Partners in Care Diabetes Self-management Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01235429|
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : November 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Partners in Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Specific Aim 3: Partners in Care Randomized Controlled Trial|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
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
- hemoglobin A1c [ Time Frame: 3 months ]Hemoglobin A1c will be assessed at baseline and post intervention in the intervention and delayed intervention participants.
- Quality of life [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235429
|United States, Hawaii|
|University of Hawaii|
|Honolulu, Hawaii, United States, 96813|
|Principal Investigator:||Joseph K Kaholokula, PhD||University of Hawaii|