Partners in Care Diabetes Self-management Intervention

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Hawaii
ClinicalTrials.gov Identifier:
NCT01235429
First received: November 3, 2010
Last updated: November 12, 2013
Last verified: August 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Hawaii:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Study Completion Date: September 2011
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
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235429

Locations
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
Investigators
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: November 12, 2013
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014