West Virginia ranks 1st & 2nd nationally in the prevalence of diabetes and hypertension. Yet many rural patients with comorbid diabetes and hypertension do not receive self-management support from their providers. The goal of this R34 planning project is to test the feasibility and acceptability of a culturally-tailored, multimodal, 6-week modified Diabetes and Hypertension Self-Management Program (M-DHSMP), that will incorporate evidence-based key elements of diet, physical activity and medication adherence (with medication therapy management or MTM). The M-DHSMP is an adaptation of the evidence-based curriculum of the American Association of Diabetes Educator (AADE-7) and the JNC guidelines. Seventy five adults with comorbid diabetes and hypertension will be recruited from the northern counties of West Virginia and randomized with a 1:1:1 ratio. We propose to conduct a 3-arm randomized controlled trial (RCT) to compare the 6-week M-DHSMP core intervention (diet and physical activity; n=25), 6-week M-DHSMP core plus medication adherence with MTM (n=25) or enhanced usual care (EUC); n=25) in two geographically separated Patient Centered Medical Homes (PCMH). We will use post-regression decomposition technique derived from the field of econometrics to examine the extent to which key components (diet, physical activity, and medication adherence) contribute to the differences in clinical outcomes (HbA1c and blood pressure) between groups (M-DHSMP core and M-DHSMP core plus medication adherence). In addition, we will use qualitative focus groups and the RE-AIM evaluation framework to evaluate the reach, efficacy, adoption, sustainability of behavior changes, and participants? experience and satisfaction with the program. Measures of behavioral changes will include dietary intake, physical activity, medication adherence, using surveys, food /activity logs and prescription filling reports. As in our prior studies, trained Health Coaches (HCs) will administer the program and provide weekly follow-up coaching, review food/activity logs for continuous feedback and reinforcement of health education messages. An understanding of the independent and combined effects of key health behavior components and the role of/adoption of behavior modifications in patients with diabetes and hypertension can validate self-management interventions models in real-world settings to reduce the metabolic risk. The longer term effects of the intervention will be evaluated in a subsequent R01 clinical trial. The project builds on the PI?s successful prior community-based lifestyle intervention studies in rural Appalachia and rural India.
/Relevance West Virginia ranks 1st & 2nd nationally in the prevalence of diabetes and hypertension. Yet current health care delivery models inadequately address the self-management needs of many rural patients with comorbid diabetes and hypertension. This proposal will test the feasibility and acceptability of a culturally-tailored, multimodal, 6-week self-management program, using trained Health Coaches, to improve diet, physical activity and medication adherence in two Patient Centered Medical Homes in WV.