Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT06712966

EngageRx With Integrated Self-Measurement of Blood Pressure

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University of California, San Francisco · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHEREngageRx_SMBPPatients in the EngageRx\_SMBP arm will be automatically registered in the CareSimple system and mailed a device they can use at home. They may also choose to install a smartphone application from CareSimple that will provide reminders about measuring their BP. The clinician will then manage the patient's hypertension according to the standard of care. The SMBP measurements from CareSimple will be available through EngageRx for them to use, and they will receive a weekly staff message to check EngageRx if there are new SMBP measurements for them to review. The clinician will also be able to indicate when they would like to stop using the CareSimple system.

Timeline

Start date
2025-02-01
Primary completion
2025-08-01
Completion
2025-08-01
First posted
2024-12-03
Last updated
2025-04-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06712966. Inclusion in this directory is not an endorsement.