Health TrialsbyHealthPanel

LINK-IT: Leveraging vIdeos and commuNity Health worKers to Improve Diabetes OuTcomes

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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 Americans with uncontrolled type 2 diabetes in NYC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

self-identify as ethnically Chinese;

be above 18 years old;

have a diagnosis of Type 2 diabetes (T2D) in the medical record;

have an HbA1c≥7% in the past 12 months

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

    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

    Behavioral

    CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.

Treatment groups

540 Participants
are divided into 3 treatment groups
Group A: VIDEOExperimental treatment 1 intervention
Group B: VIDEO+CHWExperimental treatment 2 interventions
Group C: CONTROLNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hemoglobin A1c (HbA1c) Levels

Time frame
Baseline
2

Hemoglobin A1c (HbA1c) Levels

Time frame
Month 6
3

Hemoglobin A1c (HbA1c) Levels

Time frame
Month 12

Secondary outcomes

1

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 can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.

Time frame
Baseline
2

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 can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.

Time frame
Month 6
3

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 can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.

Time frame
Month 12
4

Starting the Conversation (STC) Diet Scale Score

8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Source ClinicalTrials.gov
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