Trials / Completed
CompletedNCT06034548
Diabetes and Hypertension Self Management Program
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- West Virginia University · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | diabetes and hypertension self-management | 12-weeks of 75 minutes of educational sessions |
Timeline
- Start date
- 2018-08-27
- Primary completion
- 2020-08-12
- Completion
- 2020-08-12
- First posted
- 2023-09-13
- Last updated
- 2025-07-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06034548. Inclusion in this directory is not an endorsement.