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

NCT06991608 | Active Not Recruiting

• 1 other identifier: CLOU064ADE01
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 20

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.

Conditions

Chronic Spontaneous Urticaria

Keywords

NIS

Outcome Measures

Primary Outcomes (11)

• Average number of UCT usage per patient

  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

  52 weeks

• Total number of contacts per patient

  Total number of contacts per patient over the course of 52 weeks

  52 weeks

• Time interval in between visits per patient

  Time interval in between visits per patient over the course of 52 weeks

  52 weeks

• Average number of visits in F2F arm

  Average number of visits in face to face (F2F) arm over the time course of 52 weeks

  52 weeks

• Average number of contacts in digital arm

  Average number of contacts in digital arm (stratified for type of contact (video, chat)) over the time course of 52 weeks

  52 weeks

• Median time of patients in the medical department in F2F arm

  Median time of a patients in the medical department (time between entry and exit of the office)

  52 weeks

• Median time of a patient for each digital contact in the digital arm

  Median time of a patient for each digital contact stratified for type of contact (total time of video call, total time for chat messages)

  52 weeks

• Score of urticaria control test [UCT]

  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)

  Baseline, week 52

• Score of urticaria activity test 7 [UAS7]

  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).

  Baseline, week 52

• score of dermatology life quality index [DLQI]

  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)

  Baseline, week 52

• Survey to assess satisfaction with current consultations for HCPs and patients

  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.

  Baseline, week 52

Study Arms (2)

arm A: F2F

Monitoring via face to face (F2F) visits

Other: Collection of patient data

Arm B: Teledermatology

Monitoring via teledermatological visits

Other: Collection of patient data

Interventions

Collection of patient data OTHER

This non-interventional study and will not influence treatment decisions

Arm B: Teledermatology; arm A: F2F

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Simultaneous participation in any clinical trial

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Hamburg, Hamburg, 22391, Germany

Location

Novartis Investigative Site

Lingen Ems, Lower Saxony, 49809, Germany

Location

Novartis Investigative Site

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

Novartis Investigative Site

Leipzig, Saxony, 04103, Germany

Location

Novartis Investigative Site

Halle, Saxony-Anhalt, 06122, Germany

Location

Novartis Investigative Site

Ahaus, 48683, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Berlin, 13086, Germany

Location

Novartis Investigative Site

Bremen, 28779, Germany

Location

Novartis Investigative Site

Dortmund, 44143, Germany

Location

Novartis Investigative Site

Dresden, 01109, Germany

Location

Novartis Investigative Site

Freising, 85354, Germany

Location

Novartis Investigative Site

Gelsenkirchen, 45879, Germany

Location

Novartis Investigative Site

Gera, 07548, Germany

Location

Novartis Investigative Site

Kamen, 59174, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

München, 80377, Germany

Location

Novartis Investigative Site

Nuremberg, 90402, Germany

Location

Novartis Investigative Site

Remscheid, 42897, Germany

Location

Novartis Investigative Site

Selters, 56242, Germany

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 28, 2025
• Study Start: June 11, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (20)