Trial document




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  DRKS00025933

Trial Description

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Title

Investigation of a positive care effect of the NichtraucherHelden App (Medicine): Implementation of a Randomized Controlled Trial (RCT).

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The NichtraucherHelden App is used to treat and alleviate a diagnosed tobacco addiction. Through a cognitive-behavioral therapy approach, patients are encouraged to overcome their tobacco dependence. The aim of this study is to investigate the effectiveness of the app in smoking cessation together with a brief medical consultation.

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Brief Summary in Scientific Language

The aim of this study is the scientific evaluation of the NichtraucherHelden App (Medicine) in combination with brief advice from a physician. The effectiveness of the NichtraucherHelden App (Medicine) in combination with brief advice (intervention group, IG) is tested in comparison to a control group (KG), which only receives brief advice. The following parameters will be evaluated as part of the study:
• 7-day point prevalence of smoking abstinence 6 months after smoking cessation.
• prolonged smoking abstinence
• objective smoking abstinence measured by cotinine detection in saliva
• changes in health-related quality of life
• influence on shortness of breath
• influence on cough

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00025933
  •   2021/07/30
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  •   no
  •   Approved
  •   Eth-52/20, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

  •   U1111-1268-2181 
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Health Condition or Problem studied

  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
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Interventions/Observational Groups

  •   Intervention Group (IG). Subjects receive a 3-minute, brief medical consultation and the NichtraucherHelden App (Medicine). At the end of the study, successful non-smokers provide a saliva sample for cotinine measurement.
  •   Control group (CG). Subjects receive a 3-minute, brief medical consultation, but no app.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

7-day point prevalence of smoking abstinence 6 months after smoking cessation

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Secondary Outcome

- prolonged smoking abstinence
- objective smoking abstinence measured by cotinine detection in saliva
- changes in health-related quality of life
- influence on shortness of breath
- influence on cough

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2021/08/31
  •   640
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- diagnosed tobacco dependence according to ICD-10 F17.2
- intention to quit smoking
- age ≥ 18 years
- device for use of the NichtraucherHelden App (Medicine)
- resident (primary residence) in Germany
- valid private e-mail address

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Exclusion Criteria

- concomitant alcohol, pill, or illicit drug addiction
- acutely symptomatic psychiatric illness
- severe cognitive impairment
- dementia-related illnesses
- lack of German language skills
- work in 24h shifts (e.g. rescue service, fire department)
- participation in another tobacco cessation program
- use of another smartphone app for tobacco cessation

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Addresses

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    • NichtraucherHelden GmbH
    • Im Himmel 20
    • 70569  Stuttgart
    • Germany
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    • novineon CRO GmbH
    • Friedrich-Miescher-Straße 9
    • 72076  Tübingen
    • Germany
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    • NichtraucherHelden GmbH
    • Ms.  Dr.  Maddalena Angela  Di Lellis 
    • Im Himmel 20
    • 70569  Stuttgart
    • Germany
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    • NichtraucherHelden GmbH
    • Ms.  Dr.  Maddalena Angela  Di Lellis 
    • Im Himmel 20
    • 70569  Stuttgart
    • Germany
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Sources of Monetary or Material Support

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    • NichtraucherHelden GmbH
    • Im Himmel 20
    • 70569  Stuttgart
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.