Partners in Care Diabetes Self-management Intervention

Type 2 Diabetes Clinical Trial

Official title:

Specific Aim 3: Partners in Care Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235429
• Other study ID #: PILI ARRA Supplement
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: November 12, 2013
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: August 2011
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Type 2 diabetes is common among Native Hawaiians and Pacific Peoples. Diabetes related complications decrease quality of life and can result in early morbidity. The purpose of the Partners in Care diabetes self-management educational intervention is to teach participants how to manage their diabetes to avoid or delay diabetes-related complications and how to better work with their health care team.

Description:

This is a feasibility study using a randomized controlled trial (RCT) design in which 100 Native Hawaiians (NHs) and other Pacific Islanders (PPs) will be randomized to either a 3-month diabetes self-management group (DSMG; N=50) or a delayed intervention control group (CG; N=50). Participants in the DSMG will receive culturally-tailored, group diabetes self-management education delivered in a community setting by trained community peer educators. To meet this objective, we have partnered with four community-based organizations: 1) Hawai`i Maoli Association of Hawaiian Civic Clubs, 2) Ke Ola Mamo Native Hawaiian Health Care System, 3) Kokua Kalihi Valley Comprehensive Family Services, and 4) Kula No Nā Po`e Hawai`i. These four organizations provide services to a large number of Pacific People to include, but not limited to, Native Hawaiians, Samoans, Filipinos, and Chuukese. They already have intervention research experience as members of the PILI 'Ohana CBPR Project. The 3-month face-to-face intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) >=8% will be recruited for the study because they represent the most at-risk for diabetes-related complications.

Over a 1-year accrual period, the community partners will recruit and enroll 100 eligible NHs and PPs (25 participants per a participating community), 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: 100
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background,

2. Adults age >=18 years,

3. English-speaking,

4. Physician-diagnosed type 2 diabetes, and

5. Baseline hemoglobin A1c >=8%

Exclusion Criteria:

1. Survival less than 6 months,

2. Planning to move off island or out of state during the 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Partners in Care
Participants will be offered 12 group diabetes self-management educational lessons delivered by trained community health workers.
• Partners in Care
Diabetes self-management education

Locations

Country	Name	City	State
United States	University of Hawaii	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin A1c	Hemoglobin A1c will be assessed at baseline and post intervention in the intervention and delayed intervention participants.	3 months	No
Secondary	Quality of life	Quality of life using the Problem Areas in Diabetes survey will be assessed at baseline and post intervention in the intervention and delayed intervention participants.	3 months	No