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Completed

NCT Number: NCT02144909

Partners in Care With Semi-Structured Support Group

The investigators are conducting a feasibility study using a randomized controlled trial (RCT) design in which participants will receive the Partners in Care (PIC) diabetes self-management intervention and then be randomized to either semi-structured social support or a standard follow-up control group. Participants in the support groups will receive a culturally-tailored, semi-structured social support program delivered in a community setting by trained community peer educators and other health professionals (e.g., pharmacist). The investigators believe that the addition of a semi-structured social support component as a supplement to an evidence-based diabetes self-management intervention will improve diabetes self-care maintenance.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus 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

Ke Ola Mamao, Honolulu, Hawaii, United States

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Who can participate

Healthy volunteers accepted: No

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 of age
  • English-speaking
  • Physician-diagnosed type 2 diabetes
  • Baseline hemoglobin A1c >8%

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 with Semi-Structured Support Group

Behavioral

Primary outcomes

  1. Change from Baseline hemoglobin a1c at 3 months and at 6 months

    Time frame: baseline, 3 months, 6 months

  2. Change from Baseline diabetes management functioning as measured by the Problem Areas in Diabetes questionnaire at 3 months and 6 months

    Time frame: baseline, 3 months, 6 months

    The PAID is a 20-item instrument that assesses the physical and social functioning of patients as well as their perceived level of mental and emotional well-being specific to living with diabetes.

Secondary outcomes

  1. Change from Baseline blood pressure at 3 months and 6 months

    Time frame: baseline, 3 months, 6 months

  2. Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months

    Time frame: baseline, 3 months, 6 months

    Total Cholesterol (including HDL and LDL) and triglycerides will be measured with the Cholestech LDX analyzer

  3. Change from Baseline weight in kg at 3 months and 6 months

    Time frame: baseline, 3 months, 6 months

Other outcomes

  1. Change from Baseline reported diabetes self-care activities as measured by the Summary of Diabetes Self-Care Activities questionnaire at 3 months and 6 months

    Time frame: baseline, 3 months, 6 months

  2. Change from Baseline reported amount of support as measured a questionnaire at 3 months and 6 months

    Time frame: baseline, 3 months, 6 months

  3. Change from Baseline amount of physical activity as measured a questionnaire at 3 months and 6 months

    Time frame: baseline, 3 months, 6 months

  4. Change from Baseline dietary patterns as a questionnaire at 3 months and 6 months

    Time frame: baseline, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

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

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 22, 2014
Registry last updated
Jun 3, 2015

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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