NCT04238442

Brief Summary

The A\&D automatic blood pressure device is a new kiosk that can measure blood pressure in the general population. The investigators plan to use the existing International Standards Organization validation protocol to determine whether this device measures blood pressure accurately.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 14, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

October 1, 2019

Last Update Submit

April 9, 2020

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Accuracy per International Standards Organization Protocol

    Agreement of the device to mercury auscultation.

    3 months

Study Arms (1)

BP oscillometric measurement

EXPERIMENTAL

Oscillometric BP measurement

Device: A&D TM-2657W oscillometric device

Interventions

A&D TM-2657W oscillometric deviceDEVICE

Assessing the accuracy of the A\&D TM-2657W oscillometric device using International Standards Organization validation protocol. This involves comparing the accuracy of the A\&D device to 2 observer mercury auscultation (gold standard).

BP oscillometric measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • normal sinus rhythm
  • have capacity to give consent
  • following the International Standards Organization criteria for: gender distribution, limb size, blood pressure distribution

You may not qualify if:

  • atrial fibrillation
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

Study Officials

  • Jennifer Ringrose, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2019

First Posted

January 23, 2020

Study Start

August 14, 2019

Primary Completion

February 5, 2020

Study Completion

February 5, 2020

Last Updated

April 10, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)