Diabetes and Hypertension Self Management Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- West Virginia University
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- Clinical outcomes - A1c
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Clinical outcomes - A1c
Time Frame: 6 months after enrollment
The difference in A1c between baseline and end of program.
Clinical outcomes - BP
Time Frame: 6 months after enrollment
The difference in BP (systolic and diastolic) between baseline and end of program.
Clinical outcomes - A1c
Time Frame: 6 months after enrollment
The difference in A1c between baseline and end of program.
Clinical outcomes - BP
Time Frame: 6 months after enrollment
The difference in BP (systolic and diastolic) between baseline and end of program.
Secondary Outcomes
- Behavioral outcome - healthy eating plan; questions(6 months after enrollment)
- Behavioral outcome - exercise; questions(6 months after enrollment)