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

NCT01357226 | Completed

• 1 other identifier: 11-0519
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

measurement in two environments

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Automated Blood Pressure values of hypertensive patients in two different environments

  Day of consent

Study Arms (1)

All patients over the age of 18

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to a community-based primary care office for routine blood pressure measurement.

You may qualify if:

• Able to consent
• Over the age of 18

Sponsors & Collaborators

• North Toronto Primary Care Research Network: lead

Study Sites (1)

North York Family Health Team

North York, Ontario, M3B 3S6, Canada

Location

Study Officials

• Michelle Greiver, MD

  North Toronto Primary Care Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Michelle Greiver

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 26, 2012

Record last verified: 2012-01

Locations

CA (1)