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Recruiting NCT06730230

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

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in systolic blood pressure [Time frame: Baseline, Month 18]
  • Change in diastolic blood pressure [Time frame: Baseline, Month 18]
Secondary outcome measures (1)
  • Rate of hypertension control [Time frame: Month 18]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06730230 · 23-00746 · 1R01MD018520-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗