LINK-IT: Leveraging vIdeos and commuNity Health worKers to Improve Diabetes OuTcomes
LINK-IT
1 other identifier
interventional
540
1 country
1
Brief Summary
The overall goal of this study is to examine the efficacy of the video-based Diabetes Self-Management Education and Support (DSMES) (hereafter VIDEO), or the video-based DSMES+community health worker (CHW) intervention (hereafter VIDEO+CHW), compared with a wait-list control group (hereafter CONTROL) to improve glycemic control among Chinese immigrants with uncontrolled Type 2 diabetes in NYC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Dec 2024
Typical duration for not_applicable type-2-diabetes
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
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
December 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
May 7, 2026
May 1, 2026
3 years
March 13, 2024
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Hemoglobin A1c (HbA1c) Levels
Baseline
Hemoglobin A1c (HbA1c) Levels
Month 6
Hemoglobin A1c (HbA1c) Levels
Month 12
Secondary Outcomes (15)
Stanford Self-Efficacy for Diabetes Scale Score
Baseline
Stanford Self-Efficacy for Diabetes Scale Score
Month 6
Stanford Self-Efficacy for Diabetes Scale Score
Month 12
Starting the Conversation (STC) Diet Scale Score
Baseline
Starting the Conversation (STC) Diet Scale Score
Month 6
- +10 more secondary outcomes
Study Arms (3)
VIDEO
EXPERIMENTALParticipants assigned to the VIDEO arm will receive one brief Diabetes Self-Management Education and Support (DSMES) video per week for 24 weeks. The videos will be delivered via text message.
VIDEO+CHW
EXPERIMENTALParticipants assigned to the VIDEO+CHW arm will receive one brief DSMES video per week, in addition to bi-weekly support calls from a community health worker (CHW), for 24 weeks. The DSMES videos will be delivered via text message.
CONTROL
NO INTERVENTIONParticipants assigned to the CONTROL group will continue to receive usual care.
Interventions
The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.
CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.
Eligibility Criteria
You may qualify if:
- self-identify as Chinese American;
- be above 18 years old;
- have a diagnosis of Type 2 diabetes (T2D) in the medical record;
- have had an appointment with a physician for routine T2D care within the past 12 months;
- have a most recent HbA1c of at least 7%;
- be willing to receive brief videos regarding T2D management; and
- possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.
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);
- unwilling to accept randomization assignment;
- is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study; or
- is breastfeeding (e.g., they may have potential dietary restrictions).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Related Publications (1)
Hu L, Liu J, Yang X, Teng C, Li H, Zhao Y, Levy N, Zhu K, Vang S, Kwon SC, Feldman N, Lau J, Jiang Y, Trinh-Shevrin C, Islam N. Leveraging videos and community health workers to address social determinants of health in immigrants (LINK-IT): Protocol for a randomized controlled trial. PLoS One. 2026 Feb 2;21(2):e0341217. doi: 10.1371/journal.pone.0341217. eCollection 2026.
PMID: 41628090DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lu Hu, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2024
First Posted
March 20, 2024
Study Start
December 29, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
May 7, 2026
Record last verified: 2026-05
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 Lu.hu@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Lu.hu@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.