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NCT Number: NCT07709117

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Behavioral

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.

Enhanced routine care

Behavioral

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.

Primary outcomes

  1. 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
  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Lai

CONTACT

[email protected]

808- 476-1747

Maile Taualii, PhD, MPH

CONTACT

[email protected]

808-462-1437

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Northwell Health

Registry information

Acronym: HOOKELE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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