Implementing an Effective Diabetes Intervention Among Low-Income Immigrants

NCT ID: NCT06319703

Last Updated: 2025-04-10

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

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-29

Study Completion Date

2028-06-30

Brief Summary

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The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D 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.

Detailed Description

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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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DSMES+CHW (IDEAL)

Participants in this group will receive brief pre-recorded DSMES videos, which include both educational and Social Cognitive Theory-based behavioral content. Participants will receive 1 DSMES video via text message each week for a total of 24 weeks with each video lasting about 5 minutes in duration. In addition, they will also receive brief phone calls from CHWs every 2 weeks during the 24 weeks video program. During these calls, CHWs will assess whether participants need assistance on social determinants of health (SDOH) barriers. If needed, CHWs will link participants to available services within the community. CHWs will also provide assistance on navigating the complex health care systems and serve as an advocate for patients during doctor visits if needed.

Group Type EXPERIMENTAL

Diabetes Self-Management Education and Support (DSMES) Videos

Intervention Type BEHAVIORAL

Text message-delivered video-based DSMES intervention.

Community Health Worker Support (CHW)

Intervention Type BEHAVIORAL

Assess participants' SDOH barriers to Type 2 diabetes care and link them to available resources in the community.

Wait-list control group (CONTROL)

Participants in this group will continue to receive the standard of usual care for their T2D at their doctor's office during the course of our study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diabetes Self-Management Education and Support (DSMES) Videos

Text message-delivered video-based DSMES intervention.

Intervention Type BEHAVIORAL

Community Health Worker Support (CHW)

Assess participants' 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

Participants must:

1. self-identify as a Chinese immigrant;
2. be between 18-70 years old,
3. have a diagnosis of T2D in the medical record;
4. have had an appointment with a physician for routine T2D care within the past 12 months;
5. have a most recent HbA1c \> or = 8%;
6. be willing to receive brief videos regarding T2D management, and
7. possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.

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. unwilling to accept randomization assignment;
4. is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study, or
5. is breastfeeding (e.g., they may have potential dietary restrictions).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

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 School of Medicine

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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22-00634

Identifier Type: -

Identifier Source: org_study_id

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