Mobile Technology for Blood Pressure Management

NCT ID: NCT04841317

Last Updated: 2024-03-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-12-07

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-arm: Blood pressure intervention

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.

Group Type EXPERIMENTAL

Mobile technology intervention

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Mobile technology intervention

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Paul Wang

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29133356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12493255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19454737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23989679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22615116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17765133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31732293 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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20FRN35360178

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

59671

Identifier Type: -

Identifier Source: org_study_id

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