Partners in Care With Semi-Structured Support Group

Study Overview
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Brief Summary
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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.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Partners in Care with Semi-Structured Support Group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partners in Care with Semi-Structured Support Group<br>Partners in Care with Semi-Structured Support Group: participants will receive the Partners in Care intervention followed by 6 semi-structured support groups, conducted every other week for 3 months. Half of the support groups will be conducted by professionals with diabetes specific knowledge, e.g., pharmacists, physicians, nutritionists. While the other half will be conducted by the trained diabetes self-management facilitator. | Behavioral: Partners in Care with Semi-Structured Support Group<br> <br> |
| No Intervention: Partners in Care Standard Follow-up<br>Participants will receive the Partners in Care intervention followed by monthly healthy lifestyle tips related to diabetes self-management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Total Cholesterol (including HDL and LDL) and triglycerides will be measured with the Cholestech LDX analyzer | baseline, 3 months, 6 months | 
| Change from Baseline weight in kg at 3 months and 6 months |  | baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes self management, support group, semi structured support group