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OpenTrials
Completed

NCT Number: NCT01357226

Using the Blood Pressure TRU in Clinical Settings: a Knowledge Translation Study

Context: Use of automated blood pressure (BP) measurement devices in the office setting is increasingly recognized as superior to manual BP measurement. Current recommendations are to have the patient alone in a quiet room, with no interactions with health care professionals during the readings. However, this may not be practical in primary care offices where the exam rooms are constantly being used.

Objective: To compare measurements with an automated BP device in private examination rooms with measurements in non-private areas of a primary care office.

Design: Randomized controlled trial with cross-over.

Setting: Community based primary care office participating in the NorTReN Practice Based Research Network in Toronto, Ontario.

Participants: Fifty consecutive consenting patients over the age of 18 having their BP checked as part of their routine care.

Intervention: Patients will be randomly allocated to either automated BP measurement in an exam room, or in a non-private area of the clinic. After being tested in the first location they will subsequently be tested in the second location with the same device.

Main outcome measure: The primary outcome measure is a comparison between the mean systolic values of the automated BP measurements in the two office areas. The investigators will use the t-test for paired samples. The secondary outcome is a comparison of systolic values for patients with previously documented hypertension. The investigators define a clinically meaningful result as a difference of 5 mmHg or more in systolic BP.

Conclusion: New technology is more readily adopted if barriers to use are minimized. If the investigators find no differences in BP readings between office locations, physicians will then have the convenience of an additional office area to implement the automated BP measurement device.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North York Family Health Team

North York, Ontario, M3B 3S6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to consent
  • Over the age of 18

Treatment and study plan

Primary outcomes

  1. Automated Blood Pressure measurements in two different environments

    Time frame: Day of consent

    Comparison of the mean systolic values of the automated blood pressure measurement in the private exam room and the common area (laboratory area).

Secondary outcomes

  1. Automated Blood Pressure values of hypertensive patients in two different environments

    Time frame: Day of consent

    Comparison of the mean systolic blood pressure measurements for patients with previously documented hypertension in the private exam room and the common area (laboratory area).

Sponsors and collaborators

Lead sponsor

North Toronto Primary Care Research Network

Network

Registry information

Official study title

Using the Bp TRU in Clinical Settings: a Knowledge Translation Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 20, 2011
Registry last updated
Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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