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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN71348772
Date of registration: 02/03/2006
Prospective Registration: No
Primary sponsor: University of Marburg, Department of General Practice and Family Medicine (Germany)
Public title: Randomized phase III trial: a decision aid in cardiovascular prevention - risk consultation related to absolute and relative risk
Scientific title: Randomized phase III trial: a decision aid in cardiovascular prevention - risk consultation related to absolute and relative risk
Date of first enrolment: 01/11/2004
Target sample size: 1100
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN71348772
Study type:  Interventional
Study design:  Two-arm parallel controlled cluster randomized intervention study (Quality of life)  
Phase:  Phase III
Countries of recruitment
Germany
Contacts
Name: Norbert    Donner-Banzhoff
Address:  University of Marburg Department of General Practice and Family Medicine Robert-Koch-Strasse 5 35033 Marburg Germany
Telephone: +49 (0)64 2128 65119
Email: norbert@med.uni-marburg.de
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Age >18 years
2. Written informed consent
3. Measurement of cholesterol

Exclusion criteria: Insufficient mental or verbal ability

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Cardiovascular disease
Circulatory System
Cardiovascular disease
Intervention(s)
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(s)
Patient's attitude towards consultation (patient's perceived assessment scale)
Secondary Outcome(s)
1. GPs: changes in prescribing behaviour and consultation related to risk status
2. Patients: cardiovascular risk status after six months
Secondary ID(s)
N/A
Source(s) of Monetary Support
Bundesministerium für Bildung und Forschung
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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