Diabetes and Hypertension Self Management Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this R15 project is to test the feasibility and effectiveness of a 12-week diabetes and hypertension self-management program using trained health coaches.

Detailed Description
-----------------
West Virginia has high prevalence of comorbid diabetes and hypertension. Most diabetes self-management programs are hospital or clinic based and none are tailored to address the unique needs of rural WV adults with comorbid diabetes (T2DM) and hypertension (HTN). There is a critical need for new and creative community-based, culturally appropriate self-management programs in this medically underserved state. This study will use a wait-listed randomized control trial (RCT) design, using evidence-based interventions, to improve patient self-management behaviors and health outcomes (HbA1c and BP). Eligible adults with comorbid T2DM and HTN will be randomized with a 1:1 ratio to the immediate diabetes and hypertension self-management program (DHSMP; n=35) or to 6-month wait-listed control group (N=35), based on an allocation sequence generated by the biostatistician using a randomly varying block randomization method to ensure equal distribution among treatment groups.

Official Title
-----------------
Diabetes and Hypertension Self Management Program

Conditions
-----------------
Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
-----------------
* Behavioral: diabetes and hypertension self-management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking adults >= 18 years of age; co-occurring diagnosis of T2DM and HTN; body mass index >= 25.0 willing to be randomized and complete 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
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT with wait-listed control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diabetes and hypertension self-management<br>12-week lifestyle and disease self-management | Behavioral: diabetes and hypertension self-management<br>* 12-weeks of 75 minutes of educational sessions<br>|
| No Intervention: Control<br>Wait-list control | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 - 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 |