D1.394 - Characteristics, healthcare provision and expectations of patients with atopic dermatitis as part of the ADCompanion study to evaluate a digital form of care

Individuals affected by atopic dermatitis (AD) and their social environment often face disease-related challenges, such as severe itching, sleep disturbance, or stigmatization. In Germany, studies on effects of structured, age-specific patient education programs demonstrated significant improvement of coping strategies as well as overall disease severity. However, these educational programs are often not widely accessible across all regions.

The aim is to demonstrate that digitally delivered patient training plus individual consultations with specifically trained dieticians, nurses and psychologists are non-inferior to educational programs in person.

The digital healthcare model is being evaluated in a German prospective, multicenter, 1:1 randomized two-arm intervention study with a non-inferiority design. Patients with a confirmed diagnosis of moderate to severe AD for at least 3 months (Scoring Atopic Dermatitis Score SCORAD ≥20) were included. Participants were stratified into three age groups (A: 3 months – 6 years; B: 7-17 years; C: 18-65 years). Self-perceived digital health literacy (eHEALS) and expected improvements were assessed at baseline. Disease severity (primary endpoint, SCORAD) was assessed after 6 months of provision of digital training (standardized training curriculum via a study app, plus up to 9 individual consultations with specially trained dieticians, nurses and psychologists) plus standard physician care (intervention group) vs. standard care including face-to-face trainings where available (control group).

605 participants were included across the age groups (A=252; B=146; C=207). As data collection for the follow-up visits is not completed, the primary endpoint cannot be reported yet. The mean age was 2.6 (SD 1.9), 11.3 (SD 3.3), and 35.9 (SD 11.5) years in groups A, B, and C respectively. Three hundred and nineteen (52.7%) of the participants were female and the mean SCORAD was 34.7/103 (SD 11.6) points. Fifty-one percent of the participants (n=306) reported that an allergy test (sIgE, skin/provocation test) had been performed previously.  Self-perceived digital health literacy of participants or their guardians was moderate to high at an average of 29.6/40 (SD 5.6) points across all age groups. In patient-expected improvement of disease due to the intervention (0=no improvement, 10=maximum improvement), the average rating was 6.0 (SD 2.2) points, while over 90% of participants in all age groups expected to gain a better understanding of the disease.

The pre-defined target sample size was successfully reached. Participants had moderate to severe AD. A majority of participants had undergone previous allergy tests and perceived their digital health literacy as medium to high. Despite some heterogeneity between age groups, participants expressed positive expectations regarding the potential of a digital healthcare model to improve access to supporting care and address the gap in real-life healthcare provision.