Partners in Control, Phase II: Using Remote Monitoring Technology With Community Health Workers to Support Hypertension Management for Latinx Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiffany Martinez; Phone Number: 646-501-2505; Email: Tiffany.Martinez@nyulangone.org
• Study Contact Backup: Name: Devin Mann, MD; Phone Number: 212-263-8313; Email: Devin.Mann@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in systolic blood pressure	Baseline, Month 18
Change in diastolic blood pressure	Baseline, Month 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of hypertension control	Outcome measure will be assessed using the National Quality Forum-defined thresholds for controlled/uncontrolled hypertension (BP<140/90 mmHg).	Month 18

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Devin Mann, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Health Services Administration; Delivery of Health Care; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Patient Care Management; Palliative Care; Remote Patient Monitoring
• Other Study ID Numbers: 23-00746; 1R01MD018520-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Devin.Mann@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Devin.Mann@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No