300 Participants Needed

Remote Monitoring + Community Health Workers for High Blood Pressure

DM
TM
Overseen ByTiffany Martinez
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
Must be taking: Anti-hypertensives
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 tests a new method to help Latinx patients manage high blood pressure using remote technology and community health workers. Researchers aim to determine if this approach, called Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support, is more effective than usual care in lowering blood pressure and if it can be sustained over time. Latinx individuals who have struggled with high blood pressure despite medication and receive care at specific clinics are eligible to participate. As an unphased trial, this study allows patients to contribute to innovative healthcare solutions tailored to their community.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves monitoring blood pressure and requires participants to have been prescribed at least one anti-hypertensive medication, it seems likely that you will continue your current medication.

What prior data suggests that this remote patient monitoring-enabled community health worker support is safe for hypertension management?

Research has shown that remote patient monitoring (RPM) with community health workers (CHWs) can effectively manage high blood pressure. In previous studies, patients using this method saw improvements in their blood pressure levels. The treatment is generally well-tolerated, with no major side effects reported.

CHWs use technology to monitor patients and provide support, helping to catch issues early and ensure adherence to treatment plans. RPM is already used for other health conditions, suggesting it is safe for individuals with high blood pressure as well. Its testing in trials indicates it is considered safe enough for larger-scale study.12345

Why are researchers excited about this trial?

Researchers are excited about the Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) support because it offers a fresh, tech-savvy approach to managing high blood pressure, especially in Latinx patients with uncontrolled hypertension. Unlike standard treatments that often rely heavily on medication and regular in-person doctor visits, this method integrates digital tools to track patient health remotely, allowing CHWs to provide personalized support and intervention as needed. This model not only aims to improve blood pressure control but also enhances patient engagement and access to care, potentially leading to better health outcomes for underserved communities.

What evidence suggests that RPM-enabled CHW support is effective for hypertension management?

Research shows that remote patient monitoring (RPM) with community health workers (CHWs) can effectively manage high blood pressure. In this trial, Latinx patients with uncontrolled hypertension will receive RPM-enabled CHW support. Studies have found that RPM significantly lowers blood pressure. For instance, patients with uncontrolled high blood pressure experienced an average drop of 8.5 mmHg in their mean arterial pressure, an important measure of blood pressure. This indicates that RPM can significantly aid in controlling high blood pressure. RPM programs have also successfully reduced blood pressure in community settings, particularly among patients with more severe hypertension. This evidence supports the use of RPM-enabled CHW support as a valuable tool for managing high blood pressure.25678

Who Is on the Research Team?

Devin Mann, MD | NYU Langone Health

Devin Mann, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for Latinx individuals, 18 or older, who are not sticking to their high blood pressure meds and have uncontrolled hypertension. They must be getting care at certain clinics, speak English or Spanish, and can't be in other related trials or planning to leave the clinic soon.

Inclusion Criteria

Self-identify as Latinx
Receiving care at one of the 10 safety-net primary care clinics
I have not consistently taken my blood pressure medication as prescribed.
See 1 more

Exclusion Criteria

Participation in other hypertension-related clinical trials
Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
Plan to discontinue care at the clinic within the next 15 months
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RPM-enabled community health worker support for hypertension management

18 months
Remote monitoring with periodic in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support
Trial Overview The study tests if remote patient monitoring (RPM) with community health worker support is better than standard RPM for managing high blood pressure in Latinx patients. It's a step-wedge randomized trial focusing on effectiveness and how well it works over time.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Latinx patients with uncontrolled hypertension (HTN)Experimental 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 on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Published Research Related to This Trial

A community health worker-led intervention significantly improved blood pressure control among participants in rural South India, with control rates increasing from 49.5% to 69.7% in the intervention group compared to a smaller increase from 52.2% to 61.7% in the usual care group.
The intervention also resulted in greater reductions in both systolic and diastolic blood pressure, indicating its efficacy in managing hypertension, while maintaining similar levels of medication use between the groups.
Effectiveness of a scalable group-based education and monitoring program, delivered by health workers, to improve control of hypertension in rural India: A cluster randomised controlled trial.Gamage, DG., Riddell, MA., Joshi, R., et al.[2020]
In a program training community health workers (CHWs) in the Sittilingi Valley, India, 7,176 individuals were screened for hypertension, with 16.5% identified as hypertensive, demonstrating the potential of CHWs in managing chronic health conditions.
After two years, 75.8% of the hypertensive patients managed by CHWs achieved controlled blood pressure, indicating that this approach can significantly improve hypertension management in communities with limited access to healthcare.
An NGO-Implemented Community-Clinic Health Worker Approach to Providing Long-Term Care for Hypertension in a Remote Region of Southern India.Sankaran, S., Ravi, PS., Wu, YE., et al.[2018]
In a randomized controlled trial involving 421 participants with elevated blood pressure, enhanced tracking and follow-up services by community health workers significantly improved medical follow-up rates by 39.4% compared to usual care.
The intervention led to 65.1% of participants completing a follow-up visit within 90 days, compared to only 46.7% in the usual-care group, demonstrating the effectiveness of community health worker support in managing hypertension.
Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers.Krieger, J., Collier, C., Song, L., et al.[2019]

Citations

Remote Monitoring + Community Health Workers for High ...Research shows that community health workers (CHWs) using technology to monitor and support patients can effectively manage high blood pressure. Studies in ...
Remote Patient Monitoring Is Associated with Improved ...There was improvement in mean arterial pressure (MAP) in all patients with uncontrolled HTN by 8.5 mmHg (p < 0.0001). RPM is associated with ...
Efficiency of remote monitoring and guidance in blood ...Regular monitoring of blood pressure (BP) is essential for managing hypertension. The long-term effectiveness of remote monitoring in BP ...
Effect of Remote Patient Monitoring on Stage 2 HypertensionA community-based remote patient monitoring (RPM) program was associated with significant reduction in blood pressure in Medicare patients with stage 2 ...
Trial Designs Implementing remote patient monitoring to ...The Monitor-BP Trial tests a scalable approach to implementing telemonitoring-enabled Supported HBPM interventions into real-world clinical settings.
Project Details - NIH RePORTERDigital health tools such as remote patient monitoring (RPM) have potential to improve the care of Latinx patients with HTN by enabling more frequent and ...
Cardiovascular Health Markers With Remote Team-Based ...This study characterized the association between a remote patient monitoring, team-based hypertension intervention and cardiovascular health ...
Cardiovascular Health Markers with Remote Team-Based ...The impact of remote patient monitoring (RPM) for hypertension (HTN) on cardiovascular health (CVH) remains ill-defined. This study ...
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