Mobile Technology for Blood Pressure Management

March 21, 2024 updated by: Paul Wang, Stanford University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Combination product: Mobile technology intervention
Home blood pressure cuff used by patients twice a week, with blood pressures transmitted to providers remotely

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure
Time Frame: Assessed at baseline and week 12
Change in systolic and diastolic blood pressure (SBP and DBP).
Assessed at baseline and week 12
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).
12 weeks
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).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

American Heart Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2021

Primary Completion (Actual)

December 7, 2021

Study Completion (Actual)

December 7, 2021

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59671
  • 20FRN35360178 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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