Partners in Care With Semi-Structured Support Group

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Partners in Care with Semi-Structured Support Group

• Registration Number: NCT02144909
• Lead Sponsor: University of Hawaii

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-22
• Primary Completion: 2014-07
• Study Completion: 2014-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partners in Care with Semi-Structured Support Group	Partners in Care with Semi-Structured Support Group	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Total Cholesterol (including HDL and LDL) and triglycerides will be measured with the Cholestech LDX analyzer

Trial Locations

Locations (3)

Ke Ola Mamao; 🇺🇸 Honolulu, Hawaii, United States

Kula no na Po'e Hawai'i; 🇺🇸 Honolulu, Hawaii, United States

Kokua Kalihi Valley; 🇺🇸 Honolulu, Hawaii, United States