Clinical Trials Logo

Clinical Trial Summary

The PCORnet Blood Pressure Home Monitoring (BP HOME) Study is a patient-level randomized controlled trial that will compare the effectiveness of home blood pressure monitoring (HPBM) with versus without a linked Smartphone application ("app") for helping patients with uncontrolled hypertension achieve a reduction in systolic blood pressure. The trial will be conducted within the National Patient-Centered Clinical Research Network (PCORnet), which supports a research network that enables distributed querying of EHR data in a common data model. It will also use the Eureka Research Platform, an online research platform hosted by UCSF that supports eConsent, online surveys, and data collection from devices such as HBPMs. Data from these two data sources will be used together to accomplish the study aims. Given that HBPM is the guideline-recommended standard of care (without specification of Smartphone linkage), the HPBM devices and the app are all commercially available and currently in use, and that clinicians, with input from patients, will maintain full control of how BP is clinically managed, we believe participation in the project poses minimal risk to participants.


Clinical Trial Description

We have designed a patient-level randomized controlled trial that will compare the effectiveness of Smartphone-linked versus standard HBPM for helping patients with uncontrolled hypertension achieve a reduction in their Systolic Blood Pressure (SBP), and patient satisfaction with the device. We aim to enroll 2000 patients who will be randomized in a 1:1 ratio to receive a Smartphone-linked or standard HBPM. We will use data from the electronic health record (EHR), an online patient portal, and the home BP monitor (in the Smartphone-linked arm) to collect outcome data for a period of at least 6 months (for the primary outcome), and up to 18 months (for secondary outcomes, depending on enrollment date). The primary BP control outcome will be reduction in SBP, by clinic measurements, at 6 months. The primary patient satisfaction outcome will be the Net Promoter Score derived from self-reported likelihood of recommending the device to a friend, at 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03796689
Study type Interventional
Source University of California, San Francisco
Contact Shiffen Getabecha, MPH
Phone 415-502-2647
Email shiffen.getabecha@ucsf.edu
Status Not yet recruiting
Phase N/A
Start date March 1, 2019
Completion date July 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Recruiting NCT03632668 - Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072 Phase 1
Recruiting NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Recruiting NCT02699645 - Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Phase 3
Enrolling by invitation NCT03660631 - Dissemination of the Cardiovascular Risk Service N/A
Recruiting NCT02796313 - Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities N/A
Recruiting NCT03266510 - Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function N/A
Completed NCT00508365 - Evaluation of Potential for Orthostatic Hypotension in Elderly Hypertensives Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Not yet recruiting NCT03678207 - The Effectiveness of a Preoperative Blood Pressure Screening Program to Identify Undiagnosed Hypertension in Ambulatory Surgery Patients
Recruiting NCT03249753 - The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects Phase 1
Completed NCT03100812 - Asian American Partnerships in Research and Empowerment (AsPIRE) N/A
Recruiting NCT03099343 - Tailored Messaging to Reduce Sodium Intake N/A
Active, not recruiting NCT03288142 - The Smart Hypertension Control Study N/A
Completed NCT02147626 - Heart Health 4 Moms N/A
Not yet recruiting NCT03661177 - Reclaiming Indigenous Food and Health N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Safety and Efficacy of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Not yet recruiting NCT03293147 - OUTREACH: Urine Analysis and Antihypertensive Treatment N/A
Withdrawn NCT03292393 - Social Norms and Antihypertensive Medication Adherence N/A
Not yet recruiting NCT03554382 - Efficient Self-management of Chronic Disease Using Health Information Technology - a Study on Hypertension N/A