NCT04784130

Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes

Enhancing Diabetes and Hypertension Self-Management for Rural Appalachian Patients In Patient-Centered Medical Homes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week modified diabetes and hypertension self-management program using trained Health Coaches.

Detailed description

West Virginians have one of the highest prevalence of comorbid diabetes and hypertension in the nation that pose an enormous disease and economic burden in this medically underserved state. Self-management of these two commonly found chronic conditions are an essential component of comprehensive disease management. The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week culturally-tailored, multimodal, diabetes and hypertension self-management program with a core (diet and physical activity) versus core plus (diet, physical activity and medication adherence) to an enhanced usual care (EUC) control group. Seventy-five eligible adults with comorbid diabetes and hypertension will be randomized with a 1:1:1 ratio, based on allocation sequence generated by the bio-statistician investigator in the team. The study will 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 three groups using quantitative and qualitative focus groups and the RE-AIM evaluation framework. The longer term effects of the intervention will be evaluated in a subsequent R01 clinical trial.

Conditions

• Diabetes Mellitus, Type 2
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Physical Activity	Respondents will complete activity logs (step count, using pedometer) and surveys (two items from the Summary of Diabetes Self-care activities measure) for physical activity.
BEHAVIORAL	Medication Adherence	Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).
BEHAVIORAL	Dietary Modification	Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2021-03-05
• Last updated: 2024-02-01

Locations

1 site across 1 country: United States