Mobile Technology for Blood Pressure Management

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Combination Product: Mobile technology intervention

• Registration Number: NCT04841317
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-31
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-12
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Results First Submitted: 2023-12-12
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Results First Posted: 2024-03-22
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm: Blood pressure intervention	Mobile technology 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.

Primary Outcome Measures

Name	Time	Method
Participant Survey	12 weeks	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).
Physician Survey	12 weeks	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).
Change in Blood Pressure	Assessed at baseline and week 12	Change in systolic and diastolic blood pressure (SBP and DBP).

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States