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

Sponsor
North Toronto Primary Care Research Network (Other)
Overall Status
Completed
CT.gov ID
NCT01357226
Collaborator
(none)
50
Enrollment
1
Location
8
Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Using the Bp TRU in Clinical Settings: a Knowledge Translation Study
    Study Start Date :
    May 1, 2011
    Actual Primary Completion Date :
    Jan 1, 2012
    Actual Study Completion Date :
    Jan 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    All patients over the age of 18

    Outcome Measures

    Primary Outcome Measures

    1. Automated Blood Pressure measurements in two different environments [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).

    Secondary Outcome Measures

    1. Automated Blood Pressure values of hypertensive patients in two different environments [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Able to consent

    • Over the age of 18

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 North York Family Health Team North York Ontario Canada M3B 3S6

    Sponsors and Collaborators

    • North Toronto Primary Care Research Network

    Investigators

    • Principal Investigator: Michelle Greiver, MD, North Toronto Primary Care Research Network

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michelle Greiver, Dr. Michelle Greiver, North Toronto Primary Care Research Network
    ClinicalTrials.gov Identifier:
    NCT01357226
    Other Study ID Numbers:
    • 11-0519
    First Posted:
    May 20, 2011
    Last Update Posted:
    Apr 26, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Michelle Greiver, Dr. Michelle Greiver, North Toronto Primary Care Research Network
    measurement in two environments

    Study Results

    No Results Posted as of Apr 26, 2012