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NCT Number: NCT06319716

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • be willing to participate in video-based interventions; 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).

Treatment and study plan

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.

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

    Time frame: Baseline

    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.

  2. Stanford Self-Efficacy for Diabetes Scale Score

    Time frame: Month 6

    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.

  3. Stanford Self-Efficacy for Diabetes Scale Score

    Time frame: Month 12

    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.

  4. Starting the Conversation (STC) Diet Scale Score

    Time frame: Baseline

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

  5. Starting the Conversation (STC) Diet Scale Score

    Time frame: Month 6

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

  6. Starting the Conversation (STC) Diet Scale Score

    Time frame: Month 12

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

  7. International Physical Activity Questionnaire (IPAQ) Short-Version Score

    Time frame: Baseline

    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.

  8. International Physical Activity Questionnaire (IPAQ) Short-Version Score

    Time frame: Month 6

    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.

  9. International Physical Activity Questionnaire (IPAQ) Short-Version Score

    Time frame: Month 12

    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.

  10. Adherence to Refills and Medications Scale for Diabetes (ARMS-D)

    Time frame: Baseline

    ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months. Responses range from 1 ("none of the time") to 4 ("all of the time"). Item scores are summed to produce an overall adherence score ranging from 11 to 44, with higher scores indicating more problems with medication adherence.

  11. Adherence to Refills and Medications Scale for Diabetes (ARMS-D)

    Time frame: Month 6

    ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months. Responses range from 1 ("none of the time") to 4 ("all of the time"). Item scores are summed to produce an overall adherence score ranging from 11 to 44, with higher scores indicating more problems with medication adherence.

  12. Adherence to Refills and Medications Scale for Diabetes (ARMS-D)

    Time frame: Month 12

    ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months. Responses range from 1 ("none of the time") to 4 ("all of the time"). Item scores are summed to produce an overall adherence score ranging from 11 to 44, with higher scores indicating more problems with medication adherence.

  13. Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales

    Time frame: Baseline

    8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months.

  14. Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales

    Time frame: Month 6

    8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months.

  15. Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales

    Time frame: Month 12

    8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months.

  16. Diabetes-Related Distress

    Time frame: Baseline

    Diabetes-related distress will be assessed using the 2-item Diabetes Distress Screening Scale (DDS-2), a validated screening instrument that measures the emotional burden and stress associated with living with diabetes. Each item is rated on a 6-point Likert scale (1 = "Not a problem" to 6 = "A very serious problem"). The overall score is calculated as the mean of the two items, with higher scores indicating greater diabetes-related distress.

  17. Diabetes-Related Distress

    Time frame: Month 6

    Diabetes-related distress will be assessed using the 2-item Diabetes Distress Screening Scale (DDS-2), a validated screening instrument that measures the emotional burden and stress associated with living with diabetes. Each item is rated on a 6-point Likert scale (1 = "Not a problem" to 6 = "A very serious problem"). The overall score is calculated as the mean of the two items, with higher scores indicating greater diabetes-related distress.

  18. Diabetes-Related Distress

    Time frame: Month 12

    Diabetes-related distress will be assessed using the 2-item Diabetes Distress Screening Scale (DDS-2), a validated screening instrument that measures the emotional burden and stress associated with living with diabetes. Each item is rated on a 6-point Likert scale (1 = "Not a problem" to 6 = "A very serious problem"). The overall score is calculated as the mean of the two items, with higher scores indicating greater diabetes-related distress.

  19. SDOH Barriers

    Time frame: Baseline

    The 14-item SDOH questionnaire assessed core health-related barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use). Items used dichotomous response options (1 = "Yes"; 0 = "No"). An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.

  20. SDOH Barriers

    Time frame: Month 6

    The 14-item SDOH questionnaire assessed core health-related barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use). Items used dichotomous response options (1 = "Yes"; 0 = "No"). An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.

  21. SDOH Barriers

    Time frame: Month 12

    The 14-item SDOH questionnaire assessed core health-related barriers across five domains: economic stability (e.g., food access and housing stability), education access and quality (e.g., need to improve English proficiency, reading skills, or educational attainment), health care access and quality (e.g., insurance coverage), neighborhood and built environment (e.g., housing conditions), and social and community context (e.g., racial discrimination; need for childcare; and need for assistance addressing tobacco, alcohol, or drug use). Items used dichotomous response options (1 = "Yes"; 0 = "No"). An overall SDOH score was calculated by summing responses across the 14 items (range: 0-14), with higher scores indicating greater SDOH-related barriers.

  22. Health-Related Social Needs

    Time frame: Baseline

    Health-related social needs (HRSNs) will be assessed using the 26-item The Accountable Health Communities Health-Related Social Needs Screening Tool. The instrument assesses unmet health-related social needs across 13 domains, including housing instability, food insecurity, transportation needs, utility assistance needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disability. These domains identify social needs that may be addressed through clinical and community-based services. Each domain includes its own set of indicators. Descriptive statistics will be used to summarize the data, with frequencies and percentages reported for categorical variables. For domains with continuous or summed measures, composite scores will be calculated by summing the relevant items, with higher scores indicating greater unmet health-related social needs.

  23. Health-Related Social Needs

    Time frame: Month 6

    Health-related social needs (HRSNs) will be assessed using the 26-item The Accountable Health Communities Health-Related Social Needs Screening Tool. The instrument assesses unmet health-related social needs across 13 domains, including housing instability, food insecurity, transportation needs, utility assistance needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disability. These domains identify social needs that may be addressed through clinical and community-based services. Each domain includes its own set of indicators. Descriptive statistics will be used to summarize the data, with frequencies and percentages reported for categorical variables. For domains with continuous or summed measures, composite scores will be calculated by summing the relevant items, with higher scores indicating greater unmet health-related social needs.

  24. Health-Related Social Needs

    Time frame: Month 12

    Health-related social needs (HRSNs) will be assessed using the 26-item The Accountable Health Communities Health-Related Social Needs Screening Tool. The instrument assesses unmet health-related social needs across 13 domains, including housing instability, food insecurity, transportation needs, utility assistance needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disability. These domains identify social needs that may be addressed through clinical and community-based services. Each domain includes its own set of indicators. Descriptive statistics will be used to summarize the data, with frequencies and percentages reported for categorical variables. For domains with continuous or summed measures, composite scores will be calculated by summing the relevant items, with higher scores indicating greater unmet health-related social needs.

  25. Cognitive Function

    Time frame: Baseline

    Cognitive function will be assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), a validated 15-point screening instrument for the rapid detection of mild cognitive impairment. Total scores range from 0 to 15, with higher scores indicating better cognitive function. A score below 11 may indicate cognitive impairment and warrant further evaluation.

  26. Cognitive Function

    Time frame: Month 6

    Cognitive function will be assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), a validated 15-point screening instrument for the rapid detection of mild cognitive impairment. Total scores range from 0 to 15, with higher scores indicating better cognitive function. A score below 11 may indicate cognitive impairment and warrant further evaluation.

  27. Cognitive Function

    Time frame: Month 12

    Cognitive function will be assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), a validated 15-point screening instrument for the rapid detection of mild cognitive impairment. Total scores range from 0 to 15, with higher scores indicating better cognitive function. A score below 11 may indicate cognitive impairment and warrant further evaluation.

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Hu, PhD

CONTACT

[email protected]

646-501-3438

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: LINK-IT

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 20, 2024
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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