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OpenTrials
Completed

NCT Number: NCT04841317

Mobile Technology for Blood Pressure Management

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile technology intervention

Combination Product

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

Primary outcomes

  1. Change in Blood Pressure

    Time frame: Assessed at baseline and week 12

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

  2. Participant Survey

    Time frame: 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).

  3. Physician Survey

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Implementing a Mobile Technology-Based System for Physician-Directed Remote Management of Hypertension: A Pilot Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2021
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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