The German Study on Tobacco Use
Organizational Data
- DRKS-ID:
- DRKS00011322
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2016-11-25
- Last update in DRKS:
- 2021-09-16
- Registration type:
- Retrospective
Acronym/abbreviation of the study
DEBRA
URL of the study
No Entry
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.
Health condition or problem studied
- ICD10:
- F17.2
- Free text:
- Smoking behaviour
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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.
Endpoints
- 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.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Deutschlandweit
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2016-06-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-12-31
- Target Sample Size:
- 36000
- Final Sample Size:
- 36732
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 14 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Informed consent
Exclusion Criteria
barriers in language, moderate-severe cognitive impairment
Addresses
Primary Sponsor
- Address:
- Medical Faculty of the Heinrich-Heine-University DuesseldorfMoorenstr. 540225 DüsseldorfGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-duesseldorf.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institute of General Practice, Addiction Research and Clinical Epidemiology unit, Medical Faculty of the Heinrich-Heine-UniversityDr. rer. nat. Sabrina KastaunPostfach 10100740001 DüsseldorfGermany
- Telephone:
- 0049 (0)211/81-19527
- Fax:
- 0049 (0)211/81-08622
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-duesseldorf.de/allgemeinmedizin
Contact for Public Queries
- Address:
- Institute of General Practice, Addiction Research and Clinical Epidemiology unit, Medical Faculty of the Heinrich-Heine-UniversityDr. rer. nat. Sabrina KastaunPostfach 10100740001 DüsseldorfGermany
- Telephone:
- 0049 (0)211/81-19527
- Fax:
- 0049 (0)211/81-08622
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-duesseldorf.de/allgemeinmedizin
Principal Investigator
- Address:
- Institute of General Practice, Addiction Research and Clinical Epidemiology unit, Medical Faculty of the Heinrich-Heine-UniversityDr. rer. nat. Sabrina KastaunPostfach 10100740001 DüsseldorfGermany
- Telephone:
- 0049 (0)211/81-19527
- Fax:
- 0049 (0)211/81-08622
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-duesseldorf.de/allgemeinmedizin
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Ministry for Innovation, Science and Research of the German Federal State of North Rhine-Westphalia GermanyVölklinger Str. 4940221 DuesseldorfGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der Medizinischen Fakultät der Heinrich-Heine-Universität DüsseldorfMoorenstr. 540225 DüsseldorfGermany
- Telephone:
- +49-211-8119591
- Fax:
- +49-211-8119592
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-01-14
- Ethics committee number:
- 5386R
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-01-26
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- The data underlying this study are third-party data and are available to researchers on reasonable request from the principal investigators (daniel.kotz@med.uni-duesseldorf.de; sabrina.kastaun@med.uni-duesseldorf.de; ). All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of the DEBRA study team before data release.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- All publications can be found under "Research" at the DEBRA website
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry