Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes self management, support group, semi structured support group
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.
Interventions
BEHAVIORALPartners in Care with Semi-Structured Support Group
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline hemoglobin a1c at 3 months and at 6 months | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Total Cholesterol (including HDL and LDL) and triglycerides will be measured with the Cholestech LDX analyzer |
| Change from Baseline weight in kg at 3 months and 6 months | baseline, 3 months, 6 months | — |
Other
| Measure | Time frame |
|---|---|
| Change from Baseline amount of physical activity as measured a questionnaire at 3 months and 6 months | baseline, 3 months, 6 months |
| Change from Baseline reported amount of support as measured a questionnaire at 3 months and 6 months | baseline, 3 months, 6 months |
| Change from Baseline dietary patterns as a questionnaire at 3 months and 6 months | baseline, 3 months, 6 months |
| Change from Baseline reported diabetes self-care activities as measured by the Summary of Diabetes Self-Care Activities questionnaire at 3 months and 6 months | baseline, 3 months, 6 months |
Countries
United States
Outcome results
None listed