Digital smoking cessation with a comprehensive guideline-based app - results of a nationwide, multicentric, parallel, randomized controlled trial in Germany

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. 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). 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. 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. 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.