Expired Study
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Honolulu, Hawaii 96813


Purpose:

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.


Criteria:

Inclusion Criteria: 1. Adults age >18 years of age, 2. English-speaking, 3. Physician-diagnosed type 2 diabetes, and 4. Baseline hemoglobin A1c >7%. Exclusion Criteria: 1. Survival less than 6 months, 2. Planning to move out of the community during the intervention 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).


Study is Available At:


Original ID:

MD001660 - PIC


NCT ID:

NCT02320344


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Hawaii


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

47


Enrollment Type:

Actual


Study Dates

Start Date:July 2013
Completion Date:December 2017
Completion Type:Actual
Primary Completion Date:December 2017
Primary Completion Type:Actual
Verification Date:October 2017
Last Changed Date:May 1, 2018
First Received Date:December 16, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Hemoglobin A1c
Time Frame:3 months
Safety Issues:False
Description:change in hemoglobin A1c from baseline to 3-months
Outcome Type:Primary Outcome
Measure:Problem Areas in Diabetes
Time Frame:3 months
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Total Cholesterol (including HDL and LDL)
Time Frame:3 months
Safety Issues:False
Description:change in cholesterol from baseline to 3 months
Outcome Type:Secondary Outcome
Measure:Triglycerides
Time Frame:3 months
Safety Issues:False
Description:change in triglycerides from baseline to 3 months

Study Interventions

Intervention Type:Behavioral
Name:Partners in Care
Description: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 communica
Arm Name:Partners in Care

Study Arms

Study Arm Type:Experimental
Arm Name:Partners in Care

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Hawaii
Agency Class:Other
Agency Type:Collaborator
Agency Name:Kula No Na Po'e Hawaii

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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