小児アトピー性皮膚炎患者（0～6歳）を対象としたスマートフォンベースのデジタル湿疹教育プログラム：多施設共同無作為化並行比較臨床試験

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin condition that affects approximately 10% to 20% of children, imposing substantial health and economic burdens. Although education for patients and caregivers is acknowledged as a crucial element in the management of AD, conventional approaches, such as workshops or in-person consultations, are often resource intensive and face challenges related to scalability, personalization, and relapse prevention. Digital tools present promising alternatives; however, empirical evidence supporting their effectiveness in young children is currently limited.

This study aimed to evaluate whether a smartphone-based patient-caregiver educational program could reduce relapse rates in children aged 0 to 6 years with moderate-to-severe AD, compared with conventional outpatient consultation alone.

In this multicenter, randomized, parallel-controlled trial, 615 children were enrolled across 12 tertiary pediatric dermatology centers in China and randomized (1:1) to receive either a smartphone-based digital education program with standard care (intervention group) or conventional face-to-face consultation only (control group). The 12-week digital program, delivered via the WeChat-based Skin Care E-Station platform, included structured multimedia modules, interactive educational materials, and a dynamic electronic action plan tailored to the child's age and disease stage. The primary endpoint was the 12-week relapse rate after the acute treatment phase. The secondary endpoints included changes in disease severity (Scoring Atopic Dermatitis, Peak Pruritus Numerical Rating Scale, and Patient-Oriented Eczema Measure) and quality of life (Children's Dermatology Life Quality Index or Infant's Dermatitis Quality of Life Index and Dermatitis Family Impact) up to 52 weeks.

Among 615 randomized participants (mean age 3.3, SD 1.7 y; n=317, 51.5% male), relapse at 12 weeks occurred significantly less frequently in the digital education group than in the control group (16.6% vs 24.0%; relative risk 0.69, 95% CI 0.50-0.96; P=.02). Kaplan-Meier analysis showed superior relapse-free survival over the first 100 days (hazard ratio 0.688, 95% CI 0.490-0.966; P=.03). Differences in relapse rates beyond 12 weeks and in secondary outcomes were not statistically significant. Engagement tracking indicated high adherence to the intervention, with 58.0% of caregivers maintaining regular weekly use of the digital platform.

A structured smartphone-based patient-caregiver educational intervention significantly reduced short-term relapse risk among young children with moderate-to-severe AD, likely through improved caregiver recognition and early management of disease flares. Although effects diminished beyond 12 weeks, this approach demonstrates that scalable digital education is a feasible and effective adjunct to standard care in pediatric AD. Future research should focus on sustaining engagement, optimizing long-term reinforcement, and assessing cost-effectiveness in diverse caregiver populations.