CHW-led Intervention for Type 2 Diabetes

NA
Overseen ByNaheed Ahmed, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach to help South Asian people in New York City manage Type 2 diabetes and depression. The treatment involves community health workers (CHWs) who provide health education that is culturally and linguistically tailored. The study also incorporates mental health support and digital tools. Individuals diagnosed with Type 2 diabetes, experiencing mild to severe depression, and having had a routine check-up in the past year may be a good fit for this trial. Participants must be South Asian and live in NYC.

As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions tailored to the community.

Will I have to stop taking my current medications?

If you are currently taking anti-depressant medication or receiving counseling services, you cannot participate in the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that this CHW-led intervention is safe for South Asians with Type 2 Diabetes?

Research has shown that programs led by community health workers (CHWs) are generally safe for patients. Various studies have found these programs effective in helping people manage type 2 diabetes (T2D). For instance, one study found that CHW involvement helped patients better control their diabetes. Another study demonstrated that CHW-led efforts improved blood sugar levels (measured by HbA1c) without increasing doctor visits.

Significant negative effects from these CHW-led programs have not been reported. Instead, the focus remains on their success in helping people manage their diabetes. This indicates that CHW-led programs are well-tolerated and do not pose major safety concerns for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the CHW-led Intervention for Type 2 Diabetes because it offers a personalized and culturally tailored approach to managing the condition. Unlike traditional treatments that often focus on medication and generic lifestyle advice, this intervention provides health education specifically designed for South Asian patients. By addressing both diabetes and depressive symptoms, the intervention aims to improve overall health outcomes in a way that respects cultural and linguistic needs. This community-based approach could enhance patient engagement and adherence, potentially leading to better management of Type 2 Diabetes in this population.

What evidence suggests that this CHW-led intervention is effective for Type 2 diabetes?

Research shows that community health worker (CHW) programs can greatly help people manage diabetes. Studies have found that these programs lead to better control of blood sugar levels, as indicated by lower HbA1c levels, an important measure of diabetes management. Participants often continue to see benefits even after the program ends. Additionally, CHW programs not only improve health but also lower healthcare costs for participants. Overall, evidence supports that CHW-led programs effectively manage Type 2 diabetes, especially in communities needing extra support.

In this trial, the CHW-led T2D Intervention will specifically target adult South Asian patients in the New York City region, providing culturally and linguistically tailored health education on managing Type 2 diabetes and depressive symptoms.46789

Who Is on the Research Team?

NA

Naheed Ahmed, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for South Asian individuals who have Type 2 Diabetes and may be at risk of developing depression. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions.

Inclusion Criteria

Aim 1 (Qualitative Component): Residing in NYC
Aim 1 (Qualitative Component): South Asian ethnicity based on self-report information
Aim 3: Pilot Intervention: South Asian ethnicity based on patient demographic information
See 8 more

Exclusion Criteria

Aim 3: Pilot Intervention: Inability to perform unsupervised physical activity
Aim 3: Pilot Intervention: Pregnant at the time of screening
I am currently on anti-depressant medication or receiving counseling.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Adaptation of CHW-led T2D intervention to include mental health and digital components using a trauma-informed care approach

4 weeks

Treatment

CHWs provide culturally and linguistically tailored health education on the management of T2D and depressive symptoms

3 months
Regular visits as per intervention protocol

Follow-up

Participants are monitored for changes in HbA1c levels, Diabetes Distress Scale, and PHQ-9 scores

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CHW-led T2D Intervention
Trial Overview The study is testing a modified diabetes intervention led by community health workers that now includes mental health support and digital tools, using an approach sensitive to trauma. It aims to see if this adapted program works well for the target group.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Adult South Asian patients in the New York City (NYC) regionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Outcomes at 18 Months From a Community Health Worker ...This study demonstrates the effectiveness of a 6-month CHW intervention on key diabetes outcomes and of a volunteer PL program in sustaining key achieved gains.
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 ...
Evaluating the effectiveness of community health worker ...Conclusions CHW interventions in type 2 diabetes showed statistically significant and clinically important reductions in HbA1c levels in people ...
The effectiveness of peer and community health worker-led ...Although limited data on economic outcomes is available, several studies demonstrated a reduction in health care expenses as a result of the CHW ...
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 ...
Health effectiveness of community health workers as a ...Integration of community health workers improved disease control for patients with type 2 diabetes mellitus during the intervention phase.
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.
Effect of a Community Health Worker Intervention Among ...In this randomized clinical trial of 300 Latino adults, a community health worker intervention resulted in modest improvements in hemoglobin A 1c levels.
Impact of a Community Health Workers–Led Structured ...The CHW intervention comprised 17 individual sessions delivered at home by CHWs over a 12-month period. Sessions addressed T2D complications, ...
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