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

ConditionDiabetes

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorKaiser Permanente

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18 or older;

identify as Native Hawaiian or Pacific Islander;

diagnosed with type 2 diabetes;

most recent A1C ≥ 8%;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Family-based group-centered DSMES plus social care navigation interventionExperimental treatment 1 intervention

Group B: Enhanced routine careActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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

Time frame

6-months follow-up

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaiser Permanente

Lead sponsor

Northwell Health

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: