Partners in Care Diabetes Self-management Intervention
Specific Aim 3: Partners in Care Randomized Controlled Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
Type 2 diabetes is common among Native Hawaiians and Pacific Peoples. Diabetes related complications decrease quality of life and can result in early morbidity. The purpose of the Partners in Care diabetes self-management educational intervention is to teach participants how to manage their diabetes to avoid or delay diabetes-related complications and how to better work with their health care team.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 3, 2010
CompletedFirst Posted
Study publicly available on registry
November 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedNovember 14, 2013
August 1, 2011
1.9 years
November 3, 2010
November 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hemoglobin A1c
Hemoglobin A1c will be assessed at baseline and post intervention in the intervention and delayed intervention participants.
3 months
Secondary Outcomes (1)
Quality of life
3 months
Study Arms (2)
Educational
EXPERIMENTALParticipants will receive 12 diabetes self-management educational lessons in a small group setting located within the participating communities and delivered by trained community health workers.
Delayed education
ACTIVE COMPARATORThe delayed education group will receive the same intervention after the intervention group has completed the educational lessons and all participants have completed the follow-up assessments.
Interventions
Participants will be offered 12 group diabetes self-management educational lessons delivered by trained community health workers.
Eligibility Criteria
You may qualify if:
- Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background,
- Adults age \>=18 years,
- English-speaking,
- Physician-diagnosed type 2 diabetes, and
- Baseline hemoglobin A1c \>=8%
You may not qualify if:
- Survival less than 6 months,
- Planning to move off island or out of state during the 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Hawaii
Honolulu, Hawaii, 96813, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph K Kaholokula, PhD
University of Hawaii
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 3, 2010
First Posted
November 5, 2010
Study Start
October 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
November 14, 2013
Record last verified: 2011-08