Implementing an Effective Diabetes Intervention Among Low-Income Immigrants

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06319703
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Diabetes Self-Management Education and Support (DSMES) Videos — BEHAVIORAL
    Text message-delivered video-based DSMES intervention.
  • Community Health Worker Support (CHW) — BEHAVIORAL
    Assess participants' SDOH barriers to Type 2 diabetes care and link them to available resources in the community.

Study Details

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.

Key Dates

Start date
Dec 29, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Change in Hemoglobin A1C (HbA1c) Test Scores [ Time Frame: Baseline, Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By condition

Related Studies