Status:
ACTIVE_NOT_RECRUITING
University of California Health Remote (Home) Monitoring Evaluation
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
University of California Office of the President- Quality and Population Health Management
University of California, Davis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 b...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
March 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT05390502
Start Date
March 28 2023
End Date
June 30 2024
Last Update
January 29 2024
Active Locations (3)
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1
University of California, Davis
Davis, California, United States, 95616
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
University of California, San Francisco
San Francisco, California, United States, 94143