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

NCT ID: NCT06730230

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

With the stepped-wedge design, each clinic will function as a control or "usual care" group prior to the implementation of the intervention. During this period, the clinic will prescribe and treat patients enrolled in the RPM hypertension program using usual protocols.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Devin Mann, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Devin Mann, MD

Role: CONTACT

212-263-8313

Tiffany Martinez

Role: CONTACT

646-501-2505

Other Identifiers

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1R01MD018520-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-00746

Identifier Type: -

Identifier Source: org_study_id

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