- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01357226
Using the Blood Pressure TRU in Clinical Settings: a Knowledge Translation Study
Using the Bp 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
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North York, Ontario, Canada, M3B 3S6
- North York Family Health Team
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Able to consent
- Over the age of 18
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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All patients over the age of 18
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Day of consent
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Day of consent
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michelle Greiver, MD, North Toronto Primary Care Research Network
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11-0519
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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