Clinical trial NCT01235429: Partners in Care Diabetes Self-management Intervention
Official title: Specific Aim 3: Partners in Care Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Behavioral intervention
diabetes self-management
Native Hawaiians
health disparities
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2010-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 criteria: 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).

Primary outcomes:
measure: hemoglobin A1c
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Joseph K Kaholokula, PhD
role: PRINCIPAL_INVESTIGATOR
References: