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ISRCTN
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ISRCTN05874865
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ClinicalTrials.gov identifier
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Public title
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Intensive Scheduled Management strategy for improving blood pressure control in patients in primary care
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Scientific title
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Acronym
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ISM
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Serial number at source
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NA 4884
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Study hypothesis
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Comparing intensive scheduled management of hypertension (aggressive achievement of target blood pressure over 16 weeks) with usual management of hypertension.
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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. Inability to provide informed consent
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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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Not provided at time of registration
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Interventions
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This study is designed to test the premise that guidelines, to be effective in primary care, need to be operationalised for the practitioner. To this end we have devised a protocol where medications are initiated at the recommended starting dose and increased by one recommended increment before adding the next drug. The goal is to increase the medications over the 16-week period such that, if necessary to reach the target blood pressure level, a patient is on a medium dose of three different antihypertensive agents.
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Primary outcome measure(s)
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Blood pressure control on 24-hour Ambulatory Blood Pressure Monitoring (ABPM), measured at 16 weeks and one year.
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Secondary outcome measure(s)
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1. Patient quality of life
2. Physician compliance with the intensive protocol
3. Patient compliance with medication
4. Adverse effects
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Sources of funding
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The Heart and Stroke Foundation of Ontario (Canada)
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Trial website
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&dopt=AbstractPlus&list_uids=14690550
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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
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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The 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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19/10/2007
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Date ISRCTN assigned
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08/09/2003
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