Clinical trial NCT06319716: Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants
Official title: LINK-IT: Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-03-20
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* self-identify as a Chinese immigrant;
* be between 18-70 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 8%;
* 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).

Primary outcomes:
measure: Hemoglobin A1c (HbA1c) Levels
timeFrame: Baseline
measure: Hemoglobin A1c (HbA1c) Levels
timeFrame: Month 6
measure: Hemoglobin A1c (HbA1c) Levels
timeFrame: Month 12
Secondary outcomes:
measure: Stanford Self-Efficacy for Diabetes Scale Score
timeFrame: Baseline
measure: Stanford Self-Efficacy for Diabetes Scale Score
timeFrame: Month 6
measure: Stanford Self-Efficacy for Diabetes Scale Score
timeFrame: Month 12
measure: Summary of Diabetes Self-Care Activities (SDSCA) Score
timeFrame: Baseline
measure: Summary of Diabetes Self-Care Activities (SDSCA) Score
timeFrame: Month 6
measure: Summary of Diabetes Self-Care Activities (SDSCA) Score
timeFrame: Month 12
measure: Starting the Conversation (STC) Diet Scale Score
timeFrame: Baseline
measure: Starting the Conversation (STC) Diet Scale Score
timeFrame: Month 6
measure: Starting the Conversation (STC) Diet Scale Score
timeFrame: Month 12
measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score
timeFrame: Baseline
measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score
timeFrame: Month 6
measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score
timeFrame: Month 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lu Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References: