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

NCT ID: NCT01357226

Last Updated: 2012-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-01-31

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

All patients over the age of 18

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Able to consent
• Over the age of 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Toronto Primary Care Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Michelle Greiver

Dr. Michelle Greiver

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Greiver, MD

Role: PRINCIPAL_INVESTIGATOR

North Toronto Primary Care Research Network

Locations

North York Family Health Team

North York, Ontario, Canada

Countries

Canada

Other Identifiers

11-0519

Identifier Type: -

Identifier Source: org_study_id