This study is in progress, not accepting new patients

University of California Health Remote (Home) Monitoring Evaluation

a study on High Blood Pressure

Eligibility: for people ages 18 years and up (full criteria)
Location: at Los Angeles, California and other locations
Dates: study started March 2023
completion around June 2024
Principal Investigator: by Catherine A. Sarkisian

Catherine A. Sarkisian

Description

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.

Official Title

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

Details

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)

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.

Keywords

Hypertension, Remote Blood Pressure Monitoring, manual monitoring and general education on use, integrated monitoring and local wrap-around hypertension program, Integrated, Manual

Eligibility

You can join if…

Open to people ages 18 years and up

Aged 18 years and older.
Participant must be willing and functionally able (with help from another person if needed) to both use the remote BP monitoring device as well as do home BP monitoring using a manual BP cuff.
Have access to the online healthcare portal (with help from another person if needed).
•-Have outpatient visit within the last 12 months, and have a prior visit within 6 months of inclusion outpatient visit with diagnosis of hypertension, defined as having two readings of SBP > 140 or DBP > 90 mmHg
Has visit with a primary care physician within one year.
Takes zero or three anti-hypertensive prescriptions (can include pills with 2 different drugs so could be on 2 medications).

You CAN'T join if...

BP > 180/110 mmHg (office) or > 175/105 mmHg (self-measured BP measurements)
Pheochromocytoma
Uncontrolled hypothyroidism or hyperthyroidism
Renal artery stenosis
Conn's syndrome
End stage renal disease (ESRD)
Chronic kidney disease (CKD) Stage 3b (CrCL < 45) and above
Transplant patients --> used the code that if they ever had a transplant
Pregnancy
Severe aortic stenosis
Hospice/End-of-life or Palliative Care
Left Ventricular Ejection Fraction < 30%
Acute cardiac event in the last 3 months (e.g. acute MI)
Heart block and arrhythmia(s)
Recurrent or symptomatic hypotension (SBP < 100 mmHg or DBP < 60 mmHg)
Drug/alcohol abuse
Orthostatic hypotension (drop in SBP >20 mmHg)
Other secondary causes of hypertension
Receiving hypertension management from other services (home health, hospice, already enrolled in hypertension management program)
White coat hypertension

Locations

University of California, Los Angeles
Los Angeles California 90095 United States
University of California, San Francisco
San Francisco California 94143 United States
University of California, Davis
Davis California 95616 United States

Lead Scientist at UCLA

Catherine A. Sarkisian
Dr. Catherine Sarkisian is a geriatrician and NIH-funded research scientist. Since early in her training she has committed her career to improving quality of life among vulnerable older adults. Most of her work has focused on implementing and evaluating academic-community partnered interventions and more recently, academic-health-system partnered pragmatic trials.

Details

Status: in progress, not accepting new patients
Start Date: March 2023
Completion Date: June 2024 (estimated)
Sponsor: University of California, Los Angeles
ID: NCT05390502
Study Type: Interventional
Participants: Expecting 660 study participants
Last Updated: January 2024