Partners in Care With Semi-Structured Support Group
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Hawaii
- Enrollment
- 65
- Locations
- 3
- Primary Endpoint
- Change from Baseline hemoglobin a1c at 3 months and at 6 months
Overview
Brief Summary
The investigators are conducting a feasibility study using a randomized controlled trial (RCT) design in which participants will receive the Partners in Care (PIC) diabetes self-management intervention and then be randomized to either semi-structured social support or a standard follow-up control group. Participants in the support groups will receive a culturally-tailored, semi-structured social support program delivered in a community setting by trained community peer educators and other health professionals (e.g., pharmacist). The investigators believe that the addition of a semi-structured social support component as a supplement to an evidence-based diabetes self-management intervention will improve diabetes self-care maintenance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background
- •Adults age \>18 years of age
- •English-speaking
- •Physician-diagnosed type 2 diabetes
- •Baseline hemoglobin A1c \>8%
Exclusion Criteria
- •Survival less than 6 months
- •Planning to move out of the community during the intervention study period
- •Pregnancy
- •Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness)
Outcomes
Primary Outcomes
Change from Baseline hemoglobin a1c at 3 months and at 6 months
Time Frame: baseline, 3 months, 6 months
Change from Baseline diabetes management functioning as measured by the Problem Areas in Diabetes questionnaire at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
The PAID is a 20-item instrument that assesses the physical and social functioning of patients as well as their perceived level of mental and emotional well-being specific to living with diabetes.
Secondary Outcomes
- Change from Baseline weight in kg at 3 months and 6 months(baseline, 3 months, 6 months)
- Change from Baseline blood pressure at 3 months and 6 months(baseline, 3 months, 6 months)
- Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months(baseline, 3 months, 6 months)
Investigators
Claire Townsend
Clinical Research Specialist
University of Hawaii