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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Behavioral: Physical Activity
* Behavioral: Medication Adherence
* Behavioral: Dietary Modification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHSMP core<br>Dietary Modification and Physical Activity | Behavioral: Physical Activity<br>* 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.<br>Behavioral: Dietary Modification<br>* Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.<br>|
| Experimental: DHSMP core plus<br>Dietary Modification, physical activity and medication adherence | Behavioral: Physical Activity<br>* 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.<br>Behavioral: Medication Adherence<br>* Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).<br>Behavioral: Dietary Modification<br>* Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.<br>|
| Active Comparator: DHSMP control<br>enhanced usual care-3 hours of education plus materials. | Behavioral: Physical Activity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes-BP | Difference in BP between baseline and end of program | 6 months after enrollment | 
| Clinical Outcomes-A1c | Difference in A1c between baseline and end of program | 6 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 6 months after enrollment | 
| Behavioral outcome - Activity log; Step count, using pedometer | All participants will be asked to wear a pedometer to record their daily step count. | 6 months after enrollment | 
| Behavioral outcome - exercise; questions | All participants will be assessed regarding the number of days they exercise using two survey questions from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. The description of the questions are as follow: Q1. On how many of the last SEVEN DAYS did you participate in at least 30 minutes of physical activity? (please list the total minutes of continuous activity, including walking) 0 1 2 3 4 5 6 7 & Q2. On how many of the last SEVEN DAYS did you participate in a specific exercise session (such as swimming, walking, biking) other than what you do around the house or as part of your work? 0 1 2 3 4 5 6 7). The total exercise score will be calculated by the mean number of days for the two questions). Changes in mean number of days exercised will be assessed at baseline and at the completion of the program. | 6 months after enrollment | 
| Behavioral outcome - medication adherence; questions | Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8). Changes in medication adherence will be assessed at baseline and completion of the program. | 6 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, hypertension, self-management