Contact information
Type
Scientific
Primary contact
Dr Anke Steckelberg
ORCID ID
Contact details
University of Hamburg
Unit of Health Sciences and Education
Martin-Luther-King-Platz 6
Hamburg
20146
Germany
ASteckelberg@uni-hamburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01EL0714
Study information
Scientific title
Acronym
EVA DK
Study hypothesis
Evidence-based patient information leads to more informed choices in colorectal cancer screening than traditional information.
Ethics approval
Local Ethics Committee in Hamburg. Date of approval: 05/06/2008 (ref: PV2955)
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Patient information can be found at: http://www.chemie.uni-hamburg.de/igtw/Gesundheit/images/pdf/Probandeninformation_2008.pdf (in German)
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/06/2008
Overall trial end date
31/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1,140
Participant exclusion criteria
No exclusion criteria
Recruitment start date
01/06/2008
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Germany
Trial participating centre
University of Hamburg
Hamburg
20146
Germany
Sponsor information
Organisation
Federal Ministry of Education and Research (BMBF) (Germany)
Sponsor details
Hannoversche Strasse 28-30
Berlin
10115
Germany
ASteckelberg@uni-hamburg.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Federal Ministry of Education and Research (BMBF) (Germany)
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Funding Body Type
unknown
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21636633
Publication citations
-
Results
Steckelberg A, Hülfenhaus C, Haastert B, Mühlhauser I, Effect of evidence based risk information on "informed choice" in colorectal cancer screening: randomised controlled trial., BMJ, 2011, 342, d3193.