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ISRCTN
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ISRCTN71348772
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ClinicalTrials.gov identifier
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Public title
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Randomized phase III trial: a decision aid in cardiovascular prevention - risk consultation related to absolute and relative risk
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Scientific title
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Acronym
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ARRIBA
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Serial number at source
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N/A
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Study hypothesis
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A consultation based on ARRIBA leads to:
1. An improved quality of counselling (patient’s perceived assessment scale)
2. Changes in prescribing behaviour based on risk status
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Ethics approval
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Approved by the Ethical Committee of the University of Marburg on 18/10/2004, reference number: 134/04
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Study design
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A two-arm parallel, controlled, cluster, randomized intervention study
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Cardiovascular disease
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Participants - inclusion criteria
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1. Age >18 years
2. Written informed consent
3. Measurement of cholesterol
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Participants - exclusion criteria
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Insufficient mental or verbal ability
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Anticipated start date
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01/11/2004
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Anticipated end date
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31/10/2006
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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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1100
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Interventions
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1. Intervention:
a. Advanced training (continuing education) in shared decision-making, risk calculation, risk communication and the use of decision aids
b. Advanced training in ARRIBA (decision aid and consultation)
2. Control:
Controls receive training after termination of the study
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Primary outcome measure(s)
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Patient’s attitude towards consultation (patient’s perceived assessment scale)
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Secondary outcome measure(s)
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1. GPs: changes in prescribing behaviour and consultation related to risk status
2. Patients: cardiovascular risk status after six months
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Sources of funding
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German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF])
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Trial website
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Publications
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Contact name
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Prof
Norbert
Donner-Banzhoff
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Address
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University of Marburg
Department of General Practice and Family Medicine
Robert-Koch-Strasse 5
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City/town
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Marburg
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Zip/Postcode
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35033
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Country
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Germany
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Tel
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+49 (0)64 2128 65119
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Fax
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+49 (0)64 2128 65121
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Email
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norbert@med.uni-marburg.de
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Sponsor
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University of Marburg, Department of General Practice and Family Medicine (Germany)
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Address
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Robert-Koch-Strasse 5
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City/town
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Marburg
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Zip/Postcode
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35033
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Country
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Germany
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Tel
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+49 (0)64 2128 65120
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Fax
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+49 (0)64 2128 65121
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Email
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baum@med.uni-marburg.de
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Date applied
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17/01/2006
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Last edited
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10/03/2006
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Date ISRCTN assigned
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02/03/2006
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