Trials · 2025
Evaluation of a smartphone app to maintain skin protection behaviour in patients with work-related hand eczema as part of a maintenance programme: protocol for the quasi-randomised controlled trial 'TecNaP-RCT'.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Rocholl Marc, Ristow Nele, Scheufler Frauke, Nordheider Kathrin, Skudlik Christoph, John Swen Malte, Ludewig Michaela, Wilke Annika
Аннотация
BACKGROUND: Work-related hand eczema (WRHE) is a common occupational disease in Europe, associated with impaired quality of life and a substantial socioeconomic burden. As skin protection behaviour critically influences disease course, mobile health interventions may help establish and maintain routines. The smartphone app 'Mein Hautschutz im Alltag' (MiA; German for 'My Skin Protection in Everyday Life') was developed to support patients with WRHE, but its clinical effectiveness has not yet been evaluated.
METHODS: This quasi-randomised controlled trial will enrol 286 adults with WRHE attending a 3-week inpatient programme at a specialised dermatology clinic. Participants are allocated in clusters based on admission date to either care as usual (control) or care as usual plus an individual goal-setting interview and a 6-month access to the MiA app (intervention). The primary outcome is change in skin protection behaviour from baseline to 6 months post-discharge. Secondary outcomes include clinical and self-rated skin condition, action control, and quality of life. Analyses will follow the intention-to-treat principle using linear mixed models.
DISCUSSION: This is the first systematic evaluation of the MiA app's effectiveness in patients with WRHE in a quasi-randomised controlled trial. By combining a structured goal-setting interview with the MiA app, the intervention aims to support the long-term adoption and maintenance of protective behaviours in both occupational and private settings. Key limitations include the quasi-random allocation by admission date (no true randomisation), lack of allocation concealment and blinding, reliance on self-reported primary outcomes, and a 6-month follow-up. Despite these constraints, the pragmatic design aims to generate decision-relevant, real-world evidence for WRHE care.
TRIAL REGISTRATION: German Clinical Trial Registry DRKS00036627. Registered on April 14, 2025.
METHODS: This quasi-randomised controlled trial will enrol 286 adults with WRHE attending a 3-week inpatient programme at a specialised dermatology clinic. Participants are allocated in clusters based on admission date to either care as usual (control) or care as usual plus an individual goal-setting interview and a 6-month access to the MiA app (intervention). The primary outcome is change in skin protection behaviour from baseline to 6 months post-discharge. Secondary outcomes include clinical and self-rated skin condition, action control, and quality of life. Analyses will follow the intention-to-treat principle using linear mixed models.
DISCUSSION: This is the first systematic evaluation of the MiA app's effectiveness in patients with WRHE in a quasi-randomised controlled trial. By combining a structured goal-setting interview with the MiA app, the intervention aims to support the long-term adoption and maintenance of protective behaviours in both occupational and private settings. Key limitations include the quasi-random allocation by admission date (no true randomisation), lack of allocation concealment and blinding, reliance on self-reported primary outcomes, and a 6-month follow-up. Despite these constraints, the pragmatic design aims to generate decision-relevant, real-world evidence for WRHE care.
TRIAL REGISTRATION: German Clinical Trial Registry DRKS00036627. Registered on April 14, 2025.