NCT05390502

University of California Health Remote (Home) Monitoring Evaluation

Evaluation of a University of California-wide Quality Improvement Effort to Improve Blood Pressure Control Using Remote (Home) Monitoring

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study sets out to evaluate a University of California-wide (Davis, San Francisco, and Los Angeles) quality improvement initiative to increase remote (home) blood pressure monitoring and improve blood pressure control for persons with hypertension. Participants at each site will be randomized to one of two types of remote monitoring: integrated versus manual. Participants using the integrated monitoring will have their home blood pressure readings sent directly to their participating health systems. Participants using the manual monitoring will record their own blood pressures and report them to their health care system as per usual care.

Detailed description

Hypertension is an important modifiable risk factor for numerous adverse health outcomes including cardiovascular and kidney disease. In 2017, about 45.3% of US adults had hypertension or were taking antihypertensive medications (1). Hypertension has historically been diagnosed and treated using office-based blood pressure measurements, however blood pressure may differ when measured in the office compared to the home setting. Because of this discrepancy, and an extensive body of evidence supporting remote monitoring, national guidelines for hypertension management now recommend that all persons with hypertension participate in remote (home) monitoring. (2) This study sets out to evaluate a University of California-wide (Davis, San Francisco, and Los Angeles) quality improvement initiative to increase remote (home) blood pressure monitoring and improve blood pressure control for persons with hypertension. Participants at each site will be randomized to one of two types of remote monitoring: integrated versus manual. Participants using the integrated monitoring will have their home blood pressure readings sent directly to their participating health systems. Participants using the manual monitoring will record their own blood pressures and report them to their health care system as per usual care. The investigators hypothesize that remote monitoring (both integrated and manual) will be associated with improved blood pressure control and that there will be no difference in control between type of remote monitoring. Aim 1: Evaluate whether this remote blood pressure quality improvement initiative leads to improved blood pressure control. Aim 2: Compare the impact of integrated versus manual remote monitoring on blood pressure control. The primary outcome measures will be: 1) the difference in blood pressure after six months (adjusted for baseline variables), and 2) whether participants achieved greater than or equal to 5 mmHg change in systolic blood pressure (SBP). Outcomes will be compared between participants in each arm to determine whether one type of monitoring is superior to the other. The investigators will convene bi-monthly meetings with site champions to foster communication and learning across sites and to learn about variation across sites.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	manual monitoring and general education on use	Patients will receive a standard blood pressure monitor and education on how to use it. Data will be reported as part of usual care.
BEHAVIORAL	integrated monitoring and local wrap-around hypertension program	Patients will receive a standard blood pressure monitor and a local wrap-around hypertension program. Data will be sent directly to their participating health system.

Timeline

• Start date: 2023-03-28
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2022-05-25
• Last updated: 2024-01-29

Locations

3 sites across 1 country: United States