Partners in Care Diabetes Self-management Intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Specific Aim 3: Partners in Care Randomized Controlled Trial|
- hemoglobin A1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]Hemoglobin A1c will be assessed at baseline and post intervention in the intervention and delayed intervention participants.
- Quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Participants will receive 12 diabetes self-management educational lessons in a small group setting located within the participating communities and delivered by trained community health workers.
Behavioral: Partners in Care
Participants will be offered 12 group diabetes self-management educational lessons delivered by trained community health workers.
Active Comparator: Delayed education
The delayed education group will receive the same intervention after the intervention group has completed the educational lessons and all participants have completed the follow-up assessments.
Behavioral: Partners in Care
Diabetes self-management education
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235429
|United States, Hawaii|
|University of Hawaii|
|Honolulu, Hawaii, United States, 96813|
|Principal Investigator:||Joseph K Kaholokula, PhD||University of Hawaii|