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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Invitation-only

Conditions

Hypertension

Treatments

Device: Cellular Home blood pressure (BP) monitoring

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05481892
R01HL159372 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

540 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • English-and Spanish-speaking patients
  • Patient within the San Francisco Health Network (SFHN)
  • Has seen primary care provide within the past 2 years
  • Uncontrolled hypertension (HTN) in the HTN registry
  • Complete Aim 1 training, in addition to patients who have not completed Aim 1 training
  • Over the age of 18

Exclusion criteria

  • Under the age of 18
  • Controlled HTN

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

540 participants in 3 patient groups

Cellular Home blood pressure (BP) monitoring with minimal support
Experimental group
Description:
Patients will be instructed to write down their blood pressures (BP) in a BP log that will be provided to them at the time of enrollment. Study staff will access the patient's home BP measurements on the BP device dashboard and send a summary of the home BP measurements (mean, median, % of BP measurements at goal) to the primary care provider in a telephone encounter (TE) 3 to 5 days prior to the next scheduled visit.
Treatment:
Device: Cellular Home blood pressure (BP) monitoring
Cellular Home blood pressure (BP) monitoring with pharmacist support for treatment intensification
Active Comparator group
Description:
For patients randomized to this intervention arm, a pharmacist will review the home blood pressure (BP) measurements and use an evidence-based algorithm to make recommendations for medication intensification. If the patient has a primary care provider (PCP) appointment within 2 weeks, the pharmacist will send a telephone encounter (TE) with BP measurements and medication recommendations to the PCP 3 -5 days prior to the scheduled appointment. If the patients has no appointment scheduled within two weeks, the pharmacist will call the patient and prescribe medication intensification if the patient is amenable.
Treatment:
Device: Cellular Home blood pressure (BP) monitoring
Non-randomized usual care
No Intervention group
Description:
To compare the two intervention arms with usual care, investigators will extract electronic health record (EHR) data on active San Francisco Health Network (SFHN) adult patients (age 18+) with diagnosis of hypertension who made at least one primary care visit during the study period.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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