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

ABSTRACT: 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.

SUBMITTER: Schoenthaler A

PROVIDER: S-EPMC4488119 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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

Schoenthaler Antoinette A De La Calle Franzenith F Barrios-Barrios Miguel M Garcia Aury A Pitaro Maria M Lum Audrey A Rosal Milagros M

Trials 20150702

<h4>Background</h4>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.<h4>Methods</h4>Using a randomized controlled desig ...[more]

PMID: 26134837

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Project description:BackgroundAdherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence.ObjectiveThe primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes.MethodsThis study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations.ResultsPhase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020.ConclusionsThis study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus.Trial registrationClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128.International registered report identifier (irrid)DERR1-10.2196/15356.

Project description:INTRODUCTION: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. METHODS AND ANALYSIS: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. ETHICS AND DISSEMINATION: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. TRIAL REGISTRATION NUMBER:ACTRN12616000661471; Pre-results.

Project description:BackgroundNonadherence to antiretroviral therapy (ART) among people living with HIV is a crucial barrier to attaining viral suppression globally. Existing behavioral interventions have successfully increased ART adherence, but typically show only short-term impact that dissipates after the interventions are withdrawn.ObjectiveThis study aims to test the feasibility, acceptability, and preliminary efficacy of a novel intervention that uses SMS text messages and conditional incentives to support ART initiators in establishing pill-taking habits.MethodsA sample of 150 participants aged ≥18 years who have initiated ART in the preceding 3 months will be recruited from Mildmay Uganda in Kampala, Uganda. All (150/150, 100%) participants will be educated on the anchoring strategy and will choose an existing routine to pair with their daily ART adherence from a set of 3 suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Then, participants will be randomized to receive either usual care (control group: 50/150, 33.3%) or 1 of the 2 interventions delivered over 3 months: daily SMS text message reminders to follow their chosen anchoring plan (messages group; treatment group 1: 50/150, 33.3%) or daily SMS text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (incentives group; treatment group 2: 50/150, 33.3%). Long-term ART adherence will be evaluated for 6 months after the intervention, and survey assessments will be conducted at baseline, 3 months, and 9 months. Outcomes include feasibility and acceptability measures and intervention efficacy outcomes defined by electronically measured mean medication adherence during the intervention and during the 6 months after the intervention, along with a measure of routine ART adherence based on taking medications around the time of participants' anchor during the intervention and during the 6 months after intervention.ResultsAs of February 18, 2022, recruitment was completed. A total of 150 participants were recruited, and data collection is expected to end in December of 2022. Final results are expected to be submitted for publication by April 2023.ConclusionsThis study is the first to use behavioral economics-based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. We hypothesize that the combination of SMS text message reminders and incentives will increase participants' use of their anchoring strategy, and thus medication adherence will be better maintained after the intervention ends in our intervention groups relative to the control group that uses only the anchoring strategy. Results of this pilot study will help to refine this combined intervention approach for testing at scale and broaden our understanding of the habit formation process.Trial registrationClinicalTrials.gov NCT05131165; https://clinicaltrials.gov/ct2/show/NCT05131165.International registered report identifier (irrid)DERR1-10.2196/42216.

Project description:BackgroundMobile health technologies have the potential to improve the reach and delivery of interventions for promoting long-term secondary prevention of coronary heart disease.ObjectiveThis study aims to determine the effectiveness of an SMS text messaging intervention (Text4HeartII) for improving adherence to medication and lifestyle changes over and above usual care in people with coronary heart disease at 24 and 52 weeks.MethodsA two-arm, parallel, randomized controlled trial was conducted in New Zealand. Participants with a recent acute coronary syndrome were randomized to receive usual cardiac services alone (control, n=153) or a 24-week SMS text message program for supporting self-management plus usual cardiac services (n=153). The primary outcome was adherence to medication at 24 weeks, defined as a medication possession ratio of 80% or more for aspirin, statin, and antihypertensive therapy. Secondary outcomes included medication possession ratio at 52 weeks, self-reported medication adherence, adherence to healthy lifestyle behaviors, and health-related quality of life at 24 and 52 weeks.ResultsParticipants were predominantly male (113/306, 80.3%) and European New Zealanders (210/306, 68.6%), with a mean age of 61 years (SD 11 years). Groups were comparable at baseline. National hospitalization and pharmacy dispensing records were available for all participants; 92% (282/306, 92.1%) of participants completed a 24-week questionnaire and 95.1% (291/306) of participants completed a 52-week questionnaire. Adherence with 3 medication classes were lower in the intervention group than in the control group (87/153, 56.8% vs 105/153, 68.6%, odds ratio 0.60, 95% CI 0.38-0.96; P=.03) and 52 weeks (104/153, 67.9% vs 83/153, 54.2%; odds ratio 0.56, 95% CI 0.35-0.89; P=.01). Self-reported medication adherence scores showed the same trend at 52 weeks (mean difference 0.3; 95% CI 0.01-0.59; P=.04). Moreover, self-reported adherence to health-related behaviors was similar between groups.ConclusionsText4HeartII did not improve dispensed medication or adherence to a favorable lifestyle over and above usual care. This finding contrasts with previous studies and highlights that the benefits of text interventions may depend on the context in which they are used.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000422426; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370398.International registered report identifier (irrid)RR2-10.1186/s13063-018-2468-z.

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

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

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