Remote Monitoring for Equity in Advancing Control of Hypertension

Hypertension Clinical Trial

— REACH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05481892
• Other study ID #: R01HL159372
• Secondary ID: R01HL159372
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 540
• Est. completion date: June 30, 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Cellular Home blood pressure (BP) monitoring
Patients receiving intervention will receive cellular home blood pressure (BP) monitoring devices. Some patients will also receive pharmacist support for treatment intervention.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital/University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure (SBP)	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.	6 months
Secondary	Medication intensification	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.	6 months
Secondary	Blood Pressure (BP) control	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.	6 months
Secondary	Change in Home BP	We will also examine change in BP (systolic and diastolic) based on the Home BP measurements from the cellular monitors.	6 months
Secondary	Patient Assessment of Chronic Illness Care (PACIC)	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.	6 months
Secondary	Krousel-Wood Adherence Scale for medication adherence	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.	6 months