SIMPLifying Elements of Standardized Automated Office Blood Pressure Measurements (Pilot Study)

NCT06317168 | Completed

• 1 other identifier: SIMPLE-AOBP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess whether removing single elements of the standardized office BP measurement procedure will affect the accuracy towards the mean awake ambulatory BP. Four arms are planned in a randomized order: 1) full standardized procedure, 2) standardized procedure but with cuff placed on a sleeve, 3) standardized procedure but arm resting vertically, 4) standardized procedure but with non-validated device. This is a pilot study to inform on the sample size required to perform adequately powered large scale studies.

Conditions

Blood Pressure

Keywords

blood pressure measurements

Outcome Measures

Primary Outcomes (1)

• Difference with mean awake ambulatory systolic BP

  Difference between systolic BP measured in each study arm (average of 3 measurements) with the mean awake ambulatory systolic BP

  at enrollment (time 0)

Secondary Outcomes (1)

• Difference with mean awake ambulatory diastolic BP

  at enrollment (time 0)

Study Arms (4)

Standardized automated office BP measurements

ACTIVE COMPARATOR

BP measured using a highly standardized procedure using a validated office-grade device on a bare arm supported at heart level.

Diagnostic Test: Mean awake ambulatory BP measurements

Sleeved arm

ACTIVE COMPARATOR

BP measured using a highly standardized procedure using a validated office-grade device over a standardized sleeve with the arm supported at heart level.

Diagnostic Test: Mean awake ambulatory BP measurements

Arm not supported

ACTIVE COMPARATOR

BP measured using a highly standardized procedure using a validated office-grade device on a bare arm resting vertically.

Diagnostic Test: Mean awake ambulatory BP measurements

Non-validated device

ACTIVE COMPARATOR

BP measured using a highly standardized procedure using a non-validated home device on a bare arm supported at heart level.

Diagnostic Test: Mean awake ambulatory BP measurements

Interventions

Mean awake ambulatory BP measurements DIAGNOSTIC_TEST

Results from all four arms will be compared to the mean awake ambulatory BP measured on the same arm and started immediately following completion of the testing protocol.

Arm not supported; Non-validated device; Sleeved arm; Standardized automated office BP measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years old

You may not qualify if:

• Upper arm size outside of cuff range of selected devices (\<22 cm or \>42 cm)
• Permanent atrial fibrillation
• Known severe aortic stenosis
• Ongoing pregnancy
• Inability or unwillingness to provide consent

Sponsors & Collaborators

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

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J1C5, Canada

Location

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: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 19, 2024
• Study Start: May 9, 2024
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)