly for the remaining 3 months (3 sessions total). Patients randomized to the usual care group receive standard hypertension treatment recommendations as determined by their primary care providers. The primary outcome is the rate of medication adherence at 6 months. The secondary outcome is reduction in systolic and diastolic blood pressure at 6 months. If successful, findings from this study will provide salient information on the translation of culturally tailored, evidence-based interventions targeted at medication adherence and blood pressure control into practice-based settings for this high-risk population. NCT01643473 on 16 July 2012.

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

    Directory of Open Access Journals (Sweden)

    Lavoie KL

    2014-11-01

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

  6. A randomized controlled trial testing an adherence-optimized Vitamin D regimen to mitigate bone change in adolescents being treated for acute lymphoblastic leukemia.

    Science.gov (United States)

    Orgel, Etan; Mueske, Nicole M; Sposto, Richard; Gilsanz, Vicente; Wren, Tishya A L; Freyer, David R; Butturini, Anna M; Mittelman, Steven D

    2017-10-01

    Adolescents with acute lymphoblastic leukemia (ALL) develop osteopenia early in therapy, potentially exacerbated by high rates of concurrent Vitamin D deficiency. We conducted a randomized clinical trial testing a Vitamin D-based intervention to improve Vitamin D status and reduce bone density decline. Poor adherence to home supplementation necessitated a change to directly observed therapy (DOT) with intermittent, high-dose Vitamin D3 randomized versus standard of care (SOC). Compared to SOC, DOT Vitamin D3 successfully increased trough Vitamin 25(OH)D levels (p = .026) with no residual Vitamin D deficiency, 100% adherence to DOT Vitamin D3, and without associated toxicity. However, neither Vitamin D status nor supplementation impacted bone density. Thus, this adherence-optimized intervention is feasible and effective to correct Vitamin D deficiency in adolescents during ALL therapy. Repletion of Vitamin D and calcium alone did not mitigate osteopenia, however, and new, comprehensive approaches are needed to address treatment-associated osteopenia during ALL therapy.

  7. Financial incentives for improving adherence to maintenance treatment in patients with psychotic disorders (Money for Medication): a multicentre, open-label, randomised controlled trial.

    Science.gov (United States)

    Noordraven, Ernst L; Wierdsma, André I; Blanken, Peter; Bloemendaal, Anthony F T; Staring, Anton B P; Mulder, Cornelis L

    2017-03-01

    Provision of financial incentives is a promising intervention for improving adherence in patients taking antipsychotic medication. We aimed to assess the effectiveness of this intervention for improving adherence to antipsychotic depot medication in patients with psychotic disorders, irrespective of their previous compliance. We did this multicentre, open-label, randomised controlled trial at three mental health-care institutions in secondary psychiatric care services in the Netherlands. Eligible patients were aged 18-65 years, had been diagnosed with schizophrenia or another psychotic disorder, had been prescribed antipsychotic depot medication or had an indication to start using depot medication, and were participating in outpatient treatment. Patients were randomly assigned (1:1), via computer-generated randomisation with a block size of four, to receive 12 months of either treatment as usual plus a financial reward for each depot of medication received (€30 per month if fully compliant; intervention group) or treatment as usual alone (control group). Randomisation was stratified by treatment site and suspected prognostic factors: sex, comorbid substance-use disorder (absent vs present), and compliance with antipsychotic medication in the 4 months before baseline (improving adherence to antipsychotic depot medication among patients with psychotic disorders. Further research is needed to study the long-term effects of this intervention. Dual Diagnosis Center. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Cluster randomized trial of text message reminders to retail staff in tanzanian drug shops dispensing artemether-lumefantrine: effect on dispenser knowledge and patient adherence.

    Science.gov (United States)

    Bruxvoort, Katia; Festo, Charles; Kalolella, Admirabilis; Cairns, Matthew; Lyaruu, Peter; Kenani, Mitya; Kachur, S Patrick; Goodman, Catherine; Schellenberg, David

    2014-10-01

    Artemisinin combination therapies are available in private outlets, but patient adherence might be compromised by poor advice from dispensers. In this cluster randomized trial in drug shops in Tanzania, 42 of 82 selected shops were randomized to receive text message reminders about what advice to provide when dispensing artemether-lumefantrine (AL). Eligible patients purchasing AL at shops in both arms were followed up at home and questioned about each dose taken. Dispensers were interviewed regarding knowledge of AL dispensing practices and receipt of the malaria-related text messages. We interviewed 904 patients and 110 dispensers from 77 shops. Although there was some improvement in dispenser knowledge, there was no difference between arms in adherence measured as completion of all doses (intervention 68.3%, control 69.8%, p [adjusted] = 0.6), or as completion of each dose at the correct time (intervention 33.1%, control 32.6%, p [adjusted] = 0.9). Further studies on the potential of text messages to improve adherence are needed. © The American Society of Tropical Medicine and Hygiene.

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

    Directory of Open Access Journals (Sweden)

    Effing TW

    2012-05-01

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

  10. The effectiveness bundling of zinc with Oral Rehydration Salts (ORS) for improving adherence to acute watery diarrhea treatment in Ethiopia: cluster randomised controlled trial.

    Science.gov (United States)

    Gebremedhin, Samson; Mamo, Girma; Gezahign, Henock; Kung'u, Jacqueline; Adish, Abdulaziz

    2016-05-31

    Presumably bundling/co-packaging of zinc with ORS encourages the combined use of the products for diarrhea treatment; however, empirical evidences are scarce. The purpose of this work is to evaluate whether co-packing using a plastic pouch can enhance the joint adherence to the treatment or not. The study also compares the cost effectiveness (CE) of two co-packaging options: 'central' and 'health center (HC)' level bundling. This cluster-randomised controlled trial was conducted in 2015 in eight districts of Ethiopia. Thirty two HCs were randomly assigned to one of the following four intervention arms: (i) 'Central bundling' (zinc and ORS bundled using a pouch that had instructional message, distributed to HCs); (ii) 'HC level bundling' (zinc, ORS and a similar pouch distributed to the HCs and bundled by health workers); (iii) 'Bundling without message' (zinc, ORS and plain pouch distributed and bundled by the health workers); and, (iv) 'Status quo' (zinc and ORS co-administered without bundling). In each of the four arms, 176 children 6-59 months of age, presented with acute diarrhea were enrolled. Twelve days after enrollment, level of adherence was assessed. A composite scale of adherence was developed and modeled using mixed effects linear regression analysis. The unit costs associated with the arms were estimated using secondary data sources. Incremental CE analysis was made by taking the cost and level of adherence in fourth arm as a base value. The follow-up rate was 95.6 %. As compared with the 'status quo' arm, the joint adherences in the 'central' and 'HC level' bundling arms raised substantially by 14.8 and 15.7 percentage points (PP), respectively (P < 0.05). No significant difference was observed between 'bundling without message' and the 'status quo' arms. The unit cost incurred by the 'central bundling' is relatively higher (USD 0.658/episode) as compared with the 'HC level bundling' approach (USD 0.608/episode). The incremental CE ratio in the

  11. MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol.

    Science.gov (United States)

    Santo, Karla; Chow, Clara K; Thiagalingam, Aravinda; Rogers, Kris; Chalmers, John; Redfern, Julie

    2017-10-08

    The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. ACTRN12616000661471; Pre-results.

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

    NARCIS (Netherlands)

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

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

  13. Electronic Monitoring-Based Counseling to Enhance Adherence Among HIV-Infected Patients: A Randomized Controlled Trial

    NARCIS (Netherlands)

    de Bruin, Marijn; Hospers, Harm J.; van Breukelen, Gerard J. P.; Kok, Gerjo; Koevoets, William M.; Prins, Jan M.

    2010-01-01

    Objective: To investigated the effectiveness of an adherence intervention (AIMS) designed to fit HIV-clinics' routine care procedures. Design: Through block randomization, patients were allocated to the intervention or control group. The study included 2 months baseline measurement, 3 months

  14. Adherence to a lifestyle programme in overweight/obese pregnant women and effect on gestational diabetes mellitus: a randomized controlled trial.

    Science.gov (United States)

    Bruno, Raffaele; Petrella, Elisabetta; Bertarini, Valentina; Pedrielli, Giulia; Neri, Isabella; Facchinetti, Fabio

    2017-07-01

    This study aims to determine whether the prescription of a detailed lifestyle programme in overweight/obese pregnant women influences the occurrence of gestational diabetes (GDM), and if this kind of prescription increases the adherence to a healthier lifestyle in comparison to standard care. The study was designed as a randomized controlled trial, with open allocation, enrolling women at 9-12 weeks of pregnancy with a BMI ≥ 25 kg/m 2 . The women assigned to the Intervention group (I = 96) received a hypocaloric, low-glycaemic, low-saturated fat diet and physical activity recommendations. Those assigned to the Standard Care group (SC = 95) received lifestyle advices regarding healthy nutrition and exercise. Follow-up was planned at the 16 th , 20 th , 28 th and 36 th weeks. A total of 131 women completed the study (I = 69, SC = 62). The diet adherence was higher in the I (57.9%) than in the SC (38.7%) group. GDM occurred less frequently in the I (18.8%) than in the SC (37.1%, P = 0.019) group. The adherent women from either groups showed a lower GDM rate (12.5% vs. 41.8%, P  4000 g were significantly lower in I group. The incidence of small for gestational age babies was not different. These findings demonstrate that the adherence to a personalized, hypocaloric, low-glycaemic, low-saturated fat diet started early in pregnancy prevents GDM occurrence, in women with BMI ≥ 25 kg/m 2 . © 2016 John Wiley & Sons Ltd.

  15. Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis.

    Science.gov (United States)

    Griva, Konstadina; Nandakumar, Mooppil; Ng, Jo-An H; Lam, Kevin F Y; McBain, Hayley; Newman, Stanton P

    2017-11-30

    Poor adherence to treatment is common in hemodialysis patients. However, effective interventions for adherence in this population are lacking. Small studies of behavioral interventions have yielded improvements, but clinical effectiveness and long-term effects are unclear. Multicenter parallel (1:1) design, blinded cluster-randomized controlled trial. Patients undergoing maintenance hemodialysis enrolled in 14 dialysis centers. Dialysis shifts of eligible patients were randomly assigned to either an interactive and targeted self-management training program (HED-SMART; intervention; n=134) or usual care (control; n=101). HED-SMART, developed using the principles of problem solving and social learning theory, was delivered in a group format by health care professionals over 4 sessions. Serum potassium and phosphate concentrations, interdialytic weight gains (IDWGs), self-reported adherence, and self-management skills at 1 week, 3 months, and 9 months postintervention. 235 participants were enrolled in the study (response rate, 44.2%), and 82.1% completed the protocol. IDWG was significantly lowered across all 3 assessments relative to baseline (Pmanagement skills, and self-efficacy at all time points. Low proportion of patients with diabetes. HED-SMART provides an effective and practical model for improving health in hemodialysis patients. The observed improvements in clinical markers and self-report adherence, if maintained at the longer follow-up, could significantly reduce end-stage renal disease-related complications. Given the feasibility of this kind of program, it has strong potential for supplementing usual care. Registered at ISRCTN with study number ISRCTN31434033. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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

    NARCIS (Netherlands)

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

    2012-01-01

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

  17. The first 100 patients in the SUN(^_^)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase.

    Science.gov (United States)

    Shimodera, Shinji; Kato, Tadashi; Sato, Hirotoshi; Miki, Kazuhira; Shinagawa, Yoshihiro; Kondo, Masaki; Fujita, Hirokazu; Morokuma, Ippei; Ikeda, Yoshio; Akechi, Tatsuo; Watanabe, Norio; Yamada, Mitsuhiko; Inagaki, Masatoshi; Yonemoto, Naohiro; Furukawa, Toshi A

    2012-06-08

    Initial glitches and unexpected inconsistencies are unavoidable in the early stage of a large, multi-centre trial. Adaptive modifications of the trial's protocol and operational procedures to ensure its smooth running are therefore imperative. We started a large pragmatic, multi-centre, assessor-blinded, 25-week trial to investigate the optimal first- and second-line treatments for untreated episodes of nonpsychotic major depression in 2010 [Strategic Use of New generation antidepressants for Depression, abbreviated SUN(^_^)D] and would like to herein report an examination of the trial's feasibility and adherence among the first 100 participants. We examined the participants' characteristics, the treatments that were allocated and received during each step of the trial, and the quality of the outcome assessments among the first 100 patients enrolled in the SUN(^_^)D trial. Of the 2,743 first-visit patients who visited the two collaborating centres between December 2010 and July 2011, 382 were judged as potentially eligible, and 100 of these patients provided written informed consent. These patients represented the whole spectrum of mild to very severe depression. Of the 93 patients who had reached Week 3 of the study by the end of July 2011, one withdrew consent for both the treatment and the assessment, and eight withdrew consent for the treatment only. Altogether, the primary outcomes were successfully assessed in 90 (96.8%) of the patients at Week 3. Of the 72 patients who had reached Week 9, three withdrew consent for the treatment, but 70 were successfully interviewed (97.2%). Of the 32 patients who had reached Week 25, 29 (90.5%) were successfully followed up. The inter-rater reliability of the assessments of the primary outcomes was nearly perfect and their successful blinding was confirmed. Minor modifications and clarifications to the protocol were deemed necessary. Given the satisfactory feasibility and adherence to the study protocol and the minor

  18. Determinants of Adherence to the Online Component of a Blended Intervention for Patients with Hip and/or Knee Osteoarthritis: A Mixed Methods Study Embedded in the e-Exercise Trial.

    Science.gov (United States)

    de Vries, Herman J; Kloek, Corelien J J; de Bakker, Dinny H; Dekker, Joost; Bossen, Daniël; Veenhof, Cindy

    2017-05-19

    Embedding Web-based interventions within physiotherapy has potential, but knowledge on patient adherence to these interventions is limited. This study explores which patient-, intervention-, and environment-related factors are determinants of adherence to the online component of e-Exercise, a 12-week blended intervention for patients with hip and/or knee osteoarthritis. A convergent mixed methods study was performed, embedded within an ongoing trial. Quantitative data of 109 participants that received e-Exercise were used for negative binomial regression analysis. Adherence was defined as the number of online evaluated weeks. Next, semistructured interviews on factors related to adherence to the online component were analyzed. Nineteen participants with missing outcome data because their program was not started were excluded. Of the 90 analyzed participants, 81.1% were evaluated for at least 8 weeks. Adherence was highest for participants with middle education, 1-5-year osteoarthritis duration, and participants who were physiotherapist recruited. The 10 analyzed interviews revealed that sufficient Internet skills, self-discipline, execution of the exercise plan, the intervention's usability, flexibility, persuasive design, added value, and acceptable required time, and research participation were linked to favorable adherence. It is unknown if patients who adhered to the online component also adhered to their exercise plans. The relationship between adherence to the online component and clinical outcomes will be addressed in a future study. The majority of the participants adhered to the online component of e-Exercise, illustrating its applicability. The integration within the physiotherapy setting and intervention's persuasive design appear to have an important role in optimizing patient adherence.

  19. The first 100 patients in the SUN(^_^D trial (strategic use of new generation antidepressants for depression: examination of feasibility and adherence during the pilot phase

    Directory of Open Access Journals (Sweden)

    Shimodera Shinji

    2012-06-01

    Full Text Available Abstract Background Initial glitches and unexpected inconsistencies are unavoidable in the early stage of a large, multi-centre trial. Adaptive modifications of the trial’s protocol and operational procedures to ensure its smooth running are therefore imperative. We started a large pragmatic, multi-centre, assessor-blinded, 25-week trial to investigate the optimal first- and second-line treatments for untreated episodes of nonpsychotic major depression in 2010 [Strategic Use of New generation antidepressants for Depression, abbreviated SUN(^_^D] and would like to herein report an examination of the trial’s feasibility and adherence among the first 100 participants. Methods We examined the participants’ characteristics, the treatments that were allocated and received during each step of the trial, and the quality of the outcome assessments among the first 100 patients enrolled in the SUN(^_^D trial. Results Of the 2,743 first-visit patients who visited the two collaborating centres between December 2010 and July 2011, 382 were judged as potentially eligible, and 100 of these patients provided written informed consent. These patients represented the whole spectrum of mild to very severe depression. Of the 93 patients who had reached Week 3 of the study by the end of July 2011, one withdrew consent for both the treatment and the assessment, and eight withdrew consent for the treatment only. Altogether, the primary outcomes were successfully assessed in 90 (96.8% of the patients at Week 3. Of the 72 patients who had reached Week 9, three withdrew consent for the treatment, but 70 were successfully interviewed (97.2%. Of the 32 patients who had reached Week 25, 29 (90.5% were successfully followed up. The inter-rater reliability of the assessments of the primary outcomes was nearly perfect and their successful blinding was confirmed. Minor modifications and clarifications to the protocol were deemed necessary. Discussion Given the satisfactory

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

    Directory of Open Access Journals (Sweden)

    Broekaert Eric

    2011-05-01

    at and beyond eight sessions. Results Individual treatment that included assessment with feedback increased adherence to treatment at and beyond eight sessions (RR = 1.6,95%CI:1.2-2.2. Benefit was also found at and beyond twelve sessions, which was the number of sessions required to complete 90% of the assessments with feedback in practice (RR = 1.6,95%CI:1.2-2.5. Conclusions Assessment with feedback in routine practice improved adherence to treatment. More research is needed to evaluate progress in social functioning and motivation to change in outpatient treatment of substance use disorder, thereby using objective measures Trial registration Current Controlled Trials ISRCTN65456186

  1. Improving Adherence to Long-term Opioid Therapy Guidelines to Reduce Opioid Misuse in Primary Care A Cluster-Randomized Clinical Trial

    Science.gov (United States)

    Liebschutz, Jane M.; Xuan, Ziming; Shanahan, Christopher W.; LaRochelle, Marc; Keosaian, Julia; Beers, Donna; Guara, George; O’Connor, Kristen; Alford, Daniel P.; Parker, Victoria; Weiss, Roger D.; Samet, Jeffrey H.; Crosson, Julie; Cushman, Phoebe A.; Lasser, Karen E.

    2017-01-01

    IMPORTANCE Prescription opioid misuse is a national crisis. Few interventions have improved adherence to opioid-prescribing guidelines. OBJECTIVE To determine whether a multicomponent intervention, Transforming Opioid Prescribing in Primary Care (TOPCARE; http://mytopcare.org/), improves guideline adherence while decreasing opioid misuse risk. DESIGN, SETTING, AND PARTICIPANTS Cluster-randomized clinical trial among 53 primary care clinicians (PCCs) and their 985 patients receiving long-term opioid therapy for pain. The study was conducted from January 2014 to March 2016 in 4 safety-net primary care practices. INTERVENTIONS Intervention PCCs received nurse care management, an electronic registry, 1-on-1 academic detailing, and electronic decision tools for safe opioid prescribing. Control PCCs received electronic decision tools only. MAIN OUTCOMES AND MEASURES Primary outcomes included documentation of guideline-concordant care (both a patient-PCC agreement in the electronic health record and at least 1 urine drug test [UDT]) over 12 months and 2 or more early opioid refills. Secondary outcomes included opioid dose reduction (ie, 10% decrease in morphine-equivalent daily dose [MEDD] at trial end) and opioid treatment discontinuation. Adjusted outcomes controlled for differing baseline patient characteristics: substance use diagnosis, mental health diagnoses, and language. RESULTS Of the 985 participating patients, 519 were men, and 466 were women (mean [SD] patient age, 54.7 [11.5] years). Patients received a mean (SD) MEDD of 57.8 (78.5) mg. At 1 year, intervention patients were more likely than controls to receive guideline-concordant care (65.9% vs 37.8%; P opioid treatment discontinuation (AOR, 1.6; 95% CI, 1.3–2.1; P opioid refills. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01909076 PMID:28715535

  2. Randomised controlled trial of two sequential artemisinin-based combination therapy regimens to treat uncomplicated falciparum malaria in African children: a protocol to investigate safety, efficacy and adherence

    DEFF Research Database (Denmark)

    Schallig, Henk D. F. H.; Tinto, Halidou; Sawa, Patrick

    2017-01-01

    susceptibility to ACT in Africa have now been well documented. Strategies that retain current ACT as efficacious treatments are urgently needed. Methods We present an open-label, randomised three-arm clinical trial protocol in three African settings representative of varying malaria epidemiology to investigate......-inferior safety compared with standard single-course ACT given to 540 children. The primary endpoint is PCR-corrected clinical and parasitological response at day 42 or day 63 of follow-up. Persistence of PCR-detectable parasitaemia at day 3 is analysed as a key covariate. Secondary endpoints include...... gametocytaemia, occurrence of treatment-related adverse events in the double-ACT versus single-ACT arms, carriage of molecular markers of drug resistance, drug kinetics and patient adherence to treatment. Discussion This protocol addresses efficacy and safety of sequential ACT regimens in P. falciparum malaria...

  3. A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    OpenAIRE

    Emmanuel eStip; Emmanuel eStip; Emmanuel eStip; Philippe D. Vincent; Philippe D. Vincent; Philippe D. Vincent; Catherine eGuevremont; Simon eZhornitsky; Constantin eTranulis; Constantin eTranulis; Constantin eTranulis; Juliette eSablier; Juliette eSablier

    2013-01-01

    Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improv...

  4. A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    OpenAIRE

    Stip, Emmanuel; Vincent, Philippe D.; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

    2013-01-01

    Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR...

  5. High adherence to a neuromuscular injury prevention programme (FIFA 11+) improves functional balance and reduces injury risk in Canadian youth female football players: a cluster randomised trial.

    Science.gov (United States)

    Steffen, Kathrin; Emery, Carolyn A; Romiti, Maria; Kang, Jian; Bizzini, Mario; Dvorak, Jiri; Finch, Caroline F; Meeuwisse, Willem H

    2013-08-01

    A protective effect on injury risk in youth sports through neuromuscular warm-up training routines has consistently been demonstrated. However, there is a paucity of information regarding the quantity and quality of coach-led injury prevention programmes and its impact on the physical performance of players. The aim of this cluster-randomised controlled trial was to assess whether different delivery methods of an injury prevention programme (FIFA 11+) to coaches could improve player performance, and to examine the effect of player adherence on performance and injury risk. During the 2011 football season (May-August), coaches of 31 tiers 1-3 level teams were introduced to the 11+ through either an unsupervised website or a coach-focused workshop with and without additional on-field supervisions. Playing exposure, adherence to the 11+, and injuries were recorded for female 13-year-old to 18-year-old players. Performance testing included the Star Excursion Balance Test (SEBT), single-leg balance, triple hop and jumping-over-a-bar tests. Complete preseason and postseason performance tests were available for 226 players (66.5%). Compared to the unsupervised group, single-leg balance (OR=2.8; 95% CI 1.1 to 4.6) and the anterior direction of the SEBT improved significantly in the onfield supervised group of players (OR=4.7; 95% CI 2.2 to 7.1), while 2-leg jumping performance decreased (OR=-5.1; 95% CI -9.9 to -0.2). However, significant improvements in 5 of 6 reach distances in the SEBT were found, favouring players who highly adhered to the 11+. Also, injury risk was lower for those players (injury rate ratio, IRR=0.28, 95% CI 0.10 to 0.79). Different delivery methods of the FIFA 11+ to coaches influenced players' physical performance minimally. However, high player adherence to the 11+ resulted in significant improvements in functional balance and reduced injury risk.

  6. Rationale and design of mDOT-HuA study: a randomized trial to assess the effect of mobile-directly observed therapy on adherence to hydroxyurea in adults with sickle cell anemia in Tanzania

    Directory of Open Access Journals (Sweden)

    Abel Makubi

    2016-10-01

    Full Text Available Abstract Background Hydroxyurea (HU has been demonstrated to be efficacious in reducing complications in individuals with sickle cell anemia (SCA but poor adherence is a barrier. Directly Observed Therapy (DOT has been shown to improve adherence in various chronic diseases but there is limited data in adults with SCA. Methods and design To examine the effect of mobile-directly observed therapy (mDOT on adherence to HU (mDOT-HuA in adults with SCA at Muhimbili National Hospital in Tanzania. The mDOT-HuA study is a single centre, prospective, randomized, open label clinical trial. One-hundred individuals with SCA with haemoglobin SS genotype, aged ≥18 years, living in Dar es Salaam, able and willing to record and submit videos electronically will be included. Participants will be divided into two treatment arms; 50 in the standard monitoring (SM arm will receive mobile phones and fixed dose HU therapy with standard monitoring; 50 in the mDOT arm will receive mobile phones, fixed dose HU therapy with standard monitoring and a mobile directly observed web based medication adherence monitoring system. The primary outcome is the proportion of participants achieving ≥80 % HU adherence compared between the two arms as assessed through medication possession ratio at the end of 3 months of treatment. REDCap, an open source software application will be used to collect data using clinical research forms. The proportions of adherence in the two arms will be compared by Fisher’s exact test. Analysis of outcomes will have performed by both the intention-to treat and per-protocol methods. Discussion Should this study become sucessful, it will have the potential for the development of novel strategies for improving HU adherence in SCA. Trial registration ClinicalTrials.gov Identifier: NCT02844673 , registered on 25tht July 2016 (retrospectively registered.

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    encountered problems with attrition and adherence. Objective: In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE. Methods......: Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group. Results: The treatment arm of WEBCARE contained 146 patients....... Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase...

  8. Short- and long-term effects of real-time medication monitoring with short message service (SMS) reminders for missed doses on the refill adherence of people with Type 2 diabetes: evidence from a randomised controlled trial.

    NARCIS (Netherlands)

    Vervloet, M.; Dijk, L. van; Bakker, D.H. de; Souverein, P.C.; Santen-Reestman, J.; Vlijmen, B. van; Aarle, M.C.W. van; Hoek, L.S. van der; Bouvy, M.L.

    2014-01-01

    Aims: To investigate short- and long-term effects of real-time monitoring medication use combined with short message service (SMS) reminders for missed doses on refill adherence to oral anti-diabetic medication. Methods: A randomized controlled trial with two intervention groups and one control

  9. A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines.

    Science.gov (United States)

    Richardson, Thomas; Johnston, Andrew McDonald; Draper, Heather

    2017-01-01

    Objective: To determine to what extent each trial met criteria specified in three research frameworks for ethical trial conduct. Design: Systematic review and narrative analysis. Data sources: MEDBASE and EMBASE databases were searched using a specific search strategy. The Cochrane database for systematic reviews, the PROSPERO database and trial registries were examined. A grey literature search and citation search were also carried out. Eligibility criteria for selecting studies: Studies were included where the intervention was being used to treat Ebola in human subjects regardless of study design, comparator or outcome measured. Studies were eligible if they had taken place after the 21st March 2014. Unpublished as well as published studies were included. Included studies: Sixteen studies were included in the data synthesis. Data was extracted on study characteristics as well as any information relating to ten ethical areas of interest specified in the three research frameworks for ethical trial conduct and an additional criterion of whether the study received ethics approval from a research ethics committee. Synthesis of results: Eight studies were judged to fully comply with all eleven criteria. The other eight studies all had at least one criteria where there was not enough information available to draw any conclusions. In two studies there were ethical concerns regarding the information provided in relation to at least one ethical criteria. Description of the effect: One study did not receive ethical approval as the authors argued that treating approximately one hundred patients consecutively for compassionate reasons did not constitute a clinical trial. Furthermore, after the patients were treated, physicians in Sierra Leone did not release reports of treatment results and so study conclusions had to be made based on unpublished observations. In another study the risk-benefit ratio of the trial drug does not appear to be favourable and the pre-trial evidence

  10. A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines.

    Directory of Open Access Journals (Sweden)

    Thomas Richardson

    Full Text Available Objective: To determine to what extent each trial met criteria specified in three research frameworks for ethical trial conduct. Design: Systematic review and narrative analysis.Data sources: MEDBASE and EMBASE databases were searched using a specific search strategy. The Cochrane database for systematic reviews, the PROSPERO database and trial registries were examined. A grey literature search and citation search were also carried out. Eligibility criteria for selecting studies: Studies were included where the intervention was being used to treat Ebola in human subjects regardless of study design, comparator or outcome measured. Studies were eligible if they had taken place after the 21st March 2014. Unpublished as well as published studies were included. Included studies: Sixteen studies were included in the data synthesis. Data was extracted on study characteristics as well as any information relating to ten ethical areas of interest specified in the three research frameworks for ethical trial conduct and an additional criterion of whether the study received ethics approval from a research ethics committee. Synthesis of results: Eight studies were judged to fully comply with all eleven criteria. The other eight studies all had at least one criteria where there was not enough information available to draw any conclusions. In two studies there were ethical concerns regarding the information provided in relation to at least one ethical criteria. Description of the effect: One study did not receive ethical approval as the authors argued that treating approximately one hundred patients consecutively for compassionate reasons did not constitute a clinical trial. Furthermore, after the patients were treated, physicians in Sierra Leone did not release reports of treatment results and so study conclusions had to be made based on unpublished observations. In another study the risk-benefit ratio of the trial drug does not appear to be favourable and the

  11. Do emergency medicine journals promote trial registration and adherence to reporting guidelines? A survey of "Instructions for Authors".

    Science.gov (United States)

    Sims, Matthew T; Henning, Nolan M; Wayant, C Cole; Vassar, Matt

    2016-11-24

    The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of emergency medicine journals. We performed a web-based data abstraction from the "Instructions for Authors" of the 27 Emergency Medicine journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports and Google Scholar Metrics h5-index to identify whether each journal required, recommended, or made no mention of the following reporting guidelines: EQUATOR Network, ICMJE, ARRIVE, CARE, CONSORT, STARD, TRIPOD, CHEERS, MOOSE, STROBE, COREQ, SRQR, SQUIRE, PRISMA-P, SPIRIT, PRISMA, and QUOROM. We also extracted whether journals required or recommended trial registration. Authors were blinded to one another's ratings until completion of the data validation. Cross-tabulations and descriptive statistics were calculated using IBM SPSS 22. Of the 27 emergency medicine journals, 11 (11/27, 40.7%) did not mention a single guideline within their "Instructions for Authors," while the remaining 16 (16/27, 59.3%) mentioned one or more guidelines. The QUOROM statement and SRQR were not mentioned by any journals whereas the ICMJE guidelines (18/27, 66.7%) and CONSORT statement (15/27, 55.6%) were mentioned most often. Of the 27 emergency medicine journals, 15 (15/27, 55.6%) did not mention trial or review registration, while the remaining 12 (12/27, 44.4%) at least mentioned one of the two. Trial registration through ClinicalTrials.gov was mentioned by seven (7/27, 25.9%) journals while the WHO registry was mentioned by four (4/27, 14.8%). Twelve (12/27, 44.4%) journals mentioned trial registration through any registry platform. The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of

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

    Directory of Open Access Journals (Sweden)

    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

  13. Randomized Clinical Trial of a Self-Adhering Flowable Composite for Class I Restorations: 2-Year Results.

    Science.gov (United States)

    Sabbagh, J; Dagher, S; El Osta, N; Souhaid, P

    2017-01-01

    Objectives. To compare the clinical performances of a self-adhering resin composite and a conventional flowable composite with a self-etch bonding system on permanent molars. The influence of using rubber dam versus cotton roll isolation was also investigated. Materials and Methods. Patients aged between 6 and 12 years and presenting at least two permanent molars in need of small class I restorations were selected. Thirty-four pairs of restorations were randomly placed by the same operator. Fifteen patients were treated under rubber dam and nineteen using cotton rolls isolation and saliva ejector. They were evaluated according to the modified USPHS criteria at baseline, 6 months, and 1 and 2 years by two independent evaluators. Results. All patients attended the two-year recall. For all measured variables, there was no significant difference between rubber dam and cotton after 2 years of restoration with Premise Flowable or Vertise Flow (p value > 0.05). The percentage of restorations scored alpha decreased significantly over time with Premise Flowable and Vertise Flow for marginal adaptation and surface texture as well as marginal discoloration while it did not vary significantly for color matching. After 2 years, Vertise Flow showed a similar behaviour to the Premise Flowable used with a self-adhesive resin system.

  14. Randomized Clinical Trial of a Self-Adhering Flowable Composite for Class I Restorations: 2-Year Results

    Directory of Open Access Journals (Sweden)

    J. Sabbagh

    2017-01-01

    Full Text Available Objectives. To compare the clinical performances of a self-adhering resin composite and a conventional flowable composite with a self-etch bonding system on permanent molars. The influence of using rubber dam versus cotton roll isolation was also investigated. Materials and Methods. Patients aged between 6 and 12 years and presenting at least two permanent molars in need of small class I restorations were selected. Thirty-four pairs of restorations were randomly placed by the same operator. Fifteen patients were treated under rubber dam and nineteen using cotton rolls isolation and saliva ejector. They were evaluated according to the modified USPHS criteria at baseline, 6 months, and 1 and 2 years by two independent evaluators. Results. All patients attended the two-year recall. For all measured variables, there was no significant difference between rubber dam and cotton after 2 years of restoration with Premise Flowable or Vertise Flow (p value > 0.05. The percentage of restorations scored alpha decreased significantly over time with Premise Flowable and Vertise Flow for marginal adaptation and surface texture as well as marginal discoloration while it did not vary significantly for color matching. After 2 years, Vertise Flow showed a similar behaviour to the Premise Flowable used with a self-adhesive resin system.

  15. A Multicomponent Intervention to Improve Primary Care Provider Adherence to Chronic Opioid Therapy Guidelines and Reduce Opioid Misuse: A Cluster Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Lasser, Karen E; Shanahan, Christopher; Parker, Victoria; Beers, Donna; Xuan, Ziming; Heymann, Orlaith; Lange, Allison; Liebschutz, Jane M

    2016-01-01

    Prescription opioid misuse is a significant public health problem as well as a patient safety concern. Primary care providers (PCPs) are the leading prescribers of opioids for chronic pain, yet few PCPs follow standard practice guidelines regarding assessment and monitoring. This cluster randomized controlled trial will determine whether four implementation strategies; nurse care management, use of a patient registry, academic detailing, and electronic tools, will increase PCP adherence to chronic opioid therapy guidelines and reduce opioid misuse among patients, relative to electronic tools alone. The implementation strategies and intervention content are based on the chronic care model. We include 53 PCPs from three Boston-area community health centers and one urban safety-net hospital-based primary care practice who have at least four patients meeting the following inclusion criteria: 1) age≥18; 2) one or more completed visits to the primary care practice in the past year; 3) long-term opioid treatment defined as three or more opioid prescriptions written at least 21days apart within 6months and 4) an inpatient or outpatient ICD-9-CM diagnosis for musculoskeletal or neuropathic pain. We consider PCPs to be study subjects, and obtained a waiver of informed consent for patients because the study is promoting an established standard of care. We enrolled participants (PCPs) from December 2012 through March 2015. PCPs were randomized to receive the intervention, which includes four components: 1) nurse care management, 2) use of a patient registry, 3) academic detailing, and 4) electronic tools, or a control condition, which includes only the use of the electronic tools. The intervention PCPs receive the services of a nurse-managed registry for planning individual patient care and conducting population-based care for patients receiving opioids for chronic pain. In academic detailing visits, trained co-investigators provide intervention PCPs with individualized

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

    Science.gov (United States)

    Rosal, Milagros C; Ayers, David; Li, Wenjun; Oatis, Carol; Borg, Amy; Zheng, Hua; Franklin, Patricia

    2011-10-07

    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. 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%. 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 to enhance adherence to independent activity and exercise will

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

    NARCIS (Netherlands)

    Kooij, J.J.; Rosler, M.; Philipsen, A.; Wachter, S.; Dejonckheere, J.; Kolk, A. van der; Agthoven, M. van; Schauble, B.

    2013-01-01

    BACKGROUND: Medication non-adherence has an important impact on treatment efficacy and healthcare burden across a range of conditions and therapeutic areas. The aim of this analysis was to determine predictors of non-adherence and impact of non-adherence on treatment response in adults with

  18. Assessment of the quality of reporting of randomised controlled trials in otorhinolaryngologic literature - adherence to the CONSORT statement.

    Directory of Open Access Journals (Sweden)

    Jeroen P M Peters

    Full Text Available Randomised Controlled Trials (RCTs are the preferred study design when comparing therapeutical interventions in medicine. To improve clarity, consistency and transparency of reporting RCTs, the Consolidated Standards of Reporting Trials (CONSORT statement was developed.(1 To assess the quality of reports and abstracts of RCTs in otorhinolaryngologic literature by using CONSORT checklists, (2 to compare the quality of reports and abstracts of otorhinolaryngologic RCTs between the top 5 general medical journals and top 5 otorhinolaryngologic journals, and (3 to formulate recommendations for authors and editors of otorhinolaryngologic ('ENT' journals.Based on 2012 ISI Web of Knowledge impact factors, the top 5 general medical and ENT journals were selected. On 25 June 2014, using a highly sensitive Cochrane RCT filter and ENT filter, possibly relevant articles since January 1st, 2010 were retrieved and relevant RCTs were selected. We assessed how many CONSORT items were reported adequately in reports and abstracts and compared the two journal types.Otorhinolaryngologic RCTs (n = 15 published in general medical journals reported a mean of 92.1% (95% confidence interval: 89.5%-94.7% of CONSORT items adequately, whereas RCTs (n = 18 published in ENT journals reported a mean of 71.8% (66.7%-76.8% adequately (p < 0.001. For abstracts, means of 70.0% (63.7%-76.3% and 32.3% (26.6-38.0% were found respectively (p < 0.001. Large differences for specific items exist between the two journal types.The quality of reporting of RCTs in otorhinolaryngologic journals is suboptimal. RCTs published in general medical journals have a higher quality of reporting than RCTs published in ENT journals. We recommend authors to report their trial according to the CONSORT Statement and advise editors to endorse the CONSORT Statement and implement the CONSORT Statement in the editorial process to ensure more adequate reporting of RCTs and their abstracts.

  19. A Randomized Controlled Trial Protocol to Evaluate the Effectiveness of an Integrated Care Management Approach to Improve Adherence Among HIV-Infected Patients in Routine Clinical Care: Rationale and Design.

    Science.gov (United States)

    Crane, Heidi M; Fredericksen, Rob J; Church, Anna; Harrington, Anna; Ciechanowski, Paul; Magnani, Jennifer; Nasby, Kari; Brown, Tyler; Dhanireddy, Shireesha; Harrington, Robert D; Lober, William B; Simoni, Jane; Safren, Stevan A; Edwards, Todd C; Patrick, Donald L; Saag, Michael S; Crane, Paul K; Kitahata, Mari M

    2016-10-05

    Adherence to antiretroviral medications is a key determinant of clinical outcomes. Many adherence intervention trials investigated the effects of time-intensive or costly interventions that are not feasible in most clinical care settings. We set out to evaluate a collaborative care approach as a feasible intervention applicable to patients in clinical care including those with mental illness and/or substance use issues. We developed a randomized controlled trial (RCT) investigating an integrated, clinic-based care management approach to improve clinical outcomes that could be integrated into the clinical care setting. This is based on the routine integration and systematic follow-up of a clinical assessment of patient-reported outcomes targeting adherence, depression, and substance use, and adapts previously developed and tested care management approaches. The primary health coach or care management role is provided by clinic case managers allowing the intervention to be generalized to other human immunodeficiency virus (HIV) clinics that have case managers. We used a stepped-care approach to target interventions to those at greatest need who are most likely to benefit rather than to everyone to maintain feasibility in a busy clinical care setting. The National Institutes of Health funded this study and had no role in study design, data collection, or decisions regarding whether or not to submit manuscripts for publication. This trial is currently underway, enrollment was completed in 2015, and follow-up time still accruing. First results are expected to be ready for publication in early 2017. This paper describes the protocol for an ongoing clinical trial including the design and the rationale for key methodological decisions. There is a need to identify best practices for implementing evidence-based collaborative care models that are effective and feasible in clinical care. Adherence efficacy trials have not led to sufficient improvements, and there remains

  20. 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

    Directory of Open Access Journals (Sweden)

    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

  1. Tailored message interventions versus typical messages for increasing participation in colorectal cancer screening among a non-adherent population: A randomized controlled trial.

    Science.gov (United States)

    Hirai, Kei; Ishikawa, Yoshiki; Fukuyoshi, Jun; Yonekura, Akio; Harada, Kazuhiro; Shibuya, Daisuke; Yamamoto, Seiichiro; Mizota, Yuri; Hamashima, Chisato; Saito, Hiroshi

    2016-05-24

    The purpose of this study was to examine the effectiveness and cost-efficiency of a tailored message intervention compared with a non-tailored message intervention for increasing colorectal cancer (CRC) screening rates among a non-adherent population, in a community-based client reminder program. After a baseline survey for psychological segmentation, 2140 eligible individuals were randomly assigned either to a group with a tailored matched-message condition (N = 356), a group with a non-tailored unmatched-message condition (N = 355), or to two control groups, one using a typical message with a professional design (N = 717) and one without a professional design (N = 712). The main outcome measure was attendance rates in a community-organized CRC screening program within five months of receiving a print reminder. There was a significant difference in fecal occult blood test (FOBT) attendance rates at follow-up assessments between the tailored matched-message condition (14.0 %) and the control (9.9 %; OR = 1.48, p = 0.026), while there was no significant difference between the unmatched-message condition (11.0 %) and the control (OR = 1.12, p = 0.558), and between the matched-message condition and the unmatched-message condition (OR = 1.32, p = 0.219). The cost of a one-person increase in FOBT screening was 3,740 JPY for the tailored matched-message condition, while it was 2,747 JPY for the control. A tailored-message intervention for segmented individuals designed to increase CRC screening rates in a community-based client reminder program was significantly effective compared to a usual reminder, but not more effective than an unmatched message in a randomized controlled trial, and was not sufficiently effective to highlight its value from a cost perspective. Therefore, the tailored intervention including target segmentation needs to be improved for future implementation in a CRC screening program for a non-adherent

  2. 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.

    Directory of Open Access Journals (Sweden)

    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.

  3. Adherence, tolerance and effectiveness of two different pelvic support belts as a treatment for pregnancy-related symphyseal pain - a pilot randomized trial.

    Science.gov (United States)

    Flack, Natasha A M S; Hay-Smith, E Jean C; Stringer, Mark D; Gray, Andrew R; Woodley, Stephanie J

    2015-02-15

    Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness (symptomatic relief), tolerance (comfort) and adherence (frequency, duration of use). Unblinded, 2-arm, single-center, randomized (1:1) parallel-group trial. Twenty pregnant women recruited from the community (Dunedin, New Zealand), with physiotherapist-diagnosed symphyseal pain, were randomly allocated to wear either a flexible or rigid belt for three weeks. One author, not involved in data collection, randomized the allocation to trial group. The unblinded primary outcome was the Patient Specific Functional Scale (PSFS). Secondary outcomes were pain intensity during the preceding 24 hours and preceding week (visual analogue scale [VAS]), and disability (Modified Oswestry Disability Questionnaire [MODQ]). Duration of use (hours) was recorded daily by text messaging. Participants were assessed at baseline, by weekly phone interviews and at intervention completion (three weeks). To assess comfort, women wore the alternate belt in the fourth week. Twenty pregnant women (mean ± SD age, 29.4 ± 6.5 years; mean gestation at baseline, 30.8 ± 5.2 weeks) were randomized to treatment groups (flexible = 10, rigid =10) and all were included in analysis. When adjusted for baseline, PSFS scores were not significantly different between groups at follow up (mean difference -0.1; 95% CI: -2.5 to 2.3; p =0.94). Pain in the preceding 24 hours reached statistical significance in favor of the flexible belt (VAS, p = 0.049). Combining both groups' data, function and pain were significantly improved at three weeks (mean difference -2.3; 95% CI: 1.2 to 3.5; pBelts were worn for an average of 4.9 ± 2.9 hours per day; women preferred the flexible belt. No adverse events were

  4. The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jung, Hee-Yeon; Seong, Sook Jin; Choi, Ji-Young; Cho, Jang-Hee; Park, Sun-Hee; Kim, Chan-Duck; Yoon, Young-Ran; Kim, Hyung-Kee; Huh, Seung; Yoon, Se-Hee; Lee, Jong Soo; Kim, Yong-Lim

    2017-10-16

    Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare costs. An aggressive preemptive effort by healthcare professionals, geared to ensure adherence to immunosuppressants in KTRs, is significant and imperative. This study was designed as a prospective, open-label, multicenter, randomized controlled study aimed at evaluating the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs. One hundred fourteen KTRs registered throughout the year 2017 to 2018 are randomized into either the ICT-based centralized home monitoring system or to ambulatory follow-up. The planned follow-up duration is 6 months. The ICT-based centralized home monitoring system described consists of a smart pill box equipped with personal identification system, a home monitoring system, an electronic Case Report Form (eCRF) system, and a comprehensive clinical trial management system (CTMS). It alerts both patients and medical staff with texts and pill box alarms if there is a dosage/dosing time error or a missed dose. Medication adherence and transplant outcomes for the follow-up period are compared between the two groups, while patient satisfaction as well as the stability and cost-effectiveness of the ICT-based monitoring system are to be evaluated. This on-going study is expected to determine if consistent use of the ICT-based centralized monitoring system described could maximize mediation adherence and subsequently enhance transplant outcomes in KTRs. Further, it would lay the foundation for successful implementation of this ICT-based monitoring system for effective management of medication adherence in KTRs. ClinicalTrials.gov, Identifier: NCT03136588 . Registered on 20 April 2017.

  5. Adherence to a Mediterranean-style diet and effects on cognition in adults: A qualitative evaluation of the systematic review of longitudinal and prospective trials

    Directory of Open Access Journals (Sweden)

    Roy J Hardman

    2016-07-01

    Full Text Available The Mediterranean-style diet (MedDiet involves substantial intake of fruits, vegetables, and fish, and a lower consumption of dairy, red meat, and sugars. Over the past 15 years much empirical evidence supports the suggestion that a MedDiet may be beneficial with respect to reducing the incidence of cardiovascular disease, cancer, metabolic syndrome, and dementia. A number of cross-sectional studies that have examined the impact of MedDiet on cognition have yielded largely positive results. The objective of this review is to evaluate longitudinal and prospective trials to gain an understanding of how a MedDiet may impact cognitive processes over time. The included studies were aimed at improving cognition or minimizing of cognitive decline. Studies reviewed included assessments of dietary status using either a food frequency questionnaire or a food diary assessment. Eighteen articles meeting our inclusion criteria were subjected to systematic review. These revealed that higher adherence to a MedDiet is associated with slower rates of cognitive decline, reduced conversion to Alzheimer’s disease (AD and improvements in cognitive function. The specific cognitive domains that were found to benefit with improved Mediterranean Diet Score (MedDietS were memory (delayed recognition, long-term and working memory executive function, and visual constructs. The current review has also considered a number of methodological issues in making recommendations for future research. The utilisation of a dietary pattern such as the Mediterranean style diet will be essential as part of the armamentarium to maintain quality of life and reduce the potential social and economic burden of dementia. Key Words: Nutrition, cognition, Mediterranean diet, clinical trials

  6. Randomized Controlled Trial of a Computer-Based Education Program in the Home for Solid Organ Transplant Recipients: Impact on Medication Knowledge, Satisfaction, and Adherence.

    Science.gov (United States)

    Harrison, Jennifer J; Badr, Souzi; Hamandi, Bassem; Kim, Sang Joseph

    2017-06-01

    De novo solid organ transplant recipients (SOTR) have a steep learning curve to acquire medication knowledge. Without adequate knowledge, SOTR are at risk of nonadherence and poor transplant outcomes. In this nonblinded, randomized controlled trial, de novo SOTR received standard teaching with or without postdischarge computer-based education (CBE) at home. Primary outcomes were change in knowledge (quiz and recall) and satisfaction, assessed by questionnaires at baseline and 3 months. Adherence was evaluated via self-report and immunosuppressant levels. Two hundred forty-six patients were randomized and 209 completed the 3-month analysis. In the intervention arm, 73 (57.9%) used the CBE program. Change in knowledge quiz score did not differ between groups (4.9% vs 0.6%; P = 0.084), despite a significant increase within the intervention (72.4% vs 77.3%, P = 0.007) but not the control (76.0% vs 76.6%, P = 0.726) arms. Both groups had a significant improvement in recall (intervention, 56.7% vs 82.1%, P home and to develop effective strategies for posttransplant education.

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

    Directory of Open Access Journals (Sweden)

    Lonsdale Chris

    2012-06-01

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

  8. In patients with severe uncontrolled asthma, does knowledge of adherence and inhaler technique using electronic monitoring improve clinical decision making? A protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    Mokoka, Matshediso C

    2017-06-15

    Many patients with asthma remain poorly controlled despite the use of inhaled corticosteroids and long-acting beta agonists. Poor control may arise from inadequate adherence, incorrect inhaler technique or because the condition is refractory. Without having an objective assessment of adherence, clinicians may inadvertently add extra medication instead of addressing adherence. This study aims to assess if incorporating objectively recorded adherence from the Inhaler Compliance Assessment (INCA) device and lung function into clinical decision making provides more cost-effective prescribing and improves outcomes.

  9. Motivation and Treatment Credibility Predicts Dropout, Treatment Adherence, and Clinical Outcomes in an Internet-Based Cognitive Behavioral Relaxation Program: A Randomized Controlled Trial

    National Research Council Canada - National Science Library

    Alfonsson, Sven; Olsson, Erik; Hursti, Timo

    2016-01-01

    In previous research, variables such as age, education, treatment credibility, and therapeutic alliance have shown to affect patients' treatment adherence and outcome in Internet-based psychotherapy...

  10. Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

    Directory of Open Access Journals (Sweden)

    Usherwood Tim

    2010-08-01

    Full Text Available Abstract Background The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. Methods/Design The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. Discussion The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. Trial Registration This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

  11. Design and methods for a randomized clinical trial comparing three outreach efforts to improve screening mammography adherence

    Directory of Open Access Journals (Sweden)

    Reed George

    2011-06-01

    for an intervention. We anticipate that the outcome will provide firm data about the maximal effectiveness as well as the cost effectiveness of the interventions both for increasing the mammography rate and the repeat mammography rate. Trial registration http://clinicaltrials.gov/NCT01332032

  12. An internet-based virtual coach to promote physical activity adherence in overweight adults: randomized controlled trial.

    Science.gov (United States)

    Watson, Alice; Bickmore, Timothy; Cange, Abby; Kulshreshtha, Ambar; Kvedar, Joseph

    2012-01-26

    this technology warrant further study. ClinicalTrials.gov NCT00792207; http://clinicaltrials.gov/ct2/show/NCT00792207 (Archived by WebCite at http://www.webcitation.org/63sm9mXUD).

  13. Randomized controlled trial of a pictorial aid intervention for medication adherence among HIV-positive patients with comorbid diabetes or hypertension.

    Science.gov (United States)

    Monroe, A K; Pena, J S; Moore, R D; Riekert, K A; Eakin, M N; Kripalani, S; Chander, G

    2018-02-01

    As the HIV-infected population ages and the burden of chronic comorbidities increases, adherence to medications for HIV and diabetes and hypertension is crucial to improve outcomes. We pilot-tested a pictorial aid intervention to improve medication adherence for both HIV and common chronic conditions. Adult patients with HIV and diabetes (DM) and/or hypertension (HTN) attending a clinic for underserved patients and at risk for poor health outcomes were enrolled. Patients were randomized to receive either a pictorial aid intervention (a photographic representation of their medications, the indications, and the dosing schedule) or a standard clinic visit discharge medication list. Adherence to antiretroviral therapy (ART) for HIV and therapy for DM or HTN was compared. Predictors of ART adherence at baseline were determined using logistic regression. Medication adherence was assessed using medication possession ratio (MPR) for the 6-month interval before and after the intervention. Change in adherence by treatment group was compared by ANOVA. Among the 46 participants, there was a trend towards higher adherence to medications for HIV compared with medications for hypertension/diabetes (baseline median MPR for ART 0.92; baseline median MPR for the medication for the comorbid condition 0.79, p = 0.07). The intervention was feasible to implement and satisfaction with the intervention was high. With a small sample size, the intervention did not demonstrate significant improvement in adherence to medications for HIV or comorbid conditions. Patients with HIV are often medically complex and may have multiple barriers to medication adherence. Medication adherence is a multifaceted process and adherence promotion interventions require an approach that targets patient-specific barriers.

  14. Results of a randomized controlled trial to assess the effects of a mobile SMS-based intervention on treatment adherence in HIV/AIDS-infected Brazilian women and impressions and satisfaction with respect to incoming messages.

    Science.gov (United States)

    da Costa, Thiago Martini; Barbosa, Bárbara Jaqueline Peres; Gomes e Costa, Durval Alex; Sigulem, Daniel; de Fátima Marin, Heimar; Filho, Adauto Castelo; Pisa, Ivan Torres

    2012-04-01

    To assess whether a warning system based on mobile SMS messages increases the adherence of HIV-infected Brazilian women to antiretroviral drug-based treatment regimens and their impressions and satisfaction with respect to incoming messages. A randomized controlled trial was conducted from May 2009 to April 2010 with HIV-infected Brazilian women. All participants (n=21) had a monthly multidisciplinary attendance; each participant was followed over a 4-month period, when adherence measures were obtained. Participants in the intervention group (n=8) received SMS messages 30 min before their last scheduled time for a dose of medicine during the day. The messages were sent every Saturday and Sunday and on alternate days during the working week. Participants in the control group (n=13) did not receive messages. Self-reported adherence, pill counting, microelectronic monitors (MEMS) and an interview about the impressions and satisfaction with respect to incoming messages. The HIV Alert System (HIVAS) was developed over 7 months during 2008 and 2009. After the study period, self-reported adherence indicated that 11 participants (84.62%) remained compliant in the control group (adherence exceeding 95%), whereas all 8 participants in the intervention group (100.00%) remained compliant. In contrast, the counting pills method indicated that the number of compliant participants was 5 (38.46%) for the control group and 4 (50.00%) for the intervention group. Microelectronic monitoring indicated that 6 participants in the control group (46.15%) were adherent during the entire 4-month period compared to 6 participants in the intervention group (75.00%). According to the feedback of the 8 participants who completed the research in the intervention group, along with the feedback of 3 patients who received SMS for less than 4 months, that is, did not complete the study, 9 (81.81%) believed that the SMS messages aided them in treatment adherence, and 10 (90.90%) responded that they

  15. Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in HIV-Infected Injection Drug Users: A Randomized Controlled Trial

    Science.gov (United States)

    Safren, Steven A.; O'Cleirigh, Conall M.; Bullis, Jacqueline R.; Otto, Michael W.; Stein, Michael D.; Pollack, Mark H.

    2012-01-01

    Objective: Depression and substance use, the most common comorbidities with HIV, are both associated with poor treatment adherence. Injection drug users comprise a substantial portion of individuals with HIV in the United States and globally. The present study tested cognitive behavioral therapy for adherence and depression (CBT-AD) in patients…

  16. Web-based computer-tailoring for practice nurses aimed to improve smoking cessation guideline adherence: A study protocol for a randomized controlled effectiveness trial

    NARCIS (Netherlands)

    de Ruijter, D.; Smit, E. S.; de Vries, H.; Hoving, C.

    Background Dutch practice nurses sub-optimally adhere to evidence-based smoking cessation guidelines. Web-based computer-tailoring could be effective in improving their guideline adherence. Therefore, this paper aims to describe the development of a web-based computer-tailored program and the design

  17. Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial.

    Science.gov (United States)

    Epstein, Dawn E; Sherwood, Andrew; Smith, Patrick J; Craighead, Linda; Caccia, Carla; Lin, Pao-Hwa; Babyak, Michael A; Johnson, Julie J; Hinderliter, Alan; Blumenthal, James A

    2012-11-01

    Although the Dietary Approaches to Stop Hypertension (DASH) diet is an accepted nonpharmacologic treatment for hypertension, little is known about what patient characteristics affect dietary adherence and what level of adherence is needed to reduce blood pressure (BP). Our aim was to determine what factors predict dietary adherence and the extent to which dietary adherence is necessary to produce clinically meaningful BP reductions. Ancillary study of the ENCORE (Exercise and Nutrition Interventions for Cardiovascular Health) trial--a 16-week randomized clinical trial of diet and exercise. Participants included 144 sedentary, overweight, or obese adults (body mass index 25 to 39.9) with high BP (systolic 130 to 159 mm Hg and/or diastolic 85 to 99 mm Hg). Patients were randomized to one of three groups: DASH diet alone, DASH diet plus weight management, and Usual Diet Controls. Our primary outcomes were a composite index of adherence to the DASH diet and clinic BP. General linear models were used to compare treatment groups on post-treatment adherence to the DASH diet. Linear regression was used to examine potential predictors of post-treatment DASH adherence. Analysis of covariance was used to examine the relation of adherence to the DASH diet and BP. Participants in the DASH diet plus weight management (16.1 systolic BP [SBP]; 95% CI 13.0 to 19.2 mm Hg and 9.9 diastolic BP [DBP]; 95% CI 8.1 to 11.6 mm Hg) and DASH diet alone (11.2 SBP; 95% CI 8.1 to 14.3 mm Hg and 7.5 DBP; 95% CI 5.8 to 9.3 mm Hg) groups showed significant reductions in BP in comparison with Usual Diet Controls participants (3.4 SBP; 95% CI 0.4 to 6.4 mm Hg and DBP 3.8; 95% CI 2.2 to 5.5 mm Hg). Greater post-treatment consumption of DASH foods was noted in both the DASH diet alone (mean = 6.20; 95% CI 5.83 to 6.57) and DASH diet plus weight management groups (mean = 6.23; 95% CI 5.88 to 6.59) compared with Usual Diet Controls (mean = 3.66; 95% CI 3.30 to 4.01; Pdiet was associated with larger

  18. Efficiency of a phone coaching program on adherence to continuous positive airway pressure in sleep apnea hypopnea syndrome: a randomized trial.

    Science.gov (United States)

    Sedkaoui, Kamila; Leseux, Ludivine; Pontier, Sandrine; Rossin, Nicole; Leophonte, Paul; Fraysse, Jean-Louis; Didier, Alain

    2015-09-14

    Continuous Positive Airway Pressure (CPAP) remains the reference treatment for moderate to severe forms of the Sleep Apnea/Hypopnea Syndrome (SAHS). Compliance to the treatment appears to be a key factor to improving health status of these patients. We conducted a multicenter, prospective, randomized, controlled, parallel group trial of standard support completed or not within 3 months of coaching sessions for newly diagnosed SAHS patients starting CPAP therapy. This study has been recorded by AFSSAPS with the RCB number: 2009-A01127-50 and received favourably by the Human Studies Committee in France. The coaching session consisted of 5 sessions of telephone-based counselling by competent staff. The primary outcome was the proportion of patients using CPAP more than 3 h per night for 4 months; the secondary outcome was mean hours of CPAP usage in the 2 groups. Three hundred and seventy-nine patients fulfilled the inclusion criteria and were randomized. The percentage of patients using CPAP more than 3 h per night for 4 months was 65 % for the standard support group and 75 % for the coached group. This difference reached a statistical significance (χ2 = 3.97). The mean CPAP usage was increased in the coached group versus standard group. A difference of 26 min was observed (4 h34+/-2 h17 and 4 h08+/-2 h25 respectively, p = 0.04). This study shows that SAHS patients who benefit from phone coaching are statistically more compliant to CPAP than a standard support group is. A simple phone coaching procedure based on knowledge of the disease and reinforcement messages about treatment benefits helps to improve CPAP adherence in SAHS patients. NCT02435355.

  19. Adherence to the dietary approaches to stop hypertension trial (DASH) diet is inversely associated with incidence of insulin resistance in adults: the Tehran lipid and glucose study.

    Science.gov (United States)

    Esfandiari, Saeed; Bahadoran, Zahra; Mirmiran, Parvin; Tohidi, Maryam; Azizi, Fereidoun

    2017-09-01

    Beneficial effects of Dietary Approaches to Stop Hypertension trial (DASH) diet on features of metabolic syndrome have been indicated in clinical studies. In this study, we aimed to assess possible association of DASH diet score and the risk of insulin resistance in an Iranian population. In this prospective cohort study, 927 adult men and women, were recruited. Fasting serum insulin and glucose were measured at baseline and again after 3 years. Usual dietary intakes were measured using a validated 168 item semi-quantitative food frequency questionnaire and DASH score was calculated. Multivariate logistic regression models were used to estimate the occurrence of the insulin resistance across tertiles of DASH diet. To investigate possible superiority of DASH score over other scoring system, we also assessed the association of healthy eating index and Mediterranean diet score with the risk of insulin resistance. Mean age of the participants was 40.34 ± 12.14 years old. The incidence rate of insulin resistance was 12.8%. Participants with higher DASH score had also higher intakes of potassium, calcium, magnesium, fiber, and lower intakes of cholesterol (pDASH score and the risk insulin resistance in the highest compared to the lowest tertile (OR = 0.39, 95% CI = 0.20-0.76, p for trend = 0.007). There was no significant association between healthy eating index and Mediterranean diet score with the incidence of insulin resistance. In conclusion, adherence to the DASH dietary pattern may be associated with a lower risk of insulin resistance and its related metabolic outcomes.

  20. Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP) study: a randomised controlled trial of a polypill-based strategy amongst indigenous and non indigenous people at high cardiovascular risk.

    Science.gov (United States)

    Liu, Hueiming; Patel, Anushka; Brown, Alex; Eades, Sandra; Hayman, Noel; Jan, Stephen; Ring, Ian; Stewart, Greg; Tonkin, Andrew; Weeramanthri, Tarun; Wade, Vicki; Rodgers, Anthony; Usherwood, Tim; Neal, Bruce; Peiris, David; Burke, Hugh; Reid, Christopher; Cass, Alan; Kanyini GAP Study Team

    2010-08-05

    The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP) Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents) amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels. The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations. The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated. This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.

  1. Treatment Efficacy, Adherence, and Quality of Life Among Women Younger Than 35 Years in the International Breast Cancer Study Group TEXT and SOFT Adjuvant Endocrine Therapy Trials.

    Science.gov (United States)

    Saha, Poornima; Regan, Meredith M; Pagani, Olivia; Francis, Prudence A; Walley, Barbara A; Ribi, Karin; Bernhard, Jürg; Luo, Weixiu; Gómez, Henry L; Burstein, Harold J; Parmar, Vani; Torres, Roberto; Stewart, Josephine; Bellet, Meritxell; Perelló, Antonia; Dane, Faysal; Moreira, Antonio; Vorobiof, Daniel; Nottage, Michelle; Price, Karen N; Coates, Alan S; Goldhirsch, Aron; Gelber, Richard D; Colleoni, Marco; Fleming, Gini F

    2017-09-20

    Purpose To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results For 240 human epidermal growth factor receptor 2-negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer-free interval (BCFI) was 67.1% (95% CI, 54.6% to 76.9%) with tamoxifen alone, 75.9% with tamoxifen plus OFS (95% CI, 64.0% to 84.4%), and 83.2% with exemestane plus OFS (95% CI, 72.7% to 90.0%). For 145 human epidermal growth factor receptor 2-negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2% (95% CI, 66.2% to 87.7%) with tamoxifen plus OFS and 81.6% (95% CI, 69.8% to 89.2%) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8% of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion In women younger than 35 years with hormone receptor-positive breast cancer, adjuvant OFS combined with tamoxifen or

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

    Science.gov (United States)

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

    2014-01-01

    Concerns that standard didactic adherence counselling may be inadequate to maximise antiretroviral therapy (ART) adherence led us to evaluate more intensive individualised motivational adherence counselling. We randomised 297 HIV-positive ART-naïve patients in Durban, South Africa, to receive either didactic counselling, prior to ART initiation (n=150), or an intensive motivational adherence intervention after initiating ART (n=147). Study arms were similar for age (mean 35.8 years), sex (43.1% male), CD4+ cell count (median 121.5 cells/μl) and viral load (median 119 000 copies/ml). Virologic suppression at nine months was achieved in 89.8% of didactic and 87.9% of motivational counselling participants (risk ratio [RR] 0.98, 95% confidence interval [CI] 0.90-1.07, p=0.62). 82.9% of didactic and 79.5% of motivational counselling participants achieved >95% adherence by pill count at six months (RR 0.96, 95%CI 0.85-1.09, p=0.51). Participants receiving intensive motivational counselling did not achieve higher treatment adherence or virological suppression than those receiving routinely provided didactic adherence counselling. These data are reassuring that less resource intensive didactic counselling was adequate for excellent treatment outcomes in this setting. PMID:24696226

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

    Science.gov (United States)

    Lonsdale, Chris; Hall, Amanda M; Williams, Geoffrey C; McDonough, Suzanne M; Ntoumanis, Nikos; Murray, Aileen; Hurley, Deirdre A

    2012-06-15

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

  4. Adherence as a predictor of sexual behaviors in people living with HIV/AIDS during the first year of antiretroviral therapy in rural Cameroon: data from Stratall ANRS 12110/ESTHER trial.

    Directory of Open Access Journals (Sweden)

    Gilbert Ndziessi

    Full Text Available This study aims to investigate the time pattern of inconsistence condom use (ICU during the first year of antiretroviral therapy (ART and its relationship with treatment adherence in naïve HIV-infected adult patients.Data collection was nested within a longitudinal trial on HIV treatment. ICU was defined as reporting to have "never", "sometimes" or "nearly always" used condoms with one's main or casual partner(s--either HIV-negative or of unknown HIV status in the three previous months. Adherence was defined as taking 100% of their ART prescribed doses in the 4 days before the visit and "not having interrupted treatment", even once, for more than two consecutive days during the 4 previous weeks. Mixed logistic regression was used to study the relationship between adherence and ICU.Among the 459 patients enrolled, 212 (46% during 334 visits reported to have had sexual intercourse at least once with their partner(s--either HIV-negative or of unknown HIV status--during the first 12 months of ART. The proportion of ICU was 76%, 50% and 59% at month 0 (M0, month 6 (M6 and month 12 (M12, while 60% and 66% of patients were ART-adherent at M6 and M12, respectively. After adjustment for the frequency of sexual activity, type of sexual partner(s, perceived social class and desire for a child, patients adherent to ART were less likely to report ICU when compared with baseline (AOR [95% CI]: 0.38 [0.19-0.76]; P = 0.006.Adherence to ART is associated with a lower risk of ICU but this result needs to be interpreted carefully. As adherence behaviors are not only determined by problems with the healthcare systems but also by social barriers encountered by patients in their daily life, counseling should not only be ART adherence-centered but also patient-centered, including sexual risk minimization and psychosocial support.

  5. Effect of text messages to improve health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled pilot trial

    OpenAIRE

    Yamagata, Zentaro; Suzuki,Kohta; Yokomichi, Hiroshi; Shinohara, Ryoji; Sugita, Hideki

    2017-01-01

    ABSTRACT It has been suggested that low health literacy (HL) is associated with poor medication adherence. This study aimed to examine the effect of a text message-based HL intervention to promote medication adherence, compared with text messages that only sent medication reminders, in patients with type 2 diabetes. This was a single-center, open-label, randomized (1:1) controlled pilot study. The study period was 6 months. Intervention group was sent HL related text messages, compared to the...

  6. A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Emmanuel eStip

    2013-08-01

    Full Text Available Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill® and the BARS, in order to verify whether the DoPill® provides reliable assessment of medication adherence. Methods: The DoPill® is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill® or Treatment As Usual group (TAU for six weeks. The BARS was used as a reference measure. Results: Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67 % after six weeks. DoPill® recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. Conclusion: These results suggest that DoPill® is a valid tool that provides more reliable and objective data for the clinician about their patient’s adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

  7. Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women: A Randomized Controlled Trial. Addendum

    Science.gov (United States)

    2009-09-01

    AD_________________ AWARD NUMBER: DAMD17-03-1-0676 TITLE: Increasing Adherence to Follow-up of...TITLE AND SUBTITLE 5a. CONTRACT NUMBER Increasing Adherence to Follow-up of Breast Abnormalities in Low-Income Korean American Women: A...who refused participation, could never be contacted or dropped out, self-reported completion of follow-up was 61% in the intervention arm and 46% in

  8. A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia.

    Science.gov (United States)

    Stip, Emmanuel; Vincent, Philippe D; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

    2013-01-01

    Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill(®) improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill(®) and the BARS, in order to verify whether the DoPill(®) provides reliable assessment of medication adherence. The DoPill(®) is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill(®) or treatment as usual groups for 6 weeks. The BARS was used as a reference measure. Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67% after 6 weeks. DoPill(®) recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. These results suggest that DoPill(®) is a valid tool that provides more reliable and objective data for the clinician about their patient's adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

  9. STAAR: a randomised controlled trial of electronic adherence monitoring with reminder alarms and feedback to improve clinical outcomes for children with asthma.

    Science.gov (United States)

    Morton, Robert W; Elphick, Heather E; Rigby, Alan S; Daw, William J; King, David A; Smith, Laurie J; Everard, Mark L

    2017-04-01

    Suboptimal adherence to inhaled steroids is common in children with asthma and is associated with poor disease control, reduced quality of life and even death. Previous studies using feedback of electronically monitored adherence data have demonstrated improved adherence, but have not demonstrated a significant impact on clinical outcomes. The aim of this study was to determine whether introduction of this approach into routine practice would result in improved clinical outcomes. Children with asthma aged 6-16 years were randomised to the active intervention consisting of electronic adherence monitoring with daily reminder alarms together with feedback in the clinic regarding their inhaled corticosteroid (ICS) use or to the usual care arm with adherence monitoring alone. All children had poorly controlled asthma at baseline, taking ICS and long-acting β-agonists. Subjects were seen in routine clinics every 3 months for 1 year. The primary outcome was the Asthma Control Questionnaire (ACQ) score. Secondary outcomes included adherence and markers of asthma morbidity. 77 of 90 children completed the study (39 interventions, 38 controls). Adherence in the intervention group was 70% vs 49% in the control group (p≤0.001). There was no significant difference in the change in ACQ, but children in the intervention group required significantly fewer courses of oral steroids (p=0.008) and fewer hospital admissions (p≤0.001). The results indicate that electronic adherence monitoring with feedback is likely to be of significant benefit in the routine management of poorly controlled asthmatic subjects. NCT02451709; pre-result. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  10. Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30-60 years: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ashoorkhani, Mahnaz; Bozorgi, Ali; Majdzadeh, Reza; Hosseini, Hamed; Yoonessi, Ali; Ramezankhani, Ali; Eftekhar, Hassan

    2016-10-21

    Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment. A two-arm, parallel-design randomized controlled clinical trial will be conducted on 30 to 60 year-old patients with primary hypertension who are attending the Tehran Heart Center. One hundred and thirty-two (132) patients will be randomly assigned to the intervention and control (usual method) groups. The most important inclusion criteria are, having primary hypertension and being pharmacologically treated for it, and not having developed the complications of hypertension, such as myocardial infarction, cerebral stroke and cardiac insufficiency. The participants should be able to read Persian and be able to use the application. The most important outcomes of the study include adherence to treatment, weight control, and regular monitoring of blood pressure which are assessed in the primary assessment (baseline data questionnaire) and again at the 8 th and 24 th weeks. The intervention is a mobile application that has capabilities such as reminders and scientific and supportive information. This application has been programmed to reduce many of the nonadherence factors of hypertension treatment. Therefore, the findings may contribute to a rise in adherence to treatment. If proven to have an appropriate impact, it may be extended for use in the national hypertension control plan. This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

  11. The Influence of Wireless Self-Monitoring Program on the Relationship Between Patient Activation and Health Behaviors, Medication Adherence, and Blood Pressure Levels in Hypertensive Patients: A Substudy of a Randomized Controlled Trial.

    Science.gov (United States)

    Kim, Ju Young; Wineinger, Nathan E; Steinhubl, Steven R

    2016-06-22

    Active engagement in the management of hypertension is important in improving self-management behaviors and clinical outcomes. Mobile phone technology using wireless monitoring tools are now widely available to help individuals monitor their blood pressure, but little is known about the conditions under which such technology can effect positive behavior changes or clinical outcomes. To study the influence of wireless self-monitoring program and patient activation measures on health behaviors, medication adherence, and blood pressure levels as well as control of blood pressure in hypertensive patients. We examined a subset of 95 hypertensive participants from a 6-month randomized controlled trial designed to determine the utility of a wireless self-monitoring program (n=52 monitoring program, n=43 control), which consisted of a blood pressure monitoring device connected with a mobile phone, reminders for self-monitoring, a Web-based disease management program, and a mobile app for monitoring and education, compared with the control group receiving a standard disease management program. Study participants provided measures of patient activation, health behaviors including smoking, drinking, and exercise, medication adherence, and blood pressure levels. We assessed the influence of wireless self-monitoring as a moderator of the relationship between patient activation and health behaviors, medication adherence, and control of blood pressure. Improvements in patient activation were associated with improvements in cigarette smoking (beta=-0.46, Pself-monitoring program. No differences were observed with respect to medication adherence. Participation in a wireless self-monitoring program provides individuals motivated to improve their health management with an added benefit above and beyond that of motivation alone. Hypertensive individuals eager to change health behaviors are excellent candidates for mobile health self-monitoring.. ClinicalTrials.gov NCT01975428, https

  12. Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial

    Science.gov (United States)

    Mendes, Romeu; Moreira, Amélia; Lunet, Nuno

    2017-01-01

    Introduction Screening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a—customised text message invitation; step 1b—customised automated phone call invitation; step 2—secretary phone call; step 3—family health professional phone call and face-to-face appointment. Methods A population-based randomised controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomised (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automated phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (written letter). The primary outcome is the proportion of women adherent to screening after step 1 or sequences of steps from 1 to 3. The secondary outcomes are: proportion of women screened after each step (1a, 2 and 3); proportion of text messages/phone calls delivered; proportion of women previously screened in a private health institution who change to organised screening. The intervention and control groups will be compared based on intention-to-treat and per-protocol analyses. Ethics and dissemination The study was

  13. A randomized controlled trial to evaluate the effectiveness of a cognitive behavioural group approach to improve patient adherence to peritoneal dialysis fluid restrictions: a pilot study.

    Science.gov (United States)

    Hare, Jennifer; Clark-Carter, David; Forshaw, Mark

    2014-03-01

    Peritoneal dialysis (PD) requires patients to take an active role in their adherence to fluid restrictions. Although fluid non-adherence had been identified among this patient group, no specific interventions have been researched or published with in the PD population. The current study sought to investigate whether an applied cognitive behavioural therapy (CBT-based intervention) used among haemodialysis patients would improve fluid adherence among PD patients; utilizing clinical indicators used in practice. Fifteen PD patients identified as fluid non-adherent were randomly assigned to an intervention group (IG) or a deferred-entry control group (CG). The study ran for a total of 21 weeks, with five data collection points; at baseline, post-intervention and at three follow-up points; providing a RCT phase and a combined longitudinal analysis phase. The content of the group intervention encompassed educational, cognitive and behavioural components, aimed to assist patients' self-management of fluid. No significant differences in weight (kg) reduction were found in either phase and undesirable changes in blood pressure (BP) were observed. However, in the longitudinal phase, a statistically significant difference in oedematous status was observed at 6-week follow-up; which may be indicative of fluid adherence. Positive and significant differences were observed in the desired direction for measures of psychological well-being, quality of life and health beliefs; areas correlated with enhanced fluid adherence in other research. This study reveals encouraging and significant changes in predictors of fluid adherence. Although there were no significant changes in weight as a crude clinical measure of fluid intake, significant reductions in oedematous status were observed as a consequence of this CBT-based group intervention.

  14. HIV disclosure and other factors that impact on adherence to ...

    African Journals Online (AJOL)

    Some authors argue that there are no predictors of adherence to medication, while others proffer indicators of likely adherence. These contextual factors are wide-ranging and may be interdependent. There are few studies of adherence in resource-poor settings. Of these, many were linked to particular trials whose ...

  15. Multi-center randomized trial on the impact of “CONFIDENCE” communication program aimed at evaluating therapy adherence of patients with registered myocardial infarction who underwent successful revascularization by stenting or thrombolysis after discharg

    Directory of Open Access Journals (Sweden)

    А. Р. Таркова

    2017-04-01

    Full Text Available Aim. The article looks at the effect of the program "Confidence" to increase the proportion of patients’ therapy in patients with coronary heart disease for two years after successful revascularization using thrombolytic or stenting of the coronary arteries on the myocardial infarction.Methods. This is a prospective, randomized, controlled, parallel-group trial including 4.000 patients. They will be divided into two groups: patients receiving standard outpatient observation (n=2000 and those enrolled for the program "Confidence" (n=2000. The total duration is 24 months. The trial will take place in two stages. In the first stage (0-12 months the impact of the program "Confidence" on therapy adherence and outcomes of cardiovascular diseases will be assessed. In the second stage (after the change of groups in 12 months, 12-24 months the effect of changing the way to remind patients of therapy adherence will be evaluated.Conclusion. The trial was designed in such a way as to show that the proposed program "Confidence" increases the proportion of patients who adhere to therapy in the cohort of those with coronary heart disease for two years after successful revascularization by using thrombolytic or stenting of the coronary arteries against the background of myocardial infarction.Received 13 February 2017. Accepted 9 March 2017.Financing: KRKA company’s grant. Sponsorship had no effect on data acquisition, analysis and interpretation.Conflict of interest: Kretov E.I. served as executive editor of “Endovascular surgery” section. All other authors declare no conflict of interest.Author contributionsStudy conception and design: Kretov E.I., Grazhdankin I.O., Baystrukov V.I., Zubarev D.D. Statistical data processing: Krestyaninov O.V., Kozyr K.V., Obedinskiy A.A., Prokhorikhin A.A.Drafting the article: Tarkova A.R., Anisimova V.D.Critical revision: Tarkova A.R., Anisimova V.D., Kretov E.I.

  16. Internet-based incentives increase blood glucose testing with a non-adherent, diverse sample of teens with type 1 diabetes mellitus: a randomized controlled Trial.

    Science.gov (United States)

    Raiff, Bethany R; Barrry, Victoria B; Ridenour, Ty A; Jitnarin, Natinee

    2016-06-01

    Non-adherence with self-monitoring blood glucose (SMBG) among teenagers with type 1 diabetes can be a problem. The purpose of this study was to investigate the feasibility, acceptability, and preliminary efficacy of using Internet-based incentives to improve adherence with SMBG in non-adherent teenagers. Participants were randomly assigned to contingent (CS; N = 23), where they had to meet web camera-verified SMBG goals to earn incentives, or non-contingent (NS) groups (N = 18), where they earned incentives independent of adherence. Brief motivational interviewing (MI) was given prior to the intervention. Attrition was 15 % in the CS group. Participants and parents endorsed the intervention on all intervention dimensions. Daily SMBG increased after one MI session, and further increased when incentives were added, but significantly more for so for older participants. SMBG declined slowly over time, but only returned to baseline levels for younger NS participants. Internet-based incentive interventions are feasible, acceptable, and show promise for improving adherence with SMBG.

  17. Adherence-adjusted estimates of benefits and harms from treatment with amoxicillin for LRTI: secondary analysis of a 12-country randomised placebo-controlled trial using randomisation-based efficacy estimators.

    Science.gov (United States)

    Gillespie, David; Hood, Kerenza; Farewell, Daniel; Butler, Christopher C; Verheij, Theo; Goossens, Herman; Stuart, Beth; Mullee, Mark; Little, Paul

    2015-03-06

    Estimate the efficacy of amoxicillin for acute uncomplicated lower-respiratory-tract infection (LRTI) in primary care and demonstrate the use of randomisation-based efficacy estimators. Secondary analysis of a two-arm individually-randomised placebo-controlled trial. Primary care practices in 12 European countries. Patients aged 18 or older consulting with an acute LRTI in whom pneumonia was not suspected by the clinician. Amoxicillin (two 500 mg tablets three times a day for 7 days) or matched placebo. Clinician-rated symptom severity between days 2-4; new/worsening symptoms and presence of side effects at 4-weeks. Adherence was captured using self-report and tablet counts. 2061 participants were randomised to the amoxicillin or placebo group. On average, 88% of the prescribed amoxicillin was taken. The original analysis demonstrated small increases in both benefits and harms from amoxicillin. Minor improvements in the benefits of amoxicillin were observed when an adjustments for adherence were made (mean difference in symptom severity -0.08, 95% CI -0.17 to 0.01, OR for new/worsening symptoms 0.81, 95% CI 0.66 to 0.98) as well as minor increases in harms (OR for side effects 1.32, 95% CI 1.12 to 1.57). Adherence to amoxicillin was high, and the findings from the original analysis were robust to non-adherence. Participants consulting to primary care with an acute uncomplicated LRTI can on average expect minor improvements in outcome from taking amoxicillin. However, they are also at an increased risk of experiencing side effects. Eudract-CT 2007-001586-15 and ISRCTN52261229. The trial was registered at EudraCT in 2007 due to an administrative misunderstanding that EudraCT was a suitable registry--which it was not in 2007, but has become since. On discovery of this error, the trial was also registered at ISRCTN (January 2009). Trial procedures did not change between the two registrations. Published by the BMJ Publishing Group Limited. For permission to use

  18. Persisting with prevention: The importance of adherence for HIV prevention

    Directory of Open Access Journals (Sweden)

    Hayes Richard J

    2008-07-01

    Full Text Available Abstract Background Only four out of 31 completed randomized controlled trials (RCTs of HIV prevention strategies against sexual transmission have shown significant efficacy. Poor adherence may have contributed to the lack of effect in some of these trials. In this paper we explore the impact of various levels of adherence on measured efficacy within an RCT. Analysis We used simple quantitative methods to illustrate the impact of various levels of adherence on measured efficacy by assuming a uniform population in terms of sexual behavior and the binomial model for the transmission probability per partnership. At 100% adherence the measured efficacy within an RCT is a reasonable approximation of the true biological efficacy. However, as adherence levels fall, the efficacy measured within a trial substantially under-estimates the true biological efficacy. For example, at 60% adherence, the measured efficacy can be less than half of the true biological efficacy. Conclusion Poor adherence during a trial can substantially reduce the power to detect an effect, and improved methods of achieving and maintaining high adherence within trials are needed. There are currently 12 ongoing HIV prevention trials, all but one of which require ongoing user-adherence. Attention must be given to methods of maximizing adherence when piloting and designing RCTs and HIV prevention programmes.

  19. A trial examining an advanced practice nurse intervention to promote medication adherence and symptom management in adult cancer patients prescribed oral anti-cancer agents: study protocol.

    Science.gov (United States)

    Spoelstra, Sandra L; Burhenn, Peggy S; DeKoekkoek, Tracy; Schueller, Monica

    2016-02-01

    To report a study protocol that refines then examines feasibility, preliminary efficacy and satisfaction of ADHERE, an intervention using motivational interviewing and brief cognitive behaviorial therapy as a mechanism for goal-oriented systematic patient education to promote symptom management and adherence among cancer patients prescribed oral anti-cancer agents. Cancer treatment with oral anti-cancer agents shifts responsibility for managing treatment from clinicians in supervised cancer centres to patients and their caregivers. Thus, a need exists to standardize start-of-care to support patient self-management of care at home. A two-phase quasi-experimental sequential design with repeated measures. Sixty-five adult patients newly prescribed an oral anti-cancer agent will be recruited from three community cancer centres. Phase 1 will enrol five patients to refine the ADHERE intervention prior to testing. After completion, Phase 2 will enrol 30 patients who receive usual care. Advanced practice nurses will then be trained. Thirty patients will be then enrolled in the intervention group and provided ADHERE, a 4-week intervention using semi-structured interactions (initial face-to-face session and once a week phone sessions over 3 weeks) and a Toolkit to promote self-management of care. Outcome measures include: oral anti-cancer agents adherence rate, symptom presence and severity, feasibility and satisfaction with ADHERE. This protocol was approved January 2014. This nurse-led intervention has the potential to standardize the start-of-care training for the patients to self-manage when oral anti-cancer agents for treatment were prescribed. © 2015 John Wiley & Sons Ltd.

  20. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes.

    Science.gov (United States)

    Safren, Steven A; Gonzalez, Jeffrey S; Wexler, Deborah J; Psaros, Christina; Delahanty, Linda M; Blashill, Aaron J; Margolina, Aleksandra I; Cagliero, Enrico

    2014-01-01

    To test cognitive behavioral therapy for adherence and depression (CBT-AD) in type 2 diabetes. We hypothesized that CBT-AD would improve adherence; depression; and, secondarily, hemoglobin A1c (A1C). Eighty-seven adults with unipolar depression and uncontrolled type 2 diabetes received enhanced treatment as usual (ETAU), including medication adherence, self-monitoring of blood glucose (SMBG), and lifestyle counseling; a provider letter documented psychiatric diagnoses. Those randomized to the intervention arm also received 9-11 sessions of CBT-AD. Immediately after acute treatment (4 months), adjusting for baseline, CBT-AD had 20.7 percentage points greater oral medication adherence on electronic pill cap (95% CI -31.14 to -10.22, P = 0.000); 30.2 percentage points greater SMBG adherence through glucometer downloads (95% CI -42.95 to -17.37, P = 0.000); 6.44 points lower depression scores on the Montgomery-Asberg Depression Rating Scale (95% CI 2.33-10.56, P = 0.002); 0.74 points lower on the Clinical Global Impression (95% CI 0.16-1.32, P = 0.01); and 0.72 units lower A1C (95% CI 0.29-1.15, P = 0.001) relative to ETAU. Analyses of 4-, 8-, and 12-month follow-up time points indicated that CBT-AD maintained 24.3 percentage points higher medication adherence (95% CI -38.2 to -10.3, P = 0.001); 16.9 percentage points greater SMBG adherence (95% CI -33.3 to -0.5, P = 0.043); and 0.63 units lower A1C (95% CI 0.06-1.2, P = 0.03) after acute treatment ended. For depression, there was some evidence of continued improvement posttreatment, but no between-group differences. CBT-AD is an effective intervention for adherence, depression, and glycemic control, with enduring and clinically meaningful benefits for diabetes self-management and glycemic control in adults with type 2 diabetes and depression.

  1. Short-term effectiveness of a community health worker intervention for HIV-infected pregnant women in Tanzania to improve treatment adherence and retention in care: A cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Nerissa Nance

    Full Text Available Community health workers (CHWs are lay workers who have the potential to enhance services to prevent mother-to-child HIV transmission (PMTCT and improve the health of women living with HIV infection. We conducted a cluster-randomized trial of an intervention to integrate CHWs with 'Option B+' PMTCT services in Shinyanga Region, Tanzania.The intervention was implemented for 11 months and included four integrated components: 1 formal linkage of CHWs to health facilities; 2 CHW-led antiretroviral therapy (ART adherence counseling; 3 loss to follow-up tracing by CHWs; and 4 distribution of Action Birth Cards (ABCs, a birth planning tool. We cluster-randomized 32 facilities offering PMTCT services, within strata of size, to the intervention (n = 15 or comparison (standard of care, n = 17 groups. Intervention effectiveness was determined with a difference-in-differences strategy based on clinical and pharmacy data from HIV-infected postpartum women at baseline (births in 2014 and endline (births April-Oct 2015. The primary outcome was retention in care between 60 and 120 days postpartum. Secondary outcomes included ART initiation, timing of ART initiation (as measured by week of gestation, and ART adherence 90 days postpartum, measured using the medication possession ratio (MPR≥95%.Intervention and comparison facilities were similar at baseline. Data were collected from 1,152 and 678 mother-infant pairs at baseline and endline, respectively. There were no significant differences in retention in care, ART initiation, or timing of ART initiation between the intervention and control groups. Adherence (MPR≥95% at 90 days postpartum was 11.3 percentage points higher in the intervention group in ITT analyses (95% CI: -0.7, 23.3, p = 0.06, though this effect was attenuated after adjusting for baseline imbalance (9.5 percentage points, 95% CI: -2.9, 22.0, p = 0.13. Among only sites that had the greatest fidelity to the intervention, however, we found a

  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

    Directory of Open Access Journals (Sweden)

    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. The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA®, in a community pharmacy setting: study protocol for a randomised controlled trial.

    Science.gov (United States)

    O'Dwyer, Susan Mary; MacHale, Elaine; Sulaiman, Imran; Holmes, Martin; Hughes, Cian; D'Arcy, Shona; Rapcan, Viliam; Taylor, Terence; Boland, Fiona; Bosnic-Anticevich, Sinthia; Reilly, Richard B; Ryder, Sheila A; Costello, Richard W

    2016-05-04

    time relative to the prescribed interval. Secondary outcomes include exacerbation rates and quality of life measures. Differences in the timing and technique of inhaler use as altered by the interventions will also be assessed. Data will be analysed on an intention-to-treat and a per-protocol basis. Sample size has been calculated with reference to comparisons to be made between the intervention and comparator clusters and indicates 75 participants per cluster. With an estimated 10 % loss to follow-up we will be able to show a 20 % difference between the population means of the intervention and comparator groups with a power of 0.8. The Type I error probability associated with the test of the null hypothesis is 0.05. This clinical trial will establish whether providing personalised feedback to individuals on their inhaler use improves adherence. It may also be possible to enhance the role of pharmacists in clinical care by identifying patients in whom alteration of either therapy or inhaler device is appropriate. ClinicalTrials.gov NCT02203266 .

  4. Stepwise strategy to improve Cervical Cancer Screening Adherence (SCAN-CC): automated text messages, phone calls and face-to-face interviews: protocol of a population-based randomised controlled trial.

    Science.gov (United States)

    Firmino-Machado, João; Mendes, Romeu; Moreira, Amélia; Lunet, Nuno

    2017-10-05

    Screening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a-customised text message invitation; step 1b-customised automated phone call invitation; step 2-secretary phone call; step 3-family health professional phone call and face-to-face appointment. A population-based randomised controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomised (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automated phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (written letter). The primary outcome is the proportion of women adherent to screening after step 1 or sequences of steps from 1 to 3. The secondary outcomes are: proportion of women screened after each step (1a, 2 and 3); proportion of text messages/phone calls delivered; proportion of women previously screened in a private health institution who change to organised screening. The intervention and control groups will be compared based on intention-to-treat and per-protocol analyses. The study was approved by the Ethics Committee of the Northern Health

  5. Cryptococcal meningitis screening and community-based early adherence support in people with advanced HIV infection starting antiretroviral therapy in Tanzania and Zambia: an open-label, randomised controlled trial.

    Science.gov (United States)

    Mfinanga, Sayoki; Chanda, Duncan; Kivuyo, Sokoine L; Guinness, Lorna; Bottomley, Christian; Simms, Victoria; Chijoka, Carol; Masasi, Ayubu; Kimaro, Godfather; Ngowi, Bernard; Kahwa, Amos; Mwaba, Peter; Harrison, Thomas S; Egwaga, Saidi; Jaffar, Shabbar

    2015-05-30

    Mortality in people in Africa with HIV infection starting antiretroviral therapy (ART) is high, particularly in those with advanced disease. We assessed the effect of a short period of community support to supplement clinic-based services combined with serum cryptococcal antigen screening. We did an open-label, randomised controlled trial in six urban clinics in Dar es Salaam, Tanzania, and Lusaka, Zambia. From February, 2012, we enrolled eligible individuals with HIV infection (age ≥18 years, CD4 count of treatment for cryptococcal infection combined with a short initial period of adherence support after initiation of ART could substantially reduce mortality in HIV programmes in Africa. European and Developing Countries Clinical Trials Partnership. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Effect of text messages to improve health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled pilot trial.

    Science.gov (United States)

    Sugita, Hideki; Shinohara, Ryoji; Yokomichi, Hiroshi; Suzuki, Kohta; Yamagata, Zentaro

    2017-08-01

    It has been suggested that low health literacy (HL) is associated with poor medication adherence. This study aimed to examine the effect of a text message-based HL intervention to promote medication adherence, compared with text messages that only sent medication reminders, in patients with type 2 diabetes. This was a single-center, open-label, randomized (1:1) controlled pilot study. The study period was 6 months. Intervention group was sent HL related text messages, compared to the reminder messages that were sent to the control group. The primary outcome was the difference in the change rate of scores on the Morisky Eight-Item Medication Adherence Scale (MMAS-8). Forty-one participants were randomized into the intervention (n = 21) and control (n = 20) groups and completed the 6-month follow-up. Although almost participants read and understood the information provided in the messages, no significant difference was observed between groups for the primary outcome (p = 0.78). Our results suggested that medication adherence at 6 months after discharge in patients with type 2 diabetes did not significantly change by text messages, which aimed to improve their HL levels.

  7. Can You Teach a Teen New Tricks? Problem Solving Skills Training Improves Oral Medication Adherence in Pediatric Patients with Inflammatory Bowel Disease Participating in a Randomized Trial.

    Science.gov (United States)

    Greenley, Rachel N; Gumidyala, Amitha P; Nguyen, Eve; Plevinsky, Jill M; Poulopoulos, Natasha; Thomason, Molly M; Walter, Jennifer G; Wojtowicz, Andrea A; Blank, Ellen; Gokhale, Ranjana; Kirschner, Barbara S; Miranda, Adrian; Noe, Joshua D; Stephens, Michael C; Werlin, Steven; Kahn, Stacy A

    2015-11-01

    Medication nonadherence is associated with higher disease activity, greater health care utilization, and lower health-related quality of life in pediatric inflammatory bowel diseases (IBD). Problem solving skills training (PSST) is a useful tool to improve adherence in patients with chronic diseases but has not been fully investigated in IBD. This study assessed feasibility, acceptability, and preliminary efficacy of PSST in pediatric IBD. Recruitment occurred during outpatient clinic appointments. After completion of baseline questionnaires, families were randomized to a treatment group or wait-list comparison group. The treatment group received either 2 or 4 PSST sessions. Youth health-related quality of life was assessed at 3 time points, and electronic monitoring of oral medication adherence occurred for the study duration. Seventy-six youth (ages 11-18 years) on an oral IBD maintenance medication participated. High retention (86%) and treatment fidelity rates (95%) supported feasibility. High satisfaction ratings (mean values ≥4.2 on 1-5 scale) supported intervention acceptability. Modest increases in adherence occurred after 2 PSST sessions among those with imperfect baseline adherence (d = 0.41, P 0.05). Phone-delivered PSST was feasible and acceptable. Efficacy estimates were similar to those of lengthier interventions conducted in other chronic illness populations. Older adolescents benefited more from the intervention than their younger counterparts.

  8. Can we improve cognitive-behavioral therapy for chronic back pain treatment engagement and adherence? A controlled trial of tailored versus standard therapy.

    Science.gov (United States)

    Kerns, Robert D; Burns, John W; Shulman, Marc; Jensen, Mark P; Nielson, Warren R; Czlapinski, Rebecca; Dallas, Mary I; Chatkoff, David; Sellinger, John; Heapy, Alicia; Rosenberger, Patricia

    2014-09-01

    This study evaluated whether tailored cognitive-behavioral therapy (TCBT) that incorporated preferences for learning specific cognitive and/or behavioral skills and used motivational enhancement strategies would improve treatment engagement and participation compared with standard CBT (SCBT). We hypothesized that participants receiving TCBT would show a lower dropout rate, attend more sessions, and report more frequent intersession pain coping skill practice than those receiving SCBT. We also hypothesized that indices of engagement and adherence would correlate with pre- to posttreatment changes in outcome factors. One hundred twenty-eight of 161 consenting persons with chronic back pain who completed baseline measures were allocated to either TCBT or SCBT using a modified randomization procedure. Participants completed daily ratings of pain coping skill practice and goal accomplishment during treatment, as well as measures of pain severity, disability, and other key outcomes at the end of treatment. No significant differences between treatment groups were noted on measures of treatment engagement or adherence. However, these factors were significantly related to some pre- to posttreatment improvements in outcomes, regardless of treatment condition. Participants in this study evidenced a high degree of participation and adherence, but treatment tailored to take into account participant preferences, and that employed motivational enhancement strategies, failed to increase treatment participation over and above SCBT for chronic back pain. Evidence that participation and adherence were associated with positive outcomes supports continued clinical and research efforts focusing on these therapeutic processes. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

  9. Behavioural graded activity results in better exercise adherence and more physicial activity than usual care in people with osteoarthritis: a cluster-randomised trial.

    NARCIS (Netherlands)

    Pisters, M.F.; Veenhof, C.; Schellevis, F.; Twisk, J.W.R.; Dekker, J.; Bakker, D.H. de

    2010-01-01

    OBJECTIVE: To determine the effect of patient exercise adherence within the prescribed physical therapy treatment period and after physical therapy discharge on patients' outcome on pain, physical function and patient self-perceived effect in individuals with osteoarthritis (OA) of the hip and/or

  10. Predictors of Patient Cognitive Therapy Skills and Symptom Change in Two Randomized Clinical Trials: The Role of Therapist Adherence and the Therapeutic Alliance

    Science.gov (United States)

    Webb, Christian A.; DeRubeis, Robert J.; Dimidjian, Sona; Hollon, Steven D.; Amsterdam, Jay D.; Shelton, Richard C.

    2012-01-01

    Objective: Previous research has found that therapist adherence to concrete, problem-focused cognitive therapy (CT) techniques predicts depressive symptom change (e.g., Feeley, DeRubeis, & Gelfand, 1999). More recently, Strunk, DeRubeis, Chui, and Alvarez (2007) demonstrated that in-session evidence of patients' use of CT skills was related to…

  11. Failure to Adhere to Protocol Specified Radiation Therapy Guidelines Was Associated With Decreased Survival in RTOG 9704-A Phase III Trial of Adjuvant Chemotherapy and Chemoradiotherapy for Patients With Resected Adenocarcinoma of the Pancreas

    Energy Technology Data Exchange (ETDEWEB)

    Abrams, Ross A., E-mail: Ross_a_abrams@rush.edu [Rush University Medical Center, Chicago, IL (United States); Winter, Kathryn A. [Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA (United States); Regine, William F. [University of Maryland, Baltimore, MD (United States); Safran, Howard [Brown University, Providence, RI (United States); Hoffman, John P. [Fox Chase Cancer Center, Philadelphia, PA (United States); Lustig, Robert [Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA (United States); Konski, Andre A. [Wayne State Medical Center, Detroit, MI (United States); Benson, Al B. [Northwestern University, Chicago, IL (United States); Macdonald, John S. [St. Vincent' s Cancer Care Center, New York, NY (United States); Rich, Tyvin A. [University of Virginia, Charlottesville, VA (United States); Willett, Christopher G. [Duke University, Durham, NC (United States)

    2012-02-01

    Purpose: In Radiation Therapy Oncology Group 9704, as previously published, patients with resected pancreatic adenocarcinoma received continuous infusion 5-FU and concurrent radiotherapy (5FU-RT). 5FU-RT treatment was preceded and followed by randomly assigned chemotherapy, either 5-FU or gemcitabine. This analysis explored whether failure to adhere to specified RT guidelines influenced survival and/or toxicity. Methods and Materials: RT requirements were protocol specified. Adherence was scored as per protocol (PP) or less than per protocol (trial analysis and without knowledge of individual patient treatment outcomes. Scoring was done for all tumor locations and for the subset of pancreatic head location. Results: RT was scored for 416 patients: 216 PP and 200 adherence to specified RT protocol guidelines on protocol outcomes. Failure to adhere to specified RT guidelines was associated with reduced survival and, for patients receiving gemcitabine, trend toward increased nonhematologic toxicity.

  12. 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

    Directory of Open Access Journals (Sweden)

    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

  13. A culturally adapted telecommunication system to improve physical activity, diet quality, and medication adherence among hypertensive African-Americans: a randomized controlled trial.

    Science.gov (United States)

    Migneault, Jeffrey P; Dedier, Julien J; Wright, Julie A; Heeren, Timothy; Campbell, Marci Kramish; Morisky, Donald E; Rudd, Peter; Friedman, Robert H

    2012-02-01

    Hypertension is more prevalent and clinically severe among African-Americans than whites. Several health behaviors influence blood pressure (BP) control, but effective, accessible, culturally sensitive interventions that target multiple behaviors are lacking. We evaluated a culturally adapted, automated telephone system to help hypertensive, urban African-American adults improve their adherence to their antihypertensive medication regimen and to evidence-based guidelines for dietary behavior and physical activity. We randomized 337 hypertensive primary care patients to an 8-month automated, multi-behavior intervention or to an education-only control. Medication adherence, diet, physical activity, and BP were assessed at baseline and every 4 months for 1 year. Data were analyzed using longitudinal modeling. The intervention was associated with improvements in a measure of overall diet quality (+3.5 points, p telecommunications systems can promote self-management of diet and energy balance in urban African-Americans.

  14. Short-Term Effectiveness of a Mobile Phone App for Increasing Physical Activity and Adherence to the Mediterranean Diet in Primary Care: A Randomized Controlled Trial (EVIDENT II Study).

    Science.gov (United States)

    Recio-Rodriguez, Jose I; Agudo-Conde, Cristina; Martin-Cantera, Carlos; González-Viejo, Mª Natividad; Fernandez-Alonso, Mª Del Carmen; Arietaleanizbeaskoa, Maria Soledad; Schmolling-Guinovart, Yolanda; Maderuelo-Fernandez, Jose-Angel; Rodriguez-Sanchez, Emiliano; Gomez-Marcos, Manuel A; Garcia-Ortiz, Luis

    2016-12-19

    The use of mobile phone apps for improving lifestyles has become generalized in the population, although little is still known about their effectiveness in improving health. We evaluate the effect of adding an app to standard counseling on increased physical activity (PA) and adherence to the Mediterranean diet, 3 months after implementation. A randomized, multicenter clinical trial was carried out. A total of 833 participants were recruited in six primary care centers in Spain through random sampling: 415 in the app+counseling group and 418 in the counseling only group. Counseling on PA and the Mediterranean diet was given to both groups. The app+counseling participants additionally received training in the use of an app designed to promote PA and the Mediterranean diet over a 3-month period. PA was measured with the 7-day Physical Activity Recall (PAR) questionnaire and an accelerometer; adherence to the Mediterranean diet was assessed using the Mediterranean Diet Adherence Screener questionnaire. Participants were predominantly female in both the app+counseling (249/415, 60.0%) and counseling only (268/418, 64.1%) groups, with a mean age of 51.4 (SD 12.1) and 52.3 (SD 12.0) years, respectively. Leisure-time moderate-to-vigorous physical activity (MVPA) by 7-day PAR increased in the app+counseling (mean 29, 95% CI 5-53 min/week; P=.02) but not in the counseling only group (mean 17.4, 95% CI -18 to 53 min/week; P=.38). No differences in increase of activity were found between the two groups. The accelerometer recorded a decrease in PA after 3 months in both groups: MVPA mean -55.3 (95% CI -75.8 to -34.9) min/week in app+counseling group and mean -30.1 (95% CI -51.8 to -8.4) min/week in counseling only group. Adherence to the Mediterranean diet increased in both groups (8.4% in app+counseling and 10.4% in counseling only group), with an increase in score of 0.42 and 0.53 points, respectively (PMediterranean diet, although the app does not increase adherence

  15. 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.

    Science.gov (United States)

    Duggan, Catherine; Coronado, Gloria; Martinez, Javiera; Byrd, Theresa L; Carosso, Elizabeth; Lopez, Cathy; Benavides, Maria; Thompson, Beti

    2012-05-06

    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. 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 navigator program as a method to improve adherence and

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

    Directory of Open Access Journals (Sweden)

    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.

  17. Educational intervention to improve adherence to the Mediterranean diet among parents and their children aged 1-2 years. EniM clinical trial.

    Science.gov (United States)

    Roset-Salla, Margarita; Ramon-Cabot, Joana; Salabarnada-Torras, Jordi; Pera, Guillem; Dalmau, Albert

    2016-04-01

    The objective of the present study was to evaluate the effectiveness of an educational programme on healthy alimentation, carried out in day-care centres and aimed at the parents of children from 1 to 2 years of age, regarding the acquisition of healthy eating habits among themselves and their children. We performed a multicentre, multidisciplinary, randomized controlled study in a community setting. The EniM study (nutritional intervention study among children from Mataró) was performed in twelve day-care centres in Mataró (Spain). Centres were randomized into a control group (CG) and an intervention group (IG). IG received four or five educational workshops on diet, CG did not have workshops. Children, not exclusively breast-fed, from 1 to 2 years of age, in the participating day-care centres and the persons responsible for their alimentation (mother or father). Thirty-five per cent of the IG did not attend the minimum of three workshops and were excluded. The CG included seventy-four children and seventy-two parents and the IG seventy-five children and sixty-seven parents. Both groups were comparable at baseline. Basal adherence to the Mediterranean diet was 56·4 % in parents (Gerber index) and 7·7 points in children (Kidmed test). At 8 months, Mediterranean diet adherence had improved in the IG by 5·8 points in the Gerber index (P=0·01) and 0·6 points in the Kidmed test (P=0·02) compared with the CG. This educational intervention performed in parents at the key period of incorporation of a 1-2-year-old child to the family table showed significant increases in adherence of the parents to the Mediterranean diet, suggesting future improvement in different indicators of health and an expected influence on the diet of their children.

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

    Directory of Open Access Journals (Sweden)

    Catarina Gomes Cani

    2015-02-01

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

  19. Adherence-adjusted estimates of benefits and harms from treatment with amoxicillin for LRTI : Secondary analysis of a 12-country randomised placebocontrolled trial using randomisationbased efficacy estimators

    NARCIS (Netherlands)

    Gillespie, David; Hood, Kerenza; Farewell, Daniel; Butler, Christopher C.; Verheij, Theo; Goossens, Herman; Stuart, Beth; Mullee, Mark; Little, Paul

    2015-01-01

    Objectives: Estimate the efficacy of amoxicillin for acute uncomplicated lower-respiratory-tract infection (LRTI) in primary care and demonstrate the use of randomisationbased efficacy estimators. Design: Secondary analysis of a two-arm individuallyrandomised placebo-controlled trial. Setting:

  20. Effects of tailored telemonitoring on heart failure patients' knowledge, self-care, self-efficacy and adherence: a randomized controlled trial.

    Science.gov (United States)

    Boyne, Josiane J J; Vrijhoef, Hubertus J M; Spreeuwenberg, Marieke; De Weerd, Gerjan; Kragten, Johannes; Gorgels, Anton P M

    2014-06-01

    The education of patients with heart failure (HF) is an essential part of disease management. The perspectives of an increasing number of patients and a shortage of professionals force healthcare to explore new strategies in supporting patients to be better informed and more active. Three hundred and eighty-two patients with HF (age 71±SD 11.2 years) were randomly assigned to either a telemonitoring or a usual care group. Patients received four postal questionnaires to assess their levels of self-reported knowledge, self-care, self-efficacy and adherence. Generalized estimating equations analysis was performed to assess the effects of telemonitoring during the 1-year follow-up. Corrections for baseline were performed if needed. Baseline differences between groups were found for self-care (p=0.001) and self-efficacy (p=0.024). Knowledge of patients in the telemonitoring group significantly improved with 0.9 point on a 15-points scale (ppatients receiving usual care (ppatients in the intervention group improved significantly after 6 months yet was not significantly different after 3 months and 1 year. For patients in the intervention group adherence improved for daily weighing (ptelemonitoring was found to educate patients with HF and to improve their self-care abilities and sense of self-efficacy.

  1. Medication adherence interventions that target subjects with adherence problems: Systematic review and meta-analysis.

    Science.gov (United States)

    Conn, Vicki S; Ruppar, Todd M; Enriquez, Maithe; Cooper, Pam

    2016-01-01

    Inadequate medication adherence is a pervasive, under-recognized cause of poor health outcomes. Many intervention trials designed to improve medication adherence have targeted adults with adherence problems. No previous reviews have synthesized the effectiveness of medication adherence interventions focused on subjects with medication adherence difficulties. This systematic review and meta-analysis synthesized findings from medication adherence intervention studies conducted among adults with medication adherence difficulties. Primary research studies were eligible for inclusion if they tested an intervention designed to increase medication adherence among adults with documented adherence difficulties and reported medication adherence behavior outcomes. Comprehensive search strategies of 13 computerized databases, author and ancestry searches, and hand searches of 57 journals were used to locate eligible primary research. Participant demographics, intervention characteristics, and methodological features were reliably coded from reports along with medication adherence outcomes. Effect sizes for outcomes were calculated as standardized mean differences, and random effects models were used to estimate overall mean effects. Exploratory dichotomous and continuous variable moderator analyses were employed to examine potential associations between medication adherence effect size and sample, intervention, and methodological characteristics. Data were extracted from 53 reports of studies involving 8243 individual primary study participants. The overall standardized mean difference effect size for treatment vs. control subjects was 0.301. For treatment pre- vs. post-intervention comparisons, the overall effect size was 0.533. Significantly larger effect sizes were associated with interventions incorporating prompts to take medications than interventions lacking medication prompts (0.497 vs. 0.234). Larger effect sizes were also found for interventions that linked

  2. Medication Adherence Interventions That Target Subjects with Adherence Problems: Systematic Review and Meta-analysis

    Science.gov (United States)

    Conn, Vicki S.; Ruppar, Todd M.; Enriquez, Maithe; Cooper, Pam

    2015-01-01

    Background Inadequate medication adherence is a pervasive, under-recognized cause of poor health outcomes. Many intervention trials designed to improve medication adherence have targeted adults with adherence problems. No previous reviews have synthesized the effectiveness of medication adherence interventions focused on subjects with medication adherence difficulties. Objective This systematic review and meta-analysis synthesized findings from medication adherence intervention studies conducted among adults with medication adherence difficulties. Methods Primary research studies were eligible for inclusion if they tested an intervention designed to increase medication adherence among adults with documented adherence difficulties and reported medication adherence behavior outcomes. Comprehensive search strategies of 13 computerized databases, author and ancestry searches, and hand searches of 57 journals were used to locate eligible primary research. Participant demographics, intervention characteristics, and methodological features were reliably coded from reports along with medication adherence outcomes. Effect sizes for outcomes were calculated as standardized mean differences, and random effects models were used to estimate overall mean effects. Exploratory dichotomous and continuous variable moderator analyses were employed to examine potential associations between medication adherence effect size and sample, intervention, and methodological characteristics. Results Data were extracted from 53 reports of studies involving 8,243 individual primary study participants. The overall standardized mean difference effect size for treatment vs. control subjects was 0.301. For treatment pre- vs. post-intervention comparisons, the overall effect size was 0.533. Significantly larger effect sizes were associated with interventions incorporating prompts to take medications than interventions lacking medication prompts (0.497 vs. 0.234). Larger effect sizes were also found

  3. Linguistic and Cultural Adaptation of a Computer-Based Counseling Program (CARE+ Spanish) to Support HIV Treatment Adherence and Risk Reduction for People Living With HIV/AIDS: A Randomized Controlled Trial.

    Science.gov (United States)

    Kurth, Ann E; Chhun, Nok; Cleland, Charles M; Crespo-Fierro, Michele; Parés-Avila, José A; Lizcano, John A; Norman, Robert G; Shedlin, Michele G; Johnston, Barbara E; Sharp, Victoria L

    2016-07-13

    Human immunodeficiency virus (HIV) disease in the United States disproportionately affects minorities, including Latinos. Barriers including language are associated with lower antiretroviral therapy (ART) adherence seen among Latinos, yet ART and interventions for clinic visit adherence are rarely developed or delivered in Spanish. The aim was to adapt a computer-based counseling tool, demonstrated to reduce HIV-1 viral load and sexual risk transmission in a population of English-speaking adults, for use during routine clinical visits for an HIV-positive Spanish-speaking population (CARE+ Spanish); the Technology Acceptance Model (TAM) was the theoretical framework guiding program development. A longitudinal randomized controlled trial was conducted from June 4, 2010 to March 29, 2012. Participants were recruited from a comprehensive HIV treatment center comprising three clinics in New York City. Eligibility criteria were (1) adults (age ≥18 years), (2) Latino birth or ancestry, (3) speaks Spanish (mono- or multilingual), and (4) on antiretrovirals. Linear and generalized mixed linear effects models were used to analyze primary outcomes, which included ART adherence, sexual transmission risk behaviors, and HIV-1 viral loads. Exit interviews were offered to purposively selected intervention participants to explore cultural acceptability of the tool among participants, and focus groups explored the acceptability and system efficiency issues among clinic providers, using the TAM framework. A total of 494 Spanish-speaking HIV clinic attendees were enrolled and randomly assigned to the intervention (arm A: n=253) or risk assessment-only control (arm B, n=241) group and followed up at 3-month intervals for one year. Gender distribution was 296 (68.4%) male, 110 (25.4%) female, and 10 (2.3%) transgender. By study end, 433 of 494 (87.7%) participants were retained. Although intervention participants had reduced viral loads, increased ART adherence and decreased sexual

  4. Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kamal, Ayeesha Kamran; Muqeet, Abdul; Farhat, Kashfa; Khalid, Wardah; Jamil, Anum; Gowani, Ambreen; Muhammad, Aliya Amin; Zaidi, Fabiha; Khan, Danyal; Elahi, Touseef; Sharif, Shahrukh; Raz, Sibtain; Zafar, Taha; Bokhari, Syedah Saira; Rahman, Nasir; Sultan, Fateh Ali Tipoo; Sayani, Saleem; Virani, Salim S

    2016-03-05

    Vascular disease, manifesting as myocardial infarction and stroke, is a major cause of morbidity and mortality, especially in low- and middle-income countries. Current estimates are that only one in six patients have good adherence to medications and very few have sufficient health literacy. Our aim is to explore the effectiveness and acceptability of Prescription Interactive Voice Response (IVR) Talking Prescriptions (Talking Rx) and SMS reminders in increasing medication adherence and health literacy in Pakistani patients with vascular disease. This is a randomized, controlled, single center trial. Adult participants, with access to a cell phone and a history of vascular disease, taking multiple risk-modifying medications (inclusive of anti-platelets and statins) will be selected from cerebrovascular and cardiovascular clinics. They will be randomized in a 1:1 ratio via a block design to the intervention or the control arm with both groups having access to a helpline number to address their queries in addition to standard of care as per institutional guidelines. Participants in the intervention group will also have access to Interactive Voice Response (IVR) technology tailored to their respective prescriptions in the native language (Urdu) and will have the ability to hear information about their medication dosage, correct use, side effects, mechanism of action and how and why they should use their medication, as many times as they like. Participants in the intervention arm will also receive scheduled SMS messages reminding them to take their medications. The primary outcome measure will be the comparison of the difference in adherence to anti-platelet and statin medication between baseline and at 3-month follow-up in each group measured by the Morisky Medication Adherence Scale. To ascertain the impact of our intervention on health literacy, we will also compare a local content-validated and modified version of Test of Health Literacy in Adults (TOFHLA) between

  5. Patient's adherence in asthma.

    Science.gov (United States)

    Gillisen, Adrian

    2007-11-01

    Nonadherence in asthma treatment results in increasing mortality, morbidity, and it is associated with increasing treatment costs. In asthma, adherence rates are often below 50%. Understanding of the needs and behaviors of asthma patients as well as treatment barriers to comply with asthma guidelines is important in developing programs to promote adherence. This article presents information on common types of nonadherence in asthma patients, the causes, and it reviews the literature on interventions to overcome these factors to maximize adherence rates. Although several interventions are effective in improving medication adherence in asthma, only few significantly enhance adherence rates and clinical outcomes of these patients. An improvement in treatment adherence is a complex task, requiring asthma self-management, education programs coupled with educational reinforcements, simplifying treatment planes and applications forms. Good communications skills among clinicians and patient education are also central for improving adherence. Methods to overcoming physician barriers ensure consistency in implementing guideline recommendations in practice.

  6. Adherence to Colorectal Cancer Screening

    Science.gov (United States)

    Inadomi, John M.; Vijan, Sandeep; Janz, Nancy K.; Fagerlin, Angela; Thomas, Jennifer P.; Lin, Yunghui V.; Muñoz, Roxana; Lau, Chim; Somsouk, Ma; El-Nachef, Najwa; Hayward, Rodney A.

    2012-01-01

    Background Despite evidence that several colorectal cancer (CRC) screening strategies can reduce CRC mortality, screening rates remain low. This study aimed to determine whether the approach by which screening is recommended influences adherence. Methods We used a cluster randomization design with clinic time block as the unit of randomization. Persons at average risk for development of CRC in a racially/ethnically diverse urban setting were randomized to receive recommendation for screening by fecal occult blood testing (FOBT), colonoscopy, or their choice of FOBT or colonoscopy. The primary outcome was completion of CRC screening within 12 months after enrollment, defined as performance of colonoscopy, or 3 FOBT cards plus colonoscopy for any positive FOBT result. Secondary analyses evaluated sociodemographic factors associated with completion of screening. Results A total of 997 participants were enrolled; 58% completed the CRC screening strategy they were assigned or chose. However, participants who were recommended colonoscopy completed screening at a significantly lower rate (38%) than participants who were recommended FOBT (67%) (PChinese) completed screening more often than African Americans. Moreover, non-white participants adhered more often to FOBT, while white participants adhered more often to colonoscopy. Conclusions The common practice of universally recommending colonoscopy may reduce adherence to CRC screening, especially among racial/ethnic minorities. Significant variation in overall and strategy-specific adherence exists between racial/ethnic groups; however, this may be a proxy for health beliefs and/or language. These results suggest that patient preferences should be considered when making CRC screening recommendations. Trial Registration clinicals.gov Identifier: NCT00705731 PMID:22493463

  7. Assessing treatment-as-usual provided to control groups in adherence trials: exploring the use of an open-ended questionnaire for identifying behaviour change techniques

    NARCIS (Netherlands)

    Oberjé, E.J.M.; Dima, A.L.; Pijnappel, F.J.; Prins, J.M.; de Bruin, M.

    2015-01-01

    Objective: Reporting guidelines call for descriptions of control group support in equal detail as for interventions. However, how to assess the active content (behaviour change techniques (BCTs)) of treatment-as-usual (TAU) delivered to control groups in trials remains unclear. The objective of this

  8. Adherence to antidepressants

    Directory of Open Access Journals (Sweden)

    Abimbola Farinde

    2013-01-01

    Full Text Available While major depression is considered a frequent mental illness there are ongoing reports of high non-adherence to antidepressant medications which places suffers at high risk for relapse, recurrence, or greater impairment,. The World Health Organization (WHO defines adherence as the extent to which a person′s behavior (e.g. taking medications can align with the agreed recommendations of a health care provider. Unfortunately while patient may recognize the importance of adherence to antidepressant medications the majority of patients do not adhere to their prescribed antidepressants. Some of the factors that may contribute to or lead to non-adherence include knowingly or unknowingly missing doses, taking extra doses, delaying administration times, or taking drug holidays. Pharmacists have the unique ability to deter non-adherence through the performance of continuous assessment and monitoring of adherence in this population given these accessibility. Additionally, pharmacists are able to develop therapeutic alliances with patients that can help to increase the likelihood of achieving positive patient outcomes. Antidepressant non-adherence can be viewed as a significant public health concern so it is important for patients to be educated about the importance of adherence, and health care professionals should be aware of factors or patient characteristics that can serve as barriers to non-adherence.

  9. Adherence to inhaled therapy, mortality and hospital admission in COPD

    DEFF Research Database (Denmark)

    Vestbo, J; Anderson, J A; Calverley, P M A

    2009-01-01

    BACKGROUND: Little is known about adherence to inhaled medication in chronic obstructive pulmonary disease (COPD) and the impact on mortality and morbidity. METHODS: Data on drug adherence from a randomised double-blind trial comparing inhaled salmeterol 50 microg + fluticasone propionate 500...... as an ancillary study. RESULTS: Of the 4880 patients (79.8%) with good adherence defined as >80% use of study medication, 11.3% died compared with 26.4% of the 1232 patients (20.2%) with poor adherence. The annual rates of hospital admission for exacerbations were 0.15 and 0.27, respectively. The association...... was more pronounced in patients with good adherence than in those with poor adherence. CONCLUSION: Adherence to inhaled medication is significantly associated with reduced risk of death and admission to hospital due to exacerbations in COPD. Further research is needed to understand these strong...

  10. Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards

    Directory of Open Access Journals (Sweden)

    Grimshaw Jeremy M

    2010-02-01

    Full Text Available Abstract Background Cluster randomized trials (CRTs present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues require efficient electronic search strategies (filters or hedges to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a evaluate sensitivity ("recall" and precision of a well-known electronic search strategy ("randomized controlled trial" as publication type with respect to identifying CRTs, (b evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time. Methods We manually examined a wide range of health journals to identify a gold standard set of CRTs. Search strategies were evaluated against the gold standard set, as well as an independent set of CRTs included in previous systematic reviews. Results The existing strategy (randomized controlled trial.pt is sensitive (93.8% for identifying CRTs, but has relatively low precision (9%, number needed to read 11; the number needed to read can be halved to 5 (precision 18.4% by combining with cluster design-related terms using the Boolean operator AND; combining with the Boolean operator OR maximizes sensitivity (99.4% but would require 28.6 citations read to identify one CRT. Only about 50% of CRTs are clearly identified as cluster randomized in titles or abstracts; approximately 25% can be identified based on the reported units of randomization but are not amenable to electronic searching; the remaining 25% cannot be identified except through manual inspection of the full-text article. The

  11. Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards.

    Science.gov (United States)

    Taljaard, Monica; McGowan, Jessie; Grimshaw, Jeremy M; Brehaut, Jamie C; McRae, Andrew; Eccles, Martin P; Donner, Allan

    2010-02-16

    Cluster randomized trials (CRTs) present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues) require efficient electronic search strategies (filters or hedges) to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a) evaluate sensitivity ("recall") and precision of a well-known electronic search strategy ("randomized controlled trial" as publication type) with respect to identifying CRTs, (b) evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c) determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time. We manually examined a wide range of health journals to identify a gold standard set of CRTs. Search strategies were evaluated against the gold standard set, as well as an independent set of CRTs included in previous systematic reviews. The existing strategy (randomized controlled trial.pt) is sensitive (93.8%) for identifying CRTs, but has relatively low precision (9%, number needed to read 11); the number needed to read can be halved to 5 (precision 18.4%) by combining with cluster design-related terms using the Boolean operator AND; combining with the Boolean operator OR maximizes sensitivity (99.4%) but would require 28.6 citations read to identify one CRT. Only about 50% of CRTs are clearly identified as cluster randomized in titles or abstracts; approximately 25% can be identified based on the reported units of randomization but are not amenable to electronic searching; the remaining 25% cannot be identified except through manual inspection of the full-text article. The proportion of trials clearly identified has

  12. Determinants of adherence to the online component of a blended intervention for patients with hip and/or knee osteoarthritis : A mixed methods study embedded in the e-exercise trial

    NARCIS (Netherlands)

    De Vries, H.J.; Kloek, C.J.J.; De Bakker, Dinny H.; Dekker, J.; Bossen, D.; Veenhof, C.

    2017-01-01

    Background: Embedding Web-based interventions within physiotherapy has potential, but knowledge on patient adherence to these interventions is limited. Iintroduction: This study explores which patient-, intervention-, and environment-related factors are determinants of adherence to the online

  13. High adherence to a neuromuscular injury prevention programme (FIFA 11+) improves functional balance and reduces injury risk in Canadian youth female football players: A cluster randomised trial

    OpenAIRE

    Steffen, Kathrin; Emery, Carolyn; Romiti, Maria; Kang, Jian; Bizzini, Mario; Dvorak, Jiri; Finch, Caroline; Meeuwisse, Willem

    2013-01-01

    A protective effect on injury risk in youth sports through neuromuscular warm-up training routines has consistently been demonstrated. However, there is a paucity of information regarding the quantity and quality of coach-led injury prevention programmes and its impact on the physical performance of players. The aim of this cluster-randomised controlled trial was to assess whether different delivery methods of an injury prevention programme (FIFA 11+) to coaches could improve player performan...

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

    Directory of Open Access Journals (Sweden)

    Ester Amado Guirado

    2011-02-01

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

  15. Hypertension guideline adherence of private practitioners and ...

    African Journals Online (AJOL)

    Background: Hypertension remains a healthcare problem in South Africa. When prescribing evidence-based, cost-effective anti-hypertensive treatment, guideline adherence is essential. The Joint National Committee's Sixth Report (JNC VI) built its evidence-based review on the outcome of clinical trials. The objective of this ...

  16. Psoriasis: improving adherence to topical therapy.

    NARCIS (Netherlands)

    Feldman, S.R.; Horn, E.J.; Balkrishnan, R.; Basra, M.K.; Finlay, A.Y.; McCoy, D.; Menter, A.; Kerkhof, P.C.M. van de

    2008-01-01

    Topical therapy has an important role in psoriasis treatment. It is efficacious and has a favorable safety profile as demonstrated in clinical trials. However, poor treatment outcomes from topical therapy regimens likely result from poor adherence and ineffective use of the medication. The

  17. Improved Adherence to Vision Self-monitoring with the Vision and Memory Stimulating (VMS) Journal for Non-neovascular Age-related Macular Degeneration during a Randomized Controlled Trial.

    Science.gov (United States)

    Bittner, Ava K; Torr-Brown, Sheryl; Arnold, Ellen; Nwankwo, Antonia; Beaton, Patricia; Rampat, Radhika; Dagnelie, Gislin; Roser, Mark

    2014-01-22

    An educational, interactive journal [Vision and Memory Stimulating (VMS) journal] was developed to boost patient confidence and promote long-term adherence with weekly vision self-monitoring in age-related macular degeneration (AMD) patients at risk for vision loss from new-onset neovascularization. In a multicenter randomized controlled trial, 198 subjects with intermediate stage, non-neovascular AMD received the VMS journal or followed usual care (e.g. their doctor's instructions for vision monitoring; Amsler grid). At 6 and/or 12 months post-enrollment, 157 subjects completed a questionnaire on vision self-monitoring. At 6 and 12 months, respectively, 85% and 80% of the VMS journal subjects reported vision monitoring at least weekly, which represent statistically significant 7.1 and 4.2 times greater odds than the 50% of controls who monitored weekly at both follow-up times (pself-monitoring. At 6 and 12 months, respectively, only 15% and 13% of the VMS journal subjects vs. 53% and 44% of the controls reported that they did not feel confident that they were taking care of their sight by self-monitoring (pself-monitoring between the groups (p=0.68), with 81% of all subjects reporting no change in frequency between 6 and 12 months. These findings support the efficacy of the VMS journal for increasing vision self-monitoring adherence and confidence, in addition to promoting persistence in weekly monitoring over the course of a year in AMD subjects at risk for exudative retinal changes.

  18. Mobile.net: Mobile Telephone Text Messages to Encourage Adherence to Medication and to Follow up With People With Psychosis: Methods and Protocol for a Multicenter Randomized Controlled Two-Armed Trial.

    Science.gov (United States)

    Välimäki, Maritta; Hätönen, Heli; Adams, Clive E

    2012-08-02

    Schizophrenia is a high-cost, chronic, serious mental illness. There is a clear need to improve treatments and expand access to care for persons with schizophrenia, but simple, tailored interventions are missing. To evaluate the impact of tailored mobile telephone text messages to encourage adherence to medication and to follow up with people with psychosis at 12 months. Mobile.Net is a pragmatic randomized trial with inpatient psychiatric wards allocated to two parallel arms. The trial will include 24 sites and 45 psychiatric hospital wards providing inpatient care in Finland. The participants will be adult patients aged 18-65 years, of either sex, with antipsychotic medication (Anatomical Therapeutic Chemical classification 2011) on discharge from a psychiatric hospital, who have a mobile phone, are able to use the Finnish language, and are able to give written informed consent to participate in the study. The intervention group will receive semiautomatic system (short message service [SMS]) messages after they have been discharged from the psychiatric hospital. Patients will choose the form, content, timing, and frequency of the SMS messages related to their medication, keeping appointments, and other daily care. SMS messages will continue to the end of the study period (12 months) or until participants no longer want to receive the messages. Patients will be encouraged to contact researchers if they feel that they need to adjust the message in any way. At all times, both groups will receive usual care at the discretion of their team (psychiatry and nursing). The primary outcomes are service use and healthy days by 12 months based on routine data (admission to a psychiatric hospital, time to next hospitalization, time in hospital during this year, and healthy days). The secondary outcomes are service use, coercive measures, medication, adverse events, satisfaction with care, the intervention, and the trial, social functioning, and economic factors. Data will be

  19. ADHERE: randomized controlled trial comparing renal function in de novo kidney transplant recipients receiving prolonged-release tacrolimus plus mycophenolate mofetil or sirolimus.

    Science.gov (United States)

    Rummo, Oleg O; Carmellini, Mario; Rostaing, Lionel; Oberbauer, Rainer; Christiaans, Maarten H L; Mousson, Christiane; Langer, Robert M; Citterio, Franco; Charpentier, Bernard; Brown, Malcolm; Kazeem, Gbenga; Lehner, Frank

    2017-01-01

    ADHERE was a randomized, open-label, Phase IV study comparing renal function at Week 52 postkidney transplant, in patients who received prolonged-release tacrolimus-based immunosuppressive regimens. On Days 0-27, patients received prolonged-release tacrolimus (initially 0.2 mg/kg/day), corticosteroids, and mycophenolate mofetil (MMF). Patients were randomized on Day 28 to receive either prolonged-release tacrolimus plus MMF (Arm 1) or prolonged-release tacrolimus (≥25% dose reduction on Day 42) plus sirolimus (Arm 2). The primary endpoint was glomerular filtration rate by iohexol clearance (mGFR) at Week 52. Secondary endpoints included eGFR, creatinine clearance (CrCl), efficacy failure (patient withdrawal or graft loss), and patient/graft survival. Tolerability was analyzed. The full-analysis set comprised 569 patients (Arm 1: 287; Arm 2: 282). Week 52 mean mGFR was similar in Arm 1 versus Arm 2 (40.73 vs. 41.75 ml/min/1.73 m2 ; P = 0.405), as were the secondary endpoints, except composite efficacy failure, which was higher in Arm 2 versus 1 (18.2% vs. 11.5%; P = 0.002) owing to a higher postrandomization withdrawal rate due to adverse events (AEs) (14.4% vs. 5.2%). Results from this study show comparable renal function between arms at Week 52, with fewer AEs leading to study discontinuation with prolonged-release tacrolimus plus MMF (Arm 1) versus lower dose prolonged-release tacrolimus plus sirolimus (Arm 2). © 2016 The Authors. Transplant International published by John Wiley & Sons Ltd on behalf of Steunstichting ESOT.

  20. The ARBITER 6-HALTS Trial (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies in Atherosclerosis): final results and the impact of medication adherence, dose, and treatment duration.

    Science.gov (United States)

    Villines, Todd C; Stanek, Eric J; Devine, Patrick J; Turco, Mark; Miller, Michael; Weissman, Neil J; Griffen, Len; Taylor, Allen J

    2010-06-15

    This report describes the final results of the ARBITER 6-HALTS (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies in Atherosclerosis) trial. The ARBITER 6-HALTS trial was terminated early on the basis of a pre-specified interim analysis showing superiority of niacin over ezetimibe on change in carotid intima-media thickness (CIMT). After termination, an additional 107 subjects completed a close-out assessment. Patients with coronary heart disease (CHD) or CHD equivalent with low-density lipoprotein cholesterol <100 mg/dl and high-density lipoprotein cholesterol <50 mg/dl for men or 55 mg/dl for women while receiving stable statin treatment were randomly assigned to ezetimibe (10 mg/day) or extended-release niacin (target dose, 2,000 mg/day). The primary end point was change in mean CIMT, analyzed according to a last observation carried forward method. The relationships of study medication adherence, dosage, and cumulative exposure (product of adherence, dose, and time) with change in CIMT were explored. Results in 315 patients included 208 with 14-month follow-up and 107 after mean treatment of 7 +/- 3 months. Niacin (n = 154) resulted in significant reduction (regression) in mean CIMT (-0.0102 +/- 0.0026 mm; p < 0.001) and maximal CIMT (-0.0124 +/- 0.0036 mm; p = 0.001), whereas ezetimibe (n = 161) did not reduce mean CIMT (-0.0016 +/- 0.0024 mm; p = 0.88) or maximal CIMT (-0.0005 +/- 0.0029 mm; p = 0.88) compared with baseline. There was a significant difference between ezetimibe and niacin treatment groups on mean changes in CIMT, favoring niacin, for both mean CIMT (p = 0.016) and maximal CIMT (p = 0.01). Increased cumulative drug exposure was related to regression of CIMT with niacin, and progression of CIMT with ezetimibe. Niacin induces regression of CIMT and is superior to ezetimibe for patients taking statins. (Comparative Study of the Effect of Ezetimibe Versus Extended

  1. Adherence to ART in PLWHA

    African Journals Online (AJOL)

    Women were less adhering than men and adherence was related to depression among drug users (10). A study in. Brazil showed the cumulative incidence of non- adherence to be 36.9% (11). Adherence among patients in Soweto, South Africa was 88% (12). In Cape Town;. 63% of patients maintained adherence levels of ...

  2. The effect of placebo adherence on reducing cardiovascular mortality: a meta-analysis.

    Science.gov (United States)

    Yue, Zhao; Cai, Cheng; Ai-Fang, Yang; Feng-Min, Tang; Li, Chen; Bin, Wang

    2014-03-01

    We aim to demonstrate the effect of placebo adherence on reducing CV mortality. Good adherence, whether to drug or placebo treatment, is associated with lower CV mortality. However, current evidence for the positive effect of placebo adherence on reducing CV mortality is relatively weak. We conducted a fixed-effect meta-analysis of eight randomized clinical trials to evaluate the effect of placebo adherence on reducing CV mortality. We made a comparison between good placebo adherence and poor drug adherence. Compared with poor adherence to drug treatment, good adherence to placebo treatment was associated with lower CV mortality (OR = 0.68, 95% CI 0.60-0.77). Good adherence to placebo has a positive effect on reducing CV mortality. The effect of adherence on reducing CV mortality may be independent of the drug effect.

  3. Mobile Exergaming for Health-Effects of a serious game application for smartphones on physical activity and exercise adherence in type 2 diabetes mellitus-study protocol for a randomized controlled trial.

    Science.gov (United States)

    Höchsmann, Christoph; Walz, Steffen P; Schäfer, Juliane; Holopainen, Jussi; Hanssen, Henner; Schmidt-Trucksäss, Arno

    2017-03-06

    Exergaming is a novel approach to increase motivation for regular physical activity (PA) among sedentary individuals such as patients with type 2 diabetes mellitus (T2DM). Because existing exergames do not offer fitness-level adjusted, individualized workouts and are normally stationary (TV bound), thus not enabling PA anywhere and at any time, we developed a smartphone-based, game-like software application (MOBIGAME) specifically designed for middle-aged T2DM patients to induce a healthier, more active lifestyle as part of successful T2DM treatment and management. In a randomized controlled trial we aim to examine whether our smartphone-based game application can lead to increases in daily PA in T2DM patients that are persistent in the mid to long term and whether these increases are greater than those in a control group. This study is designed as a randomized controlled trial. We plan to recruit a total of 42 T2DM patients [45-70 years, body mass index (BMI) ≥25 kg/m(2), low daily PA, regular smartphone use]. The experimental intervention (duration 24 weeks) includes individualized multidimensional home-based exercise and daily PA promotion administered through MOBIGAME. The control intervention consists of a one-time standard lifestyle counseling including the promotion of baseline activities. The primary outcome is daily PA measured as steps per day. Secondary outcome is exercise adherence measured via the usage data from the participants' smartphones (experimental intervention) and as self-recorded exercise log entries (control intervention). We will test the hypothesis that there will be differences between the experimental and control group with respect to post-interventional daily PA (as well as all other outcomes) using analysis of covariance. For each analysis, an estimate (with 95% confidence interval) of the difference in outcome between both groups will be reported. This research will investigate the effectiveness of a novel smartphone-based, game

  4. Cluster-randomized non-inferiority trial to compare supplement consumption and adherence to different dosing regimens for antenatal calcium and iron-folic acid supplementation to prevent preeclampsia and anaemia: rationale and design of the Micronutrient Initiative study

    Directory of Open Access Journals (Sweden)

    Moshood O. Omotayo

    2015-11-01

    Full Text Available Background: To prevent pre-eclampsia in populations with insufficient dietary calcium (Ca intake, the World Health Organisation (WHO recommends routine Ca supplementation during antenatal care (ANC. WHO guidelines suggest a complex dosing regimen, requiring as many as 5 pill-taking events per day when combined with iron and folic acid (IFA supplements. Poor adherence may undermine public health effectiveness, so simpler regimens may be preferable. This trial will compare the effect of the WHO-recommended (higher-dose regimen vs. a simpler, lower-dose regimen on supplement consumption and pill-taking behaviours in Kenyan ANC clients. Design and methods: This is a parallel, non-inferiority, cluster-randomized trial; we examined 16 primary care health facilities in Kenya, 1047 pregnant women between 16-30 weeks gestational age. Higher-dose regimen: 1.5 g elemental calcium in 3 separate doses (500 mg Ca/pill and IFA (60 mg Fe + 400 μg folic acid taken with evening dose. Lower-dose regimen: 1.0 g calcium in 2 separate doses (500 mg Ca/pill with IFA taken as above. Measurements: Primary outcome is Ca pills consumed per day, measured by pill counts. Secondary outcomes include IFA pills consumed per day, client knowledge, motivation, social support, and satisfaction, measured at 4 to 10 weeks post-enrolment. Statistical analyses: Unit of randomization is the health-care facility; unit of analysis is individual client. Intent-to-treat analysis will be implemented with multi-level models to account for clustering. Expected public health impact: If pregnant women prescribed lower doses of Ca ingest as many pills as women prescribed the WHO-recommended regimen, developing a lower-dose recommendation for antenatal Ca and IFA supplementation programs could save resources.

  5. Community health workers adherence to referral guidelines

    DEFF Research Database (Denmark)

    Lal, Sham; Ndyomugenyi, Richard; Paintain, Lucy

    2016-01-01

    and symptoms. CHW treatment registers were reviewed to identify children eligible for referral according to training guidelines (temperature of ≥38.5 °C), to assess whether CHWs adhered to the guidelines and referred them. Factors associated with adherence were examined with logistic regression models. Results...... to the referral guideline. Methods A secondary analysis was undertaken of data collected during two cluster-randomized trials conducted between January 2010 and July 2011, one in a moderate-to-high malaria transmission setting and the other in a low malaria transmission setting. All CHWs were trained to prescribe...

  6. Improving adherence and clinical outcomes in self-guided internet treatment for anxiety and depression: a 12-month follow-up of a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Nickolai Titov

    symptoms, but may not improve longer term outcomes. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610001058066.

  7. A single session of motivational interviewing as an additive means to improve adherence in periodontal infection control: a randomized controlled trial.

    Science.gov (United States)

    Stenman, Jane; Lundgren, Jesper; Wennström, Jan L; Ericsson, Jessica S; Abrahamsson, Kajsa H

    2012-10-01

    To evaluate the effect of a single session of motivational interviewing (MI) on self-performed periodontal infection control. A randomized, examiner masked, controlled clinical trial of 6-month duration was performed involving 44 patients with chronic periodontitis, referred for periodontal treatment. At baseline, all subjects were examined concerning marginal gingival bleeding (MBI) and plaque (PI). Test subjects received a single MI-session before initiation of the periodontal treatment. Otherwise, all patients followed the same treatment protocol for conventional educational intervention and non-surgical periodontal therapy. Efficacy variables for evaluation of self-performed periodontal infection control were MBI (primary variable) and PI. The MI intervention resulted in a negligible decrease (3-4%) in MBI and PI that was not significantly different from the changes observed in the control group without any intervention. Neither was any additive effect of the initial MI-session found on the standard of oral hygiene subsequent to conventional treatment. A desirable MBI score of ≤20% at the end of treatment was associated with being a female patient, whereas high plaque scores at baseline counteracted a corresponding desirable final PI of ≤20%. A single freestanding MI session as a prelude to conventional periodontal treatment had no significant effect on the individuals' standard of self-performed periodontal infection control in a short-term perspective. © 2012 John Wiley & Sons A/S.

  8. Accurate reporting of adherence to inhaled therapies in adults with cystic fibrosis: methods to calculate normative adherence

    Directory of Open Access Journals (Sweden)

    Hoo ZH

    2016-05-01

    Full Text Available Zhe Hui Hoo,1,2 Rachael Curley,1,2 Michael J Campbell,1 Stephen J Walters,1 Daniel Hind,3 Martin J Wildman1,2 1School of Health and Related Research (ScHARR, University of Sheffield, 2Sheffield Adult Cystic Fibrosis Centre, Northern General Hospital, 3Sheffield Clinical Trials Research Unit, University of Sheffield, Sheffield, UK Background: Preventative inhaled treatments in cystic fibrosis will only be effective in maintaining lung health if used appropriately. An accurate adherence index should therefore reflect treatment effectiveness, but the standard method of reporting adherence, that is, as a percentage of the agreed regimen between clinicians and people with cystic fibrosis, does not account for the appropriateness of the treatment regimen. We describe two different indices of inhaled therapy adherence for adults with cystic fibrosis which take into account effectiveness, that is, “simple” and “sophisticated” normative adherence. Methods to calculate normative adherence: Denominator adjustment involves fixing a minimum appropriate value based on the recommended therapy given a person’s characteristics. For simple normative adherence, the denominator is determined by the person’s Pseudomonas status. For sophisticated normative adherence, the denominator is determined by the person’s Pseudomonas status and history of pulmonary exacerbations over the previous year. Numerator adjustment involves capping the daily maximum inhaled therapy use at 100% so that medication overuse does not artificially inflate the adherence level. Three illustrative cases: Case A is an example of inhaled therapy under prescription based on Pseudomonas status resulting in lower simple normative adherence compared to unadjusted adherence. Case B is an example of inhaled therapy under-prescription based on previous exacerbation history resulting in lower sophisticated normative adherence compared to unadjusted adherence and simple normative adherence

  9. Race and residential socioeconomics as predictors of CPAP adherence.

    Science.gov (United States)

    Billings, Martha E; Auckley, Dennis; Benca, Ruth; Foldvary-Schaefer, Nancy; Iber, Conrad; Redline, Susan; Rosen, Carol L; Zee, Phyllis; Kapur, Vishesh K

    2011-12-01

    There are few established predictors of CPAP adherence; poor adherence limits its effectiveness. We investigated whether race, education level, and residential economic status predict CPAP adherence in participants enrolled in a trial with standard access to treatment. A multi-center randomized trial of home vs. lab-based evaluation and treatment of OSA assessing adherence to CPAP at 1 and 3 months. Seven AASM-accredited sleep centers in 5 U.S. cities. Subjects with moderate to severe OSA (AHI ≥ 15 and Epworth Sleepiness Scale score > 12) who completed follow-up at 1 and/or 3 months (n = 135). Subjects' demographic data were collected upon enrollment; CPAP use at 1 and 3 months was assessed at clinic follow-up. In unadjusted analyses, CPAP adherence (average minutes per night of CPAP use) at 3 months was lower in black subjects and in subjects from lower socioeconomic status ZIP codes. In adjusted analyses using multivariate linear regression, black race was predictive of CPAP adherence at one month (P = 0.03). At 3 months, black race was predictive in analyses only when ZIP code SES was not adjusted for. Black race and lower socioeconomic residential areas are associated with poorer adherence to CPAP in subjects with standardized access to care and treatment. Disparities remain despite provision of standardized care in a clinical trial setting. Future research is needed to identify barriers to adherence and to develop interventions tailored to improve CPAP adherence in at risk populations. Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP) CLINICAL TRIAL INFORMATION: NIH CLINICAL TRIALS REGISTRY NUMBER: NCT00642486. URL: http://clinicaltrials.gov/show/NCT00642486.

  10. Are participants concerned about privacy and security when using short message service to report product adherence in a rectal microbicide trial?

    Science.gov (United States)

    Giguere, Rebecca; Brown Iii, William; Balán, Ivan C; Dolezal, Curtis; Ho, Titcha; Sheinfil, Alan; Ibitoye, Mobolaji; Lama, Javier R; McGowan, Ian; Cranston, Ross D; Carballo-Diéguez, Alex

    2017-08-24

    During a Phase 2 rectal microbicide trial, men who have sex with men and transgender women (n = 187) in 4 countries (Peru, South Africa, Thailand, United States) reported product use daily via short message service (SMS). To prevent disclosure of study participation, the SMS system program included privacy and security features. We evaluated participants' perceptions of privacy while using the system and acceptability of privacy/security features. To protect privacy, the SMS system: (1) confirmed participant availability before sending the study questions, (2) required a password, and (3) did not reveal product name or study participation. To ensure security, the system reminded participants to lock phone/delete messages. A computer-assisted self-interview (CASI), administered at the final visit, measured burden of privacy and security features and SMS privacy concerns. A subsample of 33 participants underwent an in-depth interview (IDI). Based on CASI, 85% had no privacy concerns; only 5% were very concerned. Most were not bothered by the need for a password (73%) or instructions to delete messages (82%). Based on IDI, reasons for low privacy concerns included sending SMS in private or feeling that texting would not draw attention. A few IDI participants found the password unnecessary and more than half did not delete messages. Most participants were not concerned that the SMS system would compromise their confidentiality. SMS privacy and security features were effective and not burdensome. Short ID-related passwords, ambiguous language, and reminders to implement privacy and security-enhancing behaviors are recommended for SMS systems.

  11. Improving medication adherence in patients with hypertension

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  12. Cost-effectiveness of a team and leaders-directed strategy to improve nurses' adherence to hand hygiene guidelines: a cluster randomised trial.

    Science.gov (United States)

    Huis, Anita; Hulscher, Marlies; Adang, Eddy; Grol, Richard; van Achterberg, Theo; Schoonhoven, Lisette

    2013-04-01

    Many strategies have been designed and evaluated to address poor hand hygiene compliance. Unfortunately, well-designed economic evaluations of hand hygiene improvement strategies are lacking. To compare the cost-effectiveness of two successful implementation strategies for improving nurses' hand hygiene compliance and reducing hospital acquired infections (HAI's). A cost-effectiveness analysis alongside a cluster randomised controlled trial was conducted in 67 nursing wards of three hospitals in the Netherlands. The evaluation used a hospital perspective. All affiliated nurses of the nursing wards. Wards were randomly assigned to either the control group (n=30) or the experimental group (n=37). The control group received a state-of-the-art strategy including education, reminders feedback and optimising materials and facilities. The experimental group received a team and leaders-directed strategy which included all elements of the state-of-the-art strategy supplemented with interventions aimed at the social context of teams and enhancing leadership. The most efficient implementation strategy was determined by the incremental cost-effectiveness ratio per extra percentage of hand hygiene compliance gained and the incremental cost-effectiveness ratio per additional percentage reduction in the HAI rate. Bootstrap methods were used to determine confidence intervals for these incremental cost-effectiveness ratio's. Two scenarios of 15 and 30% were used to express the association between increased hand hygiene compliance and the reduction in HAIs. The team and leaders-directed strategy was significantly more effective in improving hand hygiene compliance. The mean difference effect was 8.91% (95% CI, 0.75-17.06). This extra increase was achieved at an average cost of €5497 per ward. The incremental cost per extra percentage of hand hygiene gained on ward level was €622. The incremental cost per additional percentage reduction in the HAI rate on ward level was €2074

  13. Participation in a mobile health intervention trial to improve retention in HIV care: does gender matter?

    Science.gov (United States)

    van der Kop, Mia L; Muhula, Samuel; Ekström, Anna M; Jongbloed, Kate; Smillie, Kirsten; Abunah, Bonface; Kinagwi, Koki; Kyomuhangi, Lennie B; Gelmon, Lawrence; Ojakaa, David I; Lester, Richard T; Awiti, Patricia O

    2017-02-01

    Background To be consistent with the United Nations' sustainable development goals on gender equality, mobile health (mHealth) programmes should aim to use communications technology to promote the empowerment of women. We conducted a pre-trial analysis of data from the WelTel Retain study on retention in HIV care to assess gender-based differences in phone access, phone sharing and concerns about receiving text messages from a healthcare provider. Methods Between April 2013-June 2015, HIV-positive adults were screened for trial participation at two clinics in urban slums in Nairobi, Kenya. Proportions of men and women excluded from the trial due to phone-related criteria were compared using a chi-square test. Gender-based differences in phone sharing patterns and concerns among trial participants were similarly compared. Results Of 1068 individuals screened, there was no difference in the proportion of men ( n = 39/378, 10.3%) and women ( n = 71/690, 10.3%) excluded because of phone-related criteria ( p-value = 0.989). Among those who shared their phone, women ( n = 52/108, 48.1%) were more likely than men ( n = 6/60, 10.0%) to share with other non-household and household members ( p equally able to participate in a trial of an mHealth intervention. Equitable access in these urban slums may indicate the 'gender digital divide' is narrowing in some settings; however, gender-specific phone sharing patterns and concerns regarding privacy must be fully considered in the development and scale-up of mHealth programmes.

  14. A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART.

    Science.gov (United States)

    Madhombiro, Munyaradzi; Dube-Marimbe, Bazondlile; Dube, Michelle; Chibanda, Dixon; Zunza, Moleen; Rusakaniko, Simbarashe; Stewart, David; Seedat, Soraya

    2017-01-28

    Interventions for alcohol use disorders (AUDs) in HIV infected individuals have been primarily targeted at HIV risk reduction and improved antiretroviral treatment adherence. However, reduction in alcohol use is an important goal. Alcohol use affects other key factors that may influence treatment course and outcome. In this study the authors aim to administer an adapted intervention for AUDs to reduce alcohol use in people living with HIV/AIDS (PLWHA). This study is a cluster randomised controlled trial at 16 HIV care clinics. A motivational interviewing and cognitive behavioural therapy based intervention for AUDs, developed through adaptation and piloted in Zimbabwe, will be administered to PLWHA with AUDs recruited at HIV clinics. The intervention will be administered over 16 sessions at 8 HIV clinics. This intervention will be compared with an equal attention control in the form of the World Health Organization Mental Health Gap Action Programme (WHO mhGAP) guide, adapted for the Zimbabwean context. General function, quality of life, and adherence to highly active antiretroviral treatment (HAART) will be secondary outcomes. Booster sessions will be administered to both groups at 3 and 6 months respectively. The primary outcome measure will be the Alcohol Use Disorder Identification Test (AUDIT) score. The World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0), World Health Organisation Quality of Life (WHOQoL) HIV, viral load, and CD4 counts will be secondary outcome measures. Outcome assessments will be administered at baseline, 3, 6, and 12 months. Moderating factors such as perceived social support, how people cope with difficult situations and post-traumatic exposure and experience will be assessed at baseline. Trained research assistants will recruit participants. The outcome assessors who will be trained in administering the outcome and moderating tools will be blinded to the treatment arms allocated to the participants. However, the

  15. Polypill, hypertension and medication adherence: The solution strategy?

    Science.gov (United States)

    Cimmaruta, D; Lombardi, N; Borghi, C; Rosano, G; Rossi, F; Mugelli, A

    2018-02-01

    Hypertension is an important global health challenge and a leading preventable risk factor for premature death and disability worldwide. In current cardiology practice, the main obstacles in the management of patients affected by hypertension are comorbidities and poor adherence to pharmacological treatments. The World Health Organization has recently highlighted increased adherence as a key development need for reducing cardiovascular disease. Principal observational and clinical trial data regarding adherence, reductions in cardiovascular risk and safety of the polypill approach are summarized and reviewed. The polypill approach has been conclusively shown to increase adherence relative to usual care in all cardiovascular patients, furthermore, concomitant risk factor reductions have also been suggested. To date, the use of polypill could represent a solution strategy in patients affected by hypertension, comorbidities and non-adherence even though further studies, especially in the real-world settings, are needed in order to better understand its role in clinical practice. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  16. adherence to antiretroviral regimens

    African Journals Online (AJOL)

    to macro- and microeconomic costs.' What soon became evident, however, was the vital importance of patient adherence with prescribed medication in order to garner the benefits that were so rapidly becoming available. As a result, much attention has recently been paid to this aspect of management. Both clinicians and ...

  17. Adherence to raloxifene therapy: assessment methods and relationship with efficacy.

    Science.gov (United States)

    Finigan, J; Naylor, K; Paggiosi, M A; Peel, N F; Eastell, R

    2013-11-01

    Response to therapy depends on patient compliance but accurate assessment is difficult and adequate levels of adherence are uncertain. Adherence to raloxifene treatment may be assessed more accurately by electronic monitoring than by counting returned tablets. The level of adherence is positively associated with the degree of bone response. Adherence to study medication is usually estimated by counting returned tablets. This method relies on subjects' honesty and may be inaccurate. We aimed to assess adherence more accurately, and examine its effect on measures of bone response, by using electronic monitoring. Osteopenic women, ages 50 to 80, were prescribed daily raloxifene for 2 years. Electronic bottle caps (Medication Event Monitoring System (MEMS), Aardex) recorded the date and time on opening. Returned tablets were also counted. We measured bone mineral density (BMD) in duplicate at the spine and hip at baseline and 2 years. We also measured urinary N-terminal cross-linked telopeptide of type I collagen (NTX) at baseline, 1 and 2 years. We calculated the percentage changes in BMD and NTX from mean baseline to mean follow up measurements. Percentage adherence was assessed by both methods for 71 subjects that completed the study. The two methods correlated significantly (p caps (95.7 vs. 85.0%, p caps may assess adherence more accurately than tablet counts and would be the preferred method in clinical trials. The degree of adherence is associated with both bone turnover and BMD responses to anti-resorptive therapy.

  18. Evaluation of how different implementation strategies of an injury prevention programme (FIFA 11+) impact team adherence and injury risk in Canadian female youth football players: a cluster-randomised trial.

    Science.gov (United States)

    Steffen, Kathrin; Meeuwisse, Willem H; Romiti, Maria; Kang, Jian; McKay, Carly; Bizzini, Mario; Dvorak, Jiri; Finch, Caroline; Myklebust, Grethe; Emery, Carolyn A

    2013-05-01

    Injury prevention programme delivery on adherence and injury risk, specifically involving regular supervisions with coaches and players on programme execution on field, has not been examined. The objective of this cluster-randomised study was to evaluate different delivery methods of an effective injury prevention programme (FIFA 11+) on adherence and injury risk among female youth football teams. During the 4-month 2011 football season, coaches and 13-year-old to 18-year-old players from 31 tier 1-3 level teams were introduced to the 11+ through either an unsupervised website ('control') or a coach-focused workshop with ('comprehensive') and without ('regular') additional supervisions by a physiotherapist. Team and player adherence to the 11+, playing exposure, history and injuries were recorded. Teams in the comprehensive and regular intervention groups demonstrated adherence to the 11+ programme of 85.6% and 81.3% completion of total possible sessions, compared to 73.5% for teams in the control group. These differences were not statistically significant, after adjustment for cluster by team, age, level and injury history. Compared to players with low adherence, players with high adherence to the 11+ had a 57% lower injury risk (IRR 0.43, 95% CI 0.19 to 1.00). However, adjusting for covariates, this between-group difference was not statistically significant (IRR=0.44, 95% CI 0.18 to 1.06). Following a coach workshop, coach-led delivery of the FIFA 11+ was equally successful with or without the additional field involvement of a physiotherapist. Proper education of coaches during an extensive preseason workshop was more effective in terms of team adherence than an unsupervised delivery of the 11+ programme to the team. ISRCTN67835569.

  19. Symptom severity, self-reported adherence, and electronic pill monitoring in poorly adherent patients with bipolar disorder.

    Science.gov (United States)

    Sajatovic, Martha; Levin, Jennifer B; Sams, Johnny; Cassidy, Kristin A; Akagi, Kouri; Aebi, Michelle E; Ramirez, Luis F; Safren, Steven A; Tatsuoka, Curtis

    2015-09-01

    This analysis of screening and baseline data from an ongoing trial examined self-report versus automated adherence monitoring and assessed the relationship between bipolar disorder (BD) symptoms and adherence in 104 poorly adherent individuals. Adherence was measured with the Tablets Routine Questionnaire (TRQ) and the Medication Event Monitoring System (MEMS). Symptoms were measured with the Montgomery-Åsberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), and the Brief Psychiatric Rating Scale (BPRS). The mean age of the sample was 46.3 years [standard deviation (SD) = 9.41 years], with 72% (n = 75) women and 71% (n = 74) African American subjects. Adherence improved from screening to baseline, with a mean missed drug proportion measured by TRQ of 61.43% (SD = 26.48%) versus a baseline mean of 46.61% (SD = 30.55%). The mean proportion of missed medication using MEMS at baseline was 66.43% (SD = 30.40%). The correlation between TRQ and MEMS was 0.47. The correlation between a single index drug and all BD medications was 0.95. Symptoms were generally positively correlated with TRQ (worse adherence = more severe symptoms), but in most instances was only at a trend level (p > 0.05), with the exception of the correlations between baseline TRQ and MADRS and BPRS, which were positive (r = 0.20 and r = 0.21, respectively) and significant (p ≤ 0.05). In patients with BD, monitoring increased adherence by 15%. MEMS identified 20% more non-adherence than self-report. Using a standard procedure to identify a single index drug for adherence monitoring may be one way to assess global adherence in patients with BD receiving polypharmacy treatment. Greater BD symptom severity may be a clinical indicator to assess for adherence problems. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. Predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people

    Directory of Open Access Journals (Sweden)

    Landorf Karl B

    2011-08-01

    Full Text Available Abstract Background Despite emerging evidence that foot problems and inappropriate footwear increase the risk of falls, there is little evidence as to whether foot-related intervention strategies can be successfully implemented. The aim of this study was to evaluate adherence rates, barriers to adherence, and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people. Methods The intervention group (n = 153, mean age 74.2 years of a randomised trial that investigated the effectiveness of a multifaceted podiatry intervention to prevent falls was assessed for adherence to the three components of the intervention: (i foot orthoses, (ii footwear advice and footwear cost subsidy, and (iii a home-based foot and ankle exercise program. Adherence to each component and the barriers to adherence were documented, and separate discriminant function analyses were undertaken to identify factors that were significantly and independently associated with adherence to the three intervention components. Results Adherence to the three components of the intervention was as follows: foot orthoses (69%, footwear (54% and home-based exercise (72%. Discriminant function analyses identified that being younger was the best predictor of orthoses use, higher physical health status and lower fear of falling were independent predictors of footwear adherence, and higher physical health status was the best predictor of exercise adherence. The predictive accuracy of these models was only modest, with 62 to 71% of participants correctly classified. Conclusions Adherence to a multifaceted podiatry intervention in this trial ranged from 54 to 72%. People with better physical health, less fear of falling and a younger age exhibited greater adherence, suggesting that strategies need to be developed to enhance adherence in frailer older people who are most at risk of falling. Trial registration Australian New Zealand Clinical Trials

  1. Health-Related Quality of Life, Treatment Satisfaction, Adherence and Persistence in β-Thalassemia and Myelodysplastic Syndrome Patients with Iron Overload Receiving Deferasirox: Results from the EPIC Clinical Trial

    Directory of Open Access Journals (Sweden)

    John Porter

    2012-01-01

    Full Text Available Treatment of iron overload using deferoxamine (DFO is associated with significant deficits in patients' health-related quality of life (HRQOL and low treatment satisfaction. The current article presents patient-reported HRQOL, satisfaction, adherence, and persistence data from β-thalassemia (n=274 and myelodysplastic syndrome (MDS patients (n=168 patients participating in the Evaluation of Patients' Iron Chelation with Exjade (EPIC study (NCT00171821; a large-scale 1-year, phase IIIb study investigating the efficacy and safety of the once-daily oral iron chelator, deferasirox. HRQOL and satisfaction, adherence, and persistence to iron chelation therapy (ICT data were collected at baseline and end of study using the Medical Outcomes Short-Form 36-item Health Survey (SF-36v2 and the Satisfaction with ICT Questionnaire (SICT. Compared to age-matched norms, β-thalassemia and MDS patients reported lower SF-36 domain scores at baseline. Low levels of treatment satisfaction, adherence, and persistence were also observed. HRQOL improved following treatment with deferasirox, particularly among β-thalassemia patients. Furthermore, patients reported high levels of satisfaction with deferasirox at end of study and greater ICT adherence, and persistence. Findings suggest deferasirox improves HRQOL, treatment satisfaction, adherence, and persistence with ICT in β-thalassemia and MDS patients. Improving such outcomes is an important long-term goal for patients with iron overload.

  2. Patient adherence with COPD therapy

    Directory of Open Access Journals (Sweden)

    C. S. Rand

    2005-12-01

    Full Text Available Although there are very few published studies on adherence to treatment regimens in chronic obstructive pulmonary disease (COPD, the evidence that exists suggests that, as with asthma therapy, adherence is poor. Patient beliefs about COPD, as well as their motivation and expectations about the likelihood of success of medical interventions, can influence adherence rates. Other critical factors include the patient's understanding of their illness and therapy, and the complexity of the prescribed treatment regimen. Incorrect inhaler technique is also a common failing. When prescribing in primary or specialist care, healthcare professionals should address adherence as a vital part of the patient consultation. Improved patient education may also increase adherence rates.

  3. An ingestible sensor for measuring medication adherence.

    Science.gov (United States)

    Hafezi, Hooman; Robertson, Timothy L; Moon, Greg D; Au-Yeung, Kit-Yee; Zdeblick, Mark J; Savage, George M

    2015-01-01

    In this paper, we describe the design and performance of the first integrated-circuit microsensor developed for daily ingestion by patients. The ingestible sensor is a device that allows patients, families, and physicians to measure medication ingestion and adherence patterns in real time, relate pharmaceutical compliance to important physiologic metrics, and take appropriate action in response to a patient's adherence pattern and specific health metrics. The design and theory of operation of the device are presented, along with key in-vitro and in-vivo performance results. The chemical, toxicological, mechanical, and electrical safety tests performed to establish the device's safety profile are described in detail. Finally, aggregate results from multiple clinical trials involving 412 patients and 5656 days of system usage are presented to demonstrate the device's reliability and performance as part of an overall digital health feedback system.

  4. To adhere or not to adhere: Rates and reasons of medication adherence in hematological cancer patients.

    Science.gov (United States)

    Hall, Alix E; Paul, Chris; Bryant, Jamie; Lynagh, Marita C; Rowlings, Philip; Enjeti, Anoop; Small, Hannah

    2016-01-01

    To conduct a comprehensive review to examine among hematological cancer patients: (1) rates of adherence to self-administered cancer treatments; and (2) factors impacting on their adherence. Fifty two eligible publications were identified. The majority focused on Chronic Myeloid Leukaemia (CML) (n=40) and Acute Lymphoid Leukaemia (ALL) (n=11) patients. Adherence rates varied and depended on the definition and measures used. Patient understanding about their disease and treatment, and forgetting to take their medication impacted on patients' level of adherence; while the use of reminders reduced forgetfulness. There is a lack of valid and reliable information relating to medication adherence of hematological cancer patients. Based on the limited data available we provide a profile of CML and ALL patients at potential risk of medication non-adherence, as well as a proposed checklist that can be used by health care providers in assessing and supporting patients in adhering to their medication. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  5. Adherence to Biobehavioral Recommendations in Pediatric Migraine as Measured by Electronic Monitoring: The Adherence in Migraine (AIM) Study

    Science.gov (United States)

    Van Diest, Ashley M. Kroon; Ramsey, Rachelle; Aylward, Brandon; Kroner, John W.; Sullivan, Stephanie M.; Nause, Katie; Allen, Janelle R.; Chamberlin, Leigh A.; Slater, Shalonda; Hommel, Kevin; LeCates, Susan L.; Kabbouche, Marielle A.; O’Brien, Hope L.; Kacperski, Joanne; Hershey, Andrew D.; Powers, Scott W.

    2016-01-01

    Objective The purpose of this investigation was to examine treatment adherence to medication and lifestyle recommendations among pediatric migraine patients using electronic monitoring systems. Background Nonadherence to medical treatment is a significant public health concern, and can result in poorer treatment outcomes, decreased cost-effectiveness of medical care, and increased morbidity. No studies have systematically examined adherence to medication and lifestyle recommendations in adolescents with migraine outside of a clinical trial. Methods Participants included 56 adolescents ages 11 – 17 who were presenting for clinical care. All were diagnosed with migraine with or without aura or chronic migraine and had at least 4 headache days per month. Medication adherence was objectively measured using electronic monitoring systems (Medication Event Monitoring Systems technology) and daily, prospective self-report via personal electronic devices. Adherence to lifestyle recommendations of regular exercise, eating, and fluid intake were also assessed using daily self-report on personal electronic devices. Results Electronic monitoring indicates that adolescents adhere to their medication 75% of the time, which was significantly higher than self-reported rates of medication adherence (64%). Use of electronic monitoring of medication detected rates of adherence that were significantly higher for participants taking once daily medication (85%) versus participants taking twice daily medication (59%). Average reported adherence to lifestyle recommendations of consistent non-caffeinated fluid intake (M = 5 cups per day) was below recommended levels of a minimum of 8 cups per day. Participants on average also reported skipping 1 meal per week despite recommendations of consistently eating three meals per day. Conclusions Results suggest that intervention focused on adherence to preventive treatments (such as medication) and lifestyle recommendations may provide more

  6. Adherence to oral antineoplastic therapy

    Directory of Open Access Journals (Sweden)

    R. Olivera-Fernandez

    2014-04-01

    Full Text Available Background: Oral chemotherapy agents offer advantages including cost, patient comfort and potential improvement in quality of life versus intravenous drugs. However ensuring adherence and monitoring adverse effects is more difficult. The aim of this study was to examine the real adherence in patients with oral chemotherapy agents in our hospital, to assess the influence of patient and treatment characteristics, to identify reasons for non adherence, to identify pportunities for improvement pharmaceutical care and to assess the potential relation between adherence and treatment outcomes. Method: observational, prospective study for a period of four month, in the patients who were dispensing oral chemotherapy agents in outpatient setting. The medical prescriptions, medical history and patient interviews were used to collect data. Results: 141 patients were assessing. 72% were considered as fully adherent, while 28% reported some kind of non adherence. Adherence was influenced by time from diagnosis and adverse effects. No relationship between adherence and treatment outcomes was found. Conclusions: Adherence to oral chemotherapy was 72%, identifing opportunities for improvement pharmaceutical care to prevent adverse effects and to improve our patient adherence

  7. Improving medication adherence in diabetes type 2 patients through Real Time Medication Monitoring: a randomised controlled trial to evaluate the effect of monitoring patients' medication use combined with short message service (SMS) reminders.

    NARCIS (Netherlands)

    Vervloet, M.; Dijk, L. van; Santen-Reestman, J.; Vlijmen, B. van; Bouvy, M.L.; Bakker, D.H. de

    2011-01-01

    Background: Innovative approaches are needed to support patients' adherence to drug therapy. The Real Time Medication Monitoring (RTMM) system offers real time monitoring of patients' medication use combined with short message service (SMS) reminders if patients forget to take their medication. This

  8. Predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people.

    Science.gov (United States)

    Spink, Martin J; Fotoohabadi, Mohammad R; Wee, Elin; Landorf, Karl B; Hill, Keith D; Lord, Stephen R; Menz, Hylton B

    2011-08-26

    Despite emerging evidence that foot problems and inappropriate footwear increase the risk of falls, there is little evidence as to whether foot-related intervention strategies can be successfully implemented. The aim of this study was to evaluate adherence rates, barriers to adherence, and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people. The intervention group (n = 153, mean age 74.2 years) of a randomised trial that investigated the effectiveness of a multifaceted podiatry intervention to prevent falls was assessed for adherence to the three components of the intervention: (i) foot orthoses, (ii) footwear advice and footwear cost subsidy, and (iii) a home-based foot and ankle exercise program. Adherence to each component and the barriers to adherence were documented, and separate discriminant function analyses were undertaken to identify factors that were significantly and independently associated with adherence to the three intervention components. Adherence to the three components of the intervention was as follows: foot orthoses (69%), footwear (54%) and home-based exercise (72%). Discriminant function analyses identified that being younger was the best predictor of orthoses use, higher physical health status and lower fear of falling were independent predictors of footwear adherence, and higher physical health status was the best predictor of exercise adherence. The predictive accuracy of these models was only modest, with 62 to 71% of participants correctly classified. Adherence to a multifaceted podiatry intervention in this trial ranged from 54 to 72%. People with better physical health, less fear of falling and a younger age exhibited greater adherence, suggesting that strategies need to be developed to enhance adherence in frailer older people who are most at risk of falling. Australian New Zealand Clinical Trials Registry ACTRN12608000065392.

  9. Recruitment of minority ethnic groups into clinical cancer research trials to assess adherence to the principles of the Department of Health Research Governance Framework: national sources of data and general issues arising from a study in one hospital trust in England.

    Science.gov (United States)

    Godden, Sylvia; Ambler, Gareth; Pollock, Allyson M

    2010-06-01

    This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England. (i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study at one hospital trust to ascertain whether the ethnicity of cancer trial participants was representative of admitted cancer patients. (i) The lack of a comparator population makes it problematic to assess recruitment levels by ethnic group in clinical research. (ii) The odds of being in a trial were 30% lower for a member of a minority ethnic group compared to a white cancer patient after adjusting for disease, age and gender, OR 0.70 (0.53 to 0.94). These results differed for each ethnic group; Asian patients did not appear under-represented while Black and Chinese did so. However, there are important caveats to the findings based on the limited recording of ethnicity. The lack of available data on the ethnicity of participants in clinical research and the prevalence of cancer in the population according to ethnicity makes it difficult to design a study to monitor representation of minority ethnic groups. This information is necessary to assess adherence to the Research Governance Framework principle that research evidence reflects the diversity of the population.

  10. Treatment Adherence in Psychiatric Disorders

    Directory of Open Access Journals (Sweden)

    Mehmet Emin Demirkol

    2016-03-01

    Full Text Available Despite developments in treatment options there is no significant increase in treatment adherence ratios. Inadherence in psychiatric disorders is higher than the other diseases. Loss of insight, drugs' side effects, sociodemographic features, personality traits are major factors affecting the treatment adherence. Determining and overcoming these factors for each disorder will help to improve adherence and reduce the treatment costs and hospitalization. [Psikiyatride Guncel Yaklasimlar - Current Approaches in Psychiatry 2016; 8(1: 85-93

  11. Using a treatment partner and text messaging to improve adherence ...

    African Journals Online (AJOL)

    This paper reports on preliminary qualitative research preceding a randomised controlled trial that aims to improve adherence to psychotropic medication and to follow up treatment visits. The intervention will entail the support of individuals with serious mental disorder by a treatment partner and short message service ...

  12. Interventions to improve adherence to inhaled steroids for asthma.

    Science.gov (United States)

    Normansell, Rebecca; Kew, Kayleigh M; Stovold, Elizabeth

    2017-04-18

    Despite its proven efficacy in improving symptoms and reducing exacerbations, many patients with asthma are not fully adherent to their steroid inhaler. Suboptimal adherence leads to poorer clinical outcomes and increased health service utilisation, and has been identified as a contributing factor to a third of asthma deaths in the UK. Reasons for non-adherence vary, and a variety of interventions have been proposed to help people improve treatment adherence. To assess the efficacy and safety of interventions intended to improve adherence to inhaled corticosteroids among people with asthma. We identified trials from the Cochrane Airways Trials Register, which contains studies identified through multiple electronic searches and handsearches of other sources. We also searched trial registries and reference lists of primary studies. We conducted the most recent searches on 18 November 2016. We included parallel and cluster randomised controlled trials of any duration conducted in any setting. We included studies reported as full-text articles, those published as abstracts only and unpublished data. We included trials of adults and children with asthma and a current prescription for an inhaled corticosteroid (ICS) (as monotherapy or in combination with a long-acting beta2-agonist (LABA)). Eligible trials compared an intervention primarily aimed at improving adherence to ICS versus usual care or an alternative intervention. Two review authors screened the searches, extracted study characteristics and outcome data from included studies and assessed risk of bias. Primary outcomes were adherence to ICS, exacerbations requiring at least oral corticosteroids and asthma control. We graded results and presented evidence in 'Summary of findings' tables for each comparison.We analysed dichotomous data as odds ratios, and continuous data as mean differences or standardised mean differences, all using a random-effects model. We described skewed data narratively. We made no a

  13. Therapeutic Adherence in Smoking Therapy

    Directory of Open Access Journals (Sweden)

    María Salvador Manzano

    2010-02-01

    Full Text Available Therapeutic adherence is a complex and multidimensional concept. The percentage of adherence to treatments involving a change in lifestyle, such as quitting smoking, is lower than in other disorders, a fact which has relevant clinical, psychological and economic consequences. This paper aims to review the associated factors with adherence to therapy in smoking treatment. Strategies to enhance therapeutic adherence involve the adequate choice of treatment, to know the smoker´s characteristics, breaking down organizational barriers in health system and the training of health professionals in communication skills with patients.

  14. Predictors of adherence to a brief behavioral insomnia intervention: daily process analysis.

    Science.gov (United States)

    Ruiter Petrov, Megan E; Lichstein, Kenneth L; Huisingh, Carrie E; Bradley, Laurence A

    2014-05-01

    Behavioral interventions for insomnia are effective in improving sleep, yet adherence is variable, and predictors of adherence have not been consistently replicated. The relationships between daily variations in state factors at the initiation of treatment and adherence have not been investigated. Using 2-week, self-report online logs, this study determined, among 53 college students with probable insomnia, the associations of pretreatment factors and daily factors during treatment on daily variations in adherence to one session of behavioral treatments for insomnia. These treatments included stimulus control therapy (SCT), sleep restriction therapy (SRT), and sleep hygiene (SH). Low self-efficacy was associated with poorer SCT and SH adherence. Participants with a "bed partner or pet" at least some of the time had better SCT adherence. Greater total sleep time and poorer sleep quality were associated with poor SCT and SRT adherence the following night. Greater sleep efficiency was related to greater next night SCT and SRT adherence. Alcohol consumption was related to poorer SRT and SH adherence the following night. Future studies should test the replicability of these findings. Adherence trials may want to test whether discouraging alcohol intake, enhancing treatment-related self-efficacy, and monitoring and providing feedback on sleep, early in treatment, affects adherence. Copyright © 2014. Published by Elsevier Ltd.

  15. Recommendations for improving ART adherence

    African Journals Online (AJOL)

    This article reports on the fi ndings of a study that aimed to explore experts' and patients' opinions and recommendations regarding adherence to antiretroviral medication. This study was prompted firstly by the lack of existing local research on adherence to antiretroviral therapy (ART) and secondly by the importance of ...

  16. [Treatment adherence: a key element].

    Science.gov (United States)

    Bastida, Guillermo; Sánchez Montes, Cristina; Aguas, Mariam

    2011-12-01

    A substantial percentage of patients fail to follow health professionals' recommendations, which affects the management of chronic diseases, reducing the effectiveness of therapeutic interventions and increasing the costs of the disease. Lack of adherence is a multidimensional phenomenon and is influenced by numerous factors that should be identified. A multiplicity of measures is available to improve adherence, such as simplifying treatment administration, but none of these measures is effective when used alone. One way of tackling lack of adherence is by identifying patients' barriers to medication and involving them in decision making. Ulcerative colitis (UC) poses a risk for lack of treatment adherence. In this disease, poor adherence correlates with poor disease control (drug effectiveness) and with higher costs. As in other chronic diseases, the causes associated with poor adherence are multiple, including psychosocial factors, the physician-patient relationship and patients' prejudices toward medication. A single dose of aminosalycylates (5-ASA) should be recommended, as this dose is as safe and effective as other regimens. However, by itself, this recommendation does not seem to improve adherence. Identifying the scale of the problem and developing strategies to involve the patient in decision making is crucial to improve treatment adherence. Copyright © 2011 Elsevier España, S.L.U. All rights reserved.

  17. Optimizing adherence to antiretroviral therapy.

    Science.gov (United States)

    Sahay, Seema; Reddy, K Srikanth; Dhayarkar, Sampada

    2011-12-01

    HIV has now become a manageable chronic disease. However, the treatment outcomes may get hampered by suboptimal adherence to ART. Adherence optimization is a concrete reality in the wake of 'universal access' and it is imperative to learn lessons from various studies and programmes. This review examines current literature on ART scale up, treatment outcomes of the large scale programmes and the role of adherence therein. Social, behavioural, biological and programme related factors arise in the context of ART adherence optimization. While emphasis is laid on adherence, retention of patients under the care umbrella emerges as a major challenge. An in-depth understanding of patients' health seeking behaviour and health care delivery system may be useful in improving adherence and retention of patients in care continuum and programme. A theoretical framework to address the barriers and facilitators has been articulated to identify problematic areas in order to intervene with specific strategies. Empirically tested objective adherence measurement tools and approaches to assess adherence in clinical/ programme settings are required. Strengthening of ART programmes would include appropriate policies for manpower and task sharing, integrating traditional health sector, innovations in counselling and community support. Implications for the use of theoretical model to guide research, clinical practice, community involvement and policy as part of a human rights approach to HIV disease is suggested.

  18. EAMJ May Adherence.indd

    African Journals Online (AJOL)

    2009-05-05

    May 5, 2009 ... The aim of this study was to determine adherence levels among HIV/AIDS adult patients using timing of medications and keeping of clinic appointments for drug refills as key indicators of adherence. It also determined the association between the two indicators. MATERIALS AND METHODS. Study area and ...

  19. Adherence compounds in embryo transfer media for assisted reproductive technologies.

    Science.gov (United States)

    Bontekoe, Stephan; Heineman, Maas Jan; Johnson, Neil; Blake, Debbie

    2014-02-25

    This is an update of a Cochrane review first published in The Cochrane Library (2010, Issue 7).To increase the success rate of assisted reproductive technologies (ART), adherence compounds such as hyaluronic acid (HA) and fibrin sealant have been introduced into subfertility management. Adherence compounds are added to the embryo transfer medium to increase the likelihood of embryo implantation, with the potential for higher clinical pregnancy and live birth rates. To determine whether embryo transfer media containing adherence compounds improved live birth and pregnancy rates in ART cycles. The Menstrual Disorders and Subfertility Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) and MEDLINE, EMBASE and PsycINFO electronic databases were searched (up to 13 November 2013) to look for publications that described randomised controlled trials on the addition of adherence compounds to embryo transfer media. Furthermore, reference lists of all obtained studies were checked, and conference abstracts were handsearched. Only truly randomised controlled trials comparing embryo transfer media containing functional (e.g. 0.5 mg/ml HA) concentrations of adherence compounds versus transfer media containing low or no concentrations of adherence compounds were included. The adherence compounds that were identified for evaluation were HA and fibrin sealant. Two review authors selected trials for inclusion according to the above criteria, after which two review authors independently extracted the data for subsequent analysis. Statistical analysis was performed in accordance with the guidelines developed by The Cochrane Collaboration. Seventeen studies with a total of 3898 participants were analysed. One studied fibrin sealant, and the other 16 studied HA. No evidence was found of a treatment effect of fibrin sealant as an adherence compound. For HA, evidence of a positive treatment effect was identified in the six trials that reported live birth

  20. Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: adherence companion study 60104.

    Science.gov (United States)

    Partridge, Ann H; Archer, Laura; Kornblith, Alice B; Gralow, Julie; Grenier, Debjani; Perez, Edith; Wolff, Antonio C; Wang, Xiaofei; Kastrissios, Helen; Berry, Donald; Hudis, Clifford; Winer, Eric; Muss, Hyman

    2010-05-10

    Patient adherence is critical in evaluating the effectiveness of an oral therapy. We sought to measure adherence among women randomly assigned to capecitabine in a preplanned substudy of a multicenter clinical trial. Cancer and Leukemia Group B study CALGB 49907 was a randomly assigned trial comparing standard chemotherapy versus oral chemotherapy with capecitabine in patients age 65 years or older with early-stage breast cancer. We used microelectronic monitoring system (MEMS) caps on participants' capecitabine bottles to record pill bottle openings. Capecitabine was given in two divided daily doses for 14 consecutive days of a 21-day cycle for six cycles. Adherence was calculated as the number of doses taken divided by doses expected, taking into account toxicity-related dosing changes. A participant was defined as adherent if 80% or more of expected doses were recorded by MEMS. Overall, 161 patients were enrolled. Median age was 71 years (range, 65 to 89 years); 124 patients (83%) persisted with capecitabine to completion of planned protocol therapy. Adherence was 78% across all cycles, and adherence did not vary by cycle (P = .32). Twenty-five percent of participants took fewer than 80% of expected doses and were nonadherent. In a logistic regression model, participants with node-negative disease (P = .01) and mastectomy (P = .01) were more likely to be nonadherent. Adherence was not related to age, tumor stage, or hormone receptor status. Adherence was not significantly associated with relapse-free survival or grade 3 or 4 toxicity. Most older women with early-stage breast cancer were adherent to short-term oral chemotherapy in a randomized clinical trial. Age was not associated with adherence.

  1. Secondary Prevention by Enhancing Adherence in Diabetic Patients

    Directory of Open Access Journals (Sweden)

    Habibeh Ahmadipour

    2010-01-01

    Full Text Available Objectives: Adherence to prescribed medications is a key dimensionof healthcare quality. Poor medication adherence might be a significantbarrier to achievement of positive clinical outcomes. This study aimedto compare the adherence to oral hypoglycemic agents in patients withtype 2 diabetes by using two methods of completing diary checklist andcollecting drug shells.Methods: This randomized clinical trial was conducted in IsfahanDiabetes Institute. A number of 100 type 2-diabetic patients were selectedthrough systematic sampling method and then were randomlyallocated to two groups of equal number. Each group was invited toattend our 12-week educational program. We asked one group to completediary checklist about how they took their drugs during the studyperiod. The other group was asked to collect the shells of oral hypoglycemicagents after taking in a pocket. Medication adherence ratiowas calculated for both groups.Results: Overall, 87 patients completed the study, of which 30 cases(34.5% were in the check list group and 57 (65.5% in the referencegroup. In the check list group, the adherence ratio was good in 96.7%and moderate in 3.3%, with no case of poor adherence. In the referencegroup, the corresponding figures were 55.2%, %6.9 and 37.9%,respectively (p<0.05 between groups.Conclusions: Although the adherence ratio was greater than 80% inboth groups, it was significantly higher in the check list group. Therefore,we suggest that by increasing adherence to prescribed medications,diary checklist can be an effective method of secondary preventionof chronic diseases, as diabetes mellitus.

  2. Secondary prevention by enhancing adherence in diabetic patients

    Directory of Open Access Journals (Sweden)

    Habibeh Ahmadipour

    2010-01-01

    Full Text Available Objectives: Adherence to prescribed medications is a key dimen-sion of healthcare quality. Poor medication adherence might be a significant barrier to achievement of positive clinical outcomes. This study aimed to compare the adherence to oral hypoglycemic agents in patients with type 2 diabetes by using two methods of completing diary checklist and collecting drug shells. Methods: This randomized clinical trial was conducted in Isfahan Diabetes Institute. A number of 100 type 2-diabetic patients were selected through systematic sampling method and then were ran-domly allocated to two groups of equal number. Each group was invited to attend our 12-week educational program. We asked one group to complete diary checklist about how they took their drugs during the study period. The other group was asked to col-lect the shells of oral hypoglycemic agents after taking in a pocket. Medication adherence ratio was calculated for both groups. Results: Overall, 87 patients completed the study, of which 30 cases (34.5% were in the check list group and 57 (65.5% in the reference group. In the check list group, the adherence ratio was good in 96.7% and moderate in 3.3%, with no case of poor adherence. In the reference group, the corresponding figures were 55.2%, %6.9 and 37.9%, respectively (p<0.05 between groups. Conclusions: Although the adherence ratio was greater than 80% in both groups, it was significantly higher in the check list group. Therefore, we suggest that by increasing adherence to prescribed medications, diary checklist can be an effective method of secon-dary prevention of chronic diseases, as diabetes mellitus.

  3. Stages of change for adherence to antiretroviral medications.

    Science.gov (United States)

    Genberg, Becky L; Lee, Yoojin; Rogers, William H; Willey, Cynthia; Wilson, Ira B

    2013-10-01

    Providers do not predict reliably which of their HIV-positive patients are having difficulty adhering to antiretroviral therapy (ART). The transtheoretical, or stages of change model, may be a useful tool to help providers identify patients who are having difficulty with ART adherence. The objective of the current study was to determine the relationship between stages of change and ART adherence among patients who were actively taking ART. Data from a randomized trial of a provider-focused intervention were used to examine the relationship between the stages of change and adherence, measured using electronic monitoring devices in the 30 days following the stages of change assessment. Individuals were eligible for inclusion if they were taking ART and had detectable plasma viral load (HIV-RNA). Repeated measures analysis of covariance was used to determine the impact of stages of change on adherence after controlling for potential confounders. The sample of 137 participants was 22% female, 48% white, 28% African-American, with a mean age of 42 years. Fifty-eight percent reported sex with a man as an HIV risk factor, while 13% reported sex with a woman, 14% reported injecting drugs and 15% reported other risk factors. In adjusted models, those in earlier stages of change (i.e., contemplation and preparation) had significantly lower adherence (-9.8%, p=0.04) compared to those in the action and maintenance phases. No demographic characteristics predicted adherence. The stages of change model may function as a screening tool for clinicians to discover patients at-risk of lower adherence.

  4. Antiretroviral treatment adherence among HIV patients in KwaZulu-Natal, South Africa

    Directory of Open Access Journals (Sweden)

    Ramlagan Shandir

    2010-03-01

    Full Text Available Abstract Background Successful antiretroviral treatment is dependent on sustaining high rates of adherence. In the southern African context, only a handful of studies (both quantitative and qualitative have looked at the determinants including a health behaviour theory of adherence to antiretroviral therapy. The aim of this study is to assess factors including the information, motivation and behavioural skills model (IMB contributing to antiretroviral (ARV adherence six months after commencing ARVs at three public hospitals in KwaZulu-Natal, South Africa. Methods Using systematic sampling, 735 HIV-positive patients were selected prior to commencing on ART from outpatient departments from three hospitals and followed-up at six months and interviewed with a questionnaire. Results A good proportion of patients were found to be adherent using both adherence instruments (visual analog scale = VAS 82.9%; Adult AIDS Clinical Trials Group = AATCG 70.8%. After adjusting for significant socio-economic variables, both the VAS and the dose, schedule and food adherence indicator found levels of adherence amongst urban residents to be almost 3 times greater than that of rural residents. After adjusting for health-related variables, for both indicators better adherence was associated with low depression and poorer adherence was associated with poor environmental factors. Adjusted odds ratios for adherence when taking into account different behavioural variables were for both adherence indicators, discrimination experiences were associated with lower adherence, and higher scores in adherence information and behavioural skills were associated with higher adherence. For the VAS adherence indicator, higher social support scores were associated with higher adherence. For the dose, schedule and food adherence indicator, using herbal medicines for HIV was associated with lower adherence. Conclusion For the patients in this study, particularly those not living in

  5. Work-related barriers and facilitators to antiretroviral therapy adherence in persons living with HIV infection.

    Science.gov (United States)

    Torres-Madriz, Gilberto; Lerner, Debra; Ruthazer, Robin; Rogers, William H; Wilson, Ira B

    2011-10-01

    Little is known about how the structure of work affects adherence to HIV antiretroviral therapy. We surveyed participants in an adherence intervention study to learn more about job characteristics, including measures of psychological demand and control, and job accommodations. Adherence was assessed using the Medication Event Monitoring System. Of 156 trial subjects, 69 were employed, and these 69 made 229 study visits. Psychological demands and control were unrelated to adherence, but the presence of workplace accommodations was significantly associated with adherence (P side effects affecting work performance. Having the ability to institute job accommodations was more important to adherence than the psychosocial structure of the work. These potential benefits of requesting modifications need to be weighed against the possible risks of workplace disclosure.

  6. Effects of exercise adherence on physical function among overweight older adults with knee osteoarthritis.

    Science.gov (United States)

    van Gool, Coen H; Penninx, Brenda W J H; Kempen, Gertrudis I J M; Rejeski, W Jack; Miller, Gary D; van Eijk, Jacques Th M; Pahor, Marco; Messier, Stephen P

    2005-02-15

    To determine whether high exercise adherence improved physical function among older adults with knee osteoarthritis (OA) who were overweight or obese. Associations between exercise adherence, changes in 6-minute walking distance in meters, and self-reported disability (Western Ontario and McMaster Universities Osteoarthritis Index function subscale) after 6 and 18 months were examined among an Arthritis, Diet, and Activity Promotion Trial subsample (n = 134) using multiple linear regression models. Higher exercise adherence was associated with greater improvements in 6-minute walking distance after 6 and 18 months and in disability after 6 months. Pain and body mass index (BMI) contributed, to some extent, to explaining the link between exercise adherence and changes in physical performance and self-reported disability. Higher exercise adherence is associated with improved physical function in overweight and obese older adults with knee OA. This indicates that promoting adherence is clinically relevant when prescribing exercise regimens that also focus on decreasing pain and BMI.

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

    Science.gov (United States)

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

    2016-07-01

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

  8. Motivational interviewing for medication adherence.

    Science.gov (United States)

    Salvo, Marissa C; Cannon-Breland, Michelle L

    2015-01-01

    To familiarize pharmacists with motivational interviewing as a way to engage patients in discussions about medication adherence. Motivational interviewing is a collaborative, patient-centered communications skill set that can increase behavior change by stimulating a patient's own internal motivation for change. Pharmacists using motivational interviewing can explore factors associated with medication nonadherence, assess patient ambivalence and/or resistance, and educate a patient to promote medication-adherent behaviors. Pharmacists can use motivational interviewing to effectively engage patients in a conversation that addresses medication adherence.

  9. The ARBITER 6-HALTS Trial (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies in Atherosclerosis): final results and the impact of medication adherence, dose, and treatment duration

    National Research Council Canada - National Science Library

    Villines, Todd C; Stanek, Eric J; Devine, Patrick J; Turco, Mark; Miller, Michael; Weissman, Neil J; Griffen, Len; Taylor, Allen J

    2010-01-01

    This report describes the final results of the ARBITER 6-HALTS (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies in Atherosclerosis) trial...

  10. Improving adherence and outcomes in diabetic patients

    Directory of Open Access Journals (Sweden)

    Joshi R

    2017-02-01

    Full Text Available Renu Joshi, Disha Joshi, Pramil Cheriyath Department of Endocrinology, Pinnacle Health Hospitals, Harrisburg, PA, USA Objective: Nonadherence in diabetes is a problem leading to wasted resources and preventable deaths each year. Remedies for diminishing nonadherence are many but marginally effective, and outcomes remain suboptimal. Aim: The aim of this study was to test a new iOS “app”, PatientPartner. Derived from complexity theory, this novel technology has been extensively used in other fields; this is the first trial in a patient population. Methods: Physicians referred patients who were “severely non-adherent” with HbA1c levels >8. After consent and random assignment (n=107, subjects in the intervention group were immersed in the 12-min PatientPartner game, which assesses and trains subjects on parameters of thinking that are critical for good decision making in health care: information management, stress coping, and health strategies. The control group did not play PatientPartner. All subjects were called each week for 3 weeks and self-reported on their medication adherence, diet, and exercise. Baseline and 3-month post-intervention HbA1c levels were recorded for the intervention group.Results: Although the control group showed no difference on any measures at 3 weeks, the intervention group reported significant mean percentage improvements on all measures: medication adherence (57%, standard deviation [SD] 18%–96%, SD 9, diet (50%, SD 33%–75%, SD 28, and exercise (29%, SD 31%–43%, SD 33. At 3 months, the mean HbA1c levels in the intervention group were significantly lower (9.6 than baseline (10.7. Conclusion: Many programs to improve adherence have been proved to be expensive and marginally effective. Therefore, improvements from the single use of a 12-min-long “app” are noteworthy. This is the first ever randomized, controlled trial to demonstrate that an “app” can impact the gold standard biological marker, HbA1c

  11. [Effects of Education about Action Plans according to Self-Monitoring on Self-Management Adherence, Knowledge, Symptom Control, and Quality of Life among Adult Asthma Patients: A Randomized Controlled Trial].

    Science.gov (United States)

    Choi, Ja Yun; Kweon, Young Ran

    2017-10-01

    This study was conducted to identify the effects of education regarding action plans according to a self-monitoring program on self-management adherence, knowledge, symptom control, and health-related quality of life (HRQoL) among adults with asthma. Thirty-four patients were randomly assigned to the intervention group and thirty-two to the control group in this study. A tailored 50-minute intervention based on the contents of self-monitoring and action plans developed by the National Heart Lung and Blood Institute was provided to the intervention group. Structured and well developed questionnaires were used to measure the dependent variables. There were no differences in all general and clinical characteristics, and the dependent variables between two groups in the pre-test. In the post-test, there were differences in the level of self-management adherence (t=4.41, pcontrol (t=-2.56, p=.013), and total HRQoL (t=2.14, p=.036) between the two groups, although there was a difference only in the sub-domain of emotion (t=2.03, p=.047) in HRQoL. This study found that action plans according to self-monitoring that enhance a participatory interaction in the treatment and care could help patients with moderate to severe asthma to engagead equately in self-care, to control their symptoms, and to improve their HRQoL. Further studies are still needed to identify longitudinal effects of this program.

  12. Investigator experiences with financial conflicts of interest in clinical trials

    Directory of Open Access Journals (Sweden)

    Van Laethem Marleen

    2011-01-01

    Full Text Available Abstract Background Financial conflicts of interest (fCOI can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Methods Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. Results 844 investigators responded (76% and 732 (66% provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively. Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%. Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43% and dissemination (53% to 64% stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85 or witnessed (n = 236 a fCOI; over 70% of these situations related to industry trials. Conclusion Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.

  13. Investigator experiences with financial conflicts of interest in clinical trials.

    Science.gov (United States)

    Rochon, Paula A; Sekeres, Melanie; Hoey, John; Lexchin, Joel; Ferris, Lorraine E; Moher, David; Wu, Wei; Kalkar, Sunila R; Van Laethem, Marleen; Gruneir, Andrea; Gold, Jennifer; Maskalyk, James; Streiner, David L; Taback, Nathan; Chan, An-Wen

    2011-01-12

    Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. 844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials. Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.

  14. Adherence measures and their utility.

    Science.gov (United States)

    Dunbar, J

    1984-12-01

    This article addresses the variety of adherence measures available to the researcher, with particular reference to the utility of markers. It is proposed that the generic nature of the research question will suggest both the adherence definition and the appropriate assessment methodology. Each measurement procedure offers somewhat different information and has unique advantages and disadvantages. It is suggested that markers are limited by the relatively short duration of the measurement period, the lack of quantitative data on adherence, and, with some, the potential for confounding influences on their specificity. The probable value of markers lies in validating the subject's recent self-report, determining recent medication ingestion, and estimating the probability of adherence over time.

  15. Improving adherence to medication in adults with diabetes in the United Arab Emirates

    Directory of Open Access Journals (Sweden)

    Mohammed M. M. Al-Haj Mohd

    2016-08-01

    Full Text Available Abstract Background Diabetes is a chronic medical condition and adherence to medication in diabetes is important. Improving medication adherence in adults with diabetes would help prevent the chronic complications associated with diabetes. A case control trial was used to study the effects of an educational session on medication adherence among adults with diabetes as measured by the Morisky Medication adherence scale (MMAS-8©. Methods The study took place at the Dubai Police Health Centre between February 2015 and November 2015. Questionnaires were used to collect socio-demographic, clinical and disease related variables and the primary measure of outcome was adherence levels as measured by the Morisky Medication Adherence Scale (MMAS-8©. The intervention group involved a standardized thirty minute educational session focusing on the importance of adherence to medication. The change in MMAS-8© was measured at 6 months. Results Four hundred and forty six patients were enrolled. Mean age 61 year +/− 11. 48.4 % were male. The mean time since diagnosis of diabetes was 3.2 years (Range 1–15 years. At baseline two hundred and eighty eight (64.6 % patients were considered non-adherent (MMAS-8© adherence score < 6 while 118 (26.5 % and 40 (9.0 % had low adherence (MMAS-8© adherence score < 6 and medium adherence (MMAS-8© adherence scores of 6 to 7 to their medication respectively. The percentage of patients scoring low adherence MMAS-8 scores in the interventional group dropped from 64.60 % at baseline to 44.80 % at 6-months (p = 0.01. There was no obvious change in the adherence scores at baseline and at 6-months in the control group. Based on the study data, the Wilcoxon signed-rank test showed that at 6 months, the educational 30-min session on diabetes and adherence to medication did elicit a statistically significant change in adherence levels in adults with diabetes enrolled in the intervention arm (Z = −6

  16. Clinical pharmacist interventions to support adherence to thrombopreventive therapy

    DEFF Research Database (Denmark)

    Hedegaard, Ulla

    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 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...... individualised interventions and team-based care, e.g. integrating a clinical pharmacist with particular focus on patients’ drug-related problems. One approach with growing evidence of improving medication adherence is motivational interviewing (MI). So far, no clinical pharmacist intervention using MI has...

  17. Relationship of prospective memory to neuropsychological function and antiretroviral adherence.

    Science.gov (United States)

    Contardo, Christopher; Black, Anne C; Beauvais, John; Dieckhaus, Kevin; Rosen, Marc I

    2009-09-01

    Prospective memory is defined as the ability to "remember to remember" something at a future time despite intervening distractions and may be particularly important in remembering to take prescribed medication among people infected with HIV. Ninety-seven HIV-positive participants in a clinical trial had their adherence measured by electronic pillcaps and were administered neuropsychological screening tests and the memory for intentions screening test (MIST). Factor analysis of the MIST and other neuropsychological measures identified four factors. Two were derived from MIST subscales and accounted for approximately 50% of the variance in cognitive functioning. Only one factor was significantly correlated with adherence, and this was a MIST factor. In this preliminary study, the MIST assessed a memory function that (a) could be distinguished from traditional retrospective recall and executive functioning and (b) was correlated with antiretroviral adherence.

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

    Directory of Open Access Journals (Sweden)

    Kekwaletswe CT

    2014-03-01

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

  19. Medication Adherence Measures: An Overview

    Science.gov (United States)

    Lam, Wai Yin; Fresco, Paula

    2015-01-01

    WHO reported that adherence among patients with chronic diseases averages only 50% in developed countries. This is recognized as a significant public health issue, since medication nonadherence leads to poor health outcomes and increased healthcare costs. Improving medication adherence is, therefore, crucial and revealed on many studies, suggesting interventions can improve medication adherence. One significant aspect of the strategies to improve medication adherence is to understand its magnitude. However, there is a lack of general guidance for researchers and healthcare professionals to choose the appropriate tools that can explore the extent of medication adherence and the reasons behind this problem in order to orchestrate subsequent interventions. This paper reviews both subjective and objective medication adherence measures, including direct measures, those involving secondary database analysis, electronic medication packaging (EMP) devices, pill count, and clinician assessments and self-report. Subjective measures generally provide explanations for patient's nonadherence whereas objective measures contribute to a more precise record of patient's medication-taking behavior. While choosing a suitable approach, researchers and healthcare professionals should balance the reliability and practicality, especially cost effectiveness, for their purpose. Meanwhile, because a perfect measure does not exist, a multimeasure approach seems to be the best solution currently. PMID:26539470

  20. Comparison of pharmacy-based measures of medication adherence

    Directory of Open Access Journals (Sweden)

    Vollmer William M

    2012-06-01

    Full Text Available Abstract Background Pharmacy databases are commonly used to assess medication usage, and a number of measures have been developed to measure patients’ adherence to medication. An extensive literature now supports these measures, although few studies have systematically compared the properties of different adherence measures. Methods As part of an 18-month randomized clinical trial to assess the impact of automated telephone reminders on adherence to inhaled corticosteroids (ICS among 6903 adult members of a managed care organization, we computed eight pharmacy-based measures of ICS adherence using outpatient pharmacy dispensing records obtained from the health plan’s electronic medical record. We used simple descriptive statistics to compare the relative performance characteristics of these measures. Results Comparative analysis found a relative upward bias in adherence estimates for those measures that require at least one dispensing event to be calculated. Measurement strategies that require a second dispensing event evidence even greater upward bias. These biases are greatest with shorter observation times. Furthermore, requiring a dispensing to be calculated meant that these measures could not be defined for large numbers of individuals (17-32 % of participants in this study. Measurement strategies that do not require a dispensing event to be calculated appear least vulnerable to these biases and can be calculated for everyone. However they do require additional assumptions and data (e.g., pre-intervention dispensing data to support their validity. Conclusions Many adherence measures require one, or sometimes two, dispensings in order to be defined. Since such measures assume all dispensed medication is used as directed, they have a built in upward bias that is especially pronounced when they are calculated over relatively short timeframes ( Trial registration The study was funded by grant R01HL83433 from the National Heart, Lung and

  1. Predictors of adherence to different types and doses of supervised exercise during breast cancer chemotherapy

    Science.gov (United States)

    2014-01-01

    Background Exercise is beneficial for breast cancer patients during chemotherapy but adherence to different types and doses of exercise is a challenge. The purpose of this study was to examine predictors of adherence to different types and doses of exercise during breast cancer chemotherapy in a multicenter randomized controlled trial. Methods Breast cancer patients in Edmonton, Vancouver, and Ottawa, Canada receiving chemotherapy (N = 301) were randomized to a standard dose of 25–30 minutes of aerobic exercise (STAN), a higher dose of 50–60 minutes of aerobic exercise (HIGH), or a higher dose of 50–60 minutes of combined aerobic and resistance exercise (COMB). Predictors included demographic, medical, fitness, and quality of life variables. Exercise adherence was measured as the percentage of supervised exercise sessions completed. Results Overall adherence to the supervised exercise sessions was 73% (SD = 24%). In a multivariate regression model, six independent predictors explained 26.4% (p exercise adherence. Higher exercise adherence was achieved by breast cancer patients in Vancouver (p exercise limitations (p = 0.009), receiving shorter chemotherapy protocols (p = 0.015), and with higher VO2peak (p = 0.017). Disease stage (p for interaction = 0.015) and body mass index (p for interaction = 0.030) interacted with group assignment to predict adherence. For disease stage, patients with stage I/IIa disease adhered equally well to all three exercise interventions whereas patients with stage IIb/III disease adhered better to the STAN intervention than the two higher dose exercise interventions. For body mass index, healthy weight patients adhered equally well to all three exercise interventions whereas overweight patients adhered best to STAN and worst to COMB; and obese patients adhered best to STAN and worst to HIGH. Conclusions Determinants of exercise adherence in breast cancer patients receiving chemotherapy are

  2. Implementation and Operational Research: Pulling the Network Together: Quasiexperimental Trial of a Patient-Defined Support Network Intervention for Promoting Engagement in HIV Care and Medication Adherence on Mfangano Island, Kenya.

    Science.gov (United States)

    Hickey, Matthew D; Salmen, Charles R; Omollo, Dan; Mattah, Brian; Fiorella, Kathryn J; Geng, Elvin H; Bacchetti, Peter; Blat, Cinthia; Ouma, Gor B; Zoughbie, Daniel; Tessler, Robert A; Salmen, Marcus R; Campbell, Harold; Gandhi, Monica; Shade, Starley; Njoroge, Betty; Bukusi, Elizabeth A; Cohen, Craig R

    2015-08-01

    Despite progress in the global scale-up of antiretroviral therapy, sustained engagement in HIV care remains challenging. Social capital is an important factor for sustained engagement, but interventions designed to harness this powerful social force are uncommon. We conducted a quasiexperimental study evaluating the impact of the Microclinic Social Network intervention on engagement in HIV care and medication adherence on Mfangano Island, Kenya. The intervention was introduced into 1 of 4 similar communities served by this clinic; comparisons were made between communities using an intention-to-treat analysis. Microclinics, composed of patient-defined support networks, participated in 10 biweekly discussion sessions covering topics ranging from HIV biology to group support and group HIV status disclosure. Nevirapine concentrations in hair were measured before and after study. One hundred thirteen (74%) intervention community participants joined a microclinic group, 86% of whom participated in group HIV status disclosure. Over 22-month follow-up, intervention community participants experienced one-half the rate of ≥ 90-day clinic absence as those in control communities (adjusted hazard ratio: 0.48; 95% confidence interval: 0.25 to 0.92). Nevirapine hair levels declined in both study arms; in adjusted linear regression analysis, the decline was 6.7 ng/mg less severe in the intervention arm than control arm (95% confidence interval: -2.7 to 16.1). The microclinic intervention is a promising and feasible community-based strategy to improve long-term engagement in HIV care and possibly medication adherence. Reducing treatment interruptions using a social network approach has important implications for individual patient virologic suppression, morbidity, and mortality and for broader community empowerment and engagement in healthcare.

  3. Predictors of adherence to an exercise program for shoulder pain and dysfunction in head and neck cancer survivors.

    Science.gov (United States)

    McNeely, Margaret L; Parliament, Matthew B; Seikaly, Hadi; Jha, Naresh; Magee, David J; Haykowsky, Mark J; Courneya, Kerry S

    2012-03-01

    Achieving acceptable levels of adherence to exercise may be a challenge with head and neck cancer (HNC) survivors given the high morbidity associated with treatment. The purpose of the present trial was to identify the key predictors of adherence during our shoulder exercise rehabilitation trial. Fifty-two HNC survivors were randomly assigned to a 12-week progressive resistance exercise training protocol (n = 27) or a standardized therapeutic exercise protocol (n = 25) that was prescribed to address shoulder pain and dysfunction. Baseline data were collected on standard demographic, medical, behavioral, symptom, psychosocial, and motivational variables from the theory of planned behavior. The exercise adherence rate for the trial was 91%. In multivariate analysis, the independent predictors of reduced adherence were undergoing a more extensive neck dissection procedure (β = -0.361; P = 0.007) and reporting daily alcohol consumption (β = -0.298; P = 0.031). Higher exercise adherence was achieved by HNC participants who had undergone nerve sparing neck dissection procedures and who were not regular drinkers. Excellent adherence to exercise was achieved in the trial despite high morbidity associated with HNC treatment. The high adherence achieved was likely due to the select and highly motivated sample of HNC survivors as well as to factors associated with trial design such as the support offered to participants. The findings of this trial need to be further explored and confirmed in a larger study that includes a more diverse sample of HNC survivors.

  4. Determinants of adherence to diabetes treatment.

    Science.gov (United States)

    Larkin, Amy T; Hoffman, Christina; Stevens, Adrienne; Douglas, Andrew; Bloomgarden, Zachary

    2015-11-01

    Understanding and improving medication adherence is crucial in diabetes management. Adherence to a diabetes regimen can improve glucose control and limit the development of complications. The aim of the present study was to evaluate the extent to which a variety of factors influence diabetes medication adherence. A medication adherence survey was made available on WebMD, a medical information website for patients and/or consumers. Respondents were residents of the US, ≥18 years old, and diagnosed with either type 1 or type 2 diabetes mellitus (self-reported). Behavioral adherence (self-reported doses missed per week) correlated with perceived adherence (patients' self-report of their overall impression of medication adherence, ranked 0-5; P Adherent patients (very few [0%-10%] issues with adherence) were more likely to report having received information from their physician. Mostly adherent patients (few [11%-26%] issues with adherence) were less likely to obtain information from their physician, but reported more medication self-titration. Somewhat non-adherent patients (some [27%-46%] adherence issues) reported more "self-consciousness factors" and hypoglycemia. Non-adherent patients (many [47%-88%] adherence issues) were more likely to report worries about medication side effects. Receiving information from a healthcare provider is associated with greater diabetes medication adherence, suggesting the importance of clinicians making time to provide patient education. © 2015 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

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

    Science.gov (United States)

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

    2012-01-01

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

  6. 7B.06: ROUTINE URINARY DETECTION OF ANTIHYPERTENSIVE DRUGS FOR ESTIMATION OF ADHERENCE TO TREATMENT: A CROSS SECTIONAL STUDY.

    Science.gov (United States)

    Hamdidouche, I; Jullien, V; Billaud, E M; Boutouyrie, P; Azizi, M; Laurent, S

    2015-06-01

    Adherence to antihypertensive treatment (AHT) is usually assessed by scales such as Morisky Medication Adherence Scale questionnaire (MMAS-4) but objective urinary drug levels quantification by liquid chromatography mass spectrometry (LCMS-MS) is now available. Our aim was to compare adherence assessed by LCMS-MS or MMAS-4, in patients with resistant hypertension (RH), compared to patients with well controlled hypertension (CH). RH cohort consisted in 82 patients with daytime ABPM > 135/85 mmHg after 4 weeks treatment with a standardised triple AHT participating to a clinical trial. The CH cohort consisted in 91 patients followed in a routine care practice with controlled office BP (LCMS-MS results: in the RH cohort, 63 patients (77%) were adherent, 11 (13%) were partly non-adherent and 8 (10%) were fully non-adherent. In the CH cohort, 86 (93%) were adherent, 5 (6%) were partly non-adherent, and 1 (1%) was fully non-adherent. Office SBP in the CH cohort was significantly higher in non-adherent (partially or fully) than in fully adherent patients (median: 140 vs. 130 mmHg, respectively; p = 0.01). Office DBP did not differ. According to LCMS-MS, the full adherence rate was significantly higher in CH compared to RH cohort (p = 0.002). According to MMAS-4 available in 88 CH patients, 76 (86%) were fully adherent, and 12 (14%) were medium or low adherent and no significant difference in office SBP/DBP was observed between the two subgroups. There was low or no agreement between LCMS-MS and MMAS-4, with 15/88 non concordant tests. In conclusion, measurement of urinary AHT by LCMS-MS gives relevant information on adherence to treatment in patients attending an outpatient clinic. This information is not overlapping with questionnaire tests. It confirms the role of objective non-adherence to treatment in resistance to treatment.

  7. Adherence to Mediterranean diet and health status: meta-analysis

    OpenAIRE

    Sofi, Francesco; Cesari, Francesca; Abbate, Rosanna; Gensini, Gian Franco; Casini, Alessandro

    2008-01-01

    Objective To systematically review all the prospective cohort studies that have analysed the relation between adherence to a Mediterranean diet, mortality, and incidence of chronic diseases in a primary prevention setting. Design Meta-analysis of prospective cohort studies. Data sources English and non-English publications in PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials from 1966 to 30 June 2008. Studies reviewed Studies that analysed prospectively th...

  8. Relationship of Prospective Memory to Neuropsychological Function and Antiretroviral Adherence

    OpenAIRE

    Contardo, Christopher; Black, Anne C.; Beauvais, John; Dieckhaus, Kevin; Rosen, Marc I.

    2009-01-01

    Prospective memory is defined as the ability to “remember to remember” something at a future time despite intervening distractions and may be particularly important in remembering to take prescribed medication among people infected with HIV. Ninety-seven HIV-positive participants in a clinical trial had their adherence measured by electronic pillcaps and were administered neuropsychological screening tests and the memory for intentions screening test (MIST). Factor analysis of the MIST and ot...

  9. Adherence to asthma medication regimens in urban African American adolescents: application of self-determination theory.

    Science.gov (United States)

    Bruzzese, Jean-Marie; Idalski Carcone, April; Lam, Phebe; Ellis, Deborah A; Naar-King, Sylvie

    2014-05-01

    Asthma medication adherence is low, particularly among African American adolescents, a high-risk group with respect to asthma prevalence, morbidity, and mortality. This study tested the utility of self-determination theory (SDT), a theory of motivation, to explain adherence to asthma medication regimens in African American adolescents. We used baseline data from 168 urban African American adolescents (Mage = 13.94 years; 61% male) with poorly controlled asthma who were part of a trial testing the efficacy of interventions to improve adherence. Participants and their caregivers were interviewed using the Family Asthma Management System Scale; this study used the Asthma Medication Adherence subscale. Adolescents completed four asthma-specific scales representing the SDT constructs of autonomous motivation (one importance scale), competence (one confidence scale), and relatedness (two scales--family routines and parental support). Using multiple linear regression, we tested the hypothesis that SDT variables would predict adherence. Adherence was significantly correlated with three SDT variables--importance, confidence, and family routines. In multivariate analysis, family routines was the only significant predictor of asthma adherence (p < .001). Asthma management behaviors integrated into and shared among family members was associated with better adherence. Greater confidence was marginally associated with increased adherence (p = .07). Though several variables representing SDT constructs were correlated with adherence, results demonstrate that family routines may be more relevant for African American adolescents' adherence than other SDT constructs. Thus, helping families to share and better integrate asthma care into daily schedules may be an important intervention strategy to improve medication adherence among high-risk African American adolescents. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  10. Adherence to inhaled therapies of COPD patients from seven Latin American countries: The LASSYC study

    Science.gov (United States)

    Menezes, Ana; Wehrmeister, Fernando C.; Lopez Varela, Maria Victorina; Casas, Alejandro; Ugalde, Luis; Ramirez-Venegas, Alejandra; Mendoza, Laura; López, Ana; Surmont, Filip; Miravitlles, Marc

    2017-01-01

    Background This study assessed the adherence profiles to inhaled therapies and the agreement between two patient self-report adherence methods in stable COPD lpatients from seven Latin American countries. Methods This observational, cross-sectional, multinational, multicenter study involved 795 COPD patients (post-bronchodilator forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] <0.70). Adherence to inhaled therapy was assessed using the specific Test of Adherence to Inhalers (10-item TAI) and the generic 8-item Morisky Medication Adherence Scale (MMAS-8) questionnaires. The percentage agreement and the kappa index were used to compare findings. Results 59.6% of patients were male (69.5±8.7 years); post-bronchodilator FEV1 percent predicted was 50.0±18.6%. Mean values for 10-item TAI and MMAS-8 questionnaires were 47.4±4.9 and 6.8±1.6, respectively. Based on the TAI questionnaire, 54.1% of patients had good, 26.5% intermediate, and 19.4% poor adherence. Using the MMAS-8 questionnaire, 51% had high, 29.1% medium, and 19.9% low adherence. According to both questionnaires, patients with poor adherence had lower smoking history, schooling but higher COPD Assessment Test score, exacerbations in the past-year and post-bronchodilator FEV1. The agreement between 10-item TAI and MMAS-8 questionnaires was moderate (Kappa index: 0.42; agreement: 64.7%). Conclusion Suboptimal adherence to medication was frequent in COPD patients from Latin America. Low adherence was associated with worse health status impairment and more exacerbations. There was inadequate agreement between the two questionnaires. Greater effort should be made to improve COPD patients’ adherence to treatment, and assessment of adherence with more specific instruments, such as the TAI questionnaire, would be more convenient in these patients. Clinical Trial Registration NCT02789540 PMID:29140978

  11. Adherence with Preventive Medication in Childhood Asthma

    Directory of Open Access Journals (Sweden)

    Scott Burgess

    2011-01-01

    Full Text Available Suboptimal adherence with preventive medication is common and often unrecognised as a cause of poor asthma control. A number of risk factors for nonadherence have emerged from well-conducted studies. Unfortunately, patient report a physician's estimation of adherence and knowledge of these risk factors may not assist in determining whether non-adherence is a significant factor. Electronic monitoring devices are likely to be more frequently used to remind patients to take medication, as a strategy to motivate patients to maintain adherence, and a tool to evaluate adherence in subjects with poor disease control. The aim of this paper is to review non-adherence with preventive medication in childhood asthma, its impact on asthma control, methods of evaluating non-adherence, risk factors for suboptimal adherence, and strategies to enhance adherence.

  12. Adherence and side effects of three ferrous sulfate treatment regimens on anemic pregnant women in clinical trials Adesão e efeitos colaterais em ensaio clínico comparando três esquemas de tratamento com sulfato ferroso em gestantes anêmicas

    Directory of Open Access Journals (Sweden)

    Ariani Impieri de Souza

    2009-06-01

    Full Text Available The objective of this study was to analyze adherence and side effects of three iron supplement regimens (ferrous sulfate on anemic pregnant women. The clinical trial involved 150 women between the 16th and 20th gestational weeks, at low obstetric risk and with hemoglobin concentration of between 8.0 and 11.0g/dL. Treatment was provided by ferrous sulfate with 60mg of elemental iron during 16 (± 1 weeks, in three regimens: single tablet a week (n = 48; single tablet twice a week (n = 53 or single tablet a day (n = 49. The outcomes were adherence, assessed through interviews and by counting tablets, and side effects, according to patient information. The adherence showed a declining trend (92%, 83% and 71%; p = 0.010 and the side effects revealed a growing trend (40%, 45% and 71%; p = 0.002 as the dosage increased. Diarrhea and epigastric pain were significantly associated with the dose administered (p = 0.002. These results suggest that in anemic pregnant women, complaints are directly proportional and the compliance is inversely proportional to the amount of medicinal iron.O objetivo deste estudo foi analisar a adesão e os efeitos colaterais de três esquemas de suplementação com sulfato ferroso em gestantes anêmicas. O ensaio clínico incluiu 150 mulheres entre a 16ª e 20ª semanas de gestação, de baixo risco obstétrico e com concentração de hemoglobina entre 8,0 e 11,0g/dL. A intervenção foi realizada com 60mg de ferro elementar, durante 16 (±1 semanas, em três esquemas: uma drágea semanal (n = 48; uma drágea duas vezes por semana (n = 53 ou uma drágea diariamente (n = 49. Os desfechos foram adesão, verificada por entrevista e contagem das drágeas, e efeitos colaterais auto-relatados pelas pacientes. A adesão apresentou tendência declinante (92%, 83% e 71%; p = 0,010 e os efeitos colaterais, ascendente (40%, 45% e 71%; p = 0,002 com o aumento da dose prescrita. Diarréia e dor epigástrica estiveram significativamente

  13. Predictors and Profiles of Antiretroviral Therapy Adherence Among African American Adolescents and Young Adult Males Living with HIV

    Science.gov (United States)

    Hosek, Sybil; Richards, Maryse Heather; Fernandez, M. Isabel

    2016-01-01

    Abstract Adherence to antiretroviral therapy (ART) is crucial for thwarting HIV disease progression and reducing secondary HIV transmission, yet youth living with HIV (YLH) struggle with adherence. The highest rates of new HIV infections in the United States occur in young African American men. A sample of 387 HIV-positive young African American males on ART was selected from a cross-sectional assessment of (YLH) receiving medical care within the Adolescent Trials Network for HIV/AIDS Interventions (ATN) from 2010 to 2012 (12–24 years old, median 22.00, SD 2.08). Participants completed self-reported adherence, demographic, health, and psychosocial measures. Sixty-two percent self-reported 100% ART adherence. Optimal data analysis identified frequency of cannabis use during the past 3 months as the strongest independent predictor of adherence, yielding moderate effect strength sensitivity (ESS) = 27.1, p ART adherence and nonadherence. The CTA model evidenced a 38% improvement above chance for correctly classifying participants as ART adherent or nonadherent. Participants most likely to be adherent were those with low psychological distress and minimal alcohol use (82% were adherent). Participants least likely to be adherent were those with higher psychological distress and engaged in weekly cannabis use (69% were nonadherent). Findings suggest multiple profiles of ART adherence for young African American males living with HIV and argue for targeted psychosocial interventions. PMID:27410496

  14. Interventions combining motivational interviewing and cognitive behaviour to promote medication adherence: a literature review.

    Science.gov (United States)

    Spoelstra, Sandra L; Schueller, Monica; Hilton, Melissa; Ridenour, Kimberly

    2015-05-01

    This article presents an integrative review of the evidence for combined motivational interviewing and cognitive behavioural interventions that promote medication adherence. We undertook this review to establish a scientific foundation for development of interventions to promote medication adherence and to guide clinical practice. The World Health Organization has designated medication adherence as a global problem. Motivational interviewing and cognitive behaviour interventions have been found to individually promote medication adherence. However, there is a gap in the literature on the effect of combined motivational interviewing and cognitive behavioural approaches to promote medication adherence. Integrative review. COCHRANE, PubMed and CINAHL were searched to access relevant studies between 2004-2014. Inclusion criteria were interventions combining motivational interviewing and cognitive behavioural therapy with medication adherence as the outcome. Articles were assessed for measures of adherence and methodological rigour. Analysis was performed using an integrative review process. Six articles met the inclusion criteria. A randomised controlled trial reported pretreatment missed doses of 5·58 and post-treatment of 0·92 and trended towards significance. Four cohort studies had effect sizes of 0·19-0·35 (p adherence rate of 25% and post-treatment 77% (p medication adherence. Future studies with large rigorous randomised trials are needed. This review provides clinicians with the state of the science in relation to combined motivational interviewing and cognitive behavioural therapy interventions that promote medication adherence. A summary of intervention components and talking points are provided to aid nurses in informing decision-making and translating evidence into practice. © 2014 John Wiley & Sons Ltd.

  15. Antihypertensive Medications Adherence Among Nigerian ...

    African Journals Online (AJOL)

    way to reduce the morbidity and mortality associated with hypertension.[1,2] Hypertension is the most common cardiovascular risk factor in Nigeria.[3] A large percentage of hypertensive subjects have poor blood pressure control due to many reasons.[2-4] One major reason is due to poor medication adherence. Treatment ...

  16. Predictors of adherence to micronutrient supplementation before and during pregnancy in Vietnam

    Directory of Open Access Journals (Sweden)

    Ines Gonzalez-Casanova

    2017-05-01

    Full Text Available Abstract Background Poor adherence to micronutrient supplementation often limits the effectiveness of public health programs. While predictors of adherence to micronutrient supplementation during pregnancy are well documented, information on adherence to preconception supplements is scarce. The objective of this study was to describe the predictors of adherence to preconception and prenatal micronutrient supplementation among women participating in a randomized control trial in Vietnam. Methods Adherence data were collected prospectively from a double blind randomized controlled trial in rural Vietnam. Five thousand eleven women of reproductive age were randomized to receive preconception supplements for weekly consumption containing either: Folic Acid, Iron and Folic Acid (IFA, or Multiple Micronutrients. Women who became pregnant received prenatal IFA supplements for daily consumption through delivery. Village health workers visited participants’ homes every two weeks to deliver supplements and record consumption and side effects. Multivariate logistic regression was used to assess individual, household, and programmatic predictors of supplement adherence. Results Adherence was high with 78 and 82% of the women consuming more than 80% of the preconception and prenatal supplements, respectively. Women of minority ethnicity (OR = 0.78 95% CI = 0.67, 0.91 and farmers (OR = 0.71 95% CI = 0.58, 0.88 were less likely to consume >80% of the preconception supplements while socioeconomic status (SES (OR = 2.71 highest vs. lowest quintile; 95% CI = 2.10, 3.52 was positively associated with >80% adherence in the entire preconception sample with available information (n = 4417. Women in their first pregnancy had lower prenatal adherence compared to multiparous women. At the programmatic level, each village health worker visit was associated with higher odds of >80% adherence by 3–5% before pregnancy and 18% during pregnancy. Conclusions

  17. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each...... relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies...

  18. Preliminary Evidence for Feasibility, Use, and Acceptability of Individualized Texting for Adherence Building for Antiretroviral Adherence and Substance Use Assessment among HIV-Infected Methamphetamine Users

    Directory of Open Access Journals (Sweden)

    David J. Moore

    2013-01-01

    Full Text Available The feasibility, use, and acceptability of text messages to track methamphetamine use and promote antiretroviral treatment (ART adherence among HIV-infected methamphetamine users was examined. From an ongoing randomized controlled trial, 30-day text response rates of participants assigned to the intervention (individualized texting for adherence building (iTAB, n = 20 were compared to those in the active comparison condition (n = 9. Both groups received daily texts assessing methamphetamine use, and the iTAB group additionally received personalized daily ART adherence reminder texts. Response rate for methamphetamine use texts was 72.9% with methamphetamine use endorsed 14.7% of the time. Text-derived methamphetamine use data was correlated with data from a structured substance use interview covering the same time period (P<0.05. The iTAB group responded to 69.0% of adherence reminder texts; among those responses, 81.8% endorsed taking ART medication. Standardized feedback questionnaire responses indicated little difficulty with the texts, satisfaction with the study, and beliefs that future text-based interventions would be helpful. Moreover, most participants believed the intervention reduced methamphetamine use and improved adherence. Qualitative feedback regarding the intervention was positive. Future studies will refine and improve iTAB for optimal acceptability and efficacy. This trial is registered with ClinicalTrials.gov NCT01317277.

  19. Investigator experiences with financial conflicts of interest in clinical trials

    OpenAIRE

    Van Laethem Marleen; Kalkar Sunila R; Wu Wei; Moher David; Ferris Lorraine E; Lexchin Joel; Hoey John; Sekeres Melanie; Rochon Paula A; Gruneir Andrea; Gold Jennifer; Maskalyk James; Streiner David L; Taback Nathan; Chan An-Wen

    2011-01-01

    Abstract Background Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Methods Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct,...

  20. Do improved patient recall and the provision of memory support enhance treatment adherence?

    Science.gov (United States)

    Dong, Lu; Lee, Jason Y; Harvey, Allison G

    2017-03-01

    Patient adherence to psychosocial treatment is an important but understudied topic. The aim of this study was to examine whether better patient recall of treatment contents and therapist use of memory support (MS) were associated with better treatment adherence. Data were drawn from a pilot randomized controlled trial. Participants were 48 individuals (mean age = 44.27 years, 29 females) with Major Depressive Disorder randomized to receive either Cognitive Therapy (CT) with an adjunctive Memory Support Intervention (CT + Memory Support) or CT-as-usual. Therapist and patient ratings of treatment adherence were collected during each treatment session. Patient recall was assessed at mid-treatment. Therapist use of MS was manually coded for a random selection of sessions. Patient recall was significantly associated with better therapist and patient ratings of adherence. Therapist use of Application, a specific MS strategy, predicted higher therapist ratings of adherence. Attention Recruitment, another specific MS strategy, appeared to attenuate the positive impact of session number on patient ratings of adherence. Treatment groups, MS summary scores and other specific MS strategies were not significantly associated with adherence. The measure for treatment adherence is in the process of being formally validated. Results were based on small sample. These results support the importance of patient recall in treatment adherence. Although collectively the effects of MS on treatment adherence were not significant, the results support the use of certain specific MS strategy (i.e., application) as a potential pathway to improve treatment adherence. Larger-scale studies are needed to further examine these constructs. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Medication beliefs are associated with phosphate binder non-adherence in hyperphosphatemic haemodialysis patients.

    Science.gov (United States)

    Wileman, Vari; Farrington, Ken; Wellsted, David; Almond, Mike; Davenport, Andrew; Chilcot, Joseph

    2015-09-01

    Patients with end-stage kidney disease receiving haemodialysis (HD) are at risk of cardiovascular disease and bone disorders related to high levels of serum phosphate. We studied the association between medication beliefs and depressive symptoms, with non-adherence to phosphate binding medication in a group of HD patients at risk of complications due to hyperphosphatemia. Cross-sectional design. Baseline data from 112 patients participating in a randomized controlled trial, evaluating an adherence intervention, are presented. All patients had serum phosphate levels >1.6 mmol/l at baseline. Adherence was measured by (1) serum phosphate and (2) Medication Adherence Report Scales (MARS). Beliefs about Medicines (BMQ) and depressive symptoms (PHQ-9) were also evaluated. Beliefs about Medicines Questionnaire necessity, but not concerns, beliefs were found to correlate with serum phosphate (r = -.23, p adherence (r = .35, p adherence (β = .30, p ≤ .01). Both BMQ concerns and depressive symptoms were not related to non-adherence. Patients' beliefs about the necessity of their prescribed phosphate binding medications explain variation in non-adherence levels, measured both subjective and objectively. Dialysis patient's medication beliefs are potentially modifiable targets for future interventions. © 2014 The British Psychological Society.

  2. Medication adherence : patient education, communication and behaviour

    OpenAIRE

    De Brincat, Michael

    2012-01-01

    Medication adherence usually refers to whether patients take their medications as prescribed, as well as whether they continue to take a prescribed medication. Medication non-adherence is a growing concern to pharmacists, healthcare systems, and other stakeholders (e.g. payers) because of mounting evidence that it is prevalent and associated with adverse outcomes and higher costs of care. To date, measurement of patient medication adherence and use of interventions to improve adherence are ra...

  3. Analytical Chemistry for Assessing Medication Adherence

    OpenAIRE

    Tanna, Sangeeta; Lawson, Graham

    2016-01-01

    The lack of adherence to medication is a growing public health problem worldwide and is costing many patients their chance to return to good health and healthcare systems billions of dollars. Analytical Chemistry for Assessing Medication Adherence introduces the concept of assessed medication adherence/compliance and reports international perspectives on medication adherence while highlighting its importance. It then describes the opportunities for analytical chemistry to assess medication ad...

  4. Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings

    Directory of Open Access Journals (Sweden)

    Randy M Stalter

    2016-05-01

    Full Text Available Introduction: Poor adherence to product use has been observed in recent trials of antiretroviral (ARV-based oral and vaginal gel HIV prevention products, resulting in an inability to determine product efficacy. The delivery of microbicides through vaginal rings is widely perceived as a way to achieve better adherence but vaginal rings do not eliminate the adherence challenges exhibited in clinical trials. Improved objective measures of adherence are needed as new ARV-based vaginal ring products enter the clinical trial stage. Methods: To identify technologies that have potential future application for vaginal ring adherence measurement, a comprehensive literature search was conducted that covered a number of biomedical and public health databases, including PubMed, Embase, POPLINE and the Web of Science. Published patents and patent applications were also searched. Technical experts were also consulted to gather more information and help evaluate identified technologies. Approaches were evaluated as to feasibility of development and clinical trial implementation, cost and technical strength. Results: Numerous approaches were identified through our landscape analysis and classified as either point measures or cumulative measures of vaginal ring adherence. Point measurements are those that give a measure of adherence at a particular point in time. Cumulative measures attempt to measure ring adherence over a period of time. Discussion: Approaches that require modifications to an existing ring product are at a significant disadvantage, as this will likely introduce additional regulatory barriers to the development process and increase manufacturing costs. From the point of view of clinical trial implementation, desirable attributes would be high acceptance by trial participants, and little or no additional time or training requirements on the part of participants or clinic staff. We have identified four promising approaches as being high priority

  5. Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings.

    Science.gov (United States)

    Stalter, Randy M; Moench, Thomas R; MacQueen, Kathleen M; Tolley, Elizabeth E; Owen, Derek H

    2016-01-01

    Poor adherence to product use has been observed in recent trials of antiretroviral (ARV)-based oral and vaginal gel HIV prevention products, resulting in an inability to determine product efficacy. The delivery of microbicides through vaginal rings is widely perceived as a way to achieve better adherence but vaginal rings do not eliminate the adherence challenges exhibited in clinical trials. Improved objective measures of adherence are needed as new ARV-based vaginal ring products enter the clinical trial stage. To identify technologies that have potential future application for vaginal ring adherence measurement, a comprehensive literature search was conducted that covered a number of biomedical and public health databases, including PubMed, Embase, POPLINE and the Web of Science. Published patents and patent applications were also searched. Technical experts were also consulted to gather more information and help evaluate identified technologies. Approaches were evaluated as to feasibility of development and clinical trial implementation, cost and technical strength. Numerous approaches were identified through our landscape analysis and classified as either point measures or cumulative measures of vaginal ring adherence. Point measurements are those that give a measure of adherence at a particular point in time. Cumulative measures attempt to measure ring adherence over a period of time. Approaches that require modifications to an existing ring product are at a significant disadvantage, as this will likely introduce additional regulatory barriers to the development process and increase manufacturing costs. From the point of view of clinical trial implementation, desirable attributes would be high acceptance by trial participants, and little or no additional time or training requirements on the part of participants or clinic staff. We have identified four promising approaches as being high priority for further development based on the following measurements

  6. Modelling imperfect adherence to HIV induction therapy

    Directory of Open Access Journals (Sweden)

    Smith? Robert J

    2010-01-01

    Full Text Available Abstract Background Induction-maintenance therapy is a treatment regime where patients are prescribed an intense course of treatment for a short period of time (the induction phase, followed by a simplified long-term regimen (maintenance. Since induction therapy has a significantly higher chance of pill fatigue than maintenance therapy, patients might take drug holidays during this period. Without guidance, patients who choose to stop therapy will each be making individual decisions, with no scientific basis. Methods We use mathematical modelling to investigate the effect of imperfect adherence during the inductive phase. We address the following research questions: 1. Can we theoretically determine the maximal length of a possible drug holiday and the minimal number of doses that must subsequently be taken while still avoiding resistance? 2. How many drug holidays can be taken during the induction phase? Results For a 180 day therapeutic program, a patient can take several drug holidays, but then has to follow each drug holiday with a strict, but fairly straightforward, drug-taking regimen. Since the results are dependent upon the drug regimen, we calculated the length and number of drug holidays for all fifteen protease-sparing triple-drug cocktails that have been approved by the US Food and Drug Administration. Conclusions Induction therapy with partial adherence is tolerable, but the outcome depends on the drug cocktail. Our theoretical predictions are in line with recent results from pilot studies of short-cycle treatment interruption strategies and may be useful in guiding the design of future clinical trials.

  7. Adherence to Cooperative Principles among Agricultural ...

    African Journals Online (AJOL)

    User

    Abstract. This study assessed agricultural cooperatives' level of adherence to cooperative guiding principles in Oyo State, Nigeria. Multi stage sampling procedure was used to select 126 respondents for the study. Data on group characteristics, level of awareness, adherence and constraints to adherence to cooperative ...

  8. Social Support, Treatment Adherence and Outcome among ...

    African Journals Online (AJOL)

    2017-06-02

    Jun 2, 2017 ... mulating evidences on causes of increasing prevalence of poor adherence among patients with chronic diseases including hypertension and diabetes, with a view to de- sign all-encompassing adherence-enhancing interven- tion to ensure full benefits of therapy.7,8. Myriads of factors affecting adherence ...

  9. Barriers and facilitators to antiretroviral medication adherence ...

    African Journals Online (AJOL)

    Medication adherence is a complex behaviour with multiple determinants. Understanding the barriers and facilitators of adherence is invaluable for programme improvement, which assists the foundation of adherence intervention strategies. A qualitative study was conducted in six selected hospitals of Addis Ababa in 2008, ...

  10. Adherence to Childhood Tuberculosis Treatment in Mozambique

    OpenAIRE

    López-Varela, Elisa; Sequera, Victor Guillermo; Alberto L. García-Basteiro; Augusto, Orvalho; Munguambe, Khatia; Sacarlal, Jahit; Alonso, Pedro

    2016-01-01

    BACKGROUND: There is limited literature regarding adherence rates for the treatment of tuberculosis (TB) in children. We aimed to describe TB treatment outcomes and adherence as well as to evaluate associated factors to poor adherence in Mozambican children. METHODS: This is a sub-study of a community TB incidence study among children 3 weeks to treatment completion. RESULTS: Fif...

  11. Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study Desafios no recrutamento, presença e adesão ao protocolo de intervenção em um ensaio controlado aleatorizado com sobreviventes de AVE agudo no Brasil: um estudo de viabilidade

    Directory of Open Access Journals (Sweden)

    Aline Scianni

    2012-02-01

    Full Text Available BACKGROUND: There is a high demand for stroke rehabilitation in the Brazilian public health system which should make undertaking clinical trials straightforward. OBJECTIVES: The aims of this study were to 1 determine the rate of recruitment of community-dwelling stroke survivors into a randomized trial of the effects of strength training in addition to task-specific gait training, 2 compare the effectiveness of various recruitment strategies on accrual rates, and 3 determine the attendance at training sessions and adherence to the intervention protocol. METHODS: Participants within six months of a stroke were screened for eligibility and invited to participate. Recruitment strategies were classified as advertisement or referral. The number of people who were screened, eligible and recruited for each strategy was recorded. Attendance at training sessions and adherence to the intervention protocol were recorded. RESULTS: Over the first 14 months, 150 stroke survivors were screened, 10 were recruited, and 35 (23% were eligible. Twenty-five of these patients (71% were unable to participate with lack of transport given as the most common reason. The most successful strategy was referral via hospital-based physical therapists (50%. Overall attendance was 72% with lack of transport being the most common reason for non-attendance. Overall adherence to the protocol was 97% with feeling unwell being the most common reason for non-adherence. CONCLUSIONS: Recruitment of stroke survivors was inefficient. Lack of transport was the most common barrier to participate in and attend training sessions. Funding for transport is essential to make carrying out trials in Brazil feasible. Trial Registration ACTRN12609000803291.CONTEXTUALIZAÇÃO: O sistema de saúde pública no Brasil apresenta uma alta demanda para a reabilitação de indivíduos após acidente vascular encefálico (AVE. Consequentemente, a condução de ensaios clínicos com essa população deveria

  12. The impact of effective paediatric adherence promotion interventions: systematic review and meta-analysis.

    Science.gov (United States)

    McGrady, M E; Ryan, J L; Gutiérrez-Colina, A M; Fredericks, E M; Towner, E K; Pai, A L H

    2015-11-01

    Understanding the impact of effective paediatric adherence promotion interventions on patients, families and the healthcare system is necessary to inform efforts to improve healthcare quality and control costs. Building on previous research suggesting that improving adherence may have far-reaching benefits, the objective of this study was to quantify the impact of effective adherence promotion interventions for children and adolescents with a chronic medical condition on patients, families and the healthcare system. Authors systematically reviewed articles indexed in PubMed, PsycINFO and CINAHL to identify randomized controlled trials of paediatric adherence promotion interventions. Interventions that improved paediatric adherence and examined patient-level, family-level or healthcare system-level outcomes in children and adolescents (M age ≤ 18 years) with a chronic medical condition were included. Two authors independently extracted and classified outcome variables as patient-level (quality of life and disease-related activity restrictions), micro-level (family functioning, family conflict, caregiver quality of life, caregiver sleep interruption, caregiver days away from work and patient missed school days) or macro-level variables (emergency department visits, hospitalizations, outpatient visits and urgent care visits). Outcome variables detailed in previously published reviews (i.e. disease severity) were excluded. Twenty studies representing 19 unique samples met inclusion criteria. An additional eight articles representing trials that did not significantly improve adherence were included in post hoc analyses. Compared with control interventions, effective paediatric adherence promotion interventions improved patient quality of life and family-level outcomes and decreased healthcare utilization among children and adolescents with a chronic medical condition. Interdisciplinary efforts to improve healthcare quality and reduce spending among children and

  13. Investigating the association between medication adherence and health-related quality of life in COPD: Methodological challenges when using a proxy measure of adherence.

    Science.gov (United States)

    Boland, Melinde R S; van Boven, Job F M; Kruis, Annemarije L; Chavannes, Niels H; van der Molen, Thys; Goossens, Lucas M A; Rutten-van Mölken, Maureen P M H

    2016-01-01

    The association between non-adherence to medication and health-related quality-of-life (HRQoL) in Chronic Obstructive Pulmonary Disease (COPD) remains poorly understood. Different ways to deal with methodological challenges to estimate this association have probably contributed to conflicting results. To investigate the association between medication adherence and HRQoL, thereby illustrating methodological challenges that need to be addressed. We used longitudinal patient-level data from a cluster-randomized controlled trial (i.e. RECODE) including three-year data on type and dose of COPD maintenance medication prescribed and HRQoL (Clinical COPD Questionnaire [CCQ], st. George Respiratory Questionnaire [SGRQ], EuroQol 5-dimensions [EQ-5D]) of 511 patients. A linear mixed model was used to assess the association between adherence and HRQoL using a fixed cut-off of 80% of the proportion of days covered (PDC) to define adherence. Subsequently, we investigated the impact of differences in disease severity; lifestyle; and reversed causality, representing the methodological challenges. Additionally, we investigated the impact of changing the definition of adherence. In unadjusted analyses, and analyses adjusting for demographic characteristics only, SGRQ score was worse in the adherent compared to the non-adherent group. This association disappeared when correcting for disease severity and/or lifestyle. A better SGRQ score was predictive of decreased adherence in the following year. However, accounting for the previous HRQoL did not result in positive associations between adherence and HRQoL. When defining four categories of adherence, patients with a PDC between 80 and 99% had a significantly worse SGRQ score compared to patients with a PDC adherence and CCQ or EQ-5D. This study showed persistent methodological challenges in the investigation of the effect of medication adherence on HRQoL in COPD. A positive association of adherence and HRQoL was not found, even after

  14. Female and younger subjects have lower adherence in PrEP trials: a meta-analysis with implications for the uptake of PrEP service to prevent HIV.

    Science.gov (United States)

    Yun, Ke; Xu, Jun-Jie; Zhang, Jing; Li, Jia-Ming; Hu, Qing-Hai; Chu, Zhen-Xing; Jiang, Yong-Jun; Geng, Wen-Qing; Shang, Hong; Wang, Ning

    2017-07-29

    To estimate the medicine-taking compliance (MTC) level, explore its facilitators and barriers, and quantify the association between MTC level and pre-exposure prophylaxis (PrEP) protective efficacy in individuals at risk of acquiring HIV being administered oral PrEP. Meta-analysis. We searched PubMed, Cochrane and Embase databases for published randomized controlled trials (RCTs) pertaining to MTC of oral PrEP for HIV prevention up to 16 January 2017. The pooled proportion of MTC and risk ratio (RR) of HIV incidences between intervention group and control group were estimated. We identified 10 eligible studies with 24 193 participants. The overall pooled MTC for oral HIV PrEP was 59.9% (95% CI 43.1% to 74.6%). Subgroup analyses revealed that the MTC level of participants aged PrEP is almost moderate, and its proportion in women and younger participants was relatively low. The protective efficacy of oral PrEP for HIV prevention increased with MTC level. These findings indicated that it is necessary to identify measures to enhance MTC of oral PrEP in future clinical usage, especially in women and younger participants with high HIV infection risk. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Adherence and health care costs

    Directory of Open Access Journals (Sweden)

    Iuga AO

    2014-02-01

    Full Text Available Aurel O Iuga,1,2 Maura J McGuire3,4 1Johns Hopkins Bloomberg School of Public Health, 2Johns Hopkins University, 3Johns Hopkins Community Physicians, 4Johns Hopkins University School of Medicine, Baltimore, MD, USA Abstract: Medication nonadherence is an important public health consideration, affecting health outcomes and overall health care costs. This review considers the most recent developments in adherence research with a focus on the impact of medication adherence on health care costs in the US health system. We describe the magnitude of the nonadherence problem and related costs, with an extensive discussion of the mechanisms underlying the impact of nonadherence on costs. Specifically, we summarize the impact of nonadherence on health care costs in several chronic diseases, such as diabetes and asthma. A brief analysis of existing research study designs, along with suggestions for future research focus, is provided. Finally, given the ongoing changes in the US health care system, we also address some of the most relevant and current trends in health care, including pharmacist-led medication therapy management and electronic (e-prescribing. Keywords: patient, medication, adherence, compliance, nonadherence, noncompliance, cost

  16. Affective temperaments and psychotropic adherence.

    Science.gov (United States)

    Kamei, Kimie; Terao, Takeshi; Katayama, Yosuke; Hoaki, Nobuhiko

    2013-09-25

    It is generally accepted that a range of factors affect adherence to psychotropic medications. In the present study, we focused on the influence of affective temperaments (i.e., depressive, hyperthymic, cyclothymic, irritable, and anxious temperaments) on treatment adherence. Thirty-eight psychiatric consecutive inpatients were instructed to perform Temperament Evaluation of Memphis, Pisa, Paris, and San Diego-Autoquestionnaire version (TEMPS-A) for affective temperaments, Drug attitude inventory-10 (DAI-10) for concordance and persistence, and Visual Analogue Scale (VAS) for compliance. VAS scores for dose compliance were significantly and negatively associated with irritable temperament scores whereas DAI-10 scores were significantly and positively associated with male gender, depressive temperament scores and hyperthymic temperament scores. The main limitations of the study were the relatively small number of subjects and the lack of objective method of adherence. These findings suggest that patients with irritable temperament may be poor in their compliance with treatment, and that more education may be required for patients with irritable temperament in order to maintain good compliance. In contrast, men and patients with depressive or hyperthymic temperament have a relatively positive attitude towards medication. © 2013 Elsevier B.V. All rights reserved.

  17. Predictors of adherence to micronutrient supplementation before and during pregnancy in Vietnam.

    Science.gov (United States)

    Gonzalez-Casanova, Ines; Nguyen, Phuong Hong; Young, Melissa Fox; Harding, Kimberly B; Reinhart, Greg; Nguyen, Hieu; Nechitillo, Meredith; Truong, Truong V; Pham, Hoa; Nguyen, Son; Neufeld, Lynnette M; Martorell, Reynaldo; Ramakrishnan, Usha

    2017-05-16

    Poor adherence to micronutrient supplementation often limits the effectiveness of public health programs. While predictors of adherence to micronutrient supplementation during pregnancy are well documented, information on adherence to preconception supplements is scarce. The objective of this study was to describe the predictors of adherence to preconception and prenatal micronutrient supplementation among women participating in a randomized control trial in Vietnam. Adherence data were collected prospectively from a double blind randomized controlled trial in rural Vietnam. Five thousand eleven women of reproductive age were randomized to receive preconception supplements for weekly consumption containing either: Folic Acid, Iron and Folic Acid (IFA), or Multiple Micronutrients. Women who became pregnant received prenatal IFA supplements for daily consumption through delivery. Village health workers visited participants' homes every two weeks to deliver supplements and record consumption and side effects. Multivariate logistic regression was used to assess individual, household, and programmatic predictors of supplement adherence. Adherence was high with 78 and 82% of the women consuming more than 80% of the preconception and prenatal supplements, respectively. Women of minority ethnicity (OR = 0.78 95% CI = 0.67, 0.91) and farmers (OR = 0.71 95% CI = 0.58, 0.88) were less likely to consume >80% of the preconception supplements while socioeconomic status (SES) (OR = 2.71 highest vs. lowest quintile; 95% CI = 2.10, 3.52) was positively associated with >80% adherence in the entire preconception sample with available information (n = 4417). Women in their first pregnancy had lower prenatal adherence compared to multiparous women. At the programmatic level, each village health worker visit was associated with higher odds of >80% adherence by 3-5% before pregnancy and 18% during pregnancy. Key determinants of adherence included SES, ethnicity, occupation

  18. Electronic monitoring of medication adherence in a 1-year clinical study of 2 dosing regimens of mesalazine for adults in remission with ulcerative colitis.

    Science.gov (United States)

    Gillespie, David; Hood, Kerenza; Farewell, Daniel; Stenson, Rachel; Probert, Christopher; Hawthorne, A Barney

    2014-01-01

    Adherence to medication is an issue of great importance for patients with ulcerative colitis. Once daily mesalazine seems to be no worse than divided doses in preventing relapse in remitting patients. Although this has been attributed to improved adherence, detailed measures of adherence have been lacking from previous studies. A 1-year substudy was conducted alongside a trial that compared 2 different dosing regimens (once daily versus three times daily) of mesalazine for patients in remission with ulcerative colitis. Participants in the substudy had their adherence monitored electronically using the medication event monitoring system, self-report, and tablet counts. We compared measures, determined factors associated with adherence and associations between adherence and relapse, modeled adherence over time, and explored behavioral aspects. We included 58 participants. Adherence was high across all measures (89.3% self-report, 96.7% tablet counts, and 89.2% medication event monitoring system). Agreement between the measures was poor at times. Adherence according to the medication event monitoring system best distinguished between the participants who relapsed (71.4%) and those who remained in remission (93.4%), although this difference was not statistically discernible at the 5% level. Adherence deteriorated over the study period, with three times daily participants generally less adherent than once-daily participants (odds ratio, 0.03; 95% confidence interval, 0.01-0.08). Adherence was higher on weekdays (odds ratio, 1.47; 95% confidence interval, 1.31-1.65) and around clinic visit dates (odds ratio, 1.43; 95% confidence interval, 1.18-1.72). Simple dosing regimens are preferable to multiple daily dosing regimens. Electronic monitoring of adherence should be used more often in clinical studies. Self-reported adherence and tablet counts may underestimate adherence. Adherence declined over time, and adherence was generally lower and more varied for those allocated

  19. Improving Adherence to Web-Based and Mobile Technologies for People With Psychosis: Systematic Review of New Potential Predictors of Adherence.

    Science.gov (United States)

    Killikelly, Clare; He, Zhimin; Reeder, Clare; Wykes, Til

    2017-07-20

    Despite the boom in new technologically based interventions for people with psychosis, recent studies suggest medium to low rates of adherence to these types of interventions. The benefits will be limited if only a minority of service users adhere and engage; if specific predictors of adherence can be identified then technologies can be adapted to increase the service user benefits. The study aimed to present a systematic review of rates of adherence, dropout, and approaches to analyzing adherence to newly developed mobile and Web-based interventions for people with psychosis. Specific predictors of adherence were also explored. Using keywords (Internet or online or Web-based or website or mobile) AND (bipolar disorder or manic depression or manic depressive illness or manic-depressive psychosis or psychosis or schizophr* or psychotic), the following databases were searched: OVID including MedLine, EMBASE and PsychInfo, Pubmed and Web of Science. The objectives and inclusion criteria for suitable studies were defined following PICOS (population: people with psychosis; intervention: mobile or Internet-based technology; comparison group: no comparison group specified; outcomes: measures of adherence; study design: randomized controlled trials (RCT), feasibility studies, and observational studies) criteria. In addition to measurement and analysis of adherence, two theoretically proposed predictors of adherence were examined: (1) level of support from a clinician or researcher throughout the study, and (2) level of service user involvement in the app or intervention development. We provide a narrative synthesis of the findings and followed the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines for reporting systematic reviews. Of the 20 studies that reported a measure of adherence and a rate of dropout, 5 of these conducted statistical analyses to determine predictors of dropout, 6 analyzed the effects of specific adherence

  20. Pilot Study to Test the Effectiveness of Different Financial Incentives to Improve Medication Adherence.

    Science.gov (United States)

    Garza, Kimberly B; Owensby, Justin K; Braxton Lloyd, Kimberly; Wood, Elizabeth A; Hansen, Richard A

    2016-01-01

    Medication nonadherence affects health care costs, morbidity, and mortality. Concepts from behavioral economics can guide the development of interventions to improve medication adherence. To measure the relative effectiveness of 2 behavioral economic-based incentive structures to improve medication adherence. This randomized controlled trial compared adherence among participants taking antihypertensive or antihyperlipidemic medications randomized to usual care (UC), guaranteed pay-out (GPO) incentives, or lottery incentives. Daily adherence was measured over a 90-day period using electronic caps (Medication Event Monitoring System [MEMS]). The GPO group received $30 up-front in a virtual account, with $0.50 deducted for each missed dose. Lottery group participants were eligible for a weekly $50 drawing, but only if they had taken their medication as prescribed all week. An electronic survey assessed self-reported adherence. Statistical analysis included descriptive statistics, paired t tests, ANOVA, and Pearson's correlations. In all, 36 participants were randomized (UC, n = 11; GPO, n = 14; lottery, n = 11). Mean percentage (±SD) of days adherent during the incentive period was highest in the lottery group (96% ± 5%), followed by the GPO group (94% ± 9%) and the UC group (94% ± 9%). There were no statistically significant differences among groups (P > 0.05). MEMS-measured adherence was not significantly correlated with a patient's self-reported adherence (P > 0.05) at baseline but was correlated at 90-day follow-up (P statistically significant differences in adherence were demonstrated in this small sample of highly adherent participants, larger studies in a more diverse population or with other medications might show otherwise. © The Author(s) 2015.

  1. Antiretroviral therapy adherence measurement in non-clinical settings in South India.

    Science.gov (United States)

    Kleinman, Nora J; Manhart, Lisa E; Mohanraj, Rani; Kumar, Shuba; Jeyaseelan, Lakshmanan; Rao, Deepa; Simoni, Jane M

    2015-01-01

    Optimal adherence to antiretroviral therapy (ART) is key to viral suppression, but may be impeded by psychosocial consequences of HIV-infection such as stigma and depression. Measures of adherence in India have been examined in clinic populations, but little is known about the performance of these measures outside clinical settings. We conducted a cross-sectional study of 151 Tamil-speaking people living with HIV/AIDS (PLHA) in India recruited through HIV support networks and compared single item measures from the Adult AIDS Clinical Trial Group (AACTG) scale, a visual analog scale (VAS), and a question on timing of last missed dose. Depression was measured using the Major Depression Inventory (MDI) and HIV-related stigma was measured using an adaptation of the Berger Stigma Scale. Mean age was 35.6 years (SD ± 5.9); 55.6% were male; mean MDI score was 11.9 (SD ± 9.1); and mean stigma score was 67.3 (SD ± 12.0). Self-reported perfect adherence (no missed doses) was 93.3% using the AACTG item, 87.1% using last missed dose, and 83.8% using the VAS. The measures had moderate agreement with each other (kappa 0.45-0.57). Depression was associated with lower adherence irrespective of adherence measure used, and remained significantly associated in multivariable analyses adjusting for age and marital status. Stigma was not associated with adherence irrespective of the measure used. The VAS captured the greatest number of potentially non-adherent individuals and may be useful for identifying PLHA in need of adherence support. Given the consistent and strong association between poorer adherence and depression, programs that jointly address adherence and mental health for PLHA in India may be more effective than programs targeting only one.

  2. Incentives and enablers to improve adherence in tuberculosis.

    Science.gov (United States)

    Lutge, Elizabeth E; Wiysonge, Charles Shey; Knight, Stephen E; Sinclair, David; Volmink, Jimmy

    2015-09-03

    Patient adherence to medications, particularly for conditions requiring prolonged treatment such as tuberculosis (TB), is frequently less than ideal and can result in poor treatment outcomes. Material incentives to reward good behaviour and enablers to remove economic barriers to accessing care are sometimes given in the form of cash, vouchers, or food to improve adherence. To evaluate the effects of material incentives and enablers in patients undergoing diagnostic testing, or receiving prophylactic or curative therapy, for TB. We undertook a comprehensive search of the Cochrane Infectious Diseases Group Specialized Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; LILACS; Science Citation Index; and reference lists of relevant publications up to 5 June 2015. Randomized controlled trials of material incentives in patients being investigated for TB, or on treatment for latent or active TB. At least two review authors independently screened and selected studies, extracted data, and assessed the risk of bias in the included trials. We compared the effects of interventions using risk ratios (RR), and presented RRs with 95% confidence intervals (CI). The quality of the evidence was assessed using GRADE. We identified 12 eligible trials. Ten were conducted in the USA: in adolescents (one trial), in injection drug or cocaine users (four trials), in homeless adults (three trials), and in prisoners (two trials). The remaining two trials, in general adult populations, were conducted in Timor-Leste and South Africa. Sustained incentive programmesOnly two trials have assessed whether material incentives and enablers can improve long-term adherence and completion of treatment for active TB, and neither demonstrated a clear benefit (RR 1.04, 95% CI 0.97 to 1.14; two trials, 4356 participants; low quality evidence). In one trial, the incentive, given as a daily hot meal, was not well received by the population due to the inconvenience of

  3. Is the Relationship between Race and Continuous Positive Airway Pressure Adherence Mediated by Sleep Duration?

    Science.gov (United States)

    Billings, Martha E.; Rosen, Carol L.; Wang, Rui; Auckley, Dennis; Benca, Ruth; Foldvary-Schaefer, Nancy; Iber, Conrad; Zee, Phyllis; Redline, Susan; Kapur, Vishesh K.

    2013-01-01

    Study Objectives: Black race has been associated with decreased continuous positive airway pressure (CPAP) adherence. Short sleep duration, long sleep latency, and insomnia complaints may affect CPAP adherence as they affect sleep and opportunity to use CPAP. We assessed whether self-reported sleep measures were associated with CPAP adherence and if racial variations in these sleep characteristics may explain racial differences in CPAP adherence. Design: Analysis of data from a randomized controlled trial (HomePAP), which investigated home versus laboratory-based diagnosis and treatment of obstructive sleep apnea. Setting: Seven American Academy of Sleep Medicine-accredited sleep centers in five cities in the United States. Patients or Participants: Enrolled subjects (n = 191) with apnea-hypopnea index ≥ 15 and sleepiness (Epworth Sleepiness Scale > 12). Interventions: N/A. Measurements and Results: Multivariable regression was used to assess if subjective sleep measures and symptoms predicted 3-mo CPAP use. Mediation analysis was used to assess if sleep measures mediated the association of race with CPAP adherence. Black participants reported shorter sleep duration and longer sleep latency at baseline than white and Hispanic participants. Shorter sleep duration and longer sleep latency predicted worse CPAP adherence. Sleep duration mediated the association of black race with lower CPAP adherence. However, insomnia symptoms were not associated with race or CPAP adherence. Conclusions: Among subjects with similar severity of obstructive sleep apnea and sleepiness, baseline self-reported sleep duration and latency, but not perceived insomnia, predicted CPAP adherence over 3 mo. Sleep duration explains some of the observed differences in CPAP use by race. Sleep duration and latency should be considered when evaluating poor CPAP adherence. Clinical Trial Information: Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP) URL: http

  4. Antiretroviral therapy adherence and self-efficacy among people living with HIV and a history of drug use in Vietnam.

    Science.gov (United States)

    Li, Li; Lin, Chunqing; Lee, Sung-Jae; Tuan, Le Anh; Feng, Nan; Tuan, Nguyen Anh

    2017-10-01

    People living with HIV with a history of drug use face additional psychosocial challenges that could compromise their adherence to antiretroviral therapy (ART). This study examined ART treatment adherence and adherence self-efficacy among people living with HIV with a history of drug use in Vietnam. We used cross-sectional baseline data collected between October 2014 and February 2015 from a randomized controlled trial in Vietnam. Of the 900 persons with a history of drug use in the trial, a sample of 109 people living with HIV currently on ART were included in the study. The vast majority (92%) of the participants reported not missing any medications in the past 30 days. Multiple regression results indicated that social support was positively associated with adherence self-efficacy (β = 0.420, P < 0.001) and general adherence to ART (β = 0.201, P = 0.0368). General adherence to ART was negatively associated with depressive symptoms (β = -0.188, P = 0.046) and current heroin use (β = -0.196, P = 0.042). These findings underscore the importance of addressing mental health and social challenges facing people living with HIV with a history of drug use to promote ART treatment adherence. Clinical management of HIV should identify and address concurrent substance use behaviors to maximize adherence and treatment outcomes.

  5. Interventions for improving adherence to ocular hypotensive therapy.

    Science.gov (United States)

    Waterman, Heather; Evans, Jennifer R; Gray, Trish A; Henson, David; Harper, Robert

    2013-04-30

    Poor adherence to therapy is a significant healthcare issue, particularly in patients with chronic disease such as open-angle glaucoma. Treatment failure may necessitate unwarranted changes of medications, increased healthcare expenditure and risk to the patient if surgical intervention is required. Simplifying eye drop regimes, providing adequate information, teaching drop instillation technique and ongoing support according to the patient need may have a positive effect on improving adherence. To summarise the effects of interventions for improving adherence to ocular hypotensive therapy in people with ocular hypertension (OHT) or glaucoma. We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 6), MEDLINE (June 1946 to June 2012), EMBASE (June 1980 to June 2012), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (June 1937 to June 2012), PsycINFO (1806 to June 2012), PsycEXTRA (1908 to June 2012), Web of Science (1970 to June 2012), ZETOC (1993 to June 2012), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 26 June 2012. We did not search the National Research Register (NNR) as this resource has now been now archived. We contacted pharmaceutical manufacturers to request unpublished data and searched conference proceedings for the Association for Research in Vision and Ophthalmology (ARVO), and the Annual Congress for the Royal College of Ophthalmologists (RCO). We included randomised controlled trials (RCTs) and quasi-RCTs that compared interventions to improve adherence to ocular hypotensive therapy

  6. Patient adherence and treatment outcome with exposure and response prevention for OCD: Which components of adherence matter and who becomes well?

    Science.gov (United States)

    Wheaton, Michael G.; Galfalvy, Hanga; Steinman, Shari A.; Wall, Melanie M.; Foa, Edna B.; Simpson, H. Blair

    2016-01-01

    Exposure and response prevention (EX/RP) is an evidence-based treatment for obsessive-compulsive disorder (OCD), yet not all patients achieve wellness with EX/RP. The degree to which patients adhere to EX/RP procedures outside of sessions has been found to predict therapy outcomes, including who achieves post-treatment wellness. We sought to investigate which components of treatment adherence most relate to outcome and to develop adherence benchmarks to identify who does and does not become well to provide clinicians with prognostic tools. Adherence data came from 37 adult patients with DSMIV OCD who received 17 sessions of EX/RP as part of a randomized controlled trial of augmentation strategies for incomplete response to serotonin reuptake inhibitors (SRIs). Therapists rated between-session patient adherence at each exposure session by quantifying: 1) the quantity of homework exposures attempted; 2) the quality of attempted exposures; and 3) the degree of success with response prevention. Each adherence item significantly correlated with post-treatment OCD severity. Success with response prevention proved particularly strongly linked to therapy outcome. Time course analysis of this item accurately identified relatively early in treatment who would achieve post-treatment wellness. These data provide an efficient method for differentiating between those patients who will and will not achieve wellness after EX/RP augmentation of SRIs. Limitations and clinical implications of the current findings are discussed. PMID:27497840

  7. Using the Theory of Planned Behavior to Improve Treatment Adherence in Mexican Americans with Schizophrenia

    Science.gov (United States)

    Kopelowicz, Alex; Zarate, Roberto; Wallace, Charles J.; Liberman, Robert Paul; Lopez, Steven R.; Mintz, Jim

    2015-01-01

    Objective Failure to adhere to treatment with antipsychotic medication is the most common cause of relapse among patients with schizophrenia. A novel multi-family group (MFG) intervention, informed by the Theory of Planned Behavior (TPB), demonstrated efficacy in increasing medication adherence and decreasing re-hospitalizations in schizophrenia patients. This report explores the hypothesis that the improved outcomes obtained through the MFG approach were mediated by changes in the patients’ attitudes towards medications, subjective norms-social influences, and perceived behavioral control of resources. Method Data from a recently completed, randomized controlled trial of MFG was used to test the hypothesis that the improvement in adherence was mediated by the three TPB factors. Subjects were 174 Mexican American adults with schizophrenia-spectrum disorder who had participated in a study of MFG focused on improving medication adherence. Assessments occurred at baseline and at 4, 8, 12, 18 and 24 months. Results Path analysis revealed that the increased adherence associated with MFG was mediated by improvements in subjective norms but not attitudes towards medications nor perceived behavioral control. Conclusion An MFG treatment specifically tailored to increase medication adherence among Mexican Americans with schizophrenia achieved its benefits by leveraging social influences through teaching family members how to support medication adherence in their ill relatives. PMID:26030760

  8. Pattern of Timing Adherence Could Guide Recommendations for Personalized Intake Schedules

    Directory of Open Access Journals (Sweden)

    Kurt E. Hersberger

    2012-11-01

    Full Text Available Deviations in execution from the prescribed drug intake schedules (timing non adherence are frequent and may pose a substantial risk for therapeutic failure. Simple methods to monitor timing adherence with multiple drugs are missing. A new technology, i.e., the polymedication electronic monitoring system (POEMS attached to a multidrug punch card, was used in a clinical trial on outpatients with prescribed medicines for vascular risk reduction. The complete delineation of timing adherence allows for the calculation of objective adherence parameters and the linking of exposure with drug-drug interactions. A sub-analysis was performed on 68 patients, who were prescribed lipid lowering therapy. A smaller intake time variability of the lipid lowering drug was significantly associated with better levels of LDL-cholesterol, independently of the time of day. This finding may challenge current general recommendations for the timing of lipid lowering drugs’ intake and substantiate that inter-individual differences in timing adherence may contribute to response variability. Thus, objective parameters based on multidrug adherence monitoring should be considered as independent variables in personalized medicine. In clinical practice, personalized intake recommendations according to patients’ pattern of timing adherence may help to optimize the effectiveness of lipid lowering agents.

  9. Mobile technology for medication adherence in people with mood disorders: A systematic review.

    Science.gov (United States)

    Rootes-Murdy, Kelly; Glazer, Kara L; Van Wert, Michael J; Mondimore, Francis M; Zandi, Peter P

    2018-02-01

    Medication non-adherence is a critical challenge for many patients diagnosed with mood disorders (Goodwin and Jamison, 1990). There is a need for alternative strategies that improve adherence among patients with mood disorders that are cost-effective, able to reach large patient populations, easy to implement, and that allow for communication with patients outside of in-person visits. Technology-based approaches to promote medication adherence are increasingly being explored to address this need. The aim of this paper is to provide a systematic review of the use of mobile technologies to improve medication adherence in patients with mood disorders. A total of nine articles were identified as describing mobile technology targeting medication adherence in mood disorder populations. Results showed overall satisfaction and feasibility of mobile technology, and reduction in mood symptoms; however, few examined effectiveness of mobile technology improving medication adherence through randomized control trials. Given the limited number of studies, further research is needed to determine long term effectiveness. Mobile technologies has the potential to improve medication adherence and can be further utilized for symptom tracking, side effects tracking, direct links to prescription refills, and provide patients with greater ownership over their treatment progress. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Experiences of non-adherence to Internet-delivered cognitive behavior therapy: A qualitative study

    Directory of Open Access Journals (Sweden)

    Olof Johansson

    2015-05-01

    Full Text Available Many trials on Internet-delivered psychological treatments have had problems with nonadherence, but not much is known about the subjective reasons for non-adhering. The aim of this study was to explore participants' experiences of non-adherence to Internet-delivered psychological treatment. Grounded theory was used to analyze data from seven in-depth interviews with persons who had non-adhered to a study on Internet-delivered cognitive behavioral therapy for generalized anxiety disorder. The process of non-adherence is described as an interaction between patient factors and treatment factors. A working model theory was generated to illustrate the experience of nonadherence. The model describes a process where treatment features such as workload, text-content complexity and treatment process don't match personal prerequisites regarding daily routines, perceived language skills and treatment expectations respectively, resulting in the decision to nonadhere. Negative effects were also stated as a reason for non-adherence. Several common strategies used for increasing adherence to Internet-delivered therapy in general are by these non-completers regarded as factors directly related to their reason for non-adherence.

  11. Medication Adherence in People With Parkinson Disease.

    Science.gov (United States)

    Shin, Ju Young; Habermann, Barbara

    2016-01-01

    Parkinson disease (PD) is the second most common neurodegenerative disorder in the United States. Because there is no cure for PD currently, pharmacological therapy is the mainstay of PD symptom management. Despite the importance of medication adherence in PD, several studies have reported medication nonadherence and/or suboptimal adherence. This literature review provides an overview of medication adherence issues in people with PD. Articles were identified for this study using computerized database searches and journal hand searches. Of the 72 medication adherence articles reviewed, the following articles were eligible for this review: (a) 10 articles measuring medication adherence in people with PD, (b) four medication adherence intervention articles, and (c) six studies of medication adherence in hospitalized settings. The importance of adherence assessment and strategies in improving medication adherence are discussed with the goal of improving symptom management and clinical outcomes in people with PD. Because medication taking is a complex and multifaceted phenomena, patient-centered, theory-driven interventions are needed to improve medication adherence and quality of care and life in people with PD.

  12. Morbidly adherent placenta treatments and outcomes.

    Science.gov (United States)

    Bailit, Jennifer L; Grobman, William A; Rice, Madeline Murguia; Reddy, Uma M; Wapner, Ronald J; Varner, Michael W; Leveno, Kenneth J; Iams, Jay D; Tita, Alan T N; Saade, George; Rouse, Dwight J; Blackwell, Sean C

    2015-03-01

    To describe recent maternal and neonatal delivery outcomes among women with a morbidly adherent placenta in major centers across the United States. This study reviewed a cohort of 115,502 women and their neonates born in 25 hospitals in the United States between March 2008 and February 2011 from the Assessment of Perinatal EXcellence data set. All cases of morbidly adherent placenta were identified. Maternal demographics, procedures undertaken, and maternal and neonatal outcomes were analyzed. There were 158 women with a morbidly adherent placenta (1/731 births, 95% confidence interval 1/632-866). Eighteen percent of women with a morbidly adherent placenta were nulliparous and 37% had no prior cesarean delivery. Only 53% (84/158) were suspected to have a morbidly adherent placenta before delivery. Women with a prenatally suspected morbidly adherent placenta experienced large blood loss (33%), hysterectomy (92%), and intensive care unit admission (39%) compared with 19%, 45%, and 22%, respectively, in those not suspected prenatally to have a morbidly adherent placenta (P<.05 for all). Eighteen percent of women with a morbidly adherent placenta were nulliparous. Half of the morbidly adherent placenta cases were suspected before delivery and outcomes were poorer in this group, probably because the more clinically significant morbidly adherent placentas are more likely to be suspected before delivery. : II.

  13. eHealth Technologies as an Intervention to Improve Adherence to Topical Antipsoriatics

    DEFF Research Database (Denmark)

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

    2018-01-01

    interventions designed to improve adherence to topical antipsoriatics and to review applications for smartphones (apps) incorporating the word psoriasis. MATERIAL AND METHODS: Literature review: Medline, Embase, Cochrane, PsycINFO, and Web of Science were searched using search terms for eHealth, psoriasis....... CONCLUSION: There is a critical need for high-quality RCTs testing if the ubiquitous eHealth technologies, e.g. some of the numerous apps, can improve psoriasis patients' rates of adherence to topical antipsoriatics.......BACKGROUND: Topical antipsoriatics are recommended first-line treatment of psoriasis, but rates of adherence are low. Patient support by use of electronic health (eHealth) services is suggested to improve medical adherence. OBJECTIVE: To review randomised controlled trials (RCTs) testing eHealth...

  14. Impact of interview mode on accuracy of child and parent report of adherence with asthma-controller medication.

    Science.gov (United States)

    Bender, Bruce G; Bartlett, Susan J; Rand, Cynthia S; Turner, Charles; Wamboldt, Frederick S; Zhang, Lening

    2007-09-01

    Parents and children often overreport adherence to treatment regimens, which in turn complicates interpretation and application of clinical trial findings. The objective of this investigation was to test the effect of reporting mode on accuracy of inhaled corticosteroid-adherence reporting in children with asthma and their parents under conditions similar to those of an asthma clinical trial. Participants included 104 children who were being treated with an inhaled corticosteroid delivered by a metered-dose inhaler for asthma diagnosed by their health care provider. Each parent and child dyad was randomly assigned to 1 of 3 self-report adherence-assessment modes: (1) audio computer-assisted self-interviewing; (2) face-to-face interview with study staff; or (3) self-administered paper-and-pencil questionnaire. At the 4 monthly visits, the parent and child were interviewed separately and asked questions about adherence on the previous day and in the past week. Electronic devices were attached to the each participant's metered-dose inhaler to provide an objective record of actual daily medication activations. Both children and parents greatly overreported their inhaled corticosteroid adherence when queried about either time frame (1 day or 1 week) in any of the 3 interview modes. One of 3 responses reported full adherence when no medication had been taken. Inconsistent with the study hypothesis, discrepancy between self-report and objectively measured adherence was greatest in the computer-interview condition. In the optimal circumstance where children were interviewed by study staff about their adherence within the previous 24 hours, reported adherence was within the +/-25% accuracy range for only half of the participants. Larger discrepancy scores were observed for both parents and children when reporting by computer or questionnaire. Under the best of conditions in this study, accuracy of self-report was insufficient to provide a stand-alone measure of adherence

  15. Systematic review of adherence rates by medication class in type 2 diabetes: a study protocol.

    Science.gov (United States)

    McGovern, Andrew; Tippu, Zayd; Hinton, William; Munro, Neil; Whyte, Martin; de Lusignan, Simon

    2016-02-29

    Treatment options for type 2 diabetes are becoming increasingly complex with people often prescribed multiple medications, and may include both oral and injectable therapies. There is ongoing debate about which drug classes provide the optimum second-line and third-line treatment options. In the real world, patient adherence and persistence determines medication effectiveness. A better understanding of adherence may help inform the choice of second-line and third-line drug classes. This systematic review will compare adherence and persistence rates across the different classes of medication available to people with type 2 diabetes. It will include all identified studies comparing medication adherence or persistence between two or more glucose-lowering medications in people with type 2 diabetes. Research databases (MEDLINE, EMBASE, The Cochrane Library, The Register of Controlled Trials, PsychINFO and CINAHL) will be searched for relevant articles, using a comprehensive search strategy. All identified medication trials and observational studies will be included which compare adherence or persistence across classes of diabetes medication. The characteristics and outcomes of all the included studies will be reported along with a study quality grade, assessed using the Cochrane Risk Assessment Tool. The quality of adjustment for confounders of adherence or persistence will be reported for each study. Where multiple (n ≥ 3) studies provide compare adherence or persistence across the same 2 medication classes, a meta-analysis will be performed. No ethics approval is required. This review and meta-analysis (where possible) will provide important information on the relative patient adherence and persistence, with the different classes of diabetes therapies. Once complete, the results will be made available by peer-reviewed publication. CRD42015027865. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please

  16. Nurse interventions to improve medication adherence among discharged older adults: a systematic review.

    Science.gov (United States)

    Verloo, Henk; Chiolero, Arnaud; Kiszio, Blanche; Kampel, Thomas; Santschi, Valérie

    2017-09-01

    discharged older adult inpatients are often prescribed numerous medications. However, they only take about half of their medications and many stop treatments entirely. Nurse interventions could improve medication adherence among this population. to conduct a systematic review of trials that assessed the effects of nursing interventions to improve medication adherence among discharged, home-dwelling and older adults. we conducted a systematic review according to the methods in the Cochrane Collaboration Handbook and reported results according to the PRISMA statement. We searched for controlled clinical trials (CCTs) and randomised CCTs (RCTs), published up to 8 November 2016 (using electronic databases, grey literature and hand searching), that evaluated the effects of nurse interventions conducted alone or in collaboration with other health professionals to improve medication adherence among discharged older adults. Medication adherence was defined as the extent to which a patient takes medication as prescribed. out of 1,546 records identified, 82 full-text papers were evaluated and 14 studies were included-11 RCTs and 2 CCTs. Overall, 2,028 patients were included (995 in intervention groups; 1,033 in usual-care groups). Interventions were nurse-led in seven studies and nurse-collaborative in seven more. In nine studies, adherence was higher in the intervention group than in the usual-care group, with the difference reaching statistical significance in eight studies. There was no substantial difference in increased medication adherence whether interventions were nurse-led or nurse-collaborative. Four of the 14 studies were of relatively high quality. nurse-led and nurse-collaborative interventions moderately improved adherence among discharged older adults. There is a need for large, well-designed studies using highly reliable tools for measuring medication adherence.

  17. Medication adherence in people of culturally and linguistically diverse backgrounds: a meta-analysis.

    Science.gov (United States)

    Manias, Elizabeth; Williams, Allison

    2010-06-01

    Medication adherence is of particular importance for people of culturally and linguistically diverse (CALD) backgrounds due to language difficulties, lack of social and organizational supports, lack of access to healthcare resources, and disengagement with the health-care system. To evaluate the impact of interventions to improve medication adherence in people of CALD backgrounds through a systematic review and meta-analysis. A search was performed using the following databases: Cochrane Database of Systematic Reviews, Cumulative Index to Nursing & Allied Health Literature, EMBASE, Journals@Ovid, PsychInfo, PubMed, Science Direct, Scopus, and Web of Science. Databases were searched from January 1978 to October 2009. Forty-six articles reviewed were assessed as being relevant, which included 36 randomized controlled trials, 2 observational cohort studies, and 8 quasi-experimental studies. The most common method for assessing medication adherence was self-reporting measures, such as the Morisky Scale and its modifications. Few studies used combinations of adherence measures, and adherence involving a medication event monitoring system (MEMS) was used in only 6 studies. Individuals of CALD backgrounds were recruited with people of non-CALD backgrounds and subsequent analyses tended to be undertaken of the whole sample. Twenty studies showed statistically significant improvements in medication adherence, 15 of which were randomized controlled trials. Six of the successful interventions involved delivery by a bilingual person or the use of translated materials and 4 involved the use of a conceptual model. Meta-analyses demonstrated modest improvements in medication adherence. Relatively little high-quality work has been conducted on adherence-enhancing interventions for people of CALD backgrounds. Greater attention needs to be given to examining the needs of specific CALD population groups. Future researchers should consider rigorously testing interventions that take

  18. Matching adherence interventions to patient determinants using the Theoretical Domains Framework

    Directory of Open Access Journals (Sweden)

    Samuel Sebastian Allemann

    2016-11-01

    Full Text Available IntroductionDespite much research, interventions to improve medication adherence report disappointing and inconsistent results. Tailored approaches that match interventions and patient determinants of non-adherence were seldom used in clinical trials. The presence of a multitude of theoretical frameworks and models to categorize interventions and patient determinants complicated the development of common categories shared by interventions and determinants. We retrieved potential interventions and patient determinants from published literature on medication adherence, matched them like locks and keys, and categorized them according to the Theoretical Domains Framework (TDF.MethodsWe identified the most relevant literature reviews on interventions and determinants in a pragmatic literature search, extracted all interventions and determinants, grouped similar concepts to umbrella terms and assigned them to TDF categories. All steps were finalized in consensus discussion between the authors.ResultsSixteen articles (5 with determinants, 11 with interventions were included for analysis. We extracted 103 interventions and 42 determinants that we divided in 26 modifiable and 16 unmodifiable determinants. All interventions and modifiable determinants were matched within 11 categories (Knowledge; Skills; Social/professional role and identity; Beliefs about capabilities; Beliefs about consequences; Intentions; Memory, Attention and decision processes; Environmental context and resources; Social influences; Emotion; and Behavioral regulation.ConclusionIn published trials on medication adherence, the congruence between interventions and determinants can be assessed with matching interventions to determinants. To be successful, interventions in medication adherence should target current modifiable determinants and be tailored to the unmodifiable determinants. Modifiable and unmodifiable determinants need to be assessed at inclusion of intervention studies to

  19. The Effect on Treatment Adherence of Administering Drugs as Fixed-Dose Combinations versus as Separate Pills: Systematic Review and Meta-Analysis

    NARCIS (Netherlands)

    van Galen, Katy A.; Nellen, Jeannine F.; Nieuwkerk, Pythia T.

    2014-01-01

    Administering drugs as fixed-dose combinations (FDCs) versus the same active drugs administered as separate pills is assumed to enhance treatment adherence. We synthesized evidence from randomized controlled trials (RCTs) about the effect of FDCs versus separate pills on adherence. We searched

  20. Tuberculosis Treatment Adherence of Patients in Kosovo

    OpenAIRE

    Krasniqi, Shaip; Jakupi, Arianit; Daci, Armond; Tigani, Bahri; Jupolli-Krasniqi, Nora; Pira, Mimoza; Zhjeqi, Valbona; Neziri, Burim

    2017-01-01

    Setting. The poor patient adherence in tuberculosis (TB) treatment is considered to be one of the most serious challenges which reflect the decrease of treatment success and emerging of the Multidrug Resistance-TB (MDR-TB). To our knowledge, the data about patients’ adherence to anti-TB treatment in our country are missing. Objective. This study was aimed to investigate the anti-TB treatment adherence rate and to identify factors related to eventual nonadherence among Kosovo TB patients. Desi...

  1. Improving hand hygiene adherence among nursing staff.

    Science.gov (United States)

    Harne-Britner, Sarah; Allen, Marianne; Fowler, Kimberly A

    2011-01-01

    This quasi-experimental study explored initial and sustained effects of educational and behavioral interventions on hand hygiene adherence and the relationships between hand hygiene adherence and health care-associated infections. Education paired with positive reinforcement behavioral interventions significantly improved hand hygiene adherence after the first month (χ² = 4.27; P = .039); however, the improvement was not sustained over 6 months. There were no significant differences in infection rates between the treatment and control groups.

  2. Predictors of Vitamin Adherence After Bariatric Surgery.

    Science.gov (United States)

    Sunil, Supreet; Santiago, Vincent A; Gougeon, Lorraine; Warwick, Katie; Okrainec, Allan; Hawa, Raed; Sockalingam, Sanjeev

    2017-02-01

    Vitamin supplementation in bariatric aftercare is essential to prevent nutrient deficiencies; however, rates of vitamin adherence have been as low as 30 % 6 months post-surgery. Preliminary literature suggests non-adherence to prescribed treatments can be linked to demographic and psychological factors. We aimed to determine the relationship between these factors to vitamin adherence in post-bariatric surgery patients. A total of 92 bariatric patients were assessed 6 months post-surgery. Patients were administered a questionnaire collecting demographic information, psychological scores, and self-reported adherence. Nutrient deficiencies were analyzed through serum vitamin levels measured 3 and 6 months after surgery. Wilcoxon rank-sum and chi-square tests were used for analysis. Non-adherence was associated with male sex and full-time employment (p = 0.027, p = 0.015). There were no differences with respect to living situation, education level, or relationship type. Non-adherent patients did not have significantly higher scores for generalized anxiety, depressive symptoms, or avoidant behaviors. However, non-adherent patients displayed greater attachment anxiety than their adherent counterparts (p = 0.0186). Non-adherence was also associated with lower vitamin B12 levels 6 months post-surgery (p = 0.001). Male gender and full-time work have previously been shown to be associated with non-adherence. This is the first study to demonstrate that attachment anxiety is associated with poor multivitamin adherence in the post-surgical bariatric population. This result is concordant with recent literature that has demonstrated attachment anxiety is associated with poor adherence to dietary recommendations in bariatric patients 6 months postoperatively. Presurgical screening for attachment anxiety could facilitate early interventions to promote better bariatric aftercare in this group.

  3. Cost-effectiveness of increasing bisphosphonates adherence for osteoporosis in community pharmacies

    NARCIS (Netherlands)

    Van Boven, J.F.M.; Oosterhof, P.; Hiddink, E.G.; Stuurman-Bieze, A.G.G.; Postma, M.J.; Vegter, S.

    2011-01-01

    OBJECTIVES: Increasing real-life adherence to bisphosphonates therapy is important to achieve the clinical benefits of reducing fractures reported in randomized clinical trials (RCTs). The aim of this pharmacoeconomic analysis was to determine the cost-effectiveness of a pharmaceutical care

  4. Medicine non-adherence in kidney transplantation.

    Science.gov (United States)

    Williams, Allison Fiona; Manias, Elizabeth; Gaskin, Cadeyrn J; Crawford, Kimberley

    2014-06-01

    The increasing prevalence of chronic kidney disease, the relative shortage of kidney donors and the economic- and health-related costs of kidney transplant rejection make the prevention of adverse outcomes following transplantation a healthcare imperative. Although strict adherence to immunosuppressant medicine regimens is key to preventing kidney rejection, evidence suggests that adherence is sub-optimal. Strategies need to be developed to help recipients of kidney transplants adhere to their prescribed medicines. This review has found that a number of factors contribute to poor adherence, for example, attitudes towards medicine taking and forgetfulness. Few investigations have been conducted, however, on strategies to enhance medicine adherence in kidney transplant recipients. Strategies that may improve adherence include pharmacist-led interventions (incorporating counselling, medicine reviews and nephrologist liaison) and nurse-led interventions (involving collaboratively working with recipients to understand their routines and offering solutions to improve adherence). Strategies that have shown to have limited effectiveness include supplying medicines free of charge and providing feedback on a participant's medicine adherence without any educational or behavioural interventions. Transplantation is the preferred treatment option for people with end-stage kidney disease. Medicine non-adherence in kidney transplantation increases the risk of rejection, kidney loss and costly treatments. Interventions are needed to help the transplant recipient take all their medicines as prescribed to improve general well-being, medicine safety and reduce healthcare costs. © 2014 European Dialysis and Transplant Nurses Association/European Renal Care Association.

  5. Encouraging CPAP adherence: it is everyone's job

    National Research Council Canada - National Science Library

    Bollig, Suzanne M

    2010-01-01

    .... Patient adherence to prescribed CPAP is variable, however, leaving the undertreated OSA patient at risk of development or worsening of comorbid medical conditions, including hypertension and cardiovascular disease...

  6. Medication adherence among adult patients on hemodialysis

    Directory of Open Access Journals (Sweden)

    Abdulmalik M Alkatheri

    2014-01-01

    Full Text Available Medication adherence was assessed in 89 patients on hemodialysis (HD at the King Abdul Aziz Medical City using an Arabic version of the Morisky Medication Adherence Scale (MASS-8. The results of the study revealed that 31.46% and 40.45% of the participants showed low and medium adherence, respectively, while 28.09% showed high medication adherence. Accordingly, 71.91% of the patients visiting the dialysis unit were considered medication non-adherent. While being of older age (P = 0.012, being married (P = 0.012 increased the level of adherence, being of medium level of education (P = 0.024 decreased adherence levels. On the other hand, gender, presence of a care-giver, number of members in the household and employment status seems to have no effect on the level of medication adherence. These results call upon the practitioners in HD units to develop intervention programs that can increase the level of medication adherence.

  7. Medication Adherence With Diabetes Medication: A Systematic Review of the Literature.

    Science.gov (United States)

    Capoccia, Kam; Odegard, Peggy S; Letassy, Nancy

    2016-02-01

    The primary purpose of this systematic review is to synthesize the evidence regarding risk factors associated with nonadherence to prescribed glucose-lowering agents, the impact of nonadherence on glycemic control and the economics of diabetes care, and the interventions designed to improve adherence. Medline, EMBASE, the Cochrane Collaborative, BIOSIS, and the Health and Psychosocial Instruments databases were searched for studies of medication adherence for the period from May 2007 to December 2014. Inclusion criteria were study design and primary outcome measuring or characterizing adherence. Published evidence was graded according to the American Association of Clinical Endocrinologists protocol for standardized production of clinical practice guidelines. One hundred ninety-six published articles were reviewed; 98 met inclusion criteria. Factors including age, race, health beliefs, medication cost, co-pays, Medicare Part D coverage gap, insulin use, health literacy, primary nonadherence, and early nonpersistence significantly affect adherence. Higher adherence was associated with improved glycemic control, fewer emergency department visits, decreased hospitalizations, and lower medical costs. Adherence was lower when medications were not tolerated or were taken more than twice daily, with concomitant depression, and with skepticism about the importance of medication. Intervention trials show the use of phone interventions, integrative health coaching, case managers, pharmacists, education, and point-of-care testing improve adherence. Medication adherence remains an important consideration in diabetes care. Health professionals working with individuals with diabetes (eg, diabetes educators) are in a key position to assess risks for nonadherence, to develop strategies to facilitate medication taking, and to provide ongoing support and assessment of adherence at each visit. © 2015 The Author(s).

  8. Disparity in physician perception of patients' adherence to medications by obesity status.

    Science.gov (United States)

    Huizinga, Mary Margaret; Bleich, Sara N; Beach, Mary Catherine; Clark, Jeanne M; Cooper, Lisa A

    2010-10-01

    Physician perception of medication adherence may alter prescribing patterns. Perception of patients has been linked to readily observable factors, such as race and age. Obesity shares a similar stigma to these factors in society. We hypothesized that physicians would perceive patients with a higher BMI as nonadherent to medication. Data were collected from the baseline visit of a randomized clinical trial of patient-physician communication (240 patients and 40 physicians). Physician perception of patient medication adherence was measured on a Likert scale and dichotomized as fully adherent or not fully adherent. BMI was the predictor of interest. We performed Poisson regression analyses with robust variance estimates, adjusting for clustering of patients within physicians, to examine the association between BMI and physician perception of medication adherence. The mean (s.d.) BMI was 32.6 (7.7) kg/m(2). Forty-five percent of patients were perceived as nonadherent to medications by their physicians. Higher BMI was significantly and negatively associated with being perceived as adherent to medication (prevalence ratio (PrR) 0.76, 95% confidence interval (CI): 0.64-0.90; P = 0.002; per 10 kg/m(2) increase in BMI). BMI remained significantly and negatively associated with physician perception of medication adherence after adjustment for patient and physician characteristics (PrR 0.80, 95% CI: 0.66-0.96; P = 0.020). In this study, patients with higher BMI were less likely to be perceived as adherent to medications by their providers. Physician perception of medication adherence has been shown to affect prescribing patterns in other studies. More work is needed to understand how this perception may affect the care of patients with obesity.

  9. Visual Analog Scale of ART Adherence: Association With 3-Day Self-Report and Adherence Barriers

    National Research Council Canada - National Science Library

    Amico, K. Rivet; Fisher, William A; Cornman, Deborah H; Shuper, Paul A; Redding, Caroline G; Konkle-Parker, Deborah J; Barta, William; Fisher, Jeffrey D

    2006-01-01

    .... METHODS:HIV-infected patients (N = 147) at a southeastern US clinic completed a computerized assessment including an antiretroviral therapy adherence VAS, a modified version of the AACTG, and a measure of adherence...

  10. Self-reported adherence to oral cancer therapy: relationships with symptom distress, depression, and personal characteristics

    Directory of Open Access Journals (Sweden)

    Berry DL

    2015-11-01

    Full Text Available Donna L Berry,1–3 Traci M Blonquist,4 Fangxin Hong,4,5 Barbara Halpenny,1 Ann H Partridge2,3 1Phyllis F Cantor Center, Dana-Farber Cancer Institute, 2Medical Oncology, Department of Medicine, Dana-Farber Cancer Institute, 3Department of Medicine, Harvard Medical School, 4Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 5Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA Background: Therapeutic cancer chemotherapy is most successful when complete dosing is achieved. Because many newer therapeutic agents are oral and self-administered by the patient, adherence is a concern. The purpose of our analysis was to explore relationships between adherence, patient characteristics, and barriers to adherence.Methods: This secondary analysis utilized self-reported data from a randomized trial of self-care management conducted at two cancer centers in the US. Symptom distress was measured using the 15-item Symptom Distress Scale (SDS-15 and depression with the Patient Health Questionnaire-9 (PHQ-9. Adherence to oral medication was self-reported using the 8-item Morisky Medication Adherence Scale (MMAS-8. Measures were collected via Web-based, study-specific software ~8 weeks after treatment start date. Odds of low/medium adherence (score <8 were explored using univariate logistic regression. Given the number of factors and possible relationships among factors, a classification tree was built in lieu of a multivariable logistic regression model.Results: Of the eligible participants enrolled, 77 were on oral therapy and 70 had an MMAS score. Forty-nine (70% reported a high adherence score (=8. Higher odds of low/medium adherence were associated with greater symptom distress (P=0.09, more depression (P=0.05, chemotherapy vs hormonal oral medication (P=0.03, being female (P=0.02, and being randomized to the control group in the parent trial (P=0.09. Conversely, high adherence was associated with

  11. Blood Pressure Treatment Adherence and Control after Participation in the ReHOT

    Directory of Open Access Journals (Sweden)

    Nathália Silva de Jesus

    Full Text Available Abstract Background: Lack of adherence to pharmacological treatment is one of the main causes of low control rates in hypertension. Objective: To verify treatment adherence and associated factors, as well as blood pressure (BP control in participants of the Resistant Hypertension Optimal Treatment (ReHOT clinical trial. Method: Cross-sectional study including all 109 patients who had completed the ReHOT for at least 6 months. We excluded those participants who failed to respond to the new recruitment after three phone contact attempts. We evaluated the BP control by ambulatory BP monitoring (ABPM; controlled levels: 24-hour systolic and diastolic BP < 130 x 80 mmHg and analyzed the patients' treatment adherence using the Morisky Medication Adherence Scale (MMAS questionnaire validated by Bloch, Melo, and Nogueira (2008. The statistical analysis was performed with the software IBM SPSS statistics 21.0. We tested the normality of the data distribution with kurtosis and skewness. The variables tested in the study are presented with descriptive statistics. Comparisons between treatment adherence and other variables were performed with Student's t test for independent variables and Pearson's chi-square or Fisher's exact test. To conduct analyses among patients considering adherence to treatment and BP control, we created four groups: G0, G1, G2, and G3. We considered a 5% significance level in all tests. Results: During the ReHOT, 80% of the patients had good BP control and treatment adherence. Of 96 patients reevaluated in the present study, only 52.1% had controlled hypertension when assessed by ABPM, while 31.3% were considered adherent by the MMAS. Regarding other ABPM measures, we observed an absence of a nocturnal dip in 64.6% of the patients and a white-coat effect and false BP control in 23% and 12.5%, respectively. Patients' education level showed a trend towards being a determinant factor associated with lack of adherence (p = 0

  12. Determinants of medication adherence to antihypertensive medications among a Chinese population using Morisky Medication Adherence Scale.

    Directory of Open Access Journals (Sweden)

    Gabrielle K Y Lee

    Full Text Available BACKGROUND AND OBJECTIVES: Poor adherence to medications is one of the major public health challenges. Only one-third of the population reported successful control of blood pressure, mostly caused by poor drug adherence. However, there are relatively few reports studying the adherence levels and their associated factors among Chinese patients. This study aimed to study the adherence profiles and the factors associated with antihypertensive drug adherence among Chinese patients. METHODS: A cross-sectional study was conducted in an outpatient clinic located in the New Territories Region of Hong Kong. Adult patients who were currently taking at least one antihypertensive drug were invited to complete a self-administered questionnaire, consisting of basic socio-demographic profile, self-perceived health status, and self-reported medication adherence. The outcome measure was the Morisky Medication Adherence Scale (MMAS-8. Good adherence was defined as MMAS scores greater than 6 points (out of a total score of 8 points. RESULTS: From 1114 patients, 725 (65.1% had good adherence to antihypertensive agents. Binary logistic regression analysis was conducted. Younger age, shorter duration of antihypertensive agents used, job status being employed, and poor or very poor self-perceived health status were negatively associated with drug adherence. CONCLUSION: This study reported a high proportion of poor medication adherence among hypertensive subjects. Patients with factors associated with poor adherence should be more closely monitored to optimize their drug taking behavior.

  13. Plasmodium vivax adherence to placental glycosaminoglycans.

    Directory of Open Access Journals (Sweden)

    Kesinee Chotivanich

    Full Text Available Plasmodium vivax infections seldom kill directly but do cause indirect mortality by reducing birth weight and causing abortion. Cytoadherence and sequestration in the microvasculature are central to the pathogenesis of severe Plasmodium falciparum malaria, but the contribution of cytoadherence to pathology in other human malarias is less clear.The adherence properties of P. vivax infected red blood cells (PvIRBC were evaluated under static and flow conditions.P. vivax isolates from 33 patients were studied. None adhered to immobilized CD36, ICAM-1, or thrombospondin, putative ligands for P. falciparum vascular cytoadherence, or umbilical vein endothelial cells, but all adhered to immobilized chondroitin sulphate A (CSA and hyaluronic acid (HA, the receptors for adhesion of P. falciparum in the placenta. PvIRBC also adhered to fresh placental cells (N = 5. Pre-incubation with chondroitinase prevented PvIRBC adherence to CSA, and reduced binding to HA, whereas preincubation with hyaluronidase prevented adherence to HA, but did not reduce binding to CSA significantly. Pre-incubation of PvIRBC with soluble CSA and HA reduced binding to the immobilized receptors and prevented placental binding. PvIRBC adhesion was prevented by pre-incubation with trypsin, inhibited by heparin, and reduced by EGTA. Under laminar flow conditions the mean (SD shear stress reducing maximum attachment by 50% was 0.06 (0.02 Pa but, having adhered, the PvIRBC could then resist detachment by stresses up to 5 Pa. At 37 °C adherence began approximately 16 hours after red cell invasion with maximal adherence at 30 hours. At 39 °C adherence began earlier and peaked at 24 hours.Adherence of P. vivax-infected erythrocytes to glycosaminoglycans may contribute to the pathogenesis of vivax malaria and lead to intrauterine growth retardation.

  14. Adherence to cooperative principles among agricultural ...

    African Journals Online (AJOL)

    Agricultural cooperatives in the area largely adhered to the cooperatives principles. However, capacity building on innovative financial sourcing and loan recovery mechanisms should be embarked upon by management to enhance the adherence. Keywords: Cooperatives principles, loan recovery, agricultural cooperatives ...

  15. Factors influencing adherence to routine iron supplementation ...

    African Journals Online (AJOL)

    Anemia in pregnancy is a common problem especially in developing countries. and has been linked with feotal and maternal complications. Taking iron supplements could reduce anaemia in pregnancy but some pregnant women do not adhere to this. The study identified some factors associated with non adherence ...

  16. Current issues in patient adherence and persistence: focus on anticoagulants for the treatment and prevention of thromboembolism

    Directory of Open Access Journals (Sweden)

    Patrick P Kneeland

    2010-03-01

    Full Text Available Patrick P Kneeland, Margaret C FangThe University of California, San Francisco Division of Hospital Medicine, San Francisco, CA, USAAbstract: Warfarin therapy reduces morbidity and mortality related to thromboembolism. Yet adherence to long-term warfarin therapy remains challenging due to the risks of anticoagulantassociated complications and the burden of monitoring. The aim of this paper is to review determinants of adherence and persistence on long-term anticoagulant therapy for atrial fibrillation and venous thromboembolism. We evaluate what the current literature reveals about the impact of warfarin on quality of life, examine warfarin trial data for patterns of adherence, and summarize known risk factors for warfarin discontinuation. Studies suggest only modest adverse effects of warfarin on quality of life, but highlight the variability of individual lifestyle experiences of patients on warfarin. Interestingly, clinical trials comparing anticoagulant adherence to alternatives (such as aspirin show that discontinuation rates on warfarin are not consistently higher than in control arms. Observational studies link a number of risk factors to warfarin non-adherence including younger age, male sex, lower stroke risk, poor cognitive function, poverty, and higher educational attainment. In addition to differentiating the relative impact of warfarin-associated complications (such as bleeding versus the lifestyle burdens of warfarin monitoring on adherence, future investigation should focus on optimizing patient education and enhancing models of physician–patient shared-decision making around anticoagulation.Keywords: anticoagulation, warfarin, adherence, persistence, thromboembolism

  17. Patient Adherence to Biologic Agents in Psoriasis

    DEFF Research Database (Denmark)

    Hsu, Der Yi; Gniadecki, Robert

    2016-01-01

    treatment, and cause for treatment discontinuation] were obtained from the national database DERMBIO. Patients' attitudes and beliefs were measured using the Medication Adherence Rating Scale (MARS). RESULTS: A total of 93.5% of all patients had an MPR ≥0.8, indicating very good adherence. MPR......BACKGROUND: Low adherence to therapies in psoriasis decreases treatment outcomes and increases the total health care costs. In spite of the wide use of biologic agents, patients' adherence to these drugs has not been extensively investigated. OBJECTIVE: The aim of this study is to measure adherence...... to the biologic drugs in a population of patients treated for psoriasis vulgaris using the medication possession ratio (MPR) index and to survey patients' attitudes to the treatment. METHODS: This is a single-center study on 247 patients with psoriasis vulgaris treated with adalimumab (n = 113), etanercept (n...

  18. Claustrophobia and adherence to CPAP treatment.

    Science.gov (United States)

    Chasens, Eileen R; Pack, Allan I; Maislin, Greg; Dinges, David F; Weaver, Terri E

    2005-04-01

    This study evaluated the effect of claustrophobia, an abnormal dread or fear of closed spaces, on adherence to continuous positive airway pressure (CPAP) therapy. The design was a secondary analysis of data from a prospective study of participants (N = 153) that completed 3 months of CPAP therapy from seven sleep disorders centers in the United States and Canada. A 15-item subscale adapted from the Fear and Avoidance Scale measured claustrophobic tendencies pre-CPAP treatment and again after 3 months. An overt monitor attached to the CPAP machines recorded mask-on CPAP adherence. There was a statistically significant difference in claustrophobia scores by adherence group ( or = 5 hours) and time period (pre-CPAP and after 3 months CPAP). Poor CPAP adherence (claustrophobia score > or = 25. Identification of persons with increased claustrophobia tendencies and targeted interventions may increase adherence.

  19. Asthma and Adherence to Inhaled Corticosteroids

    DEFF Research Database (Denmark)

    Bårnes, Camilla Boslev; Ulrik, Charlotte Suppli

    2015-01-01

    Inhaled corticosteroids (ICS) are the cornerstone of maintenance asthma therapy. However, in spite of this, adherence to ICS remains low. The aim of this systematic literature review was to provide an overview of the current knowledge of adherence to ICS, effects of poor adherence, and means...... was found to be between 22 and 63%, with improvement up to and after an exacerbation. Poor adherence was associated with youth, being African-American, having mild asthma, ... prescribed fixed-combination therapy (ICS and long-acting β2 agonists). Good adherence was associated with higher FEV1, a lower percentage of eosinophils in sputum, reduction in hospitalizations, less use of oral corticosteroids, and lower mortality rate. Overall, 24% of exacerbations and 60% of asthma...

  20. Who takes the medicine? Adherence to antiretroviral therapy in Southern Ethiopia

    Directory of Open Access Journals (Sweden)

    Teshome W

    2015-10-01

    Full Text Available Wondu Teshome,1 Mihretu Belayneh,1 Mathewos Moges,1 Misganu Endriyas,2 Emebet Mekonnen,2 Sinafiksh Ayele,2 Tebeje Misganaw,2 Mekonnen Shiferaw,2 Palanivel Chinnakali,3 Sven Gudmund Hinderaker,4 Ajay MV Kumar5 1School of Public and Environmental Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia; 2Research Technology Transfer Process Unit, SNNP Regional Health Bureau, Hawassa, Ethiopia; 3Department of Preventive and Social Medicine, Jawaharlal Institute of Post-graduate Medical Education and Research, Puducherry, India; 4Centre for International Health, University of Bergen, Bergen, Norway; 5The International Union Against Tuberculosis and Lung Disease, South-East Asia Regional Office, New Delhi, India Background: Treatment adherence is critical for the success of antiretroviral therapy (ART for people living with HIV. There is limited representative information on ART drug adherence and its associated factors from Southern Ethiopia. We aimed at estimating the level of adherence to ART among people living with HIV and factors associated with it in 20 randomly selected ART clinics of Southern Ethiopia.Methods: In this cross-sectional study, we interviewed consecutive HIV patients on first-line antiretroviral regimen attending the clinics in June 2014 using a pretested and structured questionnaire. For measuring adherence, we used 4-day recall method based on “The AIDS Clinical Trial Group adherence assessment tool”. Patients were classified as “Incomplete adherence” if they missed any of the doses in the last 4 days. Data were singly entered using EpiData and descriptive analysis, and unadjusted odds ratios were calculated using EpiDataStat software. Multivariate logistic regression analysis was performed using Stata v12.0.Results: Of 974 patients interviewed, 539 (56% were females, and mean age was 35 years. The proportion of patients with incomplete adherence was 13% (95% confidence interval: 11%–15

  1. Therapeutic adherence and competence scales for Developmentally Adapted Cognitive Processing Therapy for adolescents with PTSD

    Directory of Open Access Journals (Sweden)

    Jana Gutermann

    2015-03-01

    Full Text Available Background: The assessment of therapeutic adherence and competence is often neglected in psychotherapy research, particularly in children and adolescents; however, both variables are crucial for the interpretation of treatment effects. Objective: Our aim was to develop, adapt, and pilot two scales to assess therapeutic adherence and competence in a recent innovative program, Developmentally Adapted Cognitive Processing Therapy (D-CPT, for adolescents suffering from posttraumatic stress disorder (PTSD after childhood abuse. Method: Two independent raters assessed 30 randomly selected sessions involving 12 D-CPT patients (age 13–20 years, M age=16.75, 91.67% female treated by 11 therapists within the pilot phase of a multicenter study. Results: Three experts confirmed the relevance and appropriateness of each item. All items and total scores for adherence (intraclass correlation coefficients [ICC]=0.76–1.00 and competence (ICC=0.78–0.98 yielded good to excellent inter-rater reliability. Cronbach's alpha was 0.59 for the adherence scale and 0.96 for the competence scale. Conclusions: The scales reliably assess adherence and competence in D-CPT for adolescent PTSD patients. The ratings can be helpful in the interpretation of treatment effects, the assessment of mediator variables, and the identification and training of therapeutic skills that are central to achieving good treatment outcomes. Both adherence and competence will be assessed as possible predictor variables for treatment success in future D-CPT trials.

  2. Patient communication tools to enhance ART adherence counseling in low and high resource settings.

    Science.gov (United States)

    Finocchario-Kessler, Sarah; Catley, Delwyn; Thomson, Domonique; Bradley-Ewing, Andrea; Berkley-Patton, Jannette; Goggin, Kathy

    2012-10-01

    Few articles have examined specific counseling tools used to increase antiretroviral therapy (ART) adherence. We present communication tools used in the context of Project MOTIV8, a randomized clinical trial. We developed, piloted, and evaluated pictorial images to communicate the importance of consistent dose timing and the concept of drug resistance. Electronic drug monitoring (EDM) review was also used to provide visual feedback and facilitate problem solving discussions. Adherence knowledge of all participants (n=204) was assessed at baseline and 48 weeks. Participant satisfaction with counseling was also assessed. Adherence knowledge did not differ at baseline, however, at 48 weeks, intervention participants demonstrated significantly increased knowledge compared to controls F(1, 172)=10.76, p=0.001 (12.4% increase among intervention participants and 1.8% decrease among controls). Counselors reported that the tools were well-received, and 80% of participants felt the counseling helped them adhere to their medications. Counseling tools were both positively received and effective in increasing ART adherence knowledge among a diverse population. While developed for research, these counseling tools can be implemented into clinical practice to help patients; particularly those with lower levels of education or limited abstract thinking skills to understand medical concepts related to ART adherence. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  3. Refractory Primary Medication Non-Adherence: Prevalence and Predictors After Pharmacist Counseling at Hospital Discharge

    Science.gov (United States)

    Wooldridge, Kathleene; Schnipper, Jeffrey L.; Goggins, Kathryn; Dittus, Robert S.; Kripalani, Sunil

    2015-01-01

    Successful secondary prevention of cardiovascular disease relies on medication therapy, thus minimizing non-adherence is a focus for improving patient outcomes. Receipt of discharge medication counseling has been associated with improved drug knowledge and adherence. We evaluated the prevalence and predictors of post-discharge primary non-adherence (not filling new prescriptions) in patients who received discharge medication counseling by a pharmacist (i.e., refractory to intervention) as part of a randomized, controlled trial. Of 341 patients, 9.4% of patients did not fill all prescriptions after discharge. Patients who were living alone were more likely to not fill their medications compared to those who were married or cohabitating (odds ratio [OR] 2.2, 95% confidence interval [CI], 1.01-4.8, p=0.047). Patients who were discharged with greater than 10 medications were also more likely to demonstrate primary non-adherence (OR 2.3, 95% CI, 1.05-4.98, p=0.036). Patients with lower income were less likely to fill prescriptions in univariate analysis (p=0.04) but not multivariable analysis. Our study demonstrates that among patients hospitalized for acute cardiovascular events, primary medication non-adherence persisted despite discharge medication counseling. Targeted or multimodal approaches that address patient-specific barriers such as cost, social isolation, and polypharmacy, in addition to discharge counseling, may further facilitate adherence. PMID:26293710

  4. eHealth Technologies as an intervention to improve adherence to topical antipsoriatics: a systematic review.

    Science.gov (United States)

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

    2018-03-01

    Topical antipsoriatics are recommended first-line treatment of psoriasis, but rates of adherence are low. Patient support by use of electronic health (eHealth) services is suggested to improve medical adherence. To review randomised controlled trials (RCTs) testing eHealth interventions designed to improve adherence to topical antipsoriatics and to review applications for smartphones (apps) incorporating the word psoriasis. Literature review: Medline, Embase, Cochrane, PsycINFO and Web of Science were searched using search terms for eHealth, psoriasis and topical antipsoriatics. General analysis of apps: The operating systems (OS) for smartphones, iOS, Google Play, Microsoft Store, Symbian OS and Blackberry OS were searched for apps containing the word psoriasis. Literature review: Only one RCT was included, reporting on psoriasis patients' Internet reporting their status of psoriasis over a 12-month period. The rate of adherence was measured by Medication Event Monitoring System (MEMS ® ). An improvement in medical adherence and reduction of severity of psoriasis were reported. General analysis of apps: A total 184 apps contained the word psoriasis. There is a critical need for high-quality RCTs testing if the ubiquitous eHealth technologies, for example, some of the numerous apps, can improve psoriasis patients' rates of adherence to topical antipsoriatics.

  5. Use of automated medication adherence monitoring in bipolar disorder research: pitfalls, pragmatics, and possibilities.

    Science.gov (United States)

    Levin, Jennifer B; Sams, Johnny; Tatsuoka, Curtis; Cassidy, Kristin A; Sajatovic, Martha

    2015-04-01

    Medication nonadherence occurs in 20-60% of persons with bipolar disorder (BD) and is associated with serious negative outcomes, including relapse, hospitalization, incarceration, suicide and high healthcare costs. Various strategies have been developed to measure adherence in BD. This descriptive paper summarizes challenges and workable strategies using electronic medication monitoring in a randomized clinical trial (RCT) in patients with BD. Descriptive data from 57 nonadherent individuals with BD enrolled in a prospective RCT evaluating a novel customized adherence intervention versus control were analyzed. Analyses focused on whole group data and did not assess intervention effects. Adherence was assessed with the self-reported Tablets Routine Questionnaire and the Medication Event Monitoring System (MEMS). The majority of participants were women (74%), African American (69%), with type I BD (77%). Practical limitations of MEMS included misuse in conjunction with pill minders, polypharmacy, cost, failure to bring to research visits, losing the device, and the device impacting baseline measurement. The advantages were more precise measurement, less biased recall, and collecting data from past time periods for missed interim visits. Automated devices such as MEMS can assist investigators in evaluating adherence in patients with BD. Knowing the anticipated pitfalls allows study teams to implement preemptive procedures for successful implementation in BD adherence studies and can help pave the way for future refinements as automated adherence assessment technologies become more sophisticated and readily available.

  6. A literature review to investigate the link between psychosocial characteristics and treatment adherence in cancer patients

    Directory of Open Access Journals (Sweden)

    Paraskevi Theofilou

    2012-06-01

    Full Text Available Adherence to medication has been recognized as a key issue in health outcomes and efforts to improve patients’ adherence are being made by the pharmaceutical industry, experts, and government bodies alike. This paper presents a review of these issues according to previous descriptive findings. Relevant studies written in English, published in 1976 or later, were identified through Medline, Embase and PsycInfo databases and reviewed. Review articles and clinical trials were excluded; all observational studies and surveys were considered. Articles were reviewed for any discussion of patients’ characteristics and psychosocial characteristics affecting adherence to cancer treatment. The search strategy included a combination of key words adherence and cancer in titles. The major findings are summarized and presented under two main headings: i patients’ characteristics; and ii psychosocial characteristics. In general, factors associated with increased likelihood of adherence to cancer treatment included younger age, higher education, higher income and Caucasian ethnicity. With regards to the psychosocial factors, lower levels of depression and anxiety, optimism as well as social support seemed to have a positive effect on treatment adherence. Studies of patterns of care in cancer treatment can help identify challenges in health care provided to particular subgroups of cancer patients and can aid researchers in designing studies that account for such factors in clinical and outcomes’ research.

  7. Medication Adherence in Children and Adolescents with HIV Infection: Associations with Behavioral Impairment

    Science.gov (United States)

    Williams, Paige; Montepiedra, Grace; McCabe, Marie; Nichols, Sharon; Sirois, Patricia A.; Storm, Deborah; Farley, John; Kammerer, Betsy

    2011-01-01

    Abstract The impact of behavioral functioning on medication adherence in children with perinatally acquired HIV infection is not well-explored, but has important implications for intervention. This report addresses the relationship between behavioral functioning and child self-report or caregiver report of medication adherence among children and adolescents enrolled in Pediatric AIDS Clinical Trials Group Protocol 219C (conducted 2000–2007). A total of 1134 participants, aged 3–17 years, received a behavioral evaluation and adherence assessment. Complete adherence was defined as taking 100% of prescribed antiretroviral medications during three days preceding the study visit. Multivariable logistic regression models were used to evaluate associations between adherence and behavioral functioning, adjusting for potential confounders, including demographic, psychosocial, and health factors. Children demonstrated higher than expected rates of behavioral impairment (≈7% expected with T > 65) in the areas of conduct problems (14%, z = 7.0, p stressful life events and higher HIV RNA levels, were also associated with nonadherence. Knowledge of behavioral, health, and social influences affecting the child and family should guide the development of appropriate, evidence-based interventions for medication adherence. PMID:21323533

  8. Improving adherence to PALS septic shock guidelines.

    Science.gov (United States)

    Paul, Raina; Melendez, Elliot; Stack, Anne; Capraro, Andrew; Monuteaux, Michael; Neuman, Mark I

    2014-05-01

    Few studies have demonstrated improvement in adherence to Pediatric Advanced Life Support guidelines for severe sepsis and septic shock. We sought to improve adherence to national guidelines for children with septic shock in a pediatric emergency department with poor guideline adherence. Prospective cohort study of children presenting to a tertiary care pediatric emergency department with septic shock. Quality improvement (QI) interventions, including repeated plan-do-study-act cycles, were used to improve adherence to a 5-component sepsis bundle, including timely (1) recognition of septic shock, (2) vascular access, (3) administration of intravenous (IV) fluid, (4) antibiotics, and (5) vasoactive agents. The intervention focused on IV fluid delivery as a key driver impacting bundle adherence, and adherence was measured using statistical process control methodology. Two-hundred forty-two patients were included: 126 subjects before the intervention (November 2009 to March 2011), and 116 patients during the QI intervention (October 2011 to May 2013). We achieved 100% adherence for all metrics, including (1) administration of 60 mL/kg IV fluid within 60 minutes (increased from baseline adherence rate of 37%), (2) administration of vasoactive agents within 60 minutes (baseline rate of 35%), and (3) 5-component bundle adherence (baseline rate of 19%). Improvement was sustained over 9 months. The number of septic shock cases between each death from this condition increased after implementation of the QI intervention. Using QI methodology, we have demonstrated improved adherence to national guidelines for severe sepsis and septic shock. Copyright © 2014 by the American Academy of Pediatrics.

  9. Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy.

    Science.gov (United States)

    Al-Aqeel, Sinaa; Gershuni, Olga; Al-Sabhan, Jawza; Hiligsmann, Mickael

    2017-02-03

    Poor adherence to antiepileptic medication is associated with increased mortality, morbidity and healthcare costs. In this review, we focus on interventions designed and tested in randomised controlled trials and quasi-randomised controlled trials to assist people with adherence to antiepileptic medication. This is an updated version of the original Cochrane review published in the Cochrane Library, Issue 1, 2010. To determine the effectiveness of interventions aimed at improving adherence to antiepileptic medication in adults and children with epilepsy. For the latest update, on 4 February 2016 we searched the Cochrane Epilepsy Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO), MEDLINE (Ovid 1946 to 4 February 2016), CINAHL Plus (EBSCOhost 1937 to 4 February 2016), PsycINFO (EBSCOhost 1887 to 4 February 2016), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform. We also searched the reference lists of relevant articles. Randomised and quasi-randomised controlled trials of adherence-enhancing interventions aimed at people with a clinical diagnosis of epilepsy (as defined in individual studies), of any age and treated with antiepileptic drugs in a primary care, outpatient or other community setting. All review authors independently assessed lists of potentially relevant citations and abstracts. At least two review authors independently extracted data and performed quality assessment of each study according to the Cochrane tool for assessing risk of bias. We graded the level of evidence for each outcome according to the GRADE working group scale.The studies differed widely according to the type of intervention and measures of adherence; therefore combining data was not appropriate. We included 12 studies reporting data on 1642 participants (intervention = 833, control = 809). Eight studies targeted adults with epilepsy, one study included participants

  10. Interventions to improve adherence to antiretroviral therapy: a systematic review and network meta-analysis.

    Science.gov (United States)

    Kanters, Steve; Park, Jay J H; Chan, Keith; Socias, Maria Eugenia; Ford, Nathan; Forrest, Jamie I; Thorlund, Kristian; Nachega, Jean B; Mills, Edward J

    2017-01-01

    High adherence to antiretroviral therapy is crucial to the success of HIV treatment. We evaluated comparative effectiveness of adherence interventions with the aim of informing the WHO's global guidance on interventions to increase adherence. For this systematic review and network meta-analysis, we searched for randomised controlled trials of interventions that aimed to improve adherence to antiretroviral therapy regimens in populations with HIV. We searched Cochrane Central Register of Controlled Trials, Embase, and MEDLINE for reports published up to July 16, 2015, and searched major conference abstracts from Jan 1, 2013, to July 16, 2015. We extracted data from eligible studies for study characteristics, interventions, patients' characteristics at baseline, and outcomes for the study populations of interest. We used network meta-analyses to compare adherence and viral suppression for all study settings (global network) and for studies in low-income and middle-income countries only (LMIC network). We obtained data from 85 trials with 16 271 participants. Short message service (SMS; text message) interventions were superior to standard of care in improving adherence in both the global network (odds ratio [OR] 1·48, 95% credible interval [CrI] 1·00-2·16) and in the LMIC network (1·49, 1·04-2·09). Multiple interventions showed generally superior adherence to single interventions, indicating additive effects. For viral suppression, only cognitive behavioural therapy (1·46, 1·05-2·12) and supporter interventions (1·28, 1·01-1·71) were superior to standard of care in the global network; none of the interventions improved viral response in the LMIC network. For the global network, the time discrepancy (whether the study outcome was measured during or after intervention was withdrawn) was an effect modifier for both adherence to antiretroviral therapy (coefficient estimate -0·43, 95% CrI -0·75 to -0·11) and viral suppression (-0·48; -0·84 to -0·12

  11. Therapist adherence to interpersonal vs. supportive therapy for social anxiety disorder.

    Science.gov (United States)

    Sinai, Dana; Gur, Merav; Lipsitz, Joshua D

    2012-01-01

    We assessed therapist adherence to interpersonal therapy (IPT) and supportive therapy (ST) in a controlled trial for social anxiety disorder. Raters blindly scored n = 133 videotapes from 53 participants using the Collaborative Study Psychotherapy Rating Scale (CSPRS). Results reveal statistical differences across groups, but higher than expected overlap. Greater use of IPT in beginning sessions predicted better outcome in both therapies. Suboptimal adherence may be due to the crossed design in which the same therapists delivered both IPT and ST. Since switching between different approaches is a clinical reality for integrative psychotherapists, these findings may have important clinical implications.

  12. Adherence to antipsychotic medication among homeless adults in Vancouver, Canada: a 15-year retrospective cohort study.

    Science.gov (United States)

    Rezansoff, Stefanie N; Moniruzzaman, A; Fazel, S; Procyshyn, R; Somers, J M

    2016-12-01

    The purpose of this study was to investigate the level of adherence to antipsychotic prescription medication in a well-defined homeless cohort over a 15-year period. We hypothesized that adherence would be well below the recommended threshold for clinical effectiveness (80 %), and that it would be strongly associated with modifiable risk factors in the social environment in which homeless people live. Linked baseline data (including comprehensive population-level administrative prescription records) were examined in a subpopulation of participants from two pragmatic-randomized trials that investigated Housing First for homeless and mentally ill adults. Adherence to antipsychotic medication was operationalized using the medication possession ratio. Multivariable logistic regression was used to estimate effect sizes between socio-demographic, homelessness-related and illness factors, and medication possession ratio. Among the 290 participants who met inclusion criteria for the current analysis, adherence to antipsychotic prescription was significantly associated with: history of psychiatric hospitalization; receipt of primary medical services; long-acting injectable antipsychotic formulations; and duration of homelessness. Mean medication possession ratio in the pre-randomization period was 0.41. Socio-demographic characteristics previously correlated with antipsychotic non-adherence were not significantly related to medication possession ratio. This is the first study to quantify the very low level of adherence to antipsychotic medication among homeless people over an extended observation period of 15 years. Each of the four factors found to be significantly associated with adherence presents opportunities for intervention. Strategies to end homelessness for this population may represent the greatest opportunity to improve adherence to antipsychotic medication.

  13. Determinants of exercise adherence and maintenance among cancer survivors: a systematic review

    Science.gov (United States)

    2014-01-01

    For an exercise intervention to be successful, it is important that cancer survivors adhere to the prescribed program. To be able to improve adherence and to preserve achieved beneficial effects, insights into the relevant and modifiable determinants is important. Therefore, we aimed to systematically review determinants of exercise adherence and maintenance in cancer survivors using a socio-ecological approach. Studies were identified in PubMed, Embase, PsycINFO and SPORTDiscus up to July 2013. We included full-text articles that: 1) were conducted among adult cancer survivors; 2) quantitatively assessed factors associated with intervention adherence and maintenance, and 3) were published in English. The methodological quality of the selected studies was examined. A best evidence synthesis was applied. Eighteen studies were included. Median methodological quality was 53% and ranged from 21-78% of maximum score. Twelve studies focused on determinants of exercise adherence and evaluated 71 potential determinants: 29 demographic and clinical, 27 psychological, ten physical, four social factors, and one environmental factor. Six studies focused on determinants of exercise maintenance after completion of an intervention, and investigated 63 factors: 22 demographic and clinical, 28 psychosocial, nine physical, three social and one environmental factor. We found moderate evidence for a positive association between exercise history and exercise adherence. Inconsistent findings were found for age, gender and education as well as for psychological factors such as stage of change, perceived behavioral control, self-efficacy, extraversion, attitude, intention, fatigue, and quality of life, and physical factors including cardiovascular fitness, body mass index, and baseline physical activity. Exercise history is positively associated with exercise adherence. Future trials should further study the influence of social and environmental determinants on exercise adherence and

  14. Sustainability of professionals’ adherence to clinical practice guidelines in medical care: a systematic review

    Science.gov (United States)

    Ament, Stephanie M C; de Groot, Jeanny J A; Maessen, José M C; Dirksen, Carmen D; van der Weijden, Trudy; Kleijnen, Jos

    2015-01-01

    Objectives To evaluate (1) the state of the art in sustainability research and (2) the outcomes of professionals’ adherence to guideline recommendations in medical practice. Design Systematic review. Data sources Searches were conducted until August 2015 in MEDLINE, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and the Guidelines International Network (GIN) library. A snowball strategy, in which reference sections of other reviews and of included papers were searched, was used to identify additional papers. Eligibility criteria Studies needed to be focused on sustainability and on professionals’ adherence to clinical practice guidelines in medical care. Studies had to include at least 2 measurements: 1 before (PRE) or immediately after implementation (EARLY POST) and 1 measurement longer than 1 year after active implementation (LATE POST). Results The search retrieved 4219 items, of which 14 studies met the inclusion criteria, involving 18 sustainability evaluations. The mean timeframe between the end of active implementation and the sustainability evaluation was 2.6 years (minimum 1.5–maximum 7.0). The studies were heterogeneous with respect to their methodology. Sustainability was considered to be successful if performance in terms of professionals’ adherence was fully maintained in the late postimplementation phase. Long-term sustainability of professionals’ adherence was reported in 7 out of 18 evaluations, adherence was not sustained in 6 evaluations, 4 evaluations showed mixed sustainability results and in 1 evaluation it was unclear whether the professional adherence was sustained. Conclusions (2) Professionals’ adherence to a clinical practice guideline in medical care decreased after more than 1 year after implementation in about half of the cases. (1) Owing to the limited number of studies, the absence of a uniform definition, the high risk of bias, and the mixed results of studies, no firm conclusion about the

  15. Sustainability of professionals' adherence to clinical practice guidelines in medical care: a systematic review.

    Science.gov (United States)

    Ament, Stephanie M C; de Groot, Jeanny J A; Maessen, José M C; Dirksen, Carmen D; van der Weijden, Trudy; Kleijnen, Jos

    2015-12-29

    To evaluate (1) the state of the art in sustainability research and (2) the outcomes of professionals' adherence to guideline recommendations in medical practice. Systematic review. Searches were conducted until August 2015 in MEDLINE, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and the Guidelines International Network (GIN) library. A snowball strategy, in which reference sections of other reviews and of included papers were searched, was used to identify additional papers. Studies needed to be focused on sustainability and on professionals' adherence to clinical practice guidelines in medical care. Studies had to include at least 2 measurements: 1 before (PRE) or immediately after implementation (EARLY POST) and 1 measurement longer than 1 year after active implementation (LATE POST). The search retrieved 4219 items, of which 14 studies met the inclusion criteria, involving 18 sustainability evaluations. The mean timeframe between the end of active implementation and the sustainability evaluation was 2.6 years (minimum 1.5-maximum 7.0). The studies were heterogeneous with respect to their methodology. Sustainability was considered to be successful if performance in terms of professionals' adherence was fully maintained in the late postimplementation phase. Long-term sustainability of professionals' adherence was reported in 7 out of 18 evaluations, adherence was not sustained in 6 evaluations, 4 evaluations showed mixed sustainability results and in 1 evaluation it was unclear whether the professional adherence was sustained. (2) Professionals' adherence to a clinical practice guideline in medical care decreased after more than 1 year after implementation in about half of the cases. (1) Owing to the limited number of studies, the absence of a uniform definition, the high risk of bias, and the mixed results of studies, no firm conclusion about the sustainability of professionals' adherence to guidelines in medical practice can be drawn

  16. Current strategies for improving access and adherence to antiretroviral therapies in resource-limited settings

    Directory of Open Access Journals (Sweden)

    Scanlon ML

    2013-01-01

    Full Text Available Michael L Scanlon,1,2 Rachel C Vreeman1,21Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA; 2USAID, Academic Model Providing Access to Healthcare (AMPATH Partnership, Eldoret, KenyaAbstract: The rollout of antiretroviral therapy (ART significantly reduced human immunodeficiency virus (HIV-related morbidity and mortality, but good clinical outcomes depend on access and adherence to treatment. In resource-limited settings, where over 90% of the world’s HIV-infected population resides, data on barriers to treatment