Implementing an Effective Diabetes Intervention Among Low-Income Immigrants (IDEAL)

NYU Langone Health

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Community Health Worker Support (CHW); Behavioral: Diabetes Self-Management Education and Support (DSMES) Videos

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06319703

22-00634

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

DSMES+CHW (IDEAL)

Experimental group

Description:

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.

Treatment:

Behavioral: Diabetes Self-Management Education and Support (DSMES) Videos

Behavioral: Community Health Worker Support (CHW)

Wait-list control group (CONTROL)

No Intervention group

Description:

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.