Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project Partners in Care

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Partners in Care

• Registration Number: NCT02320344
• Lead Sponsor: University of Hawaii

Brief Summary

The 3-month face-to-face Partners in Care intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. The intervention involves 12 weekly, group lessons with each lesson lasting about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) greater than or equal to 7% will be recruited for the study because they represent the most at-risk for diabetes-related complications. Over a 3-year accrual period, the community partners will recruit and enroll 150 eligible NHs and PPs, as well as deliver and evaluate the intervention in their respective community settings. The primary outcomes of our study are hemoglobin A1c and self-reported diabetes specific quality of life. Secondary outcomes are cholesterol levels (including HDL, LDL, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-19
• Status Verified: 2017-10
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1. Adults age >18 years of age,
2. English-speaking,
3. Physician-diagnosed type 2 diabetes, and
4. Baseline hemoglobin A1c >7%.

Exclusion Criteria

1. Survival less than 6 months,
2. Planning to move out of the community during the intervention study period,
3. Pregnancy,
4. 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partners in Care	Partners in Care	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	3 months	change in hemoglobin A1c from baseline to 3-months
Problem Areas in Diabetes	3 months	The Problem Areas in Diabetes (PAID) will be used to assess diabetes specific quality of life. Change in PAID score from baseline to 3-months

Secondary Outcome Measures

Name	Time	Method
Triglycerides	3 months	change in triglycerides from baseline to 3 months
Total Cholesterol (including HDL and LDL)	3 months	change in cholesterol from baseline to 3 months

Trial Locations

Locations (1)

Department of Native Hawaiian Health, University of Hawaii; 🇺🇸 Honolulu, Hawaii, United States