Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 20, 2025
Date Accepted: Mar 13, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
ADCompanion - Remote Interdisciplinary Care for Atopic Dermatitis Using a Digital Care Companion: Protocol for a Multicenter Randomized Trial
ABSTRACT
Background:
Atopic dermatitis (AD) is one of the most common chronic inflammatory skin diseases, associ-ated with itching, sleep disturbance, and impaired quality of life. Structured patient education can improve disease outcomes, but in-person programs are often unavailable in rural or un-derserved areas. Digital interventions may help overcome these barriers; however, their effica-cy compared with standard care has not been evaluated.
Objective:
This study aims to assess whether a digitally delivered, interdisciplinary care concept (AD-Companion) is non-inferior to standard care, as available in well-served areas, in reducing dis-ease 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, two-arm, 1:1 randomized non-inferiority 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 standard care, including face-to-face group training where available, and a basic app version for symptom tracking. The pri-mary endpoint is physician-assessed disease severity (Scoring Atopic Dermatitis Score - SCORAD) at 6 months; secondary endpoints include patient-reported outcomes, itch, quality of life, and disease-related costs.
Results:
Recruitment of 605 participants across seven centers in Germany has been completed. Data collection was finalised in June 2025, and data analysis is currently ongoing.
Conclusions:
This trial will evaluate whether digitally delivered interdisciplinary care is a scalable and effec-tive alternative to standard care for patients with AD. The future aim of this study is to offer access to educational patient information additionally to routine care for those who cannot at-tend in-person formats. Clinical Trial: German Clinical Trials Register (DRKS): DRKS00030902. Registration date: 22.05.2023. URL with access to Statistical Analysis Plan: https://drks.de/search/en/trial/DRKS00030902
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