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Completed

NCT Number: NCT02320344

Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project Partners in Care

The 3-month face-to-face Partners in Care intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. The intervention involves 12 weekly, group lessons with each lesson lasting about 1 and 1/2 hours. Individuals with a hemoglobin A1c (HbA1c; average blood sugar levels) greater than or equal to 7% will be recruited for the study because they represent the most at-risk for diabetes-related complications. Over a 3-year accrual period, the community partners will recruit and enroll 150 eligible NHs and PPs, 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Native Hawaiian Health, University of Hawaii

Honolulu, Hawaii, 96813, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults age >18 years of age,
  • English-speaking,
  • Physician-diagnosed type 2 diabetes, and
  • Baseline hemoglobin A1c >7%.

Exclusion criteria

  • Survival less than 6 months,
  • Planning to move out of the community during the intervention 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

The diabetes self-management intervention is titled, "Partners in Care," emphasizing that there are many individuals and groups that one can call upon to assist with managing one's diabetes. The content includes practical behavioral strategies to improve diabetes self-management practices. The 12 week curriculum provides a basic overview of diabetes and self-management activities, standards of care recommended by the American Diabetes Association, strategies to improve patient-provider communication, support needed for diabetes self-management, information about diabetes medications, and ways to avoid diabetes-related complications.

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 3 months

    change in hemoglobin A1c from baseline to 3-months

  2. Problem Areas in Diabetes

    Time frame: 3 months

    The Problem Areas in Diabetes (PAID) will be used to assess diabetes specific quality of life. Change in PAID score from baseline to 3-months

Secondary outcomes

  1. Total Cholesterol (including HDL and LDL)

    Time frame: 3 months

    change in cholesterol from baseline to 3 months

  2. Triglycerides

    Time frame: 3 months

    change in triglycerides from baseline to 3 months

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • Hawai'i Maoli
  • Ke Ola Mamo
  • Kokua Kalihi Valley
  • Kula No Na Po'e Hawaii

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2014
Registry last updated
May 3, 2018

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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