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Partners in Care With Semi-Structured Support Group

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Partners in Care with Semi-Structured Support Group
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes self management, support group, semi structured support group

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kula no na Po'e Hawai'i
  • Ke Ola Mamao
  • Kokua Kalihi Valley

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Partners in Care with Semi-Structured Support Group

Partners in Care Standard Follow-up

Arm Description

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.

Participants will receive the Partners in Care intervention followed by monthly healthy lifestyle tips related to diabetes self-management

Outcomes

Primary Outcome Measures

Change from Baseline hemoglobin a1c at 3 months and at 6 months
Change from Baseline diabetes management functioning as measured by the Problem Areas in Diabetes questionnaire at 3 months and 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 Outcome Measures

Change from Baseline blood pressure at 3 months and 6 months
Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months
Total Cholesterol (including HDL and LDL) and triglycerides will be measured with the Cholestech LDX analyzer
Change from Baseline weight in kg at 3 months and 6 months

Full Information

First Posted
November 15, 2013
Last Updated
June 1, 2015
Sponsor
University of Hawaii
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02144909
Brief Title
Partners in Care With Semi-Structured Support Group
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hawaii
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes self management, support group, semi structured support group

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partners in Care with Semi-Structured Support Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Partners in Care Standard Follow-up
Arm Type
No Intervention
Arm Description
Participants will receive the Partners in Care intervention followed by monthly healthy lifestyle tips related to diabetes self-management
Intervention Type
Behavioral
Intervention Name(s)
Partners in Care with Semi-Structured Support Group
Primary Outcome Measure Information:
Title
Change from Baseline hemoglobin a1c at 3 months and at 6 months
Time Frame
baseline, 3 months, 6 months
Title
Change from Baseline diabetes management functioning as measured by the Problem Areas in Diabetes questionnaire at 3 months and 6 months
Description
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.
Time Frame
baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline blood pressure at 3 months and 6 months
Time Frame
baseline, 3 months, 6 months
Title
Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months
Description
Total Cholesterol (including HDL and LDL) and triglycerides will be measured with the Cholestech LDX analyzer
Time Frame
baseline, 3 months, 6 months
Title
Change from Baseline weight in kg at 3 months and 6 months
Time Frame
baseline, 3 months, 6 months
Other Pre-specified Outcome Measures:
Title
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
Title
Change from Baseline reported amount of support as measured a questionnaire at 3 months and 6 months
Time Frame
baseline, 3 months, 6 months
Title
Change from Baseline amount of physical activity as measured a questionnaire at 3 months and 6 months
Time Frame
baseline, 3 months, 6 months
Title
Change from Baseline dietary patterns as a questionnaire at 3 months and 6 months
Time Frame
baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Kula no na Po'e Hawai'i
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Ke Ola Mamao
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kokua Kalihi Valley
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23086589
Citation
Sinclair KA, Makahi EK, Shea-Solatorio C, Yoshimura SR, Townsend CK, Kaholokula JK. Outcomes from a diabetes self-management intervention for Native Hawaiians and Pacific People: Partners in Care. Ann Behav Med. 2013 Feb;45(1):24-32. doi: 10.1007/s12160-012-9422-1.
Results Reference
background
PubMed Identifier
26703660
Citation
Townsend CK, Dillard A, Hosoda KK, Maskarinec GG, Maunakea AK, Yoshimura SR, Hughes C, Palakiko DM, Kehauoha BP, Kaholokula JK. Community-Based Participatory Research Integrates Behavioral and Biological Research to Achieve Health Equity for Native Hawaiians. Int J Environ Res Public Health. 2015 Dec 22;13(1):ijerph13010004. doi: 10.3390/ijerph13010004.
Results Reference
derived

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Partners in Care With Semi-Structured Support Group

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