Partners in Care Diabetes Self-management Intervention
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Behavioral: Partners in Care |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Educational
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
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background,
- Adults age >=18 years,
- English-speaking,
- Physician-diagnosed type 2 diabetes, and
- Baseline hemoglobin A1c >=8%
Exclusion Criteria:
- Survival less than 6 months,
- Planning to move off island or out of state during the study period,
- Pregnancy,
- Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).
Contacts and Locations| United States, Hawaii | |
| University of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Principal Investigator: | Joseph K Kaholokula, PhD | University of Hawaii |
More Information
No publications provided
| Responsible Party: | Joseph K Kaholokula, Department of Native Hawaiian Health |
| ClinicalTrials.gov Identifier: | NCT01235429 History of Changes |
| Other Study ID Numbers: | PILI ARRA Supplement |
| Study First Received: | November 3, 2010 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Hawaii:
|
Diabetes Behavioral intervention diabetes self-management Native Hawaiians health disparities |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013