Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants

NCT ID: NCT06319716

Last Updated: 2025-11-21

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

RECRUITING

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-29

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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VIDEO

Participants 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.

Group Type EXPERIMENTAL

Video-Based Diabetes Self-Management Education and Support (DSMES)

Intervention Type BEHAVIORAL

The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.

VIDEO+CHW

Participants 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.

Group Type EXPERIMENTAL

Video-Based Diabetes Self-Management Education and Support (DSMES)

Intervention Type BEHAVIORAL

The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.

Community Health Worker (CHW) Support

Intervention Type BEHAVIORAL

CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.

CONTROL

Participants assigned to the CONTROL group will continue to receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* self-identify as a Chinese immigrant;
* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lu Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lu Hu, PhD

Role: CONTACT

646-501-3438

Other Identifiers

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23-01274

Identifier Type: -

Identifier Source: org_study_id

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