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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357226
• Other study ID #: 11-0519
• Status: Completed
• Phase: N/A
• First received: May 18, 2011
• Last updated: April 25, 2012
• Start date: May 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: North Toronto Primary Care Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to consent

• Over the age of 18

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
Canada	North York Family Health Team	North York	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
North Toronto Primary Care Research Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Automated Blood Pressure measurements in two different environments	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	Automated Blood Pressure values of hypertensive patients in two different environments	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