Clinical trial NCT04841317: Mobile Technology for Blood Pressure Management
Official title: Implementing a Mobile Technology-Based System for Physician-Directed Remote Management of Hypertension: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2021-04-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the feasibility and effectiveness of a mobile-technology based system that integrates patient-facing and clinician-facing components to assist the management of hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years or older with an established diagnosis of essential hypertension

Exclusion Criteria:

* Patients on more than 2 antihypertensives at time of enrollment
* Clinical diagnosis of secondary hypertension, that is, hypertension due to a secondary cause, including but not limited to the following:
* Renal artery stenosis
* Primary hyperaldosteronism
* Cushing syndrome
* Coarctation of the aorta
* Drug-induced hypertension
* Pheochromocytoma
* Obstructive sleep apnea
* Hospitalization for malignant hypertension or severe hypertension (including stroke, cardiac events, acute kidney injury) in the preceding 6 months
* Hospitalization for unstable angina or myocardial infarction in the preceding 6 months
* Prior diagnosis of heart failure or cardiomyopathy
* Stroke or transient ischemic attack within prior 6 months
* Prior organ transplantation
* Failure to obtain informed consent
* Pregnant or currently trying to become pregnant
* Patients who are enrolled in other research studies

Primary outcomes:
measure: Change in Blood Pressure
timeFrame: Assessed at baseline and week 12
measure: Participant Survey
timeFrame: 12 weeks
measure: Physician Survey
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
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: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available.
citation: Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8.
citation: Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009 May 19;338:b1665. doi: 10.1136/bmj.b1665.
citation: Jaffe MG, Lee GA, Young JD, Sidney S, Go AS. Improved blood pressure control associated with a large-scale hypertension program. JAMA. 2013 Aug 21;310(7):699-705. doi: 10.1001/jama.2013.108769.
citation: Logan AG, Irvine MJ, McIsaac WJ, Tisler A, Rossos PG, Easty A, Feig DS, Cafazzo JA. Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabetics. Hypertension. 2012 Jul;60(1):51-7. doi: 10.1161/HYPERTENSIONAHA.111.188409. Epub 2012 May 21.
citation: Logan AG, McIsaac WJ, Tisler A, Irvine MJ, Saunders A, Dunai A, Rizo CA, Feig DS, Hamill M, Trudel M, Cafazzo JA. Mobile phone-based remote patient monitoring system for management of hypertension in diabetic patients. Am J Hypertens. 2007 Sep;20(9):942-8. doi: 10.1016/j.amjhyper.2007.03.020.
citation: Casey DE Jr, Thomas RJ, Bhalla V, Commodore-Mensah Y, Heidenreich PA, Kolte D, Muntner P, Smith SC Jr, Spertus JA, Windle JR, Wozniak GD, Ziaeian B. 2019 AHA/ACC Clinical Performance and Quality Measures for Adults With High Blood Pressure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2019 Nov 26;74(21):2661-2706. doi: 10.1016/j.jacc.2019.10.001. No abstract available.