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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357226
First Posted: May 20, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michelle Greiver, North Toronto Primary Care Research Network
  Purpose

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.


Condition
Blood Pressure

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Using the Bp TRU in Clinical Settings: a Knowledge Translation Study

Further study details as provided by Michelle Greiver, North Toronto Primary Care Research Network:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).


Enrollment: 50
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
All patients over the age of 18

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to a community-based primary care office for routine blood pressure measurement.
Criteria

Inclusion Criteria:

  • Able to consent
  • Over the age of 18
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357226


Locations
Canada, Ontario
North York Family Health Team
North York, Ontario, Canada, M3B 3S6
Sponsors and Collaborators
North Toronto Primary Care Research Network
Investigators
Principal Investigator: Michelle Greiver, MD North Toronto Primary Care Research Network
  More Information

Responsible Party: Michelle Greiver, Dr. Michelle Greiver, North Toronto Primary Care Research Network
ClinicalTrials.gov Identifier: NCT01357226     History of Changes
Other Study ID Numbers: 11-0519
First Submitted: May 18, 2011
First Posted: May 20, 2011
Last Update Posted: October 12, 2017
Last Verified: January 2012

Keywords provided by Michelle Greiver, North Toronto Primary Care Research Network:
measurement in two environments