Randomized phase III trial: a decision aid in cardiovascular prevention - risk consultation related to absolute and relative risk
| ISRCTN | ISRCTN71348772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71348772 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/01/2006
- Registration date
- 02/03/2006
- Last edited
- 24/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Norbert Donner-Banzhoff
Scientific
Scientific
University of Marburg
Department of General Practice and Family Medicine
Robert-Koch-Strasse 5
Marburg
35033
Germany
| Phone | +49 (0)64 2128 65119 |
|---|---|
| norbert@med.uni-marburg.de |
Study information
| 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 |
| Scientific title | Randomized phase III trial: a decision aid in cardiovascular prevention - risk consultation related to absolute and relative risk |
| Study acronym | ARRIBA |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1100 |
| Key inclusion criteria | 1. Age >18 years 2. Written informed consent 3. Measurement of cholesterol |
| Key exclusion criteria | Insufficient mental or verbal ability |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 31/10/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Marburg
Marburg
35033
Germany
35033
Germany
Sponsor information
University of Marburg, Department of General Practice and Family Medicine (Germany)
University/education
University/education
Robert-Koch-Strasse 5
Marburg
35033
Germany
| Phone | +49 (0)64 2128 65120 |
|---|---|
| baum@med.uni-marburg.de | |
"ROR" |
https://ror.org/01rdrb571 |
Funders
Funder type
Government
Bundesministerium für Bildung und Forschung
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
