EngageRx With Integrated Self-Measurement of Blood Pressure

Not Applicable

Withdrawn

• Conditions: Hypertension

• Registration Number: NCT06712966
• Lead Sponsor: University of California, San Francisco

Brief Summary

This pilot study will support use of EngageRx_SMBP for 70 patients in the UCSF General Internal Medicine practice. The goals of the pilot will be to assess usability and satisfaction of both patients and clinicians, and to describe BP-related process metrics and outcomes including time to intensification of BP medications and/or BP control.

Detailed Description

EngageRx is a programmable clinical decision support app that clinicians can access within the context of their electronic health record (EHR), and it can be connected with other technologies. We are integrating EngageRx with CareSimple, a company that provides a cellular-enabled BP device that patients can use for SMBP. CareSimple devices are FDA-cleared, can be shipped directly to patients, used by patients right out of the box (after installing batteries), and then deliver the SMBP measurements directly to the CareSimple cloud platform. There is no requirement to "sync" the device, and no need for patients to have a smartphone or set up an account or sign into anything. CareSimple supports a dashboard and portal that allows authorized users to sign in and access measurements for a patient, but this amounts to another barrier for clinicians to access the measurements; our integration with EngageRx will 1) allow clinicians to initiate SMBP monitoring for a patient with the click of a button (after confirming their shipping address and preferred language); 2) automatically register the patient in the CareSimple system, which triggers CareSimple to mail the patient the BP monitor device with instructions; and 3) automatically push the CareSimple SMBP measurements to EngageRx so they are available the next time the clinician opens EngageRx. The SMBP measurements will be used with EngageRx's internal algorithm, along with office BP measurements, to recommend BP management decisions to clinicians. We believe this integrated system, which we will refer to as EngageRx_SMBP, will make SMBP easy for clinicians and patients. We would like to determine if this system is truly easy to use for clinicians and providers, and whether it appears to facilitate the BP-related processes of care required for controlling hypertension.

Study Timeline

• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Study Start: 2025-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-07
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adult patient (18+ years old) with uncontrolled BP in an office visit
• Lowest SBP>140 or lowest DBP>90 during the visit at one of the Mt. Zion General Internal Medicine practices
• Speaks English or Spanish

Exclusion Criteria

• If patient is unlikely to be able to use a home BP monitor
• Cannot understand the verbal consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Net Promoter Score	3 months	This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States