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

NCT02320344 | Completed

• 1 other identifier: MD001660 - PIC
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Hemoglobin A1c

  change in hemoglobin A1c from baseline to 3-months

  3 months

• Problem Areas in Diabetes

  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

  3 months

Secondary Outcomes (2)

• Total Cholesterol (including HDL and LDL)

  3 months

• Triglycerides

  3 months

Study Arms (1)

Partners in Care

EXPERIMENTAL

Behavioral: Partners in Care

Interventions

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.

Partners in Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Hawaii: lead
• Kula No Na Po'e Hawaii: collaborator
• Ke Ola Mamo: collaborator
• Hawai'i Maoli: collaborator
• Kokua Kalihi Valley: collaborator

Study Sites (1)

Department of Native Hawaiian Health, University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2017-10

Locations

US (1)