Clinical trial NCT05481892: Remote Monitoring for Equity in Advancing Control of Hypertension
Official title: Remote Monitoring for Equity in Advancing Control of Hypertension (REACH)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertension
Keywords: Blood pressure
Telehealth
Telemedicine
Patient generated health data
Remote patient monitoring
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-08-01
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure (SBP)
timeFrame: 6 months
Secondary outcomes:
measure: Medication intensification
timeFrame: 6 months
measure: Blood Pressure (BP) control
timeFrame: 6 months
measure: Change in Home BP
timeFrame: 6 months
measure: Patient Assessment of Chronic Illness Care (PACIC)
timeFrame: 6 months
measure: Krousel-Wood Adherence Scale for medication adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital/University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Courtney Lyles, PhD
role: PRINCIPAL_INVESTIGATOR
References: