Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALdiabetes and hypertension self-management12-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.