Smartphone-Based Digital Eczema Education Program for Atopic Dermatitis in Children Aged 0 to 6 Years: Multicenter, Randomized, Parallel Controlled Clinical Study.

Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.