|
ISRCTN
|
ISRCTN75436659
|
|
ClinicalTrials.gov identifier
|
NCT00374829
|
|
Public title
|
The impact of a multidisciplinary, information technology supported program on blood pressure control in primary care
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
DCT 67995
|
|
Study hypothesis
|
It is hypothesised that blood pressure control will be improved in patients receiving the program by increasing compliance with pharmacotherapy, the use of higher doses of anti-hypertensive agents and the use of more anti-hypertensive agents when appropriate, without adversely impacting quality of life.
|
|
Lay summary
|
|
|
Ethics approval
|
Approval received from the local ethics committee (Cité de la Santé de Laval Comité d'éthique et de la recherche) in November 2003.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Canada
|
|
Disease/condition/study domain
|
Hypertension
|
|
Participants - inclusion criteria
|
1. Male and female uncontrolled hypertensive subjects
2. 18 years of age or more
|
|
Participants - exclusion criteria
|
1. Having a life-threatening disease
2. Chronic atrial fibrillation
3. Unable to use an ordinary telephone
4. Pregnant at the initial visit
5. Participating in another clinical trial
6. Living with another subject that is currently participating in the study
|
|
Anticipated start date
|
01/05/2004
|
|
Anticipated end date
|
01/02/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
500
|
|
Interventions
|
Intervention:
We have developed an Information Technology (IT)-based system to help empower patients to be responsible for monitoring their Blood Pressure (BP) and compliance and to facilitate communication with healthcare providers. The IT-based system links with actual pharmacy prescription refill and renewal data. Using these data as well as responses to questions on compliance and BP control that patients provide, the system:
a. offers patients counselling and telephone reminders
b. generates prescription refill and renewal reminder calls
c. monitors patient recorded BP
The system generates monthly reports to the treating physician and pharmacist on compliance and blood pressure control, a retroaction that we expect will guide therapy. The system also links patients with a nurse if BP is inadequately controlled and/or if patients are non-compliant. These nurses can then provide appropriate counselling to patients and refer the patients to their physician or pharmacist as appropriate.
Control:
The control group will receive standard care with no access to the IT-based system and multidisciplinary approach.
|
|
Primary outcome measure(s)
|
The primary objective of this study is to evaluate the impact of a multidisciplinary, information-technology supported hypertension management program on the mean change in 24-hour systolic and diastolic BP levels measured using Ambulatory Blood Pressure Monitoring (ABPM) compared to usual care.
|
|
Secondary outcome measure(s)
|
1. To assess the likely mechanisms that account for the results for the primary objective by measuring refill compliance and the number and dosage of anti-hypertensive agents assessed through pharmacy prescription data records over the 12-month study period as well as the number and nature of interventions by pharmacists, nurses and physicians
2. To assess the effect of the program on mean daytime and nocturnal BP, office BP measured, the proportion of subjects who achieve target office BP
3. To assess the impact of the program on patient’s perceived health related quality of life
4. To assess the impact of the program on the incidence of adverse cardiovascular events, including hospitalisation for uncontrolled hypertension, new onset angina, myocardial infarction, hospitalisation for unstable angina, hospitalisation for congestive heart failure, hospitalisation for stroke, hospitalisation for other vascular event, and cardiovascular death
5. To evaluate the potential economic benefits of the intervention, from a third-party payer’s perspective
|
|
Sources of funding
|
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT 67995)
2. Pfizer Canada Inc. (Canada)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Stéphane
Rinfret
|
|
Address
|
University of Montreal
Cardiology and Outcomes Research
Centre Hospitalier de l'Université de Montréal (Notre-Dame Hospital)
1560 Sherbrooke East
|
|
City/town
|
Montréal, QC
|
|
Zip/Postcode
|
H2L 4M1
|
|
Country
|
Canada
|
|
Tel
|
+1 514 890 8232
|
|
Fax
|
+1 514 412 7510
|
|
Email
|
s.rinfret@umontreal.ca
|
|
Sponsor
|
Canadian Institutes of Health Research (CIHR) (Canada)
|
|
Address
|
Room 97
160 Elgin Street
Address locator: 4809A
|
|
City/town
|
Ottawa, ON
|
|
Zip/Postcode
|
K1A OW9
|
|
Country
|
Canada
|
|
Tel
|
+1 888 603 4178
|
|
Fax
|
+1 613 954 1800
|
|
Email
|
info@cihr-irsc.gc.ca
|
|
Sponsor website:
|
http://www.cihr-irsc.gc.ca
|
|
Date applied
|
29/06/2004
|
|
Last edited
|
09/02/2007
|
|
Date ISRCTN assigned
|
22/07/2004
|
