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Role of Wrist Based Blood Pressure Monitoring in Clinical Practice

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ClinicalTrials.gov Identifier: NCT03862742
Recruitment Status : Unknown
Verified April 2019 by Scripps Translational Science Institute.
Recruitment status was:  Enrolling by invitation
First Posted : March 5, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Scripps Translational Science Institute

Study Description
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Brief Summary:
This is a pilot clinical study to test the overarching hypothesis that frequent and longitudinal blood pressure monitoring with FDA approved consumer wrist based device during the patient transition from inpatient to home to the first clinic visit will elicit valuable BP data that can assist in physician treatment of hypertension

Condition or disease
Blood Pressure Transitions of Care

Detailed Description:
Wrist based health devices, often with mobile connectivity, that continuously or near continuously track heart rate, blood pressure, temperature, activity and sleep are growing in everyday popularity and beginning to enter the sphere of clinical relevance. However, their accuracy and utility for clinical use is largely unstudied. As these consumer devices, some of which are FDA approved, become more commonplace, it is paramount to understand their function, know their limitations, and be able to interpret results appropriately before incorporating them into our clinical practice. The AHA/ACC 2017 guideline makes a 1A recommendation for clinical use of out of office BP measurements(1). This recommendation is based on evidence that out of office BP and frequent and longitudinal BP measurements are important in predicting cardiovascular risk and monitoring treatment efficacy(2-5). This trend towards consumer driven digital health monitoring and the new AHA/ACC guideline are essentially advancing a consumer based precision medicine strategy for diagnosis and monitoring of hypertension. As this becomes commonplace in our patient population, we need rigorous clinical study of wrist base BP monitoring to better understand its role patient care.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Wrist Based Blood Pressure Monitoring in Clinical Practice
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020
Groups and Cohorts
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Group/Cohort
Patients admitted to the hospital
We will recruit patient volunteers from the Scripps Green Hospital and Scripps Memorial Hospital inpatient teaching services.


Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure [ Time Frame: Pts will monitor BP during the transition from inpatient to home to the first clinic visit. BP measurements will be performed several times during the day and several times at night. The estimated time frame when data will be collected is 24 to 48 hours ]
    blood pressure measured by the wrist watch like blood pressure device


Secondary Outcome Measures :
  1. Survey of healthcare providers [ Time Frame: A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours. ]
    Survey to measure ease of use to the device in measuring blood pressure

  2. Survey of patients [ Time Frame: A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours. ]
    Survey to measure ease of use to the device in measuring blood pressure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Individuals 18 years of age or older with and without the known diagnosis of hypertension (regardless of level of control or therapeutic regimen), able to operate HeartVue device, able to read, write, and speak English, level of "digital savviness" and owning an iOS or Android device will be recruited for participation in this pilot study.
Criteria

Inclusion Criteria:

  • ≥18 years of age
  • Own an iOS or Android device

Exclusion Criteria:

  • Inability to give informed consent
  • <18 years of age
  • Inability to understand written English language
  • Hypertensive urgency or emergency as an admission diagnosis
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03862742


Locations
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United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Investigators
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Principal Investigator: Laura Nicholson, MD PHD Scripps Health
  Study Documents (Full-Text)

Documents provided by Scripps Translational Science Institute:
Study Protocol  [PDF] October 4, 2018
Statistical Analysis Plan  [PDF] October 4, 2018

More Information
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Publications:

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Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT03862742    
Other Study ID Numbers: IRB-18-7223
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No