Evaluation of evidence-based patient information on colorectal cancer screening
| ISRCTN | ISRCTN47105521 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47105521 |
| Secondary identifying numbers | 01EL0714 |
- Submission date
- 13/06/2008
- Registration date
- 10/07/2008
- Last edited
- 10/11/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anke Steckelberg
Scientific
Scientific
University of Hamburg
Unit of Health Sciences and Education
Martin-Luther-King-Platz 6
Hamburg
20146
Germany
| ASteckelberg@uni-hamburg.de |
Study information
| Study design | Double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| Participant information sheet | Patient information can be found at: http://www.chemie.uni-hamburg.de/igtw/Gesundheit/images/pdf/Probandeninformation_2008.pdf (in German) |
| Scientific title | |
| Study acronym | EVA DK |
| Study objectives | Evidence-based patient information leads to more informed choices in colorectal cancer screening than traditional information. |
| Ethics approval(s) | Local Ethics Committee in Hamburg. Date of approval: 05/06/2008 (ref: PV2955) |
| Health condition(s) or problem(s) studied | Healthy adults |
| Intervention | Experimental intervention: Evidence-based patient information on colorectal cancer screening and interactive teaching modules on diagnostics and risk. The interactive teaching modules are available online, and the participants are free to decide how long and how often they use the tool to study on their own. Control intervention: Standard patient information |
| Intervention type | Other |
| Primary outcome measure | Informed choice, consisting of the following three dimensions: 1. Knowledge 2. Uptake of colorectal cancer screening 3. Attitude towards colorectal cancer screening Informed choice is measured using the validated questionnaire "Measure of Informed Choice" 6 weeks after the intervention has been provided. Added as of 05/03/2009: Data analyses of knowledge, attitude and uptake questionnaires will be performed according to a predefined coding guide, which has been deposited at a staff member not involved in the study. Data entry and analyses will be carried out blinded. |
| Secondary outcome measures | Knowledge on colorectal cancer screening and uptake, surveyed within the primary endpoint are analysed separately as secondary endpoints. Uptake is also surveyed 6 months after the intervention has been provided. In addition, uptake is verified with data from the Statutory Health Insurance Company Gmünder Ersatzkasse (GEK) at 6 months. |
| Overall study start date | 01/06/2008 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,140 |
| Key inclusion criteria | 1. Both males and females 2. Age: 50 - 75 3. No colorectal cancer 4. Insured persons of the Statutory Health Insurance Company Gmünder Ersatzkasse (GEK) |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Hamburg
Hamburg
20146
Germany
20146
Germany
Sponsor information
Federal Ministry of Education and Research (BMBF) (Germany)
Government
Government
Hannoversche Strasse 28-30
Berlin
10115
Germany
| ASteckelberg@uni-hamburg.de | |
| Website | http://www.bmbf.de/en/ |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
Federal Ministry of Education and Research (BMBF) (Germany)
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 | 02/06/2011 | Yes | No |
