Video + CHW Support for Type 2 Diabetes

(LINK-IT Trial)

Overseen By Lu Hu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Breastfeeding, Sight impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

324 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether video lessons, with or without assistance from a community health worker, can help manage blood sugar levels in Chinese immigrants with uncontrolled Type 2 diabetes living in NYC. Some participants will watch weekly videos on diabetes management, while others will also receive phone support from a health worker. The trial seeks Chinese immigrants with Type 2 diabetes who struggle to manage their blood sugar levels and are open to receiving educational videos on their smartphones. As an unphased trial, participants can explore innovative educational tools that may enhance their diabetes management.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these interventions are safe for improving glycemic control?

Research has shown that using videos for Diabetes Self-Management Education and Support (DSMES) safely aids in managing diabetes. The CDC endorses DSMES as a personalized approach to help individuals control their condition.

Studies have also demonstrated that support from community health workers (CHWs) leads to positive outcomes without serious safety concerns. CHWs have participated in various programs to assist people with diabetes, resulting in health improvements without major risks. One review found that CHW interventions significantly improved blood sugar levels in individuals with Type 2 diabetes.

These findings suggest that both video-based DSMES and CHW support are safe and well-tolerated methods for managing diabetes. No evidence indicates these methods cause harm, making them promising options for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using video-based Diabetes Self-Management Education and Support (DSMES) combined with community health worker (CHW) support for managing Type 2 Diabetes because it offers a fresh approach to patient care. Unlike traditional methods that often rely on in-person consultations, this treatment leverages digital technology, delivering educational videos via text messages and providing personalized support through bi-weekly calls. This approach can increase accessibility, making it easier for patients to manage their condition from home. Additionally, the integration of CHW support provides a personal touch, potentially enhancing patient engagement and adherence to health recommendations.

What evidence suggests that this trial's treatments could be effective for Type 2 diabetes?

Research has shown that video-based education can help people with Type 2 diabetes manage their condition more effectively. For example, watching video lessons can improve self-care and blood sugar control. In this trial, participants in the VIDEO arm will receive one brief Diabetes Self-Management Education and Support (DSMES) video per week for 24 weeks. Another study found that online learning might be as effective as attending in-person classes for diabetes management. Additionally, support from community health workers (CHWs) has proven effective in helping people manage diabetes. These workers assist in understanding diabetes and provide ongoing support, leading to better long-term health. Participants in the VIDEO+CHW arm of this trial will receive both DSMES videos and bi-weekly support calls from a CHW. Both video education and CHW support have strong evidence of effectiveness in managing diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Lu Hu, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for Chinese immigrants in NYC, aged 18-70 with uncontrolled Type 2 diabetes (HbA1c of at least 8%). Participants must have seen a doctor for diabetes within the last year and be willing to watch educational videos on their smartphone or one provided by the study.

Inclusion Criteria

I am willing to watch videos about managing type 2 diabetes.

Self-identify as a Chinese immigrant

Possess a smartphone or be willing and able to use a study smartphone

Exclusion Criteria

Unable or unwilling to provide informed consent

Is breastfeeding (e.g., they may have potential dietary restrictions)

I have no major issues with my sight or hearing that would prevent me from participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DSMES videos weekly for 24 weeks, with the VIDEO+CHW group also receiving bi-weekly support calls from a community health worker

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker (CHW) Support
• Video-Based Diabetes Self-Management Education and Support (DSMES)

Trial Overview The study tests if video-based Diabetes Self-Management Education and Support (VIDEO), alone or combined with community health worker support (VIDEO+CHW), can better control blood sugar levels compared to waiting without these interventions.

How Is the Trial Designed?

Group I: VIDEO+CHW Experimental Treatment 2 Interventions

Participants assigned to the VIDEO+CHW arm will receive one brief DSMES video per week, in addition to bi-weekly support calls from a community health worker (CHW), for 24 weeks. The DSMES videos will be delivered via text message.

Group II: VIDEO Experimental Treatment 1 Intervention

Participants assigned to the VIDEO arm will receive one brief Diabetes Self-Management Education and Support (DSMES) video per week for 24 weeks. The videos will be delivered via text message.

Group III: CONTROL Active Control 1 Intervention

Participants assigned to the CONTROL group will continue to receive usual care.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Diabetes self-management education and support (DSMES) is crucial for people with diabetes, as it equips them with the necessary skills and knowledge to manage their condition effectively, leading to improved health outcomes.

The article highlights recent findings from the National Diabetes Education Program National Diabetes Survey, which identifies gaps in self-management behaviors and DSMES delivery, suggesting areas for improvement to enhance diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights From the National Diabetes Education Program National Diabetes Survey: Opportunities for Diabetes Self-Management Education and Support. Piccinino, LJ., Devchand, R., Gallivan, J., et al.[2020]

Only 6.5% of patients with newly diagnosed type 2 diabetes mellitus (T2DM) utilized diabetes self-management education and support (DSME/S), indicating a significant gap in education for this group.

In contrast, 32.7% of patients with T2DM who were prescribed insulin used DSME/S, with demographic factors such as race and insurance type influencing usage rates, highlighting the need for targeted interventions to improve access and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-specific factors associated with use of diabetes self-management education and support programs in Louisiana. Yoshida, Y., Hong, D., Nauman, E., et al.[2022]

A digital diabetes self-management education and support (DSMES) program significantly reduced hemoglobin A1c (HbA1c) levels by an average of 0.8% over 4 months in a study of 195 participants, indicating improved blood sugar control.

Participants with higher baseline HbA1c levels (>9.0%) experienced an even greater reduction of 1.4%, along with significant improvements in diabetes distress and medication adherence, suggesting the program's effectiveness in enhancing overall diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Insights From a Digitally Enhanced Diabetes Self-Management Education and Support Program: Single-Arm Nonrandomized Trial. Wilson-Anumudu, F., Quan, R., Castro Sweet, C., et al.[2021]

A digital health intervention (DHI) for diabetes self-management education and support (DSMES) should be integrated into routine care and provide structured, high-quality information to effectively meet the needs of patients with type 2 diabetes mellitus (T2DM) and diabetes specialist nurses (DSN).

Key elements for success include suggesting tasks to encourage behavioral changes and offering feedback from DSNs to patients, as identified through focus group discussions with 14 T2DM patients and 4 DSNs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming the struggle of living with type 2 diabetes - diabetes specialist nurses' and patients' perspectives on digital interventions. Jarl, F., Davelid, A., Hedin, K., et al.[2023]

Diabetes Self-Management Education and Support (DSMES) is essential for equipping individuals with the knowledge and skills needed for effective diabetes self-care, and it is increasingly being enhanced by technology to improve access and outcomes.

Despite strong evidence supporting the benefits of DSMES, it remains underutilized, highlighting the need for individualized services that cater to the specific concerns and preferences of people with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2017 National Standards for Diabetes Self-Management Education and Support. Beck, J., Greenwood, DA., Blanton, L., et al.[2022]

Educational videos for diabetes management can lead to a statistically significant reduction in HbA1C levels, with decreases ranging from -0.1% to -2.1% in several studies, indicating improved blood sugar control.

Participants reported positive feedback on the videos, highlighting the importance of cultural appropriateness and representation, which suggests that tailored educational content can enhance self-care and management of diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of videos for diabetes patient education: A systematic review. Hoe, CYW., Ahmad, B., Watterson, J.[2023]

The study aims to compare the effectiveness of Family-DSMES, which involves family members in diabetes self-management education, against Standard-DSMES for individuals with type 2 diabetes, involving participants aged 18 and older with a hemoglobin A1c of 7.0% or higher.

Data will be collected at multiple time points (baseline, post-intervention, and at 6, 12, and 18 months) to assess various outcomes, including the primary outcome of hemoglobin A1c levels, and to evaluate the impact on both the person with diabetes and their family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. Mayberry, LS., Felix, HC., Hudson, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265813/

Evaluating the effectiveness of community health worker ... Outcome heterogeneity was low (I2=21%), and the overall level of certainty was high. Conclusions. CHW interventions in type 2 diabetes showed ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524000603

Impact of community health workers on diabetes ... This program was effective in improving diabetes management among patients living in diabetes-burdened communities, and the effects were persistent throughout ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3222418/

Effectiveness of a Community Health Worker Intervention ... We report the results of a randomized controlled trial that tested whether a culturally tailored CHW intervention for diabetes self-management improved HbA1c ...

4. diabetesjournals.org diabetesjournals.org/care/article/41/7/1414/36448/Outcomes-at-18-Months-From-a-Community-Health

Outcomes at 18 Months From a Community Health Worker ... Participants in CHW-led DSME had significant improvements in diabetes social support and in understanding of diabetes self-management at 6 ...

5. researchprotocols.org researchprotocols.org/2024/1/e57313/

Training of Community Health Workers in Diabetes Lead to ... This study outlines a systematic review aiming to evaluate the impact of training programs for CHWs in diabetes management in LMICs.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6469661/

Effect of Community Health Worker Support on Clinical ... We hypothesized that, compared with patients who did not receive CHW support, those enrolled in the IMPaCT program would have improved self-rated health, ...

7. ysph.yale.edu ysph.yale.edu/news-article/perez-escamilla-receives-dollar400k-grant-to-study-novel-intervention-for-people-with-type-2-diabetes/

Study investigates impact of community health workers in ... The six-month study will determine whether providing patients with individual support by community health workers in addition to prescriptions for fresh fruits ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5766435/

Community Health Workers Supporting Clinical Pharmacists ... A pilot study partnering clinical pharmacists with CHWs to serve minority patients with poorly-controlled type 2 diabetes mellitus demonstrated feasibility of ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S105687272400120X?via%3Dihub

A community health worker led diabetes self-management ... Results suggest that HbA1c reductions resulted from the CHW-driven intervention rather than additional healthcare utilization. •. Results also suggest that the ...

10. bmjopen.bmj.com bmjopen.bmj.com/content/15/7/e096651

a systematic review and meta-analysis Conclusions CHW interventions in type 2 diabetes showed statistically significant and clinically important reductions in HbA1c levels in people from minority ...