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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: CHW-enabled CCL; Behavioral: Mobile health (mHealth) diabetes self-management education and support (DSMES) videos

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.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brita Roy; Phone Number: 347-377-3157; Email: Brita.Roy@nyulangone.org
• Study Contact Backup: Name: Julia Duch; Phone Number: 201-424-3571; Email: Julia.Duch@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

For patient participants randomized to the mHealth cohort, they must meet the below inclusion criteria

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: Mobile health (mHealth) diabetes self-management education and support (DSMES) videos; Participants will receive 24 culturally tailored DSMES videos through text message.
Experimental: 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).	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c levels	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of satisfaction with community-clinic linkage (CCL) and mHealth	Participants are asked to rate satisfaction on a scale of 1 (not satisfied at all) to 10 (very satisfied).	Month 12
Percentage of patients accepting Community Health Worker (CHW) support		Month 12
Percentage of patients accepting mHealth		Month 12
Percent completion of social service referrals		Month 6
Percent mhealth videos watched		Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nadia Islam, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; T2DM
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Health Services Administration; Delivery of Health Care; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Technology, Industry, and Agriculture; Technology; Patient Care Management; Tape Recording; Audiovisual Aids; Educational Technology; Television; Palliative Care; Telemedicine; Videotape Recording
• Other Study ID Numbers: 24-01080; 5U48DP006778 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Brita.Roy@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Brita.Roy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No