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Recruiting NCT06319716

LINK-IT: Leveraging vIdeos and commuNity Health worKers to Improve Diabetes OuTcomes

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video-Based Diabetes Self-Management Education and Support (DSMES), Community Health Worker (CHW) Support.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Participants will be randomized with equal allocation to one of the 3 groups. The VIDEO group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The VIDEO+CHW group will receive the same DSMES videos plus bi-weekly support calls from a CHW for 24 weeks. The CHW will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos.

Interventions

  • Behavioral Video-Based Diabetes Self-Management Education and Support (DSMES)
    The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.
  • Behavioral Community Health Worker (CHW) Support
    CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.

Primary outcome measures

  • Hemoglobin A1c (HbA1c) Levels [Time frame: Baseline]
  • Hemoglobin A1c (HbA1c) Levels [Time frame: Month 6]
  • Hemoglobin A1c (HbA1c) Levels [Time frame: Month 12]
Secondary outcome measures (12)
  • Stanford Self-Efficacy for Diabetes Scale Score [Time frame: Baseline]
  • Stanford Self-Efficacy for Diabetes Scale Score [Time frame: Month 6]
  • Stanford Self-Efficacy for Diabetes Scale Score [Time frame: Month 12]
  • Starting the Conversation (STC) Diet Scale Score [Time frame: Baseline]
  • Starting the Conversation (STC) Diet Scale Score [Time frame: Month 6]
  • Starting the Conversation (STC) Diet Scale Score [Time frame: Month 12]
  • International Physical Activity Questionnaire (IPAQ) Short-Version Score [Time frame: Baseline]
  • International Physical Activity Questionnaire (IPAQ) Short-Version Score [Time frame: Month 6]
  • International Physical Activity Questionnaire (IPAQ) Short-Version Score [Time frame: Month 12]
  • Adherence to Refills and Medications Scale for Diabetes (ARMS-D) [Time frame: Baseline]
  • Adherence to Refills and Medications Scale for Diabetes (ARMS-D) [Time frame: Month 6]
  • Adherence to Refills and Medications Scale for Diabetes (ARMS-D) [Time frame: Month 12]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • NYU Langone Health — New York

Publications

  • 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 41628090

Identifiers

NCT: NCT06319716 · 23-01274

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗