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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02320344
Enrollment
47
Registered
2014-12-19
Start date
2013-07-31
Completion date
2017-12-31
Last updated
2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

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.

Sponsors

Kula No Na Po'e Hawaii
CollaboratorOTHER
Ke Ola Mamo
CollaboratorOTHER
Hawai'i Maoli
CollaboratorOTHER
Kokua Kalihi Valley
CollaboratorUNKNOWN
University of Hawaii
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1c3 monthschange in hemoglobin A1c from baseline to 3-months
Problem Areas in Diabetes3 monthsThe Problem Areas in Diabetes (PAID) will be used to assess diabetes specific quality of life. Change in PAID score from baseline to 3-months

Secondary

MeasureTime frameDescription
Total Cholesterol (including HDL and LDL)3 monthschange in cholesterol from baseline to 3 months
Triglycerides3 monthschange in triglycerides from baseline to 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026