Condition category
Circulatory System
Date applied
25/07/2012
Date assigned
09/08/2012
Last edited
04/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Accurate measurement of blood pressure is the foundation of appropriate diagnosis, treatment and on-going management of hypertension (high blood pressure). Automated blood pressure devices in community settings such as pharmacies provide opportunities for additional blood pressure measurement; however it is important to ensure these measurements are accurate and valid when compared to those taken in the physicians’ offices using the same devices. The aim of the study is to assess whether blood pressure readings assessed with an automated device differed according to the setting in which they were taken, specifically in community pharmacies compared to physicians’ offices.

Who can participate?
Community dwelling adults aged 65 years and older registered with five family physicians.

What does the study involve?
Five family physician offices mailed invitations to their patients aged 65 years and older to participate in the trial. Eligible and consenting adults are randomly allocated to one of two blood pressure measurement sequences:
1. Pharmacy, physician’s office, pharmacy OR
2. Physician’s office/pharmacy/physician’s office
Automated blood pressure devices (BpTRU) are used in both settings.

What are the possible benefits and risks of participating?
Participants have their blood pressure assessed at three visits. If it is high, their family physician and pharmacist are notified. There are no side effects as only blood pressure is being monitored.

Where is the study run from?
The lead centre is the Bruyere Research Institute in Ottawa. The trial takes place in the two communities of Collingwood and Creemore, in Ontario, Canada.

When is the study starting and how long is it expected to run for?
The trial began in November 2009 and finished in July 2012. Participants were recruited from April 2010 to June 2010.

Who is funding the study?
Canadian Stroke Network, a National Centre of Excellence and the Bruyere Research Institute

Who is the main contact?
Prof Larry W Chambers
lchambers@bruyere.org

Trial website

http://chapprogram.ca

Contact information

Type

Scientific

Primary contact

Prof Larry Chambers

ORCID ID

Contact details

Bruyère Continuing Care
43 Bruyere Street
Ottawa
K1N5C8
Canada
lchambers@bruyere.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of blood pressure measurements using an automated bood pressure device in community pharmacies and physicians’ offices: the Collingwood-Creemore randomized controlled trial

Acronym

Study hypothesis

Blood pressure measurements in a community pharmacy are comparable to blood pressure measurements in a physician office.

Ethics approval

Bruyere Continuing Care Research Ethics Board, November 2009

Study design

Adults aged 65 and over randomly allocated to pharmacy/physician’s office/pharmacy or physician’s office/pharmacy/physician’s office sequences.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hypertension and related diseases

Intervention

Five family physician offices mailed invitations to their patients aged 65 years and older to participate in the trial. Eligible and consenting adults are randomly allocated to one of two blood pressure measurement sequences: pharmacy/physician’s office/pharmacy or physician’s office/pharmacy/physician’s office. Automated blood pressure devices (BpTRU) are used in both settings.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

After trial participants attended the first session to have their blood pressure measured, they were asked to come to the next two visits with less than a week between visits. The mean time interval to complete the three BP measurements for Arm A versus Arm B did not significantly differ (Arm A = 11.1 days versus Arm B = 11.8 days (p=0.36)).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/2010

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Community dwelling adults aged 65 years and older registered with five family physicians

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

300

Participant exclusion criteria

Patients in hospital or living in long-term care facilities.

Recruitment start date

01/04/2010

Recruitment end date

30/09/2010

Locations

Countries of recruitment

Canada

Trial participating centre

Bruyère Continuing Care
Ottawa
K1N5C8
Canada

Sponsor information

Organisation

Bruyere Research Institute (Canada)

Sponsor details

43 Bruyere Street
Ontario
Ottawa
K1N 5C8
Canada

Sponsor type

Research organisation

Website

http://www.bruyere.org

Funders

Funder type

Research organisation

Funder name

Canadian Stroke Network (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/25077100

Publication citations

  1. Results

    Chambers LW, Kaczorowski J, O'Rielly S, Ignagni S, Hearps SJ, Comparison of blood pressure measurements using an automated blood pressure device in community pharmacies and family physicians' offices: a randomized controlled trial., CMAJ Open, 2013, 1, 1, E37-42, doi: 10.9778/cmajo.20130005.

Additional files

Editorial Notes