Accuracy Testing of Validated and Non-validated Home BP Devices Sold on the Online Market.
VALID-HomeBP
Comparing Home Blood Pressure Measurements from Devices with and Without Evidence of Validation to Ambulatory Blood Pressure Monitoring: the VALID-HomeBP Study
1 other identifier
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Feb 2024
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 12, 2024
CompletedFirst Submitted
Initial submission to the registry
November 12, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
February 14, 2025
February 1, 2025
3.8 years
November 12, 2024
February 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean difference in systolic BP
Mean difference in systolic BP between the home BP device and the awake ABPM
At enrollment (time 0)
Secondary Outcomes (3)
Mean difference in diastolic BP
At enrollment (time 0)
Mean difference in systolic BP from validated device
At enrollment (time 0)
Mean difference in diastolic BP from validated device
At enrollment (time 0)
Study Arms (4)
Validate home BP device
ACTIVE COMPARATORBP measured with a validated home BP device
Non-validated home BP device #1
ACTIVE COMPARATORBP measured with the first non-validated home BP device
Non-validated home BP device #2
ACTIVE COMPARATORBP measured with the second non-validated home BP device
Non-validated home BP device #3
ACTIVE COMPARATORBP measured with the third non-validated home BP device
Interventions
Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after
Eligibility Criteria
You may qualify if:
- Adults aged \> 18 years scheduled to undergo an ABPM
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 12, 2024
First Posted
November 14, 2024
Study Start
February 12, 2024
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
February 14, 2025
Record last verified: 2025-02