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

Trial Summary

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 data supports the effectiveness of the treatment Community Health Worker (CHW) Support, Video-Based Diabetes Self-Management Education and Support (DSMES) for Type 2 Diabetes?

Research shows that educational videos for diabetes can significantly lower blood sugar levels and improve health knowledge and self-care skills. Additionally, diabetes self-management education programs, which include video components, have been found to enhance health outcomes and are well-received by participants. ^{1 2 3 4 5}

Is the Video + CHW Support for Type 2 Diabetes safe for humans?

The research articles reviewed do not provide specific safety data for Video + CHW Support for Type 2 Diabetes, but they suggest that diabetes self-management education and support (DSMES), including video-based interventions, is generally well-received and focuses on improving health outcomes without indicating safety concerns. ^{2 6 7 8 9}

How is the Video-Based Diabetes Self-Management Education and Support (DSMES) treatment different from other treatments for type 2 diabetes?

This treatment is unique because it combines video-based education with support from community health workers, making it more accessible and personalized compared to traditional methods. It leverages digital technology to improve the delivery and utilization of diabetes self-management education, which is often underutilized despite its proven benefits. ^{6 9 10 11 12}

What is the purpose of 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 immigrants with uncontrolled Type 2 diabetes in NYC.

Research Team

Lu Hu, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Integrating Undergraduate Patient Partners into Diabetes self-management education: Evaluating a free clinic pilot program for the Underserved. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The use of videos for diabetes patient education: A systematic review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The effectiveness of social media intervention in people with diabetes: An integrative review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Diabetes education in a Mexican-American population: pilot testing of a research-based videotape. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

To Adapt or Not to Adapt: The Association between Implementation Fidelity and the Effectiveness of Diabetes Self-Management Education. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Overcoming the struggle of living with type 2 diabetes - diabetes specialist nurses' and patients' perspectives on digital interventions. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Patient-specific factors associated with use of diabetes self-management education and support programs in Louisiana. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Insights From the National Diabetes Education Program National Diabetes Survey: Opportunities for Diabetes Self-Management Education and Support. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

2017 National Standards for Diabetes Self-Management Education and Support. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

2017 National Standards for Diabetes Self-Management Education and Support. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Early Insights From a Digitally Enhanced Diabetes Self-Management Education and Support Program: Single-Arm Nonrandomized Trial. [2021]