Clinical trial NCT06991608: A Study to Compare Digital Disease Monitoring of Patients With csU (Telemedicine to Face-to-Face Visits) in Germany
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Spontaneous Urticaria
Keywords: NIS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-05-28
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients with a physician diagnosis of CSU. Any therapy within the scope of admission will be observed and documented.

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 .

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and above
* Written informed consent for participation obtained from the subject
* Diagnosed chronic spontaneous urticaria
* Medical therapy for CSU
* Concomitant chronic inducible urticaria is allowed
* Willing and be able to perform digital visits

Exclusion Criteria:

• Simultaneous participation in any clinical trial

Primary outcomes:
measure: Average number of UCT usage per patient
timeFrame: 52 weeks
measure: Total number of contacts per patient
timeFrame: 52 weeks
measure: Time interval in between visits per patient
timeFrame: 52 weeks
measure: Average number of visits in F2F arm
timeFrame: 52 weeks
measure: Average number of contacts in digital arm
timeFrame: 52 weeks
measure: Median time of patients in the medical department in F2F arm
timeFrame: 52 weeks
measure: Median time of a patient for each digital contact in the digital arm
timeFrame: 52 weeks
measure: Score of urticaria control test [UCT]
timeFrame: Baseline, week 52
measure: Score of urticaria activity test 7 [UAS7]
timeFrame: Baseline, week 52
measure: score of dermatology life quality index [DLQI]
timeFrame: Baseline, week 52
measure: Survey to assess satisfaction with current consultations for HCPs and patients
timeFrame: Baseline, week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Lingen Ems
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Koblenz
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Halle Saale
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Ahaus
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Freising
country: Germany
facility: Novartis Investigative Site
city: Gelsenkirchen
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Kamen
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Remscheid
country: Germany
facility: Novartis Investigative Site
city: Selters
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: