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

Not Applicable

Recruiting

• Conditions: Hypertension

• Registration Number: NCT06730230
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Status Verified: 2025-02
• Study Start: 2025-02-10
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-07-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	Baseline, Month 18
Change in diastolic blood pressure	Baseline, Month 18

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States