JMIR Publications

ABSTRACT

Background:

Atopic dermatitis (AD) affects up to 30.48% of Chinese infants, causing significant health and economic burdens. While patient education is crucial for management, traditional models face limitations in scalability, personalization, and relapse prevention. Digital tools offer potential solutions, but evidence for pediatric AD relapse reduction remains limited.

Objective:

This multicenter randomized clinical trial (RCT) assessed whether a smartphone-based digital education program reduces relapse rates versus conventional outpatient care alone in children aged 0–6 years with moderate-to-severe AD.

Methods:

In this parallel RCT across 12 Chinese tertiary hospitals, 615 children (SCORAD ≥25) were randomized 1:1 to: (1) Intervention: Access to the “Skin Care E Station” smartphone platform managed by a contract research organization (CRO), delivering a structured Education Action Plan via CRO-pushed notifications thrice-weekly (Mondays, Wednesdays, Fridays) over 12 weeks, plus 54 weekly multimedia modules (illustrated texts, images, videos, animated stories) covering AD pathophysiology, behaviors, lifestyle, daily care, treatment, and mental health support, alongside real-time clinician access via encrypted telemedicine portal (response time <8 hours) during exacerbations and standard care; or (2) Control: Conventional 15-minute face-to-face counseling at scheduled visits only. All participants received 2-week standardized acute-phase topical therapy before maintenance. Primary outcome was 12-week relapse rate (SCORAD increase ≥10 points post-acute phase), analyzed by intention-to-treat. Secondary outcomes included disease severity (SCORAD, PP-NRS, POEM) and quality of life (IDQOL/CDLQI, DFI) over 52 weeks.

Results:

The digital group demonstrated significantly lower 12-week relapse rates (16.6% vs 24.0%; RR=0.69, 95%CI 0.50–0.96, p = .02) and reduced relapse risk (HR=0.688, 95%CI 0.490–0.966, p = .03), though differences at other timepoints (4–52 weeks) were non-significant. Intervention adherence (58.0%) exceeded control clinic attendance (49.0%, p = .03), with 26.7% utilizing expedited clinician access. No significant between-group differences occurred in disease severity or quality-of-life scores at any follow-up. Attrition at 12 weeks was lower in the digital group (20.2% vs 27.6%, p = .04), though overall 52-week attrition reached 51.38%.

Conclusions:

The digital program reduced early relapse rates by 31% at 12 weeks and demonstrated higher adherence than standard care, likely through improved caregiver knowledge and timely intervention. While it didn't alter long-term disease severity or quality of life, it provides a scalable strategy for short-term relapse prevention in regions with high smartphone penetration. Future research should focus on sustaining long-term engagement and equitable access. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2000031474; https://www.chictr.org.cn/bin/project/edit?pid=32400