Mobile Technology for Blood Pressure Management

NCT04841317 | Completed Results FDA Device

• 2 other identifiers: 5967120FRN35360178
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• Change in Blood Pressure

  Change in systolic and diastolic blood pressure (SBP and DBP).

  Assessed at baseline and week 12

• Participant Survey

  A survey regarding usability and feedback about the intervention completed by participants. Questions 1 through 5 were rated on a scale of 1 (strongly disagree) to 7 (strongly agree); question 6 was rated on a scale of 1 (extremely confident) to 5 (extremely doubtful).

  12 weeks

• Physician Survey

  A survey regarding usability and feedback about the intervention completed by physicians. Physicians provided survey responses, but were not enrolled in the study. Questions 1, 2, and 3 were rated on a scale of 1 (strongly agree) to 7 (strongly disagree); question 4 was rated on a scale of 1 (extremely confident) to 5 (extremely doubtful); question 5 was rated on a scale of 1 (extremely pleased) to 7 (extremely displeased).

  12 weeks

Study Arms (1)

Single-arm: Blood pressure intervention

EXPERIMENTAL

Participants will use a mobile technology system comprising of a remote home blood pressure monitoring cuff and a mobile application integrated with a clinician-facing component to view and manage remote blood pressures. Participants will use this for 12 weeks, with assessment of blood pressure outcomes and anonymous surveys regarding the technology at 12 weeks.

Combination Product: Mobile technology intervention

Interventions

Mobile technology intervention COMBINATION_PRODUCT

Home blood pressure cuff used by patients twice a week, with blood pressures transmitted to providers remotely

Single-arm: Blood pressure intervention

Eligibility Criteria

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

You may qualify if:

• years or older with an established diagnosis of essential hypertension

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• American Heart Association: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (7)

• 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.

  PMID: 29133356 BACKGROUND

• 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.

  PMID: 12493255 BACKGROUND

• 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.

  PMID: 19454737 BACKGROUND

• 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.

  PMID: 23989679 BACKGROUND

• 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.

  PMID: 22615116 BACKGROUND

• 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.

  PMID: 17765133 BACKGROUND

• 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.

  PMID: 31732293 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Paul J. Wang, MD
• Organization: Stanford University

Paul.J.Wang@stanford.edu

(650) 723-7111

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: March 31, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)