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. Identifier: NCT01235429
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : November 14, 2013
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by:
University of Hawaii

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Partners in Care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. hemoglobin A1c [ Time Frame: 3 months ]
    Hemoglobin A1c will be assessed at baseline and post intervention in the intervention and delayed intervention participants.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT01235429

United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
National Institute on Minority Health and Health Disparities (NIMHD)
Principal Investigator: Joseph K Kaholokula, PhD University of Hawaii

Responsible Party: Joseph K Kaholokula, Department of Native Hawaiian Health Identifier: NCT01235429     History of Changes
Other Study ID Numbers: PILI ARRA Supplement
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: August 2011

Keywords provided by University of Hawaii:
Behavioral intervention
diabetes self-management
Native Hawaiians
health disparities

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases