Remote Interdisciplinary Care for Atopic Dermatitis Using a Digital Care Concept (ADCompanion): Protocol for a Multicenter Randomized Trial.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Dramburg Stephanie, Hernandez Toro Camilo José, Telschow Josephine, Abraham Susanne, Almaci Meslina, Behringer Anna, Christel Simone, Cornelius Angela, Feustel Janina, Fischer Sascha, Gloeyer Isabelle, Günther Nadia, Hagemeister Katharina, Hamelmann Eckard, Harries Leonard, Heratizadeh Annice, Knappe Nora, Lämmel Sonja, Moennig Eva, Neustädter Irena, Pham Christina, Rechtien Laura, Reinhold Thomas, Schnopp Christina, Schorlemer Christina, Sollfrank Lukas, Spies Sophie, Stamos Kristina, Sticherling Michael, Tierno Piera, Trentmann Marion, Unterweger Marie-Therese, Vogelberg Christian, Winkler Hanna, Worm Margitta, Yoosefi Mehrak, Grittner Ulrike
Аннотация
OBJECTIVE: This study aims to assess whether a digitally delivered, interdisciplinary care concept (ADCompanion) is noninferior to routine, real-world care, as available in well-served areas, in reducing disease severity among patients with AD. Secondary objectives include effects on quality of life, pruritus, psychosocial burden, family well-being, and health care costs.
METHODS: This is a prospective, multicenter, 2-arm, 1:1 randomized noninferiority trial. Participants are stratified by age and disease severity. The intervention group receives standard therapy plus access to a digital platform with training modules and optional video consultations on skin care, nutrition, and psychosocial support. The control group receives routine care, optionally including face-to-face group training where available, and a basic app version for symptom tracking. The primary endpoint is physician-assessed disease severity (Scoring Atopic Dermatitis Index [SCORAD]) at 6 months; secondary endpoints include patient-reported outcomes, itch, quality of life, and disease-related costs.
RESULTS: Recruitment of 603 participants across 7 centers in Germany was completed. Data collection was finalized in June 2025. At the time of protocol submission (February 2026), data cleaning had been completed, and the statistical analysis plan was finalized; final results are expected to be published in 2026.
CONCLUSIONS: This protocol describes a randomized trial designed to evaluate whether digitally delivered interdisciplinary care is noninferior to routine care for patients with AD. The findings of this study will inform the role of digital patient education as a complementary component within established care structures.