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?

The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D 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.

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.

Is the combination of DSMES videos and CHW support safe for humans?

The research on Community Health Worker (CHW) support for diabetes management suggests that it is generally safe, as it involves education and support rather than medical interventions. CHWs help people manage their diabetes by teaching them skills and providing support, which has not been associated with any safety concerns in the studies reviewed. ^{1 2 3 4 5}

How is the DSMES Videos + CHW Support treatment for Type 2 Diabetes different from other treatments?

This treatment is unique because it combines educational videos on diabetes self-management with support from community health workers (CHWs), who help patients understand and manage their condition through personalized education and assistance in navigating healthcare resources, which is not typically offered in standard diabetes care. ^{1 2 5 6 7}

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

Research shows that community health workers (CHWs) and diabetes self-management education programs help people manage their diabetes better by improving their blood sugar levels and overall health. These programs are especially effective in supporting underserved communities by addressing barriers to care and providing peer support. ^{1 2 6 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 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]

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]

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]

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]

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]

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]

Citations

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

Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. [2022]

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

Teaching how, not what: the contributions of community health workers to diabetes self-management. [2018]

3. United States 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. [2022]

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

Using Peer Power to Reduce Health Disparities: Implementation of a Diabetes Support Coach Program in Federally Qualified Health Centers. [2023]

5. Netherlands 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. [2022]

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

Diabetes management: utilizing community health workers in a Hawaiian/Samoan population. [2022]

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

Diabetes training for community health workers on an American Indian reservation. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The Value of Community Health Workers in Diabetes Management in Low-Income Populations: A Qualitative Study. [2022]

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

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial. [2022]