NCT06991608

A Study to Compare Digital Disease Monitoring of Patients With csU (Telemedicine to Face-to-Face Visits) in Germany

A Non-Interventional Study to Compare Digital Monitoring of Patients With Chronic Spontaneous Urticaria by Telemedicine to Face-to-Face Visits in Germany (DigiMoc)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, non-randomized, non-interventional two-cohort study with prospective collection of primary data on monitoring of Chronic spontaneous urticaria (CSU) patients by telemedicine or F2F visits in routine clinical care. This implementation science study will collect data from patients during routine CSU monitoring via F2F visits or teledermatological visits. The study will be representative for the real-world patient CSU population in Germany.

Detailed description

This study will investigate the effect of digital monitoring via teledermatology on patient-reported outcomes (PRO) usage in CSU. The automatic provision of PROs at each digital patient-physician contact will allow simple and time-efficient documentation of current symptoms and might improve patients care. This study seeks to assess the impact of regular teledermatology-based monitoring on the utilization frequency of PROs in patients with CSU, as compared to the in-person visits F2F. Furthermore, the study aims to gauge the adaption, quality and assessibility of teledermatology of both health care providers and patients .

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
OTHER	Collection of patient data	This non-interventional study and will not influence treatment decisions

Timeline

• Start date: 2024-06-11
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-05-28
• Last updated: 2025-07-16

Locations

20 sites across 1 country: Germany