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A Pilot Study to Improve Diabetes Management Through Family-Based Health Care Navigation

A Pilot Study to Improve Diabetes Management Through Family-Based Health Care Navigation

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07709117
Acronym
HOOKELE
Enrollment
100
Registered
2026-07-16
Start date
2026-07-15
Completion date
2028-08-31
Last updated
2026-07-17

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

Conditions

Diabetes

Keywords

Diabetes, Native Hawaiians and Pacific Islanders, Social Health, Navigation

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.

Detailed description

The purpose of this small R01 is to test the feasibility and preliminary efficacy of a family-based DSMES and social care navigation intervention to improve diabetes-related outcomes among NHPI patients with poorly managed diabetes and social needs. KP Hawaii NHPI patients (N = 80) age ≥ 18, recent A1C \>8%, and who report \>1 social needs will be recruited and randomized to one of two study arms: 1) family-based group centered DSMES and social care navigation intervention; or 2) enhanced usual care. In the family-based intervention, participants and their family members will receive the 6-week NHPI culturally adapted DSMES program that will be delivered by a NHPI pharmacist from the Mauliola Pharmacy. In collaboration with our partners, Hui No Ke Ola Pono, a community-based organization that employs CHWs, enrolled participants and their family members 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 usual care arm will receive standard diabetes clinical care and be provided with a tailored community-based resource list. Feasibility will be determined using mixed methods and based on recruitment, retention, attendance, social need resolution, and several implementation outcomes. We will also examine intervention preliminary effects on diabetes distress, self-management, self-efficacy/empowerment, A1C, and healthcare utilization at 6 months. We propose the following aims: Aim 1. Determine feasibility of the family-based group centered DSMES and social care navigation intervention based on: a) recruitment and retention rates; b) session attendance; c) number of participants with social need(s) met, not met, or pending at 6 months; d) acceptability; e) practicality; f) fidelity; and g) cultural appropriateness. Aim 2. Explore preliminary efficacy by comparing the two study arms on the following outcomes at 6-months post-randomization: a) diabetes distress; b) diabetes self-management; c) diabetes self-efficacy; d) mean change in A1C; e) proportion of participants with a clinic-based A1C test; and f) proportion of patients who attended a scheduled follow-up primary care appointment.

Interventions

BEHAVIORALFamily-based group-centered DSMES plus social care navigation intervention

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.

BEHAVIORALEnhanced routine care

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.

Sponsors

Kaiser Permanente
Lead SponsorOTHER
Northwell Health
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Randomization after recruitment

Intervention model description

Eligible patients will be randomized to one of two study arms: 1. Ho'okele: a family-based group-centered Diabetes Self-Management Education and Support (DSMES) plus social care navigation intervention; 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, Native Hawaiians and Pacific Islanders (NHPI) culturally adapted Diabetes Self-Management Education and Support (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. 2. enhanced routine care. Participants in the enhanced routine care arm will receive the standard diabetes clinical care at Kaiser Permanente Hawaii and be provided with a tailored community-based resource list.

Eligibility

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

Inclusion criteria

1. age 18 or older; 2. identify as Native Hawaiian or Pacific Islander; 3. diagnosed with type 2 diabetes; 4. most recent A1C ≥ 8%; 5. reports ≥ 1 social need; 6. receive care at KPHI, and 7. have an adult family member who will commit to attending classes with the participant.

Exclusion criteria

Patients who are not able to provide informed consent due to cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the family-based DSMES and social care intervention6-months follow-upFidelity * 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

Contacts

CONTACTMaile Taualii, PhD, MPH
maile.m.taualii@kp.org808-462-1437
CONTACTJonathan Lai
jonathan.ws.lai@kp.org808- 476-1747
PRINCIPAL_INVESTIGATORMaile Taualii, PhD, MPH

Kaiser Permanente

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026