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

West Virginia University

Status: Completed

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Behavioral: Physical Activity; Behavioral: Medication Adherence; Behavioral: Dietary Modification

Study type: Interventional

Funder types: Other

Identifiers

NCT04784130

1908672206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 3 patient groups

DHSMP core

Experimental group

Description:

Dietary Modification and Physical Activity

Treatment:

Behavioral: Dietary Modification

Behavioral: Physical Activity

DHSMP core plus

Experimental group

Description:

Dietary Modification, physical activity and medication adherence

Treatment:

Behavioral: Dietary Modification

Behavioral: Medication Adherence

Behavioral: Physical Activity

DHSMP control

Active Comparator group

Description:

enhanced usual care-3 hours of education plus materials.

Treatment:

Behavioral: Physical Activity