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

July 15, 2026 updated by: Kaiser Permanente
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family-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.
Behavioral: Family-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.
Active Comparator: Enhanced 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.
Behavioral: Enhanced 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the family-based DSMES and social care intervention
Time Frame: 6-months follow-up

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
Feasibility of the family-based DSMES and social care intervention
Time Frame: 6-months follow-up

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

Northwell Health

Investigators

  • Principal Investigator: Maile Taualii, PhD, MPH, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK142020 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidential Patient Information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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