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Partners in Care Diabetes Self-management Intervention

NCT ID: NCT01235429

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Keywords

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Diabetes Behavioral intervention diabetes self-management Native Hawaiians health disparities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Partners in Care

Intervention Type BEHAVIORAL

Participants will be offered 12 group diabetes self-management educational lessons delivered by trained community health workers.

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.

Group Type ACTIVE_COMPARATOR

Partners in Care

Intervention Type BEHAVIORAL

Diabetes self-management education

Interventions

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Partners in Care

Participants will be offered 12 group diabetes self-management educational lessons delivered by trained community health workers.

Intervention Type BEHAVIORAL

Partners in Care

Diabetes self-management education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Hawaii

OTHER

Sponsor Role lead

Responsible Party

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Department of Native Hawaiian Health

Principal Investigators

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Joseph K Kaholokula, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii

Locations

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University of Hawaii

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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PILI ARRA Supplement

Identifier Type: -

Identifier Source: org_study_id