Protocol for evaluating the effects of the intelligent multimodal symptom assessment and response system in patients with pemphigus vulgaris: a randomised controlled trial
Clinical Snapshot
PICO Framework
| P — Population | Adults aged 18+ with confirmed pemphigus vulgaris and active skin or mucosal lesions, able to use digital devices |
| I — Intervention | Intelligent Multimodal Symptom Assessment and Response System (digital platform integrating patient-reported outcomes, wearable physiological data, and lesion imaging) |
| C — Comparator | Standard care |
| O — Outcomes | Primary: symptom alerting and management outcomes; Secondary: self-management ability, treatment adherence, health-related quality of life, system usability |
Bottom Line
This protocol describes a promising digital health intervention for pemphigus vulgaris management, addressing a significant gap in remote monitoring for this rare autoimmune condition. The multimodal approach combining patient-reported outcomes, wearable data, and image assessment represents an innovative strategy for chronic disease management. However, as this is only a protocol publication, no efficacy or safety data are available. Key methodological concerns include lack of blinding, insufficient randomisation details, and absence of sample size calculations. The intervention's complexity may limit real-world implementation, particularly in populations with lower digital literacy. Australian clinicians should await the actual trial results before considering implementation, noting that significant adaptation would be required for local healthcare systems and regulatory approval processes.
Key Findings
P Value: Not available - protocol stage
Effect Size: Not available - protocol stage
Primary Outcome: Not available - protocol stage
Nnt Or Sensitivity: Not available - protocol stage
Confidence Interval: Not available - protocol stage
Clinical Application
Moderate - requires digital infrastructure and patient technology literacy Limited applicability - developed in Chinese healthcare system. Would require adaptation for Australian digital health frameworks and TGA approval for any diagnostic components Adults with pemphigus vulgaris comfortable with digital technology
Abstract
INTRODUCTION: Pemphigus vulgaris is a rare autoimmune blistering disease characterised by recurrent mucocutaneous erosions, high symptom burden and unpredictable relapse. Current management relies mainly on pharmacological therapy and hospital-based follow-up, with limited real-time monitoring and individualised support in home-based disease management. To address these challenges, this trial aims to evaluate the effectiveness of an Intelligent Multimodal Symptom Assessment and Response System, integrating patient-reported outcomes, wearable physiological data and image-based lesion assessments, to improve symptom management and quality of life in pemphigus vulgaris patients. Primary objective is to evaluate the effectiveness of the Intelligent Multimodal Symptom Assessment and Response System in improving symptom alerting and symptom management outcomes in patients with pemphigus vulgaris. Secondary objectives are to enhance patients' self-management ability in symptom monitoring and control, to improve treatment adherence throughout the follow-up period, to promote health-related quality of life among pemphigus vulgaris patients, to assess the usability and acceptability of the system from the patients' perspective. METHODS AND ANALYSIS: This is a multicentre, parallel-group, randomised controlled trial. 160 participants will be randomly assigned to either the intervention group (receiving the Intelligent Multimodal Symptom Assessment and Response System) or the control group (receiving standard care). Eligible participants will be adults aged 18 years or older with a confirmed diagnosis of pemphigus vulgaris and active skin or mucosal lesions, who are able to use digital devices and provide written informed consent. Individuals with severe comorbidities, concurrent participation in other clinical trials or cognitive impairments that may interfere with study adherence will be excluded. The intervention will be delivered via a digital platform, integrating electronic patient-reported outcomes, wearable physiological data and lesion images over a 12-week follow-up period. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Review Board of the School of Nursing, Fudan University (IRB 2025-07-13), the Medical Ethics Committee of the Institute of Dermatology, Chinese Academy of Medical Sciences (2025-KY-034) and the Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (2025-452). Approvals were granted on 10 September, 18 July and 23 July 2025, respectively. This protocol is based on V1.0, 13 July 2025 of the protocol. The results of this study will be disseminated through peer-reviewed publications and academic conferences. TRIAL REGISTRATION NUMBER: ChiCTR2500109711.
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