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

Novartis

Status: Active, not recruiting

Conditions: Chronic Spontaneous Urticaria

Treatments: Other: Collection of patient data

Study type: Observational

Funder types: Industry

Identifiers

NCT06991608

CLOU064ADE01

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 116 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

116 participants in 2 patient groups

arm A: F2F

Description:

Monitoring via face to face (F2F) visits

Treatment:

Other: Collection of patient data

Arm B: Teledermatology

Description:

Monitoring via teledermatological visits

Treatment:

Other: Collection of patient data