Protocol for evaluating the effects of the intelligent multimodal symptom assessment and response system in patients with pemphigus vulgaris: a randomised controlled trial.

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.