Remote Monitoring + Community Health Workers for High Blood Pressure

Overseen By Tiffany Martinez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Anti-hypertensives

Disqualifiers: Psychiatric, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

300 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 5 6 7}

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. ^{1 2 3 4 8}

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

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.

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

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

Group I: Latinx patients with uncontrolled hypertension (HTN) Experimental Treatment 1 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).

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a community health worker-led program in rural Uganda, patients received hypertension care more frequently (every 35.6 days) compared to those at a central clinic (every 50.8 days), indicating improved access to care.

Patients in the community program had better hypertension control, with a lower average systolic blood pressure (147.8 mmHg) and a higher percentage of patients achieving target blood pressure levels (71.2%) compared to clinic patients (59.8%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. O'Neil, DS., Lam, WC., Nyirangirimana, P., et al.[2022]

In a study involving 60 Nigerian adults with hypertension, those receiving support from community health workers and using home blood pressure monitoring experienced greater reductions in systolic blood pressure after four weeks compared to those receiving usual care.

This suggests that integrating community health support and self-monitoring can be an effective strategy for managing hypertension in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effect of community health worker support and home monitoring for blood pressure control in Nigeria: a randomised pilot trial. Ojji, DB., Baldridge, AS., Orji, AI., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a pilot program involving 336 patients over 6-8 months in Lagos, Nigeria, a mobile health application connected pharmacists and cardiologists, leading to a significant reduction in mean systolic blood pressure by 9.9 mmHg and an increase in patients achieving target blood pressure from 24% to 56%.

Despite some challenges with data reporting and application usability, both patients and healthcare providers reported high satisfaction with the care model, indicating its feasibility and potential for improving hypertension management in sub-Saharan Africa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacy-based hypertension care employing mHealth in Lagos, Nigeria - a mixed methods feasibility study. Nelissen, HE., Cremers, AL., Okwor, TJ., et al.[2023]

References

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

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]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

Approaches and outcomes of community health worker's interventions for hypertension management and control in low-income and middle-income countries: systematic review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. South Africa pubmed.ncbi.nlm.nih.gov

Feasibility and effect of community health worker support and home monitoring for blood pressure control in Nigeria: a randomised pilot trial. [2022]

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

An NGO-Implemented Community-Clinic Health Worker Approach to Providing Long-Term Care for Hypertension in a Remote Region of Southern India. [2018]

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

Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Pharmacy-based hypertension care employing mHealth in Lagos, Nigeria - a mixed methods feasibility study. [2023]