Comparison of blood pressure measurements using an automated blood pressure device in community pharmacies and physicians offices
| ISRCTN | ISRCTN91799042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91799042 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/07/2012
- Registration date
- 09/08/2012
- Last edited
- 04/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Bruyère Continuing Care
43 Bruyere Street
Ottawa
K1N5C8
Canada
| lchambers@bruyere.org |
Study information
| 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 |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Blood pressure measurements in a community pharmacy are comparable to blood pressure measurements in a physician office. |
| Ethics approval(s) | Bruyere Continuing Care Research Ethics Board, November 2009 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/04/2010 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | Community dwelling adults aged 65 years and older registered with five family physicians |
| Key exclusion criteria | Patients in hospital or living in long-term care facilities. |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
K1N5C8
Canada
Sponsor information
Research organisation
43 Bruyere Street
Ontario
Ottawa
K1N 5C8
Canada
| Website | http://www.bruyere.org |
|---|---|
"ROR" |
https://ror.org/05bznkw77 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/04/2013 | Yes | No |
