Remote Monitoring for Equity in Advancing Control of Hypertension

Not Applicable

• Conditions: Hypertension

• Registration Number: NCT05481892
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2023-04-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure (SBP)	6 months	We will use clinic-based assessment of SBP as the primary outcome of interest, using all SBP measurements during any outpatient encounter in the 6 months prior to enrollment in the study and the 6 months during the active intervention period. Blood pressure (BP) is collected routinely during all patient encounters in our system, using a standardized BP measurement protocol that requires the use of automated BP machines at primary clinics broadly implemented as part of ongoing, previously described, qualify improvement efforts.

Secondary Outcome Measures

Name	Time	Method
Medication intensification	6 months	We will review prescribing patterns for anti-hypertensive medications for each patient in the trial. This will be measured as total proportion of patients with medication intensification (new medication or increased dosage) over the study period.
Krousel-Wood Adherence Scale for medication adherence	6 months	We will collect patient-reported outcomes on a baseline survey at onboarding, with a repeat follow-up survey at 6 months when they exit the study. Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4), is a hybrid tool developed to predict pharmacy refill and which captures four domains of adherence behavior: self-efficacy, physical function, intentional medication-taking, and forgetfulness. The 4-item scale categorized participants as low and high adherers using scores at least 1 and less than 1, respectively. The higher scores mean a better outcome.
Blood Pressure (BP) control	6 months	We will define BP control as Systolic blood pressure (SBP) \<140mmg and Diastolic blood pressure (DBP) \<90 mmHg in secondary analyses. This BP control analysis will also use all available BP readings and treat every clinic BP reading as separate repeated binary assessments.
Change in Home BP	6 months	We will also examine change in BP (systolic and diastolic) based on the Home BP measurements from the cellular monitors.
Patient Assessment of Chronic Illness Care (PACIC)	6 months	We will collect patient-reported outcomes on a baseline survey at onboarding, with a repeat follow-up survey at 6 months when they exit the study. The Patient Assessment of Care for Chronic Conditions (PACIC) is a 22-item self-measurement of how well patients perceive their chronic condition(s) are being managed by their health care team. Patients fill out a survey of 20 questions regarding elements of the care of their chronic condition(s). Patients answer using a Likert scale of answers ranging from 1-5, with 1 signifying "None of the time" and 5 signifying "Always". The mean is used to find an overall score of the PACIC. The higher scores mean a better outcome.

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital/University of California, San Francisco; 🇺🇸 San Francisco, California, United States