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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-11

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Chronic Spontaneous Urticaria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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arm A: F2F

Monitoring via face to face (F2F) visits

Collection of patient data

Intervention Type OTHER

This non-interventional study and will not influence treatment decisions

Arm B: Teledermatology

Monitoring via teledermatological visits

Collection of patient data

Intervention Type OTHER

This non-interventional study and will not influence treatment decisions

Interventions

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Collection of patient data

This non-interventional study and will not influence treatment decisions

Intervention Type OTHER

Eligibility Criteria

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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