The PCORnet Blood Pressure Home Monitoring Study (BP Home)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03796689|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : November 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Device: Smartphone-linked HBPM and associated app Device: Standard HBPM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The PCORnet Blood Pressure Home Monitoring Study|
|Actual Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||October 30, 2021|
Device: Smartphone-linked HBPM and associated app
Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publically available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.
|Active Comparator: Standard||
Device: Standard HBPM
Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publically available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.
- Reduction in Systolic Blood Pressure (SBP) [ Time Frame: 6 months ]Reduction is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used.
- Net Promoter Score [ Time Frame: 6 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796689
|Contact: Madelaine Faulkner, MPH||415-476-3393||Madelaine.Faulkner@ucsf.edu|
|Contact: Mark Pletcher, MD MPH||415-514-8008||Mark.Pletcher@ucsf.edu|
|United States, Florida|
|University of Florida Health||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Rhonda Cooper-Dehoff, PharmD|
|United States, Louisiana|
|University Medical Center||Recruiting|
|New Orleans, Louisiana, United States, 70112|
|Contact: Tom Carton, Ph.D|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Contact: Alanna Chamberlain, Ph.D|
|Principal Investigator:||Mark Pletcher, MD MPH||University of California, San Francisco|