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Completed

NCT Number: NCT01235429

Partners in Care Diabetes Self-management Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hawaii

Honolulu, Hawaii, 96813, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Partners in Care

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Specific Aim 3: Partners in Care Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 5, 2010
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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