Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:41 PM
Study NCT ID:
NCT06991608
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Digital Disease Monitoring of Patients With csU (Telemedicine to Face-to-Face Visits) in Germany
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DigiMoc
Brief 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 .
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 .
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: