Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants

Type 2 Diabetes Clinical Trial

— LINK-IT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319716
• Other study ID #: 23-01274
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Lu Hu, PhD
• Phone: 646-501-3438
• Email: Lu.hu[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 324
• Est. completion date: June 30, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Video-Based Diabetes Self-Management Education and Support (DSMES)
The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.
• Community Health Worker (CHW) Support
CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c) Levels		Baseline
Primary	Hemoglobin A1c (HbA1c) Levels		Month 6
Primary	Hemoglobin A1c (HbA1c) Levels		Month 12
Secondary	Stanford Self-Efficacy for Diabetes Scale Score	8-item self-assessment of participants' confidence level in performing specific self-management behaviors. Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). The total score is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy.	Baseline
Secondary	Stanford Self-Efficacy for Diabetes Scale Score	8-item self-assessment of participants' confidence level in performing specific self-management behaviors. Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). The total score is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy.	Month 6
Secondary	Stanford Self-Efficacy for Diabetes Scale Score	8-item self-assessment of participants' confidence level in performing specific self-management behaviors. Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). The total score is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy.	Month 12
Secondary	Summary of Diabetes Self-Care Activities (SDSCA) Score	13-item self-report questionnaire assessing participants' adherence to diabetes self-management behaviors. Participants select the number of days (0 to 7) in the past week they have performed the behavior. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater self-care.	Baseline
Secondary	Summary of Diabetes Self-Care Activities (SDSCA) Score	13-item self-report questionnaire assessing participants' adherence to diabetes self-management behaviors. Participants select the number of days (0 to 7) in the past week they have performed the behavior. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater self-care.	Month 6
Secondary	Summary of Diabetes Self-Care Activities (SDSCA) Score	13-item self-report questionnaire assessing participants' adherence to diabetes self-management behaviors. Participants select the number of days (0 to 7) in the past week they have performed the behavior. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater self-care.	Month 12
Secondary	Starting the Conversation (STC) Diet Scale Score	8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more dietary behaviors that are consistent with health.	Baseline
Secondary	Starting the Conversation (STC) Diet Scale Score	8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more dietary behaviors that are consistent with health.	Month 6
Secondary	Starting the Conversation (STC) Diet Scale Score	8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more dietary behaviors that are consistent with health.	Month 12
Secondary	International Physical Activity Questionnaire (IPAQ) Short-Version Score	Self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. The formula for calculating MET is as follows: 8(vigorous activity)(minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes) = MET.; Higher MET scores indicate higher weekly levels of physical activity.	Baseline
Secondary	International Physical Activity Questionnaire (IPAQ) Short-Version Score	Self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. The formula for calculating MET is as follows: 8(vigorous activity)(minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes) = MET.; Higher MET scores indicate higher weekly levels of physical activity.	Month 6
Secondary	International Physical Activity Questionnaire (IPAQ) Short-Version Score	Self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. The formula for calculating MET is as follows: 8(vigorous activity)(minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes) = MET.; Higher MET scores indicate higher weekly levels of physical activity.	Month 12