The German Study on Tobacco Use
Organizational Data
- DRKS-ID:
- DRKS00017157
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2019-05-22
- Last update in DRKS:
- 2022-12-19
- Registration type:
- Prospective
Acronym/abbreviation of the study
DEBRA
URL of the study
Brief summary in lay language
The DEBRA study ran in the first funding period from June 2016 to April 2019 (DRKS00011322) with a focus on the consumption of tobacco products/smoking behaviour in the German population. The second funding period (Federal Ministry of Health, BMG) will start in June 2019. ************** Summary: Electronic inhalation products (e-inhalation products) such as electronic cigarettes (e-cigarettes) and heat-not-burn products are being increasingly used by adolescents and adults in Germany as an alternative or complement to conventional tobacco smoking. However, up-to-date, detailed and representative data are missing on the prevalence (frequency) and trends of usage, consumption patterns, associated factors (particularly on the association with tobacco smoking cessation and initiation), and views and harm perception of these products. From a health policy perspective, such data are important since these products can pose both, risks (health risks, "gateway" to smoking) and opportunities (harm reduction, smoking cessation aid) for public health. The DEBRA study consists of face-to-face houselhold interviews of representative samples of the German population aged 14 and over (approx. 2,000 persons per survey wave = every second month, with a total of 17 waves over a period of 3 years). The study aims to (1) monitor the prevalence of the use of e-inhalation products at regular intervals; (2) record relevant consumption patterns in detail and monitor them over time; (3) analyse the relationship between the consumption of e-inhalation products and the initiation/quitting of tobacco smoking, as well as associations with socio-demographic consumer characteristics; and (4) assess views and harm perception of these products. Respondents who are current tobacco smokers (daily or occasional) or recent ex-smokers (<=12 months since smoking cessation) at baseline will be re-contacted by phone after six month (follow-up) and asked about the rates, duration and success of quit attempts (if so), 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 e-cigarettes. The methodology of DEBRA is closely aligned to the Smoking Toolkit Study, which will allow international comparisons of data.
Brief summary in scientific language
The DEBRA study ran in the first funding period from June 2016 to April 2019 (DRKS00011322) with a focus on the consumption of tobacco products/smoking behaviour in the German population. The second funding period (Federal Ministry of Health, BMG) will start in June 2019. ************** Summary: Electronic inhalation products (e-inhalation products) such as electronic cigarettes (e-cigarettes) and heat-not-burn products are being increasingly used by adolescents and adults in Germany as an alternative or complement to conventional tobacco smoking. However, up-to-date, detailed and representative data are missing on the prevalence and trends of usage, consumption patterns, associated factors (particularly on the association with tobacco smoking cessation and initiation), and views and harm perception of these products. From a health policy perspective, such data are important since these products can pose both, risks (health risks, "gateway" to smoking) and opportunities (harm reduction, smoking cessation aid) for public health. The DEBRA study consists of face-to-face houselhold interviews of representative samples of the German population aged 14 and over (approx. 2,000 persons per survey wave = every second month, with a total of 17 waves over a period of 3 years). The study aims to (1) monitor the prevalence of the use of e-inhalation products at regular intervals; (2) record relevant consumption patterns in detail and monitor them over time; (3) analyse the relationship between the consumption of e-inhalation products and the initiation/quitting of tobacco smoking, as well as associations with socio-demographic consumer characteristics; and (4) assess views and harm perception of these products. Respondents who are current tobacco smokers (daily or occasional) or recent ex-smokers (<=12 months since smoking cessation) at baseline will be re-contacted by phone after six month (follow-up) and asked about the rates, duration and success of quit attempts (if so), 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 e-cigarettes. The methodology of DEBRA is closely aligned to the Smoking Toolkit Study, which will allow international comparisons of data. In the course of an amendment from the 18.03.2019, the extension of the study for a further 3 years was anounced to the Ethics Committee of the Medical Faculty of the HHU Düsseldorf, and has been approved by the Committee on 17.04.2019.
Health condition or problem studied
- ICD10:
- F17.2
- Free text:
- Mental and behavioural disorders caused by tobacco : dependence syndrome
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- All participants of the computer-assisted, face-to-face household survey: Over a period of at least 3 years, every two months, a new sample of approximately 2,000 respondents aged 14 years and older will complete the survey (17 waves = approximately 34,000 respondents). *************** Smokers and recent ex-smokers (<=12 months) of these samples: 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. ************** Current or recent users of electronic inhalation products of these samples: Will be asked in detail about their consumption behaviour, harm perception of these products, motivation for and experience with these electronic inhalation products.
Endpoints
- Primary outcome:
- Primary aim of the DEBRA study is to track key variables relating to patterns and trends of consumption of electronic inhalation products (e.g., e-cigarettes, heat-not-burn products), tobacco smoking and quitting in Germany, and to provide such nationally representative data to inform tobacco control policies, cessation strategies, and future scientific studies. Data will be collected via computer-assisted household interviews at baseline. Current tobacco 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 Deutschlandweite Haushaltsbefragung Deutschlandweit (Germany nationwide)
Recruitment period and number of participants
- Planned study start date:
- 2019-06-15
- Actual study start date:
- 2019-06-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-09-20
- Target Sample Size:
- 34000
- Final Sample Size:
- 34525
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:
- Federal Ministry of Health (BMG) Germany53123 BonnGermany
- 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:
- All participant-related data in anonymised form. On application with analysis protocol and predefined objectives. We use a "data sharing agreement". Data are made available only to industry-independent scientists.
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:
- DRKS00011322 - DRKS-ID Studienteil 1/study part 1
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Study website with links to published peer-reviewed articles
- 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