Trial document




This trial has been registered retrospectively.
drksid header

  DRKS00011322

Trial Description

start of 1:1-Block title

Title

The German Study on Tobacco Use

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

DEBRA

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description 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.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011322
  •   2016/11/25
  •   [---]*
  •   yes
  •   Approved
  •   5386R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
  •   Smoking behaviour
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/06/15
  •   36000
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   14   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

barriers in language, moderate-severe cognitive impairment

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Medical Faculty of the Heinrich-Heine-University Duesseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-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 scientific-contact
    start of 1:1-Block address contact scientific-contact
    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-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Ministry for Innovation, Science and Research of the German Federal State of North Rhine-Westphalia Germany
    • Völklinger Str. 49
    • 40221  Duesseldorf
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   [---]*
  •   [---]*
  •   2019/12/31
  •   36732
  •   36732
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.