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

NCT ID: NCT07296211

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-06-30

Brief Summary

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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

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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

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Type2 Diabetes Mellitus

Keywords

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T2DM Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos

For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will receive 24 culturally tailored diabetes education videos via text message.

Group Type EXPERIMENTAL

CHW-enabled CCL

Intervention Type BEHAVIORAL

The 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.

Mobile health (mHealth) diabetes self-management education and support (DSMES) videos

Intervention Type BEHAVIORAL

Participants will receive 24 culturally tailored DSMES videos through text message.

Patients in a CHW-enabled clinic that do not receive mHealth videos

For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will continue to receive standard of care (SOC).

Group Type EXPERIMENTAL

CHW-enabled CCL

Intervention Type BEHAVIORAL

The 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.

Patients in a standard clinic that do not receive mHealth videos

For 12 months participants will be followed as they receive SOC from their clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CHW-enabled CCL

The 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.

Intervention Type BEHAVIORAL

Mobile health (mHealth) diabetes self-management education and support (DSMES) videos

Participants will receive 24 culturally tailored DSMES videos through text message.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

To be eligible to participate in this study, the patient participant must meet all the following criteria:

1. ≥18 years old and ≤ 70 years old
2. Self-identify their primary language as English, Mandarin, Cantonese, or Spanish
3. Diagnosed with T2DM
4. Has their most recent HbA1c ≥8% or have a new diagnosis of T2DM within the past 6 months


1\. Willing to receive text messages with brief videos regarding T2DM management

Exclusion Criteria

1. Unable or unwilling to provide informed consent
2. Unable to participate meaningfully in the intervention (e.g. uncorrected sight and hearing impairment)
3. Is currently pregnant (Pregnant women will be excluded from this study because they may have special dietary restrictions that are not covered by our DSMES videos for the general population with T2DM.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadia Islam, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Brita Roy

Role: CONTACT

Phone: 347-377-3157

Email: [email protected]

Julia Duch

Role: CONTACT

Phone: 201-424-3571

Email: [email protected]

Other Identifiers

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5U48DP006778

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-01080

Identifier Type: -

Identifier Source: org_study_id