Trial document




This trial has been registered retrospectively.
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  DRKS00011322

Trial Description

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Title

The German Study on Tobacco Use

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Trial Acronym

DEBRA

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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.

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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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011322
  •   2016/11/25
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  •   yes
  •   Approved
  •   5386R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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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
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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.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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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.

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Secondary Outcome

Secondary aim is to compare our primary endpoints with comparable data from other international surveys, particularly from England.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/06/15
  •   36000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   14   Years
  •   no maximum age
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Additional Inclusion Criteria

Informed consent

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Exclusion Criteria

barriers in language, moderate-severe cognitive impairment

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Addresses

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    • Medical Faculty of the Heinrich-Heine-University Duesseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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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
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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
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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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