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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320344
• Other study ID #: MD001660 - PIC
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2017

Study information

• Verified date: October 2017
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Partners in Care
The diabetes self-management intervention is titled, "Partners in Care," emphasizing that there are many individuals and groups that one can call upon to assist with managing one's diabetes. The content includes practical behavioral strategies to improve diabetes self-management practices. The 12 week curriculum provides a basic overview of diabetes and self-management activities, standards of care recommended by the American Diabetes Association, strategies to improve patient-provider communication, support needed for diabetes self-management, information about diabetes medications, and ways to avoid diabetes-related complications.

Locations

Country	Name	City	State
United States	Department of Native Hawaiian Health, University of Hawaii	Honolulu	Hawaii

Sponsors (5)

Lead Sponsor	Collaborator
University of Hawaii	Hawaii Maoli, Ke Ola Mamo, Kokua Kalihi Valley, Kula No Na Po'e Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	change in hemoglobin A1c from baseline to 3-months	3 months
Primary	Problem Areas in Diabetes	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	3 months
Secondary	Total Cholesterol (including HDL and LDL)	change in cholesterol from baseline to 3 months	3 months
Secondary	Triglycerides	change in triglycerides from baseline to 3 months	3 months