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Randomized phase III trial: a decision aid in cardiovascular prevention - risk consultation related to absolute and relative risk
ISRCTN ISRCTN71348772
DOI 10.1186/ISRCTN71348772
ClinicalTrials.gov identifier
EudraCT number
Public title Randomized phase III trial: a decision aid in cardiovascular prevention - risk consultation related to absolute and relative risk
Scientific title
Acronym ARRIBA
Serial number at source N/A
Study hypothesis A consultation based on ARRIBA leads to:
1. An improved quality of counselling (patientís perceived assessment scale)
2. Changes in prescribing behaviour based on risk status
Lay summary Not provided at time of registration
Ethics approval Approved by the Ethical Committee of the University of Marburg on 18/10/2004, reference number: 134/04
Study design A two-arm parallel, controlled, cluster, randomized intervention study
Countries of recruitment Germany
Disease/condition/study domain Cardiovascular disease
Participants - inclusion criteria 1. Age >18 years
2. Written informed consent
3. Measurement of cholesterol
Participants - exclusion criteria Insufficient mental or verbal ability
Anticipated start date 01/11/2004
Anticipated end date 31/10/2006
Status of trial Completed
Patient information material
Target number of participants 1100
Interventions 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
Primary outcome measure(s) Patientís attitude towards consultation (patientís perceived assessment scale)
Secondary outcome measure(s) 1. GPs: changes in prescribing behaviour and consultation related to risk status
2. Patients: cardiovascular risk status after six months
Sources of funding German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF])
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21450565
Contact name Prof  Norbert  Donner-Banzhoff
  Address University of Marburg

Department of General Practice and Family Medicine

Robert-Koch-Strasse 5
  City/town Marburg
  Zip/Postcode 35033
  Country Germany
  Tel +49 (0)64 2128 65119
  Fax +49 (0)64 2128 65121
  Email norbert@med.uni-marburg.de
Sponsor University of Marburg, Department of General Practice and Family Medicine (Germany)
  Address Robert-Koch-Strasse 5
  City/town Marburg
  Zip/Postcode 35033
  Country Germany
  Tel +49 (0)64 2128 65120
  Fax +49 (0)64 2128 65121
  Email baum@med.uni-marburg.de
Date applied 17/01/2006
Last edited 20/09/2012
Date ISRCTN assigned 02/03/2006
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