Clinical trial NCT01357226: Using the Blood Pressure TRU in Clinical Settings: a Knowledge Translation Study
Official title: Using the Bp TRU in Clinical Settings: a Knowledge Translation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: measurement in two environments
Lead sponsor: North Toronto Primary Care Research Network
Sponsor class: NETWORK
First posted: 2011-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to a community-based primary care office for routine blood pressure measurement.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Able to consent
* Over the age of 18

Primary outcomes:
measure: Automated Blood Pressure measurements in two different environments
timeFrame: Day of consent
Secondary outcomes:
measure: Automated Blood Pressure values of hypertensive patients in two different environments
timeFrame: Day of consent
Other outcomes:
Locations:
city: North York
country: Canada
facility: North York Family Health Team
state: Ontario
Study officials:
affiliation: North Toronto Primary Care Research Network
name: Michelle Greiver, MD
role: PRINCIPAL_INVESTIGATOR
References: