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

NCT ID: NCT02320344

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Partners in Care

Group Type: EXPERIMENTAL

Partners in Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kula No Na Po'e Hawaii

OTHER

Sponsor Role: collaborator

Ke Ola Mamo

OTHER

Sponsor Role: collaborator

Hawai'i Maoli

OTHER

Sponsor Role: collaborator

Kokua Kalihi Valley

UNKNOWN

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Joseph Keawe'aimoku Kaholokula

Professor and Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Native Hawaiian Health, University of Hawaii

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

MD001660 - PIC

Identifier Type: -

Identifier Source: org_study_id