Case Studys
DIGA (Digital Health Applications) study on smoking cessation
Key challenge
- Recruitment of 640 volunteers overall within 12 months
- a&r contribution of 58 volunteers
- Decentralized informed consent process including video information session and eConsent
- V4 at site after 6 month with a cotinine test for compliance
DIGA (Digital Health Applications) study on smoking cessation
Key challenge
- Recruitment of 640 volunteers overall within 12 months
- a&r contribution of 58 volunteers
- Decentralized informed consent process including video information session and eConsent
- V4 at site after 6 month with a cotinine test for compliance
Main study endpoint
Improvement of smoking cessation rate
Study motivation
Final inclusion in the German DiGA register of BfArM
Study motivation
Final inclusion in the German DiGA register of BfArM
Main study endpoint
Improvement of smoking cessation rate
Population
Tested product
Investigations
subjects recruited in 3 months
%
Questionnaire compliance
%
Retention rate
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