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

Condition(s) studied

Investigational drug(s) / intervention(s)

Collection of patient data: This non-interventional study and will not influence treatment decisions

Study 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.

Eligibility

Primary outcome measure(s)

• Average number of UCT usage per patient — 52 weeks
  Average number of urticaria control test (UCT) usage per patient over the course of 52 weeks will be assessed in the teledermatology arm and in the F2F arm
• Total number of contacts per patient — 52 weeks
  Total number of contacts per patient over the course of 52 weeks
• Time interval in between visits per patient — 52 weeks
  Time interval in between visits per patient over the course of 52 weeks
• Average number of visits in F2F arm — 52 weeks
  Average number of visits in face to face (F2F) arm over the time course of 52 weeks
• Average number of contacts in digital arm — 52 weeks
  Average number of contacts in digital arm (stratified for type of contact (video, chat)) over the time course of 52 weeks
• Median time of patients in the medical department in F2F arm — 52 weeks
  Median time of a patients in the medical department (time between entry and exit of the office)
• Median time of a patient for each digital contact in the digital arm — 52 weeks
  Median time of a patient for each digital contact stratified for type of contact (total time of video call, total time for chat messages)
• Score of urticaria control test [UCT] — Baseline, week 52
  UCT is a four-item questionnaire to assess symptom control and quality of life. Each question will be rated from 0 points (no control) to 4 (very well controlled) resulting in a final score from 0 (no disease control) to 16 (complete control)
• Score of urticaria activity test 7 [UAS7] — Baseline, week 52
  The UAS7 is a weekly score built up by the sum of hives (wheals; measured via hive severity score \[HSS7\]) and itch (itch severity score \[ISS7\]) over one week. For assessment of HSS7, the patient will record the number of wheals twice daily (0 (no hives), 1 (1-6 hives), 2(7-12 hives), 3 (\> 12 hives) and the final score is added at the end of the week. To calculate the weekly ISS7, the patient will rate the severity of itch twice daily according to a numeric scale (0 (none) to 3 (severe)). The UAS7 is the sum of the HSS7 score and the ISS7 score. The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
• score of dermatology life quality index [DLQI] — Baseline, week 52
  The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. Participants rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score is calculated and ranges from 0 to 30 (higher score meaning worse disease related QoL)
• Survey to assess satisfaction with current consultations for HCPs and patients — Baseline, week 52
  Participants and their treating HCPs will answer questionnaires assessing their satisfaction with current consultations (retrospectively), as well as satisfaction with the consultation assigned during the study (arm A or arm B). The survey covers questions regarding (digital) disease monitoring and their usefulness/effectiveness in the disease indication of csU, usage of (electronic) PROs and their acceptance in clinical practice, time aspects of the two consultation types, etc.

Trial sites (20)

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