Investigation of a positive care effect of the NichtraucherHelden App (Medicine): Implementation of a Randomized Controlled Trial (RCT).
- Conditions
- ICD-10 F17.2: Mental and behavioural disorders due to use of cannabinoidsDependence syndromeF17Mental and behavioural disorders due to use of tobacco
- Registration Number
- DRKS00025933
- Lead Sponsor
- Sanero Medical GmbH
- Brief Summary
Background Smoking tobacco implies significant health hazards. Digital cessation support can get more smokers in contact with guideline-based cessation. The objective was to test the efficacy of a guideline-based smoking cessation app (NichtraucherHelden®). The hypothesis was a significant higher cessation rate in the intervention group. Methods The study was a nationwide, multicentric, prospective, parallel, randomized controlled trial in Germany from November 2021 to March 2023. Recruitment took place in medical practices and by telephone via study centres. Eligible participants were adult tobacco-dependent smokers according to ICD-10 (F17.2). Randomization (1:1) was operated by a computer-generated stratified 1:1 block procedure. Intervention (IG; n = 336) and control group (CG; n = 325) were briefly advised with regard to stop smoking, IG was additionally treated with the cessation app. Primary endpoint was the self-reported 7-day-point-abstinence after 6 months with an intention to treat analysis. Secondary endpoints comprised prolonged abstinence and biochemically verified abstinence. The study was registered at the German Registry of Clinical Trials (DRKS00025933, UTN U1111-1268-2181) and was approved by the competent ethic committees (leading ethic committee Berlin #Eth-52/20). Results 336 participants (IG) and 325 (CG) were analysed. Seven-day point prevalence was significantly higher in the app group (IG) (20% vs. 10%, OR 2.2 (1.4 – 3.4)). Additionally, the prolonged abstinence and the objective abstinence rate were significantly higher in the app group. Conclusions The NichtraucherHelden App doubles the abstinence rate. Apps can bridge the gap between the small numbers of therapeutic offers and the need for modern evidence-based cessation support. Implications The study is the first to provide evidence for the feasibility and efficacy of guideline-based digital smoking cessation provided by a smartphone app for the German statutory health insurance system (SHI). Smoking cessation support by smartphone apps could be broadly distributed and thus bring more smokers in contact with guideline-based cessation support than to date and increase the number of successful quitters substantially.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 685
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 7-day point prevalence of smoking abstinence 6 months after smoking cessation
- Secondary Outcome Measures
Name Time Method - prolonged smoking abstinence<br>- objective smoking abstinence measured by cotinine detection in saliva<br>- changes in health-related quality of life<br>- influence on shortness of breath<br>- influence on cough