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Evaluation of a Structured, Guideline-Based Digitally-Supported Multimodal Care Concept for People with Inflammatory Dermatoses (EsmeDerm): Protocol for a Multicentre Randomised Controlled Trial
ABSTRACT
Background:
Chronic inflammatory skin diseases such as psoriasis and atopic dermatitis are associated with a substantial physical, psychological, and social burden. Despite the availability of evidence-based clinical guidelines, important gaps remain in the provision of coordinated, patient-centered, and multimodal care.
Objective:
To evaluate the effectiveness and implementation of a structured, multimodal digitally-supported care model for adults with psoriasis or atopic dermatitis compared with regular care.
Methods:
EsmeDerm is a German multicentre, two-arm, parallel-group, 1:1 randomized controlled trial embedded within a comprehensive evaluation framework for complex interventions. Adults with psoriasis or atopic dermatitis and a Dermatology Life Quality Index (DLQI) score ≥6 and a Hospital Anxiety and Depression Scale (HADS) total score ≥3 are eligible for participation. Participants are randomized to either an intervention group (IG), receiving multimodal care at a Center for Inflammatory Dermatoses (CiD), or a control group (CG), receiving regular care. Care delivery in the CiD is supported by a specially developed digital platform, the Inflammatory Dermatoses Assistant (iDA). From month 6 onward, participants in the CG also receive the physician-delivered CiD components; however, educational components delivered by trained medical assistants are not provided. Assessments are conducted at baseline and after 3, 6, 9, and 12 months. The primary endpoint is the absolute change in HADS score from baseline to month 6. Secondary outcomes include itch severity, health-related quality of life, self-management competence, modifiable risk factors, treatment satisfaction, and clinical disease severity. The planned sample size is 698 participants. Primary analyses are conducted according to the intention-to-treat principle, with exploratory per-protocol analyses performed as sensitivity analyses. Process and health economic evaluations complement the effectiveness evaluation to assess implementation, acceptability, and cost-effectiveness.
Results:
The study protocol has been approved by the Ethics Committee of the State Chamber of Physicians of Rhineland-Palatinate (Landesärztekammer Rheinland-Pfalz). The study employs digital informed consent procedures and pseudonymized data transfer for independent evaluation. Study conduct follows, where applicable, the principles of Good Clinical Practice, good practice recommendations for secondary data analyses, and the ethical principles of the Declaration of Helsinki. Recruitment started July 2026. Study findings will be disseminated through peer-reviewed publications and scientific conferences in accordance with consortium regulations and the recommendations of the International Committee of Medical Journal Editors (ICMJE).
Conclusions:
EsmeDerm will provide evidence on the effectiveness and implementation of a structured, multimodal care model for patients with psoriasis or atopic dermatitis. The findings may inform the further development and integration of coordinated, patient-centred care into routine practice. Clinical Trial: DRKS00038738
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