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Active Not RecruitingNCT05481892

Remote Monitoring for Equity in Advancing Control of Hypertension

Remote Monitoring for Equity in Advancing Control of Hypertension (REACH)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
540 (estimated)
Sponsor
University of California, San Francisco · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to support patients with hypertension self-management using both home blood pressure monitors and digital messaging programs. The investigators will first engage patients with technology training to use home monitors, online portal websites to view their medical record information online, and texting and mobile phone applications. Then investigators will assess the effectiveness of home blood pressure monitors and enhanced patient-clinician digital communication on blood pressure control during a 12-month intervention.

Detailed description

This study aims to launch an effectiveness-implementation hybrid randomized trial to adapt a multi-faceted hypertension (HTN) management program shown to work in integrated healthcare delivery systems to a safety net healthcare system, San Francisco Health Network (SFHN). In Aim 1 of this study, investigators will offer patients brief in-person training to support their use of the online patient portal and basics about text messaging. Investigators will examine pre-post training changes in technology use overall as well as by specific patient subgroups with known differences in technology uptake. In Aim 2 investigators will conduct a three-arm randomized controlled trial to compare varying levels of implementation support: 1) cellular-enabled blood pressure (BP) monitors (with minimal implementation support), 2) cellular-enabled BP monitors with protocol-based implementation support (text reminders for patients; aggregated BP summaries sent to primary care providers), and 3) cellular-enabled BP monitors and pharmacist-led support (pharmacist coaching and independent medication adjustments). In Aim 3 investigators will use a mixed methods approach to evaluate key implementation outcomes, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, of adapting an existing, evidence-based home BP monitoring program.

Conditions

Interventions

TypeNameDescription
DEVICECellular Home blood pressure (BP) monitoringPatients receiving intervention will receive cellular home blood pressure (BP) monitoring devices. Some patients will also receive pharmacist support for treatment intervention.

Timeline

Start date
2023-04-20
Primary completion
2026-04-01
Completion
2026-06-30
First posted
2022-08-01
Last updated
2026-03-24

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05481892. Inclusion in this directory is not an endorsement.