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

NCT ID: NCT04784130

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2023-10-31

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

DHSMP core

Dietary Modification and Physical Activity

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

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.

Dietary Modification

Intervention Type: BEHAVIORAL

Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.

DHSMP core plus

Dietary Modification, physical activity and medication adherence

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: BEHAVIORAL

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.

Medication Adherence

Intervention Type: BEHAVIORAL

Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).

Dietary Modification

Intervention Type: BEHAVIORAL

Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.

DHSMP control

enhanced usual care-3 hours of education plus materials.

Group Type: ACTIVE_COMPARATOR

Physical Activity

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Medication Adherence

Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).

Intervention Type: BEHAVIORAL

Dietary Modification

Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Ranjita Misra

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clark K. Sleeth Family Medicine Center

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

1908672206

Identifier Type: -

Identifier Source: org_study_id