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

West Virginia University98 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Hypertension

Interventions

Physical ActivityBEHAVIORAL

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 AdherenceBEHAVIORAL

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

Dietary ModificationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clark K. Sleeth Family Medicine Center

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

Clinical outcomes-BP

Difference in BP between baseline and end of program

Time frame: 6 months after enrollment

Clinical Outcomes-A1c

Difference in A1c between baseline and end of program

Time frame: 6 months after enrollment

Secondary Outcomes

Behavioral outcome - dietary modification for high fat foods; question

Dietary analysis will be based on consumption of high fat foods (such as red meat or full-fat dairy) at baseline and completion of the Program. All participants will be assessed regarding the number of days they eat high fat foods using a survey question from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. "On how many of the last SEVEN DAYS did you eat high fat foods such as red meat or full-fat dairy products?" 0 1 2 3 4 5 6 7. Changes in mean number of days of eating high fat foods will be assessed at baseline and at the completion of the program.

Time frame: 6 months after enrollment

Behavioral outcome - healthy eating plan; questions

Dietary analysis will be based on following a healthy eating plan at baseline and completion of the Program. All participants will be assessed regarding the number of days they followed a healthful eating plan using a survey question from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. "How many of the last SEVEN DAYS have you followed a healthful eating plan?" 0 1 2 3 4 5 6 7. Changes in mean number of days followed a healthy eating plan will be assessed at baseline and at the completion of the program.

Time frame: 6 months after enrollment

Behavioral outcome - dietary modification for fruits and vegetables; questions

Dietary analysis will be based on eating fruits and vegetables at baseline and completion of the Program. All participants will be assessed regarding the number of days they eat five or more servings of fruits and vegetables using a survey question from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. "On how many of the last SEVEN DAYS did you eat five or more servings of fruits and vegetables?" 0 1 2 3 4 5 6 7. Changes in mean number of days of eating fruits and vegetables will be assessed at baseline and at the completion of the program.

Data from ClinicalTrials.gov

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