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Not Yet RecruitingNCT07296211

INcreasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income VulneRablE Immigrants

Increasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income Vulnerable Immigrants

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
480 (estimated)
Sponsor
NYU Langone Health · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate a multi-level approach to improve diabetes control via access to social service supports and online, culturally-tailored diabetes self-management education and support (DSMES) videos among a community of primarily Chinese and Latino/a immigrants. The study aims to assess patient uptake, provider adoption, and INSPIRE program acceptability, appropriateness, feasibility, fidelity, penetration/reach, and maintenance.

Detailed description

In stage 1, the 8 family health center (FHC) clinics will be randomized 1:1 into Experimental Cohort A, which will receive the Community Health Worker (CHW)-enabled community-clinic linkage model (CCL) or Control Cohort B, with FHCs that will not receive the CHW-enabled CCL. Then, in stage 2, patients in clinics that received the CHW-enabled CCL will be randomized in a 1:1 ratio to Arm A who will receive text-based mhealth diabetes education videos or Arm B who will not receive mhealth.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCHW-enabled CCLThe FHCs has access to the CHW-enabled CCL. With this intervention, participants will be screened for social determinants of health (SDoH) and be referred to care and social services that address any identified needs.
BEHAVIORALMobile health (mHealth) diabetes self-management education and support (DSMES) videosParticipants will receive 24 culturally tailored DSMES videos through text message.

Timeline

Start date
2026-01-01
Primary completion
2028-12-01
Completion
2029-06-01
First posted
2025-12-22
Last updated
2025-12-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07296211. Inclusion in this directory is not an endorsement.