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 Duesseldorf
Moorenstr. 5
40225 Düsseldorf
Germany
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-University
Dr. rer. nat. Sabrina Kastaun
Postfach 101007
40001 Düsseldorf
Germany
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-University
Dr. rer. nat. Sabrina Kastaun
Postfach 101007
40001 Düsseldorf
Germany
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-University
Dr. rer. nat. Sabrina Kastaun
Postfach 101007
40001 Düsseldorf
Germany
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 Germany
Völklinger Str. 49
40221 Duesseldorf
Germany
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 Düsseldorf
Moorenstr. 5
40225 Düsseldorf
Germany
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
UTN (Universal Trial Number):
No Entry
EUDAMED 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