Diabetes and Hypertension Self Management Program
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Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
74 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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