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Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol.

ABSTRACT: INTRODUCTION:Non-adherence after kidney transplantation contributes to increased rejections, hospitalisations and healthcare expenditures. Although effective adherence interventions are sorely needed, increasing education and support to transplant recipients demands greater use of care providers' time and resources in a healthcare system that is stretched. The objective of this clinical trial is to determine the effectiveness of an electronically delivered video series and adherence behaviour contract on improving medication adherence to immunosuppressant medications. METHODS AND ANALYSIS:A multicentre, parallel arm, randomised controlled trial will be conducted with four sites across North America (Saskatoon, Calgary, Halifax, Chicago). Adult patients will be randomised (1:1) to either the intervention (ie, home-based video education +behaviour?contract plus usual care) or usual care alone. De novo transplant recipients will be enrolled prior to their hospital discharge and will be provided with electronic access to the video intervention (immediately) and adherence contract (1?month post-transplant). Follow-up electronic surveys will be provided at 3 and 12 months postenrolment. The primary outcome will be adherence at 12 months post-transplant, as measured by self-report Basel Assessment of Adherence to Immunosuppressive medications and immunosuppressant levels. Secondary outcomes include the difference in knowledge score between the intervention and control in groups (measured by the Kidney Transplant Understanding Tool); differences in self-efficacy (Generalised Self-efficacy Scale), Beliefs of Medicine Questionnaire (BMQ), quality of life (Short Form-12), patient satisfaction and cost utilisation. The study aims to recruit at least 200 participants across participating sites. ETHICS AND DISSEMINATION:Ethical approval was obtained from the University of Saskatchewan Behavioural Ethics Committee (Beh 18-63), and all patients provide informed consent prior to participating. This educational intervention aims to improve information retention and self-efficacy, leading to improved medication adherence after kidney transplantation, at low cost, with little impact to existing healthcare personnel. If proven beneficial, delivery can be easily implemented into standard of care. TRIAL REGISTRATION NUMBER:NCT03540121; Pre-results.

SUBMITTER: Mansell H

PROVIDER: S-EPMC6429879 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol.

Mansell Holly H Rosaasen Nicola N West-Thielke Patricia P Wichart Jenny J Daley Christopher C Mainra Rahul R Shoker Ahmed A Liu Juxin J Blackburn David D

BMJ open 20190313 3

<h4>Introduction</h4>Non-adherence after kidney transplantation contributes to increased rejections, hospitalisations and healthcare expenditures. Although effective adherence interventions are sorely needed, increasing education and support to transplant recipients demands greater use of care providers' time and resources in a healthcare system that is stretched. The objective of this clinical trial is to determine the effectiveness of an electronically delivered video series and adherence beha ...[more]

PMID: 30872550

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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:ObjectiveTo describe and evaluate the use of cognitive-based behaviour change techniques as interventions to improve medication adherence.DesignSystematic review and meta-analysis of interventions to improve medication adherence.Data sourcesSearch of the MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases from the earliest year to April 2013 without language restriction. References of included studies were also screened to identify further relevant articles.Review methodsWe used predefined criteria to select randomised controlled trials describing a medication adherence intervention that used Motivational Interviewing (MI) or other cognitive-based techniques. Data were extracted and risk of bias was assessed by two independent reviewers. We conducted the meta-analysis using a random effects model and Hedges' g as the measure of effect size.ResultsWe included 26 studies (5216 participants) in the meta-analysis. Interventions most commonly used MI, but many used techniques such as aiming to increase the patient's confidence and sense of self-efficacy, encouraging support-seeking behaviours and challenging negative thoughts, which were not specifically categorised. Interventions were most commonly delivered from community-based settings by routine healthcare providers such as general practitioners and nurses. An effect size (95% CI) of 0.34 (0.23 to 0.46) was calculated and was statistically significant (p?<?0.001). Heterogeneity was high with an I(2) value of 68%. Adjustment for publication bias generated a more conservative estimate of summary effect size of 0.21 (0.08 to 0.33). The majority of subgroup analyses produced statistically non-significant results.ConclusionsCognitive-based behaviour change techniques are effective interventions eliciting improvements in medication adherence that are likely to be greater than the behavioural and educational interventions largely used in current practice. Subgroup analyses suggest that these interventions are amenable to use across different populations and in differing manners without loss of efficacy. These factors may facilitate incorporation of these techniques into routine care.

Project description:BackgroundMobile text messaging and medication monitors (medication monitor boxes) have the potential to improve adherence to tuberculosis (TB) treatment and reduce the need for directly observed treatment (DOT), but to our knowledge they have not been properly evaluated in TB patients. We assessed the effectiveness of text messaging and medication monitors to improve medication adherence in TB patients.Methods and findingsIn a pragmatic cluster-randomised trial, 36 districts/counties (each with at least 300 active pulmonary TB patients registered in 2009) within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China, were randomised using stratification and restriction to one of four case-management approaches in which patients received reminders via text messages, a medication monitor, combined, or neither (control). Patients in the intervention arms received reminders to take their drugs and reminders for monthly follow-up visits, and the managing doctor was recommended to switch patients with adherence problems to more intensive management or DOT. In all arms, patients took medications out of a medication monitor box, which recorded when the box was opened, but the box gave reminders only in the medication monitor and combined arms. Patients were followed up for 6 mo. The primary endpoint was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor box. Secondary endpoints included additional adherence and standard treatment outcome measures. Interventions were not masked to study staff and patients. From 1 June 2011 to 7 March 2012, 4,292 new pulmonary TB patients were enrolled across the 36 clusters. A total of 119 patients (by arm: 33 control, 33 text messaging, 23 medication monitor, 30 combined) withdrew from the study in the first month because they were reassessed as not having TB by their managing doctor (61 patients) or were switched to a different treatment model because of hospitalisation or travel (58 patients), leaving 4,173 TB patients (by arm: 1,104 control, 1,008 text messaging, 997 medication monitor, 1,064 combined). The cluster geometric mean of the percentage of patient-months on TB treatment where at least 20% of doses were missed was 29.9% in the control arm; in comparison, this percentage was 27.3% in the text messaging arm (adjusted mean ratio [aMR] 0.94, 95% CI 0.71, 1.24), 17.0% in the medication monitor arm (aMR 0.58, 95% CI 0.42, 0.79), and 13.9% in the combined arm (aMR 0.49, 95% CI 0.27, 0.88). Patient loss to follow-up was lower in the text messaging arm than the control arm (aMR 0.42, 95% CI 0.18-0.98). Equipment malfunction or operation error was reported in all study arms. Analyses separating patients with and without medication monitor problems did not change the results. Initiation of intensive management was underutilised.ConclusionsThis study is the first to our knowledge to utilise a randomised trial design to demonstrate the effectiveness of a medication monitor to improve medication adherence in TB patients. Reminders from medication monitors improved medication adherence in TB patients, but text messaging reminders did not. In a setting such as China where universal use of DOT is not feasible, innovative approaches to support patients in adhering to TB treatment, such as this, are needed.Trial registrationCurrent Controlled Trials, ISRCTN46846388.

Project description:BackgroundLipid-lowering drugs are widely underused, despite strong evidence indicating they improve cardiovascular end points. Poor patient adherence to a medication regimen can affect the success of lipid-lowering treatment.ObjectivesTo assess the effects of interventions aimed at improving adherence to lipid-lowering drugs, focusing on measures of adherence and clinical outcomes.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO and CINAHL up to 3 February 2016, and clinical trials registers (ANZCTR and ClinicalTrials.gov) up to 27 July 2016. We applied no language restrictions.Selection criteriaWe evaluated randomised controlled trials of adherence-enhancing interventions for lipid-lowering medication in adults in an ambulatory setting with a variety of measurable outcomes, such as adherence to treatment and changes to serum lipid levels. Two teams of review authors independently selected the studies.Data collection and analysisThree review authors extracted and assessed data, following criteria outlined by the Cochrane Handbook for Systematic Reviews of Interventions. We assessed the quality of the evidence using GRADEPro.Main resultsFor this updated review, we added 24 new studies meeting the eligibility criteria to the 11 studies from prior updates. We have therefore included 35 studies, randomising 925,171 participants. Seven studies including 11,204 individuals compared adherence rates of those in an intensification of a patient care intervention (e.g. electronic reminders, pharmacist-led interventions, healthcare professional education of patients) versus usual care over the short term (six months or less), and were pooled in a meta-analysis. Participants in the intervention group had better adherence than those receiving usual care (odds ratio (OR) 1.93, 95% confidence interval (CI) 1.29 to 2.88; 7 studies; 11,204 participants; moderate-quality evidence). A separate analysis also showed improvements in long-term adherence rates (more than six months) using intensification of care (OR 2.87, 95% CI 1.91 to 4.29; 3 studies; 663 participants; high-quality evidence). Analyses of the effect on total cholesterol and LDL-cholesterol levels also showed a positive effect of intensified interventions over both short- and long-term follow-up. Over the short term, total cholesterol decreased by a mean of 17.15 mg/dL (95% CI 1.17 to 33.14; 4 studies; 430 participants; low-quality evidence) and LDL-cholesterol decreased by a mean of 19.51 mg/dL (95% CI 8.51 to 30.51; 3 studies; 333 participants; moderate-quality evidence). Over the long term (more than six months) total cholesterol decreased by a mean of 17.57 mg/dL (95% CI 14.95 to 20.19; 2 studies; 127 participants; high-quality evidence). Included studies did not report usable data for health outcome indications, adverse effects or costs/resource use, so we could not pool these outcomes. We assessed each included study for bias using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. In general, the risk of bias assessment revealed a low risk of selection bias, attrition bias, and reporting bias. There was unclear risk of bias relating to blinding for most studies.Authors' conclusionsThe evidence in our review demonstrates that intensification of patient care interventions improves short- and long-term medication adherence, as well as total cholesterol and LDL-cholesterol levels. Healthcare systems which can implement team-based intensification of patient care interventions may be successful in improving patient adherence rates to lipid-lowering medicines.

Project description:IntroductionMedication adherence for patients with chronic conditions such as gout, a debilitating form of arthritis that requires daily medication to prevent flares, is a costly problem. Existing interventions to improve medication adherence have only been moderately effective. Habit formation theory is a promising strategy to improve adherence. The cue-reward-repetition principle posits that habits are formed by repeatedly completing an activity after the same cue and having the action rewarded every time. Over time, cues become increasingly important whereas rewards become less salient because the action becomes automatic. Leveraging the cue-reward-repetition principle could improve adherence to daily gout medications.Methods and analysisThis three-arm parallel randomised controlled trial tests an adaptive intervention that leverages the repetition cue-reward principle. The trial will began recruitment in August 2021 in Boston, Massachusetts, USA. Eligible patients are adults with gout who have been prescribed a daily oral medication for gout and whose most recent uric acid is above 6 mg/dL. Participants will be randomised to one of three arms and given electronic pill bottles. In the two intervention arms, participants will select a daily activity to link to their medication-taking (cue) and a charity to which money will be donated every time they take their medication (reward). Participants in Arm 1 will receive reminder texts about their cue and their charity reward amount will be US$0.50 per day of medication taken. Arm 2 will be adaptive; participants will receive a US$0.25 per adherent-day and no reminder texts. If their adherence is <75% 6 weeks postrandomisation, their reward will increase to US$0.50 per adherent-day and they will receive reminder texts. The primary outcome is adherence to gout medications over 18 weeks.Ethics and disseminationThis trial has ethical approval in the USA. Results will be published in a publicly accessible peer-reviewed journal.Trial registration numberNCT04776161.

Project description:ObjectiveTo design and investigate a pharmacist-run intervention using low health literacy flashcards and a smartphone-activated quick response (QR) barcoded educational flashcard video to increase medication adherence and disease state understanding.DesignProspective, matched, quasi-experimental design.SettingCounty health system in Dallas, Texas.ParticipantsSixty-eight primary care patients prescribed targeted heart failure, hypertension, and diabetes medications INTERVENTION: Low health literacy medication and disease specific flashcards, which were also available as QR-coded online videos, were designed for the intervention patients. The following validated health literacy tools were conducted: Newest Vital Sign (NVS), Rapid Estimate of Adult Literacy Medicine-Short Form, and Short Assessment of Health Literacy-50.Main outcome measuresThe primary outcome was the difference in medication adherence at 180 days after pharmacist intervention compared with the control group, who were matched on the basis of comorbid conditions, targeted medications, and medication class. Medication adherence was measured using a modified Pharmacy Quality Alliance proportion of days covered (PDC) calculation. Secondary outcomes included 90-day PDC, improvement of greater than 25% in baseline PDC, and final PDC greater than 80%. Linear regression was performed to evaluate the effect of potential confounders on the primary outcome.ResultsOf the 34 patients receiving the intervention, a majority of patients scored a high possibility of limited health literacy on the NVS tool (91.2%). The medication with the least adherence at baseline was metformin, followed by angiotensin-converting enzyme inhibitors and beta blockers. At 180 days after intervention, patients in the intervention group had higher PDCs compared with their matched controls (71% vs. 44%; P = 0.0069).ConclusionThe use of flashcards and QR-coded prescription bottles for medication and disease state education is an innovative way of improving adherence to diabetes, hypertension, and heart failure medications in a low-health literacy patient population.

Project description:Background:To improve the effectiveness of interventions targeting non-adherence in older adults, a systematic approach to intervention design is required. The content of complex interventions and design decisions are often poorly described in published reports which makes it difficult to explore why they are ineffective. This intervention development study reports on the design of a community pharmacy-based adherence intervention using 11 Behaviour Change Techniques (BCTs) which were identified from previous qualitative research with older patients using the Theoretical Domains Framework.Methods:Using a group consensus approach, a five-step design process was employed. This focused on decisions regarding: (1) the overall delivery format, (2) formats for delivering each BCT; (3) methods for tailoring BCTs to individual patients; (4) intervention structure; and (5) materials to support intervention delivery. The APEASE (Affordability; Practicability; Effectiveness/cost-effectiveness; Acceptability; Side effects/safety; Equity) criteria guided the selection of BCT delivery formats.Results:Formats for delivering the 11 BCTs were agreed upon, for example, a paper medicines diary was selected to deliver the BCT 'Self-monitoring of behaviour'. To help tailor the intervention, BCTs were categorised into 'Core' and 'Optional' BCTs. For example, 'Feedback on behaviour' and 'Action planning' were selected as 'Core' BCTs (delivered to all patients), whereas 'Prompts and cues' and 'Health consequences' were selected as 'Optional' BCTs. A paper-based adherence assessment tool was designed to guide intervention tailoring by mapping from identified adherence problems to BCTs. The intervention was designed for delivery over three appointments in the pharmacy including an adherence assessment at Appointment 1 and BCT delivery at Appointments 2 and 3.Conclusions:This paper details key decision-making processes involved in moving from a list of BCTs through to a complex intervention package which aims to improve older patients' medication adherence. A novel approach to tailoring the content of a complex adherence intervention using 'Core' and 'Optional' BCT categories is also presented. The intervention is now ready for testing in a feasibility study with community pharmacists and patients to refine the content. It is hoped that this detailed report of the intervention content/design process will allow others to better interpret the future findings of this work.

Project description:BACKGROUND:Nonadherence to immunosuppressive therapy after renal transplantation is associated with poor graft outcomes. We aimed to evaluate whether the use of the Adhere4U mobile medication manager application could improve adherence among renal transplant recipients ?1 year posttransplantation. Adhere4U can provide medication reminders, monitor medication use, and provide information on immunosuppressants. METHODS:We conducted a prospective randomized controlled study to compare the rate of nonadherence to index immunosuppressant (tacrolimus or cyclosporine) in a group using the Adhere4U app (mobile group) and in another group receiving conventional care (control group). The primary outcome was the nonadherence rate, which was evaluated using an electronic medication event monitoring system during the 6-month intervention period. Our secondary outcome included self-reported adherence using the Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS) and the visual analog scale (VAS) based on a 4-week recall on days 28, 90, and 180. Longitudinal data of repeated measures of self-rated adherence were analyzed using generalized estimating equations (GEE) to compare the between-group difference in adherence change over time. RESULTS:Between November 2013 and May 2015, 138 renal transplant recipients were randomly allocated to the control (n = 67) or the mobile group (n = 71). The overall nonadherence rate over the 6-month study period by electronic monitoring was 63.6%, with no between-group difference [mobile group, 65.0% (n = 39/60); control group, 62.1% (n = 36/58); odds ratio 1.14; 95% confidence interval 0.53-2.40; p = 0.89]. Self-rated nonadherence assessed using the BAASIS and VAS at baseline was 53.7% and 51.5%, respectively. Although the self-rated nonadherence by BAASIS of the mobile group was lower than the control group throughout the study period, there was no between-group difference in the change of nonadherence over time (?2 = 2.82, df = 3, p = 0.42 by logistic GEE). There also was no significant between-group difference in the nonadherence by VAS (?2 = 1.71, df = 3, p = 0.63 by logistic GEE) over time. The main limitation of this study was the low rate of patient engagement with the app among the mobile group. The rate of app use was 47.6% (31/65) at 28 days, 33.9% (19/56) at 90 days, and 11.5% (6/52) at 180 days. CONCLUSIONS:The Adhere4U application did not improve adherence to immunosuppressive therapy. Our evidence is limited by the high rate of attrition. Further studies on strategies to facilitate patient engagement with mobile interventions are warranted.

Dataset Information

Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol.

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Randomised controlled trial of a video intervention and behaviour contract to improve medication adherence after renal transplantation: the VECTOR study protocol.

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