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)

Trial Summary

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 data supports the effectiveness of the treatment Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support for high blood pressure?

Research shows that community health workers (CHWs) using technology to monitor and support patients can effectively manage high blood pressure. Studies in countries like India and Nigeria found that CHW-led programs, which include home monitoring, helped reduce blood pressure more effectively than usual care.12345

Is the combination of remote monitoring and community health workers safe for managing high blood pressure?

The studies suggest that using community health workers with technology support for managing high blood pressure is generally safe. There were no significant safety concerns reported, and the approach has been successfully used in various settings to help manage blood pressure.23567

How is the Remote Patient Monitoring-enabled Community Health Worker Support treatment for high blood pressure different from other treatments?

This treatment is unique because it combines remote patient monitoring with support from community health workers, allowing for continuous blood pressure management and personalized care, especially in resource-limited settings. Unlike traditional treatments that may rely solely on medication or periodic doctor visits, this approach provides ongoing support and education, potentially improving blood pressure control through regular monitoring and community-based interventions.12348

What is the purpose of this trial?

This study seeks to evaluate the impact of a remote patient monitoring (RPM)-specific tech-enabled community health worker workforce on the use of RPM for the management of hypertension among Latinx patients. This study is a step-wedge randomized controlled trial that aims to assess the effectiveness and implementation of RPM-enabled community health workers (CHWs) compared to standard of care RPM hypertension management on blood pressure reduction and evaluate the implementation of the RPM-enabled CHWs for hypertension (HTN) management. The study aims to examine adoption, acceptability, fidelity, cost, sustainability, and equity as outcomes of implementation effectiveness.

Research Team

Devin Mann, MD | NYU Langone Health

Devin Mann, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Latinx patients with uncontrolled hypertension (HTN)Experimental Treatment1 Intervention
Patients will be exposed to the RPM-enabled CHW support, this will be carried out through the step-wedge design, meaning that over the course of the study (\~18 months), all clinics will carry out standard HTN care and also have exposure to the intervention (though at varying time intervals).

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+

Findings from Research

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]
A community health worker (CHW)-led program in Hyderabad effectively screened over 51,000 participants for diabetes and hypertension, demonstrating that technology-enabled interventions can manage these conditions in low-income settings.
Participants who remained in the program showed significant reductions in fasting blood glucose and blood pressure levels, indicating that long-term engagement is crucial for effective management of chronic diseases.
Community health worker-led, technology-enabled private sector intervention for diabetes and hypertension management among urban poor: a retrospective cohort study from large Indian metropolitan city.Deo, S., Singh, P.[2021]
Community health worker (CHW) interventions in low- and middle-income countries have shown positive effects on reducing blood pressure, improving treatment adherence, and lowering cardiovascular disease risk among hypertensive patients and healthy individuals, based on a review of 14 studies.
The review highlighted that while CHW interventions were effective, the diversity in intervention types and outcomes prevented a meta-analysis, indicating a need for further research to assess the overall impact and cost-effectiveness of these programs.
Approaches and outcomes of community health worker's interventions for hypertension management and control in low-income and middle-income countries: systematic review.Mbuthia, GW., Magutah, K., Pellowski, J.[2023]

References

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. [2020]
Community health worker-led, technology-enabled private sector intervention for diabetes and hypertension management among urban poor: a retrospective cohort study from large Indian metropolitan city. [2021]
Approaches and outcomes of community health worker's interventions for hypertension management and control in low-income and middle-income countries: systematic review. [2023]
Evaluation of care access and hypertension control in a community health worker driven non-communicable disease programme in rural Uganda: the chronic disease in the community project. [2022]
Feasibility and effect of community health worker support and home monitoring for blood pressure control in Nigeria: a randomised pilot trial. [2022]
An NGO-Implemented Community-Clinic Health Worker Approach to Providing Long-Term Care for Hypertension in a Remote Region of Southern India. [2018]
Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. [2019]
Pharmacy-based hypertension care employing mHealth in Lagos, Nigeria - a mixed methods feasibility study. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security