Trial document
This trial has been registered retrospectively.
DRKS00011322
Trial Description
Title
The German Study on Tobacco Use
Trial Acronym
DEBRA
URL of the Trial
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Brief Summary in Lay Language
Approximately one third of the German adult population smokes tobacco. Timely and frequent tracking of national patterns of tobacco smoking and data on the "real-world" effectiveness of smoking cessation methods are needed to inform policies and develop campaigns aimed at reducing tobacco-related harm. In England, the Smoking Toolkit Study (www.smokinginengland.info) has been successfully tracking such key performance indicators since 2006, resulting in the implementation and adaptations of tobacco control policies which have been associated with reductions in tobacco consumption. However, findings cannot be directly transferred into the German health policy context. The DEBRA study aims to provide such nationally representative data.
The DEBRA study begun in June 2016 and consists of computer-assisted, household interviews in people over 14 years. Over a period of at least 3 years, every two months, a new sample of approximately 2,000 respondents will complete the survey (18 waves = approximately 36,000 respondents). Per wave, about 500-600 people are expected to smoke tobacco daily or occasionally or to be recent ex-smokers (<12 months since quitting tobacco). At baseline and six months later, this group will answer detailed questions about rates, duration and success of quit attempts, triggers of quit attempts, exposure to health professionals' advice on quitting, and use of behavioural (medical counselling, group therapy) and pharmacological (nictoine replacement, drugs) cessation aids, including electronic cigarettes.
The DEBRA study will be able to track key variables relating to patterns and trends of smoking and quitting in Germany and will provide information for tobacco control, cessation strategies, and future scientific studies. The methodology of the study is closely aligned to the Smoking Toolkit Study, which will allow international comparisons of data.
Brief Summary in Scientific Language
The prevalence of tobacco smoking in Germany is high (30%). Timely and frequent tracking of national patterns of tobacco smoking and data on the "real-world" effectiveness of smoking cessation methods are needed to inform policies and develop campaigns aimed at reducing tobacco-related harm. In England, the Smoking Toolkit Study has been successfully tracking such key performance indicators since 2006, resulting in the implementation and adaptations of tobacco control policies, which have been associated with reductions in smoking prevalence. However, findings cannot be directly transferred into the German health policy context. The DEBRA study aims to provide such nationally representative data.
The DEBRA study begun in June 2016 and consists of cross-sectional, computer-assisted household interviews in People over 14 years. Over a period of at least 3 years, every two months, a new sample of approximately 2,000 respondents will complete the survey (18 waves = approximately 36,000 respondents). Per wave, about 500-600 people are expected to smoke tobacco daily or occasionally or to be recent ex-smokers (<12 months). At baseline and six months later, this group will answer detailed questions about rates, duration and success of quit attempts, internal and external triggers of quit attempts, exposure to health professionals' advice on quitting, and use of behavioural and pharmacological cessation aids, including electronic cigarettes. Variables will be analysed considering potential confounders (e.g., strength of urges to smoke and sociodemographic characteristics).
The DEBRA study will be able to track key variables relating to patterns and trends of smoking and quitting in Germany and will provide information for tobacco control, cessation strategies, and future scientific studies. The methodology of the study is closely aligned to the Smoking Toolkit Study, which will allow international comparisons of data.
Organizational Data
- DRKS00011322
- 2016/11/25
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- yes
- Approved
- 5386R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
Secondary IDs
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Health Condition or Problem studied
- F17.2 - Mental and behavioural disorders due to use of tobacco; Dependence syndrome
- Smoking behaviour
Interventions/Observational Groups
-
Non-smokers:
Computer-assisted household interviews in people over 14 years. Over a period of at least 3 years, every two months, a new sample of approximately 2,000 respondents will complete the survey.
Smokers and recent ex-smokers:
Computer-assisted household interviews in people over 14 years. Over a period of at least 3 years, every two months, a new sample of approximately 2,000 respondents will complete the survey (18 waves = approximately 36,000 respondents). Per wave, about 500-600 people are expected to smoke tobacco daily or occasionally or to be recent ex-smokers (<12 months). At baseline and six months later, this group will answer detailed questions about rates, duration and success of quit attempts, internal and external triggers of quit attempts, exposure to health professionals' advice on quitting, and use of behavioural and pharmacological cessation aids, including electronic cigarettes.
Characteristics
- Non-interventional
- Epidemiological study
- Other
- Open (masking not used)
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- Other
- Other
- Other
- N/A
- N/A
Primary Outcome
Primary aim of the DEBRA study is to track key variables relating to patterns and trends of smoking and quitting in Germany and to provide such nationally representative data to inform tobaccco control, cessation strategies, and future scientific studies. Data will be collected via computer-assisted household interviews at baseline. Smokers and recent ex-smokers will be followed-up 6 months later.
Secondary Outcome
Secondary aim is to compare our primary endpoints with comparable data from other international surveys, particularly from England.
Countries of Recruitment
- Germany
Locations of Recruitment
- other
Recruitment
- Actual
- 2016/06/15
- 36000
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 14 Years
- no maximum age
Additional Inclusion Criteria
Informed consent
Exclusion Criteria
barriers in language, moderate-severe cognitive impairment
Addresses
-
start of 1:1-Block address primary-sponsor
- Medical Faculty of the Heinrich-Heine-University Duesseldorf
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
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- http://www.uniklinik-duesseldorf.de
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- Institute of General Practice, Addiction Research and Clinical Epidemiology unit, Medical Faculty of the Heinrich-Heine-University
- Ms. Dr. rer. nat. Sabrina Kastaun
- Postfach 101007
- 40001 Düsseldorf
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0049 (0)211/81-19527
- 0049 (0)211/81-08622
- sabrina.kastaun at med.uni-duesseldorf.de
- http://www.uniklinik-duesseldorf.de/allgemeinmedizin
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Institute of General Practice, Addiction Research and Clinical Epidemiology unit, Medical Faculty of the Heinrich-Heine-University
- Ms. Dr. rer. nat. Sabrina Kastaun
- Postfach 101007
- 40001 Düsseldorf
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0049 (0)211/81-19527
- 0049 (0)211/81-08622
- sabrina.kastaun at med.uni-duesseldorf.de
- http://www.uniklinik-duesseldorf.de/allgemeinmedizin
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
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- Ministry for Innovation, Science and Research of the German Federal State of North Rhine-Westphalia Germany
- Völklinger Str. 49
- 40221 Duesseldorf
- Germany
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Status
- Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents
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