Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market. (VALID-HomeBP)

February 12, 2025 updated by: Remi Goupil, MD MSc, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Comparing Home Blood Pressure Measurements from Devices with and Without Evidence of Validation to Ambulatory Blood Pressure Monitoring: the VALID-HomeBP Study

This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory blood pressure monitoring.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged > 18 years scheduled to undergo an ABPM

Exclusion Criteria:

  • Upper arm size outside of cuff range of selected devices (<22 cm or >42 cm)
  • Night shift workers
  • Permanent atrial fibrillation
  • Known severe aortic stenosis
  • Contraindication to measure BP on the non-dominant arm
  • Ongoing pregnancy
  • Inability or unwillingness to provide consent

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Validate home BP device
BP measured with a validated home BP device
Diagnostic test: awake ABPM
Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after
Active Comparator: Non-validated home BP device #1
BP measured with the first non-validated home BP device
Diagnostic test: awake ABPM
Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after
Active Comparator: Non-validated home BP device #2
BP measured with the second non-validated home BP device
Diagnostic test: awake ABPM
Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after
Active Comparator: Non-validated home BP device #3
BP measured with the third non-validated home BP device
Diagnostic test: awake ABPM
Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference in systolic BP
Time Frame: At enrollment (time 0)
Mean difference in systolic BP between the home BP device and the awake ABPM
At enrollment (time 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference in diastolic BP
Time Frame: At enrollment (time 0)
Mean difference in diastolic BP between the home BP device and the awake ABPM
At enrollment (time 0)
Mean difference in systolic BP from validated device
Time Frame: At enrollment (time 0)
Mean difference in systolic BP between the non-validated home BP device and the validated home BP device
At enrollment (time 0)
Mean difference in diastolic BP from validated device
Time Frame: At enrollment (time 0)
Mean difference in diastolic BP between the non-validated home BP device and the validated home BP device
At enrollment (time 0)

Collaborators and Investigators

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

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

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)

February 12, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALID-HomeBP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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