University of California Health Remote (Home) Monitoring Evaluation

NCT05390502 | Unknown

• 1 other identifier: 22000036
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Hypertension

Keywords

Remote Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• Continuous change in blood pressure (BP)

  the difference in systolic blood pressure after six months (adjusted for baseline variables)

  Baseline, six months

Secondary Outcomes (4)

• Binary 5mm change in blood pressure

  Baseline, six months

• Binary measure of controlled vs uncontrolled hypertension

  Baseline, six months

• Exploratory pre-post analysis of overall change in BP

  Baseline, six months

• Changes in blood pressure (BP) outcomes from integrated monitor readings

  Baseline, six months

Other Outcomes (1)

• Adverse events

  Baseline, six months

Study Arms (2)

Integrated

EXPERIMENTAL

Participants will have their home blood pressure readings sent directly to their participating health systems. Participants will also receive a wrap-around intervention.

Behavioral: integrated monitoring and local wrap-around hypertension program

Manual

ACTIVE COMPARATOR

Participants will record their own blood pressures and report them to their health care system as per usual care.

Behavioral: manual monitoring and general education on use

Interventions

manual monitoring and general education on use BEHAVIORAL

Patients will receive a standard blood pressure monitor and education on how to use it. Data will be reported as part of usual care.

Manual

integrated monitoring and local wrap-around hypertension program BEHAVIORAL

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.

Integrated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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 may not qualify 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of California Office of the President- Quality and Population Health Management: collaborator
• University of California, Davis: collaborator
• University of California, San Francisco: collaborator

Study Sites (3)

University of California, Davis

Davis, California, 95616, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (3)

• Carey RM, Whelton PK. The 2017 American College of Cardiology/American Heart Association Hypertension Guideline: A Resource for Practicing Clinicians. Ann Intern Med. 2018 Mar 6;168(5):359-360. doi: 10.7326/M18-0025. Epub 2018 Jan 23. No abstract available.

  PMID: 29357396 BACKGROUND

• Shimbo D, Artinian NT, Basile JN, Krakoff LR, Margolis KL, Rakotz MK, Wozniak G; American Heart Association and the American Medical Association. Self-Measured Blood Pressure Monitoring at Home: A Joint Policy Statement From the American Heart Association and American Medical Association. Circulation. 2020 Jul 28;142(4):e42-e63. doi: 10.1161/CIR.0000000000000803. Epub 2020 Jun 22.

  PMID: 32567342 BACKGROUND

• Lee DR, Chenoweth M, Chuong LH, Villaflores CW, Cuevas M, Vangala S, Borenstein J, Kwak H, Chima-Melton C, Han M, Skootsky SA, Chan Tack T, Branagan L, Martin H, Gupta R, Phan L, Sanchez MA, Malaak MM, Dermenchyan A, Pearson KN, Altunyan M, Barakat PF, Pablo R, Sarkisian C. A Multisite Electronic Health Record Integrated Remote Monitoring Intervention for Hypertension Improvement: Protocol for a Randomized Pragmatic Comparative Effectiveness Trial. JMIR Res Protoc. 2023 Oct 30;12:e45915. doi: 10.2196/45915.

  PMID: 37902819 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Catherine Sarkisian, MD, MSHS

  Director, Value-Based Care Research Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Value-Based Care Research Consortium

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: March 28, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

US (3)