DSMES Videos + CHW Support for Type 2 Diabetes

(IDEAL Trial)

Overseen By Lu Hu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Breastfeeding, Sensory impairments, others

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

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a video-based diabetes education and support program for Chinese immigrants with Type 2 diabetes living in New York City. Participants will divide into two groups: one will receive weekly educational videos and support from a community health worker (Community Health Worker Support, or CHW), while the other will continue with their usual care and receive the videos later. This trial suits Chinese immigrants with Type 2 diabetes who have an HbA1c (a blood test that shows average blood sugar levels) of 8% or higher and are comfortable using or willing to use a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance diabetes care for the Chinese immigrant community.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual care, as the control group will do so.

What prior data suggests that the DSMES videos and CHW support are safe for improving glycemic control in Type 2 diabetes?

Research has shown that Diabetes Self-Management Education and Support (DSMES) safely helps people manage diabetes. Studies indicate that DSMES can lower blood sugar levels (measured as A1C) by about 0.45% to 0.57% compared to regular care, suggesting effectiveness without harm.

Support from Community Health Workers (CHWs) is also well-received. Research demonstrates that programs led by CHWs can improve blood sugar levels without requiring more doctor visits, allowing people to benefit without extra stress on their health or daily lives.

Together, DSMES videos and CHW support provide a safe way to manage type 2 diabetes. Studies have not found any serious side effects or risks with these methods, ensuring participants can feel confident about their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DSMES Videos + CHW Support approach for Type 2 Diabetes because it offers a unique combination of educational content and personalized support. Unlike standard treatments that often focus only on medication and self-monitoring, this method integrates brief, accessible educational videos with regular, supportive interactions from Community Health Workers (CHWs). The videos provide quick, digestible information based on Social Cognitive Theory to encourage positive behavior change. Meanwhile, CHWs offer personalized assistance every two weeks to address social determinants of health and help patients navigate healthcare challenges. This dual approach not only educates but also empowers patients to manage their condition more effectively and access necessary community resources.

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

This trial will compare the effectiveness of a combined approach using Diabetes Self-Management Education and Support (DSMES) videos and Community Health Worker (CHW) support against standard care. Research has shown that a mix of educational videos and CHW support can improve diabetes management. Studies indicate that participants in CHW-led programs often gain a better understanding of diabetes management and receive more social support. One study found that this approach led to better blood sugar control, as evidenced by lower HbA1c levels. Another study noted that this method is cost-effective and improves health compared to standard care. Overall, evidence supports the effectiveness of this combined approach in managing diabetes. ^{2 6 7 8 9}

Who Is on the Research Team?

Lu Hu, PhD

Principal Investigator

NYU School of Medicine

Are You a Good Fit for This Trial?

This trial is for low-income Chinese immigrants in NYC with Type 2 diabetes. Participants should not have received the DSMES videos or CHW support before. They must be willing to receive text messages and engage with community resources if needed.

Inclusion Criteria

Participants must self-identify as a Chinese immigrant

Participants must have a most recent HbA1c > or = 8%

I have been diagnosed with type 2 diabetes.

Exclusion Criteria

Participants who are breastfeeding (e.g., they may have potential dietary restrictions)

I can see and hear well enough to participate in the study.

Participants who are pregnant, plan to become pregnant in the next 6 months, or become pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the IDEAL group receive 1 DSMES video per week for 24 weeks, with CHW support every 2 weeks

24 weeks

12 phone calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study compares two groups: one receives weekly diabetes education videos via text and help from a community health worker for 24 weeks, while the other continues usual care and gets the videos after the study ends.

How Is the Trial Designed?

Group I: DSMES+CHW (IDEAL) Experimental Treatment 2 Interventions

Participants in this group will receive brief pre-recorded DSMES videos, which include both educational and Social Cognitive Theory-based behavioral content. Participants will receive 1 DSMES video via text message each week for a total of 24 weeks with each video lasting about 5 minutes in duration. In addition, they will also receive brief phone calls from CHWs every 2 weeks during the 24 weeks video program. During these calls, CHWs will assess whether participants need assistance on social determinants of health (SDOH) barriers. If needed, CHWs will link participants to available services within the community. CHWs will also provide assistance on navigating the complex health care systems and serve as an advocate for patients during doctor visits if needed.

Group II: Wait-list control group (CONTROL) Active Control 1 Intervention

Participants in this group will continue to receive the standard of usual care for their T2D at their doctor's office during the course of our study.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

A community health worker (CHW) diabetes self-management education program significantly reduced HbA1c levels and diabetes distress in Latino adults with type 2 diabetes over 6 months compared to enhanced usual care, indicating its effectiveness in managing diabetes.

Participants who continued with a peer leader (PL) program maintained their HbA1c improvements and reported fewer depressive symptoms at 18 months, suggesting that ongoing support is crucial for sustaining diabetes management gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Spencer, MS., Kieffer, EC., Sinco, B., et al.[2022]

Community health workers (CHWs) played a crucial role in a diabetes self-management intervention for low-income individuals, addressing barriers such as lack of diabetes knowledge, socioeconomic challenges, and healthcare system complexity through personalized education and support.

The study analyzed 634 encounter reports from 145 participants, highlighting that CHWs provided essential resources and guidance, demonstrating their effectiveness in improving diabetes management beyond what typical primary care can offer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of Community Health Workers in Diabetes Management in Low-Income Populations: A Qualitative Study. Silverman, J., Krieger, J., Sayre, G., et al.[2022]

Community health workers (CHWs) played a crucial role in diabetes self-management by providing encouragement and motivation during 1859 individual patient contacts, which helped patients incorporate diabetes management into their daily lives.

Patients reported that the personal connection and support from CHWs were distinct from that provided by family or healthcare teams, highlighting the importance of integrating CHWs into standard diabetes care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching how, not what: the contributions of community health workers to diabetes self-management. Davis, KL., O'Toole, ML., Brownson, CA., et al.[2018]

In a study involving 116 participants, primarily Native Hawaiian and Samoan, community health workers (CHWs) significantly improved diabetes management, leading to a mean reduction in HbA1c of 2.2% for those receiving CHW support.

In contrast, participants without CHW intervention only experienced a minimal reduction of 0.2% in HbA1c, highlighting the effectiveness of CHWs in enhancing diabetes education and management in ethnic minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes management: utilizing community health workers in a Hawaiian/Samoan population. Beckham, S., Bradley, S., Washburn, A., et al.[2022]

Patients in a Community Health Worker (CHW)-led diabetes self-management education program showed significant improvements in their blood glucose levels (A1C) and blood pressure after one year, indicating the program's effectiveness.

CHWs effectively bridged the gap between patients and primary care providers by offering support in diabetes management, education, and access to resources, demonstrating their valuable role in enhancing diabetes care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a community health worker-led diabetes self-management education program and implications for CHW involvement in care coordination strategies. Collinsworth, AW., Vulimiri, M., Schmidt, KL., et al.[2022]

The diabetes education program for community health workers led to significant improvements in patients' lipid profiles, with reductions in total cholesterol and triglycerides, indicating potential benefits beyond just blood sugar control.

While both the intervention and control groups showed a decrease in HbA1c levels, the changes were not statistically different between the two groups, suggesting that the education program did not have a unique impact on blood sugar levels compared to standard health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial. de Souza, CF., Dalzochio, MB., Zucatti, ATN., et al.[2022]

Participants in a community health worker (CHW) diabetes self-management program reported significant improvements in their ability to manage diabetes, including better information access and increased confidence in communicating with healthcare providers.

The program effectively addressed gaps in diabetes care by providing education, motivation, and peer support, which empowered participants to take a more active role in their healthcare and may help reduce racial and ethnic disparities in diabetes outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participants' assessments of the effects of a community health worker intervention on their diabetes self-management and interactions with healthcare providers. Heisler, M., Spencer, M., Forman, J., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33958424/

Cost-Effectiveness of a Diabetes Self-Management Education ... The CHW + PL-led DSME/DSMS intervention improved health and provided good value compared with the EUC intervention. The 6-month CHW-led DSME ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24052203/

Effectiveness of a community health worker-led diabetes ... The purpose of this study was to evaluate the effectiveness of a Community Health Worker (CHW)-led diabetes self-management education (DSME) program.

3. 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 ...

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. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-020-01377-8

The effectiveness of peer and community health worker-led ... COMP-DSMPs were inconsistently associated with improvements in clinical, behavioural, and psychological outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4833481/

Diabetes Self-management Education and Support in Type ... Diabetes self-management education (DSME) is the process of facilitating the knowledge, skill, and ability necessary for diabetes self-care.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38878424/

A community health worker led diabetes self-management ... Conclusions: Findings suggest that the SIMPLE trial's improved HbA1c levels stemmed from a CHW-driven intervention and not additional healthcare contact.

8. formative.jmir.org formative.jmir.org/2025/1/e79032

Assessing a Community Health Worker-Facilitated, Digitally ... Low-income Latino populations also experience significant disparities in diabetes self-management education and support (DSMES) outcomes [ ...

9. diabetesjournals.org diabetesjournals.org/care/article/43/7/1636/35565/Diabetes-Self-management-Education-and-Support-in

Diabetes Self-management Education and Support in Adults ... Based on recent data (13,14,16), DSMES results in an average A1C reduction of 0.45–0.57% when compared with usual care for people with type 2 ...