Condition category
Circulatory System
Date applied
17/01/2006
Date assigned
02/03/2006
Last edited
24/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Not specified

Trial 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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/11/2004

Overall trial end date

31/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Written informed consent
3. Measurement of cholesterol

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

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

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21450565
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23819600

Publication citations

  1. Results

    Keller H, Krones T, Becker A, Hirsch O, Sönnichsen AC, Popert U, Kaufmann-Kolle P, Rochon J, Wegscheider K, Baum E, Donner-Banzhoff N, Arriba: effects of an educational intervention on prescribing behaviour in prevention of CVD in general practice., Eur J Prev Cardiol, 2012, 19, 3, 322-329, doi: 10.1177/1741826711404502.

  2. Results

    Keller H, Hirsch O1, Kaufmann-Kolle P, Krones T, Becker A, Sönnichsen AC, Baum E, Donner-Banzhoff N, Evaluating an implementation strategy in cardiovascular prevention to improve prescribing of statins in Germany: an intention to treat analysis, BMC Public Health, 2013, 13, 623, doi: 10.1186/1471-2458-13-623.

Additional files

Editorial Notes