Blood PressureNCT01357226
Using the Blood Pressure TRU in Clinical Settings: a Knowledge Translation Study
An observational study of Blood Pressure, run by North Toronto Primary Care Research Network at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to a community-based primary care office for routine blood pressure measurement.
Who may be able to join
- Able to consent
- Over the age of 18
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using the Bp TRU in Clinical Settings: a Knowledge Translation Study
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.
Read more
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients over the age of 18 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day of consent
Secondary outcomes (1)
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).
Measured: Day of consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Toronto Primary Care Research Network
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Michelle Greiver, North Toronto Primary Care Research Network
- Investigators
- Michelle Greiver, MD, Principal investigator, North Toronto Primary Care Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357226
- Sponsor's protocol ID
- 11-0519
- Status last verified
- Jan 2012
- First submitted
- 18 May 2011
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Bp TRU in Clinical Settings: a Knowledge Translation Study
- ClinicalTrials.gov ID
- NCT01357226
- Acronym / sponsor ID
- 11-0519
- Conditions
- Blood Pressure
- Keywords
- measurement in two environments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- North Toronto Primary Care Research NetworkResearch network
- Study start
- May 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients over the age of 18 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to a community-based primary care office for routine blood pressure measurement.
Key inclusion criteria (2 listed)
- Able to consent
- Over the age of 18
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Automated Blood Pressure measurements in two different environments
Time frame: 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).
1 secondary outcome
Automated Blood Pressure values of hypertensive patients in two different environments
Time frame: Day of consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Greiver, MD principal investigator
North Toronto Primary Care Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by North Toronto Primary Care Research Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Automated Blood Pressure measurements in two different environments (time frame: Day of consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2012.