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

Alexander Rupp; Stephan Rietzler; Maddalena A Di Lellis; Timo Weiland; Claudia Tschirner; Michael Kreuter

doi:10.1093/ntr/ntae009

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

Nicotine Tob Res. 2024 Jan 18:ntae009. doi: 10.1093/ntr/ntae009. Online ahead of print.

Authors

Alexander Rupp¹, Stephan Rietzler², Maddalena A Di Lellis³, Timo Weiland⁴, Claudia Tschirner⁴, Michael Kreuter⁵

Affiliations

¹ Outpatient Clinic for Pulmonary Medicine (Pneumologische Praxis im Zentrum (PiZ)), Stuttgart, Germany.
² Benningen, Germany.
³ Sanero Medical GmbH, Stuttgart, Germany.
⁴ novineon CRO GmbH, Tübingen, Germany.
⁵ Mainz Centre for Pulmonary Medicine, Department of Pneumology, Mainz University Medical Centre and Department of Pulmonary, Critical Care & Sleep Medicine, Marienhaus Klinikum Mainz, Mainz, Germany.

PMID: 38243574
DOI: 10.1093/ntr/ntae009

Abstract

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.

Keywords: Smoking cessation; digital; guideline-based cessation; mobile app; randomized controlled trial (RCT); smartphone.