Role of Wrist Based Blood Pressure Monitoring in Clinical Practice

NCT03862742 | Withdrawn

• 1 other identifier: IRB-18-7223
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Blood Pressure; Transitions of Care

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  blood pressure measured by the wrist watch like blood pressure device

  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

Secondary Outcomes (2)

• Survey of healthcare providers

  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 of patients

  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.

Study Arms (1)

Patients admitted to the hospital

We will recruit patient volunteers from the Scripps Green Hospital and Scripps Memorial Hospital inpatient teaching services.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Inability to give informed consent
• \<18 years of age
• Inability to understand written English language
• Hypertensive urgency or emergency as an admission diagnosis

Sponsors & Collaborators

• Scripps Translational Science Institute: lead

Study Sites (1)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Related Publications (5)

• Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Soc Hypertens. 2018 Aug;12(8):579.e1-579.e73. doi: 10.1016/j.jash.2018.06.010. No abstract available.

  PMID: 30219548 BACKGROUND

• Drawz P. Clinical Implications of Different Blood Pressure Measurement Techniques. Curr Hypertens Rep. 2017 Jul;19(7):54. doi: 10.1007/s11906-017-0751-0.

  PMID: 28551831 BACKGROUND

• O'Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G, Clement D, de la Sierra A, de Leeuw P, Dolan E, Fagard R, Graves J, Head GA, Imai Y, Kario K, Lurbe E, Mallion JM, Mancia G, Mengden T, Myers M, Ogedegbe G, Ohkubo T, Omboni S, Palatini P, Redon J, Ruilope LM, Shennan A, Staessen JA, vanMontfrans G, Verdecchia P, Waeber B, Wang J, Zanchetti A, Zhang Y; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013 Sep;31(9):1731-68. doi: 10.1097/HJH.0b013e328363e964.

  PMID: 24029863 BACKGROUND

• Hermida RC, Ayala DE, Fernandez JR, Mojon A, Smolensky MH. Hypertension: New perspective on its definition and clinical management by bedtime therapy substantially reduces cardiovascular disease risk. Eur J Clin Invest. 2018 May;48(5):e12909. doi: 10.1111/eci.12909. Epub 2018 Feb 25.

  PMID: 29423914 BACKGROUND

• Staessen JA, Thijs L, Fagard R, O'Brien ET, Clement D, de Leeuw PW, Mancia G, Nachev C, Palatini P, Parati G, Tuomilehto J, Webster J. Predicting cardiovascular risk using conventional vs ambulatory blood pressure in older patients with systolic hypertension. Systolic Hypertension in Europe Trial Investigators. JAMA. 1999 Aug 11;282(6):539-46. doi: 10.1001/jama.282.6.539.

  PMID: 10450715 BACKGROUND

Study Officials

• Laura Nicholson, MD PHD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 5, 2019
• Study Start: May 22, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)