Contact information
Type
Scientific
Contact name
Prof Norbert Donner-Banzhoff
ORCID ID
Contact details
University of Marburg
Department of General Practice and Family Medicine
Robert-Koch-Strasse 5
Marburg
35033
Germany
+49 (0)64 2128 65119
norbert@med.uni-marburg.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomized phase III trial: a decision aid in cardiovascular prevention - risk consultation related to absolute and relative risk
Acronym
ARRIBA
Study hypothesis
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
Ethics approval(s)
Ethical Committee of the University of Marburg, 18/10/2004, ref: 134/04
Study design
Two-arm parallel controlled cluster randomized intervention study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
Not specified
Study type
Quality of life
Patient information sheet
Condition
Cardiovascular disease
Intervention
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
Intervention type
Other
Primary outcome measure
Patient's attitude towards consultation (patient's perceived assessment scale)
Secondary outcome measures
1. GPs: changes in prescribing behaviour and consultation related to risk status
2. Patients: cardiovascular risk status after six months
Overall study start date
01/11/2004
Overall study end date
31/10/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >18 years
2. Written informed consent
3. Measurement of cholesterol
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
1100
Participant exclusion criteria
Insufficient mental or verbal ability
Recruitment start date
01/11/2004
Recruitment end date
31/10/2006
Locations
Countries of recruitment
Germany
Study participating centre
University of Marburg
Marburg
35033
Germany
Sponsor information
Organisation
University of Marburg, Department of General Practice and Family Medicine (Germany)
Sponsor details
Robert-Koch-Strasse 5
Marburg
35033
Germany
+49 (0)64 2128 65120
baum@med.uni-marburg.de
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Bundesministerium für Bildung und Forschung
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No | |
| Results article | results | 02/07/2013 | Yes | No |