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ISRCTN
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ISRCTN25105161
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ClinicalTrials.gov identifier
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NCT00202137
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Public title
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Home Blood Pressure Monitoring and blood pressure (BP) control
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Scientific title
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Acronym
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HBPM
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Serial number at source
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NA 4882
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Study hypothesis
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Hypertension is a common problem in Canada with a prevalence of about 15%. The goal of hypertension therapy should be to maximize blood pressure control. Home Blood Pressure Monitoring (HBPM) devices are available and many patients are using them. The role that self-monitoring of blood pressure can play in optimizing blood pressure control is unclear. We hope to clarify the role of home blood pressure monitoring in the treatment of hypertension and explore how it may affect patient and physician behaviours related to blood pressure management. This study will compare a group of hypertensive patients who use HBPM with those who do not use these devices.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Hypertension
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Participants - inclusion criteria
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1. Adults (age 18 and older) who are patients of family physicians
2. Must be diagnosed with essential hypertension but not have yet achieved target levels
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Participants - exclusion criteria
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1. A diagnosis of secondary hypertension
2. Pregnancy
3. Hypertension management primarily by a consultant
4. A disability that precludes use of a home blood pressure monitor
5. Enrolled in another hypertension trial
6. White coat hypertension
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Anticipated start date
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01/07/2002
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Anticipated end date
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01/11/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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630
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Interventions
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Patients in the intervention group are provided with a home blood pressure monitor that they are to use at least once a week and report the BP measurements to their physician at each follow up visit.
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Primary outcome measure(s)
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1. The mean daytime blood pressures on Ambulatory Blood Pressure Monitoring (ABPM)
2. The mean night-time blood pressures on ABPM
3. Achieving Blood Pressure (BP) target at end of study
4. Achieving 10% drop in the mean nighttime blood pressures
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Secondary outcome measure(s)
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1. Patient lifestyle changes
2. The number of visits for hypertension
3. Compliance with hypertensive medication use
4. Compliance with the intervention
5. Intensity of treatment
6. Frequency of lifestyle counselling by physician
7. Quality of Life as measured by 36-item Short Form health survey (SF-36)
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Sources of funding
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Heart and Stroke Foundation of Ontario (Canada)
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Trial website
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Publications
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1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14690550
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15985180
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Contact name
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Dr
Marshall
Godwin
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Address
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Centre for Studies in Primary Care
Dept of Family Medicine
220 Bagot Street
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City/town
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Kingston, Ontario
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Zip/Postcode
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K7L 5E9
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Country
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Canada
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Tel
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+1 613-549-4480
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Fax
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+1 613-544-9899
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Email
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godwinm@post.queensu.ca
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Sponsor
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Heart and Stroke Foundation of Ontario (Canada)
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Address
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1920 Yonge Street
4th Floor
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City/town
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Toronto, Ontario
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Zip/Postcode
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M4S 3E2
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Country
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Canada
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Tel
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+1 416 489 7100
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Fax
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+1 416 489 6885
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Email
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mail@hsf.on.ca
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Date applied
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14/08/2003
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Last edited
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18/03/2010
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Date ISRCTN assigned
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08/09/2003
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