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Design and rationale of a mixed methods randomized control trial: ADdressing Health literacy, bEliefs, adheRence and self-Efficacy (ADHERE) program to improve diabetes outcomes.

ABSTRACT: Background:Improving medication adherence is one of the most effective approaches to improving the health outcomes of patients with diabetes. To date, enhancing diabetes medication adherence has occurred by improving diabetes-related knowledge. Unfortunately, behavior change often does not follow knowledge change. Enhancing communication between patients and healthcare professionals through addressing health literacy-related psychosocial attributes is critical. Objective:Examine whether a patient-centered intervention augmenting usual care with a health literacy-psychosocial support intervention will improve medication adherence for patients with diabetes, compared to usual care. Methods:This study is a randomized controlled trial with an intervention mixed methods design. Fifty participants being enrolled are English-speaking, 18-80 years old with diagnosed diabetes, take at least one diabetes medication, have low diabetes medication adherence (proportion of days covered less than 80% or based on clinical notes), and have poor diabetes control (hemoglobin A1c of ?8%). Participants will be allocated to either a control group receiving usual care (n?=?25) or an intervention group (n?=?25) receiving usual care and a 6-session intervention focusing on the modifiable psychosocial factors that may influence medication adherence. A questionnaire will be administered at baseline and at the end of the intervention to all participants to assess the effectiveness of the intervention. Fifteen participants from the intervention group will be interviewed to explore participants' experiences and perceptions of the intervention processes and outcomes. Conclusions:The trial will examine if a patient-centered intervention that addresses patients' health literacy and focuses on modifiable psychosocial factors will improve medication adherence among patients with diabetes.

SUBMITTER: Shiyanbola OO

PROVIDER: S-EPMC6348197 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Design and rationale of a mixed methods randomized control trial: ADdressing Health literacy, bEliefs, adheRence and self-Efficacy (ADHERE) program to improve diabetes outcomes.

Shiyanbola Olayinka O OO Walbrandt Pigarelli Denise L DL Unni Elizabeth J EJ Smith Paul D PD Maurer Martha A MA Huang Yen-Ming YM

Contemporary clinical trials communications 20190114

<h4>Background</h4>Improving medication adherence is one of the most effective approaches to improving the health outcomes of patients with diabetes. To date, enhancing diabetes medication adherence has occurred by improving diabetes-related knowledge. Unfortunately, behavior change often does not follow knowledge change. Enhancing communication between patients and healthcare professionals through addressing health literacy-related psychosocial attributes is critical.<h4>Objective</h4>Examine w ...[more]

PMID: 30705995

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Project description:BackgroundSelf-management education is a fundamental aspect in the health care of people with diabetes to develop the necessary skills for the improvement of health outcomes. Patients are required to have the competencies to manage electronic information resources-that is, an appropriate level of digital health literacy. The European project IC-Health aimed to improve digital health literacy among people with diabetes through the cocreation of massive open online courses (MOOCs).ObjectiveWe report the preliminary results obtained in 3 participating countries in the IC-Health project (Italy, Spain, and Sweden) regarding (1) experience of the participants during the cocreation process of MOOCs, (2) perceived changes in their digital health literacy level after using MOOCs, and (3) a preliminary assessment of the acceptability of MOOCs.MethodsThe cocreation of the MOOCs included focus groups with adults and adolescents with diabetes and the creation of independent communities of practice for type 1 diabetes and type 2 diabetes participants aimed to co-design the MOOCs. Quantitative measures of the acceptability of MOOCs, experience in the cocreation process, and increase in digital health literacy (dimensions of finding, understanding, and appraisal) were assessed.ResultsA total of 28 participants with diabetes participated in focus groups. Adults and adolescents agreed that the internet is a secondary source of health-related information. A total of 149 participants comprised the diabetes communities of practice. A total of 9 MOOCs were developed. Acceptability of the MOOCs and the cocreation experience were positively valued. There was a significant improvement in digital health literacy in both adults and adolescents after using MOOCs (P<.001).ConclusionsAlthough the results presented on self-perceived digital health literacy are preliminary and exploratory, this pilot study suggests that IC-Health MOOCs represent a promising tool for the medical care of diabetes, being able to help reduce the limitations associated with low digital health literacy and other communication barriers in the diabetes population.

Project description:BackgroundSupported asthma self-management improves health outcomes. However, people with limited health literacy, especially in lower-middle-income countries (LMICs), may need tailored interventions to enable them to realise the benefits. We aimed to assess the clinical effectiveness of asthma self-management interventions targeted at people with limited health literacy and to identify strategies associated with effective programmes.MethodsFollowing Cochrane methodology, we searched ten databases (January 1990 - June 2018; updated October 2019), without language restriction. We included controlled experimental studies whose interventions targeted health literacy to improve asthma self-management. Selection of papers, extraction of data and quality assessment were done independently by two reviewers. The primary outcomes were clinical (asthma control) and implementation (adoption/adherence to intervention). Analysis was narrative.ResultsWe screened 4318 titles and abstracts, reviewed 52 full-texts and included five trials. One trial was conducted in a LMIC. Risk of bias was low in one trial and high in the other four studies. Clinical outcomes were reported in two trials, both at high risk of bias: one of which reported a reduction in unscheduled care (number of visits in 6-month (SD); Intervention:0.9 (1.2) vs Control:1.8 (2.4), P?=?0.001); the other showed no effect. None reported uptake or adherence to the intervention. Behavioural change strategies typically focused on improving an individual's psychological and physical capacity to enact behaviour (eg, targeting asthma-related knowledge or comprehension). Only two interventions also targeted motivation; none sought to improve opportunity. Less than half of the interventions used specific self-management strategies (eg, written asthma action plan) with tailoring to limited health literacy status. Different approaches (eg, video-based and pictorial action plans) were used to provide education.ConclusionsThe paucity of studies and diversity of the interventions to support people with limited health literacy to self-manage their asthma meant that the impact on health outcomes remains unclear. Given the proportion of the global population who have limited health literacy skills, this is a research priority.Protocol registrationPROSPERO CRD 42018118974.

Project description:BackgroundFor many research teams, the role of community stakeholders is critical. However, community stakeholders, especially those in low-income settings, are at risk of being excluded from research and community engagement initiatives during and after the COVID-19 pandemic because of the rapid transition to digital operations.ObjectiveWe aimed to describe the implementation and feasibility of a program called Addressing the Digital Divide to Improve Patient-Centered Outcomes Research, which was designed to address barriers to technology use, and to examine changes in participants' perceived comfort with digital technology before and after the program.MethodsTo promote full engagement, we worked with 20 existing community leaders to cocreate a training course on using digital technology. We assessed the frequency of technology use and comfort with technology through an adapted 8-item version of the Functional Assessment of Comfort Employing Technology Scale and used the Wilcoxon signed-rank test for survey analysis. We also conducted a focus group session with 10 participants and then performed reflective journaling and content analysis to determine emergent themes.ResultsWe found that the program was feasible to implement and worthwhile for participants (15/16, 94%). After the program, the participants perceived an increase in the frequency of technology use (z=2.76, P=.006). The participants reported that the program was successful because of the technology training program, but recommended that the program have a slower pace and include a helpline number that they could call with questions.ConclusionsFuture programs should consider that populations with low literacy view technology training as a core element to decreasing technology disparity. This study demonstrates that through low-cost input, community members can be provided the resources and training needed to virtually participate in research studies or community engagement initiatives.

Project description:BackgroundEffective use of a patient decision aid (PtDA) can be affected by the user's health literacy and the PtDA's characteristics. Systematic reviews of the relevant literature can guide PtDA developers to attend to the health literacy needs of patients. The reviews reported here aimed to assess:MethodsWe reviewed literature for evidence relevant to these two aims. When high-quality systematic reviews existed, we summarized their evidence. When reviews were unavailable, we conducted our own systematic reviews.ResultsAim 1: In an existing systematic review of PtDA trials, lower health literacy was associated with lower patient health knowledge (14 of 16 eligible studies). Fourteen studies reported practical design strategies to improve knowledge for lower health literacy patients. In our own systematic review, no studies reported on values clarity per se, but in 2 lower health literacy was related to higher decisional uncertainty and regret. Lower health literacy was associated with less desire for involvement in 3 studies, less question-asking in 2, and less patient-centered communication in 4 studies; its effects on other measures of patient involvement were mixed. Only one study assessed the effects of a health literacy intervention on outcomes; it showed that using video to improve the salience of health states reduced decisional uncertainty. Aim 2: In our review of 97 trials, only 3 PtDAs overtly addressed the needs of lower health literacy users. In 90% of trials, user health literacy and readability of the PtDA were not reported. However, increases in knowledge and informed choice were reported in those studies in which health literacy needs were addressed.ConclusionLower health literacy affects key decision-making outcomes, but few existing PtDAs have addressed the needs of lower health literacy users. The specific effects of PtDAs designed to mitigate the influence of low health literacy are unknown. More attention to the needs of patients with lower health literacy is indicated, to ensure that PtDAs are appropriate for lower as well as higher health literacy patients.

Project description:BACKGROUND:Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. OBJECTIVE:The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). METHODS:We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. RESULTS:Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. CONCLUSIONS:Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. TRIAL REGISTRATION:ClinicalTrials.gov NCT03022669.

Dataset Information

Design and rationale of a mixed methods randomized control trial: ADdressing Health literacy, bEliefs, adheRence and self-Efficacy (ADHERE) program to improve diabetes outcomes.

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Design and rationale of a mixed methods randomized control trial: ADdressing Health literacy, bEliefs, adheRence and self-Efficacy (ADHERE) program to improve diabetes outcomes.

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