Recruiting

Hypertension Management

Sponsor:

NYU Langone Health

Code:

NCT06730230

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support

Study Details

Brief summary:

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.

Conditions

Hypertension

Study ID

NCT06730230

Start date

Feb 10, 2025

Status verified date

Dec, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Self-identify as Latinx
2. Be fluent in English or Spanish
3. Be age 18 years or older
4. Receiving care at one of the 10 safety-net primary care clinics
5. Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg)
6. Have been prescribed at least one anti-hypertensive medication and be non-adherent to their medications, defined as adherence <80% in the preceding 12 months, as determined by prescription orders obtained from the clinic EHR.

Exclusion Criteria:

1. Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
2. Participation in other hypertension-related clinical trials
3. Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
4. Plan to discontinue care at the clinic within the next 15 months

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Latinx patients with uncontrolled hypertension (HTN)

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).

Interventions

Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support

CHWs will implement RPM by being provided with training modules and implementing electronic health record (EHR) support tools for HTN management.

Primary outcome measure

  • Change in systolic blood pressure [ Time Frame: Baseline, Month 18 ]
  • Change in diastolic blood pressure [ Time Frame: Baseline, Month 18 ]

Central Contacts and Locations

Central contacts

Devin Mann, MD

212-263-8313Devin.Mann@nyulangone.org

Tiffany Martinez

646-501-2505Tiffany.Martinez@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-04.