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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:PurposeTo assess the feasibility and acceptability of a health literacy-psychosocial support intervention - ADHERE and explore changes in glycemic values and medication adherence.Patients and methodsThirty-one participants with hemoglobin A1c (HbA1c) ≥ 8% were randomly allocated to control (usual care) or intervention groups (receiving usual care plus a 6-session pharmacist-led intervention focusing on the modifiable psychosocial factors that may influence medication adherence). Feasibility metrics evaluated recruitment, retention, and intervention adherence. Questionnaires were administered to collect psychosocial factors and self-reported medication adherence at baseline, the end of the intervention, 3 months, and 6 months post intervention. HbA1c values were extracted from electronic medical records. Repeated measures analysis of variance was used to compare differences in mean outcomes between the control and intervention groups. To assess intervention acceptability, eleven individuals participated in semi-structured interviews about their intervention experiences. Qualitative content analysis was used for analyzing the interviews.ResultsThirty participants completed the study. Overall, the findings support the feasibility of the intervention. There were significant differences in HbA1c values. Participants in the intervention group had lower A1C (8.3 ± 1.4) than in the control group (9.2 ± 1.3) at the time of 6-month follow-up (p = 0.003). In addition, the participants in the intervention group showed improved HbA1c at 6-month follow-up (8.3 ± 1.4), compared to baseline (9.4 ± 1.5, p = 0.011) and after 6-session intervention (8.9 ± 1.6, p = 0.046). However, there were no significant differences in medication adherence between groups over time. Qualitative themes suggest participants liked the intervention and perceived the additional support from the pharmacist as beneficial.ConclusionA pharmacist-led intervention to provide additional health literacy-psychosocial support may contribute to long-term improvements in HbA1c. Equipping pharmacists with patient-specific diabetes medication adherence information and building in additional follow-up support for patients may improve patient health outcomes.

Project description:BackgroundVarenicline is a pharmacological intervention for tobacco dependence that is safe and effective in facilitating smoking cessation. Enhanced adherence to varenicline augments the probability of prolonged smoking abstinence. However, research has shown that one-third of people who use varenicline are nonadherent by the second week. There is evidence showing that behavioral support helps with medication adherence. We have designed an artificial intelligence (AI) conversational agent or health bot, called "ChatV," based on evidence of what works as well as what varenicline is, that can provide these supports. ChatV is an evidence-based, patient- and health care provider-informed health bot to improve adherence to varenicline. ChatV has been programmed to provide medication reminders, answer questions about varenicline and smoking cessation, and track medication intake and the number of cigarettes.ObjectiveThis study aims to explore the feasibility of the ChatV health bot, to examine if it is used as intended, and to determine the appropriateness of proceeding with a randomized controlled trial.MethodsWe will conduct a mixed methods feasibility study where we will pilot-test ChatV with 40 participants. Participants will be provided with a standard 12-week varenicline regimen and access to ChatV. Passive data collection will include adoption measures (how often participants use the chatbot, what features they used, when did they use it, etc). In addition, participants will complete questionnaires (at 1, 4, 8, and 12 weeks) assessing self-reported smoking status and varenicline adherence, as well as questions regarding the acceptability, appropriateness, and usability of the chatbot, and participate in an interview assessing acceptability, appropriateness, fidelity, and adoption. We will use "stop, amend, and go" progression criteria for pilot studies to decide if a randomized controlled trial is a reasonable next step and what modifications are required. A health equity lens will be adopted during participant recruitment and data analysis to understand and address the differences in uptake and use of this digital health solution among diverse sociodemographic groups. The taxonomy of implementation outcomes will be used to assess feasibility, that is, acceptability, appropriateness, fidelity, adoption, and usability. In addition, medication adherence and smoking cessation will be measured to assess the preliminary treatment effect. Interview data will be analyzed using the framework analysis method.ResultsParticipant enrollment for the study will begin in January 2024.ConclusionsBy using predetermined progression criteria, the results of this preliminary study will inform the determination of whether to advance toward a larger randomized controlled trial to test the effectiveness of the health bot. Additionally, this study will explore the acceptability, appropriateness, fidelity, adoption, and usability of the health bot. These insights will be instrumental in refining the intervention and the health bot.Trial registrationClinicalTrials.gov NCT05997901; https://classic.clinicaltrials.gov/ct2/show/NCT05997901.International registered report identifier (irrid)PRR1-10.2196/53556.

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.

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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