Clinical trial NCT04784130: Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes
Official title: Enhancing Diabetes and Hypertension Self-Management for Rural Appalachian Patients In Patient-Centered Medical Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Keywords: diabetes
hypertension
self-management
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* English speaking adults ≥ 18 years of age;
* co-occurring diagnosis of type 2 diabetes and hypertension
* body mass index ≥ 25.0
* willing to be randomized, and complete the intervention and all assessments.

Exclusion Criteria:

* currently pregnant or breastfeeding
* diagnosed with a severe mental illness
* have any condition that requires physical activity limitations or is contraindicated for the Dietary Assessment to Stop Hypertension (DASH) diet
* inability to complete the study protocol.

Primary outcomes:
measure: Clinical outcomes-BP
timeFrame: 6 months after enrollment
measure: Clinical Outcomes-A1c
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Behavioral outcome - dietary modification for high fat foods; question
timeFrame: 6 months after enrollment
measure: Behavioral outcome - healthy eating plan; questions
timeFrame: 6 months after enrollment
measure: Behavioral outcome - dietary modification for fruits and vegetables; questions
timeFrame: 6 months after enrollment
measure: Behavioral outcome - Activity log; Step count, using pedometer
timeFrame: 6 months after enrollment
measure: Behavioral outcome - exercise; questions
timeFrame: 6 months after enrollment
measure: Behavioral outcome - medication adherence; questions
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Clark K. Sleeth Family Medicine Center
state: West Virginia
Study officials:
References: