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Clinical Trials/NCT06730230
NCT06730230
Recruiting
N/A

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

NYU Langone Health1 site in 1 country300 target enrollmentFebruary 10, 2025
ConditionsHypertension

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypertension
Sponsor
NYU Langone Health
Enrollment
300
Locations
1
Primary Endpoint
Change in systolic blood pressure
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 10, 2025
End Date
May 31, 2027
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Self-identify as Latinx
  • Be fluent in English or Spanish
  • Be age 18 years or older
  • Receiving care at one of the 10 safety-net primary care clinics
  • 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)
  • 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

  • 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)
  • 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

Outcomes

Primary Outcomes

Change in systolic blood pressure

Time Frame: Baseline, Month 18

Change in diastolic blood pressure

Time Frame: Baseline, Month 18

Secondary Outcomes

  • Rate of hypertension control(Month 18)

Study Sites (1)

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