Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants (LINK-IT)

NYU Langone Health

Status: Enrolling

Conditions: Type 2 Diabetes

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06319716

23-01274

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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324 participants in 3 patient groups

VIDEO

Experimental group

Description:

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.

Treatment:

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

VIDEO+CHW

Experimental group

Description:

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.

Treatment:

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

Behavioral: Community Health Worker (CHW) Support

CONTROL

No Intervention group

Description:

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