A Pilot Study to Improve Diabetes Management Through Family-Based Health Care Navigation
HOOKELE
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
The purpose of this research study is to compare the impact of providing culturally-tailored, diabetes management education in a group setting to standard diabetes care. We are conducting this study because previous research has demonstrated culturally tailored care can be effective in addressing health disparities. However, it has not been offered in a group setting, among Native Hawaiians and Pacific Islanders who share similar social experiences.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Jul 2026
Typical duration for not_applicable diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
CompletedFirst Posted
Study publicly available on registry
July 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
July 17, 2026
July 1, 2026
1.1 years
July 13, 2026
July 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of the family-based DSMES and social care intervention
Fidelity * DSMES session attendance of the patient (Goal 75% of sessions attended) * DSMES session attendance of the family support (Goal 75% of sessions attended) * CHW visits scheduled and attended
6-months follow-up
Feasibility of the family-based DSMES and social care intervention
Fidelity 1. DSMES session attendance of the patient (Goal 75% of sessions attended) 2. DSMES session attendance of the family support (Goal 75% of sessions attended) 3. CHW visits scheduled and attended
6-months follow-up
Study Arms (2)
Family-based group-centered DSMES plus social care navigation intervention
EXPERIMENTALIn the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner. Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months.
Enhanced routine care
ACTIVE COMPARATORParticipants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list.
Interventions
In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner. Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months.
Participants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list.
Eligibility Criteria
You may qualify if:
- age 18 or older;
- identify as Native Hawaiian or Pacific Islander;
- diagnosed with type 2 diabetes;
- most recent A1C ≥ 8%;
- reports ≥ 1 social need;
- receive care at KPHI, and
- have an adult family member who will commit to attending classes with the participant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaiser Permanentelead
- Northwell Healthcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maile Taualii, PhD, MPH
Kaiser Permanente
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Randomization after recruitment
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2026
First Posted
July 16, 2026
Study Start
July 15, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
July 17, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Confidential Patient Information