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
2 other identifiers
interventional
480
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2025
CompletedFirst Posted
Study publicly available on registry
December 22, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
December 22, 2025
December 1, 2025
2.9 years
December 9, 2025
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c levels
Baseline, Month 6
Secondary Outcomes (5)
Level of satisfaction with community-clinic linkage (CCL) and mHealth
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
Study Arms (3)
Patients in a CHW-enabled clinic that receive mobile health (mHealth) videos
EXPERIMENTALFor 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.
Patients in a CHW-enabled clinic that do not receive mHealth videos
EXPERIMENTALFor 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).
Patients in a standard clinic that do not receive mHealth videos
NO INTERVENTIONFor 12 months participants will be followed as they receive SOC from their clinic.
Interventions
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.
Participants will receive 24 culturally tailored DSMES videos through text message.
Eligibility Criteria
You may qualify if:
- To be eligible to participate in this study, the patient participant must meet all the following criteria:
- ≥18 years old and ≤ 70 years old
- Self-identify their primary language as English, Mandarin, Cantonese, or Spanish
- Diagnosed with T2DM
- Has their most recent HbA1c ≥8% or have a new diagnosis of T2DM within the past 6 months
- \. Willing to receive text messages with brief videos regarding T2DM management
You may not qualify if:
- Unable or unwilling to provide informed consent
- Unable to participate meaningfully in the intervention (e.g. uncorrected sight and hearing impairment)
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadia Islam, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2025
First Posted
December 22, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.