EngageRx With Integrated Self-Measurement of Blood Pressure

NCT06712966 | Withdrawn

• 2 other identifiers: 24-428351R43DP006817-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Net Promoter Score

  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.

  3 months

Study Arms (1)

EngageRx_SMBP

EXPERIMENTAL

Integrated SMBP monitoring using EngageRx\_SMBP.

Other: EngageRx_SMBP

Interventions

EngageRx_SMBP OTHER

Patients 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.

EngageRx_SMBP

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• New York University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald DJ, Simpson AH, Howie CR. Assessing treatment outcomes using a single question: the net promoter score. Bone Joint J. 2014 May;96-B(5):622-8. doi: 10.1302/0301-620X.96B5.32434.

  PMID: 24788496 BACKGROUND

• Krol MW, de Boer D, Delnoij DM, Rademakers JJ. The Net Promoter Score--an asset to patient experience surveys? Health Expect. 2015 Dec;18(6):3099-109. doi: 10.1111/hex.12297. Epub 2014 Oct 27.

  PMID: 25345554 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mark Pletcher, MD MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm interventional study with comparison to historical controls

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)