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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
The purpose of this small R01 is to test the feasibility and preliminary efficacy of afamily‐based DSMES and social care navigation intervention to improve diabetes‐relatedoutcomes among NHPI patients with poorly managed diabetes and social needs. KP HawaiiNHPI patients (N = 80) age ≥ 18, recent A1C >8%, and who report >1 social needs will berecruited and randomized to one of two study arms: 1) family‐based group centered DSMESand social care navigation intervention; or 2) enhanced usual care. In the family‐basedintervention, participants and their family members will receive the 6‐week NHPIculturally adapted DSMES program that will be delivered by a NHPI pharmacist from theMauliola Pharmacy. In collaboration with our partners, Hui No Ke Ola Pono, acommunity‐based organization that employs CHWs, enrolled participants and their familymembers will be assigned a NHPI CHW who will provide navigation support to socialservices and community‐based resources to address social needs for 6 months. Participantsin the enhanced usual care arm will receive standard diabetes clinical care and beprovided with a tailored community‐based resource list. Feasibility will be determinedusing mixed methods and based on recruitment, retention, attendance, social needresolution, and several implementation outcomes. We will also examine interventionpreliminary 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 carenavigation intervention based on: a) recruitment and retention rates; b) sessionattendance; c) number of participants with social need(s) met, not met, or pending at 6months; d) acceptability; e) practicality; f) fidelity; and g) cultural appropriateness.Aim 2. Explore preliminary efficacy by comparing the two study arms on the followingoutcomes at 6‐months post‐randomization: a) diabetes distress; b) diabetesself‐management; c) diabetes self‐efficacy; d) mean change in A1C; e) proportion ofparticipants with a clinic‐based A1C test; and f) proportion of patients who attended ascheduled follow‐up primary care appointment.
Epistemonikos ID: 5c555d8529a7c2bd147c7cc8e99c9a7c9b59c98e
First added on: Jul 16, 2026