Condition category
Circulatory System
Date applied
29/06/2004
Date assigned
22/07/2004
Last edited
09/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stéphane Rinfret

ORCID ID

Contact details

University of Montreal
Cardiology and Outcomes Research
Centre Hospitalier de l'Université de Montréal (Notre-Dame Hospital)
1560 Sherbrooke East
Montréal
QC
H2L 4M1
Canada
+1 514 890 8232
s.rinfret@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00374829

Protocol/serial number

DCT 67995

Study information

Scientific title

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hypertension

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/05/2004

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female uncontrolled hypertensive subjects
2. 18 years of age or more

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant 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

Recruitment start date

01/05/2004

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Canada

Trial participating centre

University of Montreal
Montréal, QC
H2L 4M1
Canada

Sponsor information

Organisation

Canadian Institutes of Health Research (CIHR) (Canada)

Sponsor details

Room 97
160 Elgin Street
Address locator: 4809A
Ottawa
ON
K1A OW9
Canada
+1 888 603 4178
info@cihr-irsc.gc.ca

Sponsor type

Research organisation

Website

http://www.cihr-irsc.gc.ca

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT 67995)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer Canada Inc. (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

Publication citations

Additional files

Editorial Notes