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Study on the effect of ePRO-based remote management model in patients with unusual forms of pemphigus under examination.

Study on the effect of ePRO-based remote management model in patients with unusual forms of pemphigus under examination.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109711
Enrollment
Unknown
Registered
2025-09-24
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pemphigus Vulgaris, PV

Interventions

ePRO Group:The ePRO group is remotely managed by ePRO and generates an alert.
Routine Management Group:The routine management group will receive routine symptom management with no alarms generated.

Sponsors

School of Nursing at Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) meets the diagnostic criteria for pemphigus vulgaris (PV) based on the presence of serum antibodies against pemphigus core protein 1 and pemphigus core protein 3 confirmed by clinical, histopathologic, immunofluorescence, or enzyme-linked immunosorbentassay tests; (2) has a first visit to our clinic; (3) has at least one skin or/and mucous membrane lesion throughout the body; (4) is willing to use an electronic device to report symptoms; and is able to use an electronic device to report symptoms.

Exclusion criteria

Exclusion criteria: (1) patients whose skin/mucosal wounds are caused by other diseases; (2) patients who are in the acute phase of other diseases or suffering from severe comorbidities; (3) patients who visit our hospital for recurrence; (4) patients who have been diagnosed with PV by an outside hospital; (5) patients who are unable to comprehend the content of the study.

Design outcomes

Primary

MeasureTime frame
Number of symptomatic threshold events at 12 weeks post-discharge;

Secondary

MeasureTime frame
Psychological Functioning Interference Score composite score (anxiety, depression);Other interference scores (somatic functioning, fatigue, sleepiness);Quality of life score;

Countries

China

Contacts

Public ContactLing Wang

School of Nursing at Fudan University

wangling665459@163.com+86 158 5596 7582

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 29, 2026