Partners in Care With Semi-Structured Support Group

June 1, 2015 updated by: Claire Townsend, University of Hawaii
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Kula no na Po'e Hawai'i
      • Honolulu, Hawaii, United States, 96817
        • Ke Ola Mamao
      • Honolulu, Hawaii, United States, 96819
        • Kokua Kalihi Valley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Partners in Care with Semi-Structured Support Group
Partners in Care with Semi-Structured Support Group: participants will receive the Partners in Care intervention followed by 6 semi-structured support groups, conducted every other week for 3 months. Half of the support groups will be conducted by professionals with diabetes specific knowledge, e.g., pharmacists, physicians, nutritionists. While the other half will be conducted by the trained diabetes self-management facilitator.
No Intervention: Partners in Care Standard Follow-up
Participants will receive the Partners in Care intervention followed by monthly healthy lifestyle tips related to diabetes self-management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline hemoglobin a1c at 3 months and at 6 months
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
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.
baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline blood pressure at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
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
baseline, 3 months, 6 months
Change from Baseline weight in kg at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months

Other Outcome Measures

Outcome Measure
Time Frame
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
baseline, 3 months, 6 months
Change from Baseline reported amount of support as measured a questionnaire at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change from Baseline amount of physical activity as measured a questionnaire at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months
Change from Baseline dietary patterns as a questionnaire at 3 months and 6 months
Time Frame: baseline, 3 months, 6 months
baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CHS-21514
  • U54MD007584 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Partners in Care with Semi-Structured Support Group

3
Subscribe