Blood Pressure Clinical Trial
Official title:
Role of Wrist Based Blood Pressure Monitoring in Clinical Practice
Verified date | April 2019 |
Source | Scripps Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | March 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Scripps Green Hospital | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
Scripps Translational Science Institute |
United States,
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. Review. — View Citation
Hermida RC, Ayala DE, Fernández JR, Mojón 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. Review. — View Citation
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. Erratum in: J Hypertens. 2013 Dec;31(12):2467. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Survey of healthcare providers | Survey to measure ease of use to the device in measuring blood pressure | 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. | |
Secondary | Survey of patients | Survey to measure ease of use to the device in measuring blood pressure | 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. |
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