Remote Monitoring for Equity in Advancing Control of Hypertension

NCT05481892 | Completed DMC FDA Device

• 1 other identifier: R01HL159372
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Blood pressure; Telehealth; Telemedicine; Patient generated health data; Remote patient monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Medication intensification

  6 months

• Blood Pressure (BP) control

  6 months

• Change in Home BP

  6 months

• Patient Assessment of Chronic Illness Care (PACIC)

  6 months

• Krousel-Wood Adherence Scale for medication adherence

  6 months

Study Arms (3)

Cellular Home blood pressure (BP) monitoring with minimal support

EXPERIMENTAL

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.

Device: Cellular Home blood pressure (BP) monitoring

Cellular Home blood pressure (BP) monitoring with pharmacist support for treatment intensification

ACTIVE COMPARATOR

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.

Device: Cellular Home blood pressure (BP) monitoring

Non-randomized usual care

NO INTERVENTION

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.

Interventions

Cellular Home blood pressure (BP) monitoring DEVICE

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

Cellular Home blood pressure (BP) monitoring with minimal support; Cellular Home blood pressure (BP) monitoring with pharmacist support for treatment intensification

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under the age of 18
• Controlled HTN

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital/University of California, San Francisco

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Courtney Lyles, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: April 20, 2023
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)