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, physicians office, pharmacy OR
2. Physicians office/pharmacy/physicians 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
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/physicians office/pharmacy or physicians office/pharmacy/physicians 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/physicians office/pharmacy or physicians office/pharmacy/physicians office. Automated blood pressure devices (BpTRU) are used in both settings.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/25077100
Publication citations
-
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.