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

A Non-Interventional Study to Compare Digital Monitoring of Patients With Chronic Spontaneous Urticaria by Telemedicine to Face-to-Face Visits in Germany (DigiMoc)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Other: Collection of patient data

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 .

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Germany
  • Ahaus, Germany, 48683
    • Novartis Investigative Site
  • Berlin, Germany, 13086
    • Novartis Investigative Site
  • Berlin, Germany, 10117
    • Novartis Investigative Site
  • Bremen, Germany, 28779
    • Novartis Investigative Site
  • Dortmund, Germany, 44143
    • Novartis Investigative Site
  • Dresden, Germany, 01109
    • Novartis Investigative Site
  • Freising, Germany, 85354
    • Novartis Investigative Site
  • Gelsenkirchen, Germany, 45879
    • Novartis Investigative Site
  • Gera, Germany, 07548
    • Novartis Investigative Site
  • Hamburg, Germany, 22391
    • Novartis Investigative Site
  • Kamen, Germany, 59174
    • Novartis Investigative Site
  • Mainz, Germany, 55131
    • Novartis Investigative Site
  • Muenchen, Germany, 80377
    • Novartis Investigative Site
  • Nuernberg, Germany, 90402
    • Novartis Investigative Site
  • Remscheid, Germany, 42897
    • Novartis Investigative Site
  • Selters, Germany, 56242
    • Novartis Investigative Site
  • Niedersachsen
    • Lingen Ems, Niedersachsen, Germany, 49809
      • Novartis Investigative Site
  • Rheinland-Pfalz
    • Koblenz, Rheinland-Pfalz, Germany, 56068
      • Novartis Investigative Site
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Novartis Investigative Site
  • Sachsen-Anhalt
    • Halle Saale, Sachsen-Anhalt, Germany, 06122
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
arm A: F2F; Monitoring via face to face (F2F) visits	Other: Collection of patient data; This non-interventional study and will not influence treatment decisions
Arm B: Teledermatology; Monitoring via teledermatological visits	Other: Collection of patient data; This non-interventional study and will not influence treatment decisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 16, 2025
• First Submitted That Met QC Criteria: May 16, 2025
• First Posted (Actual): May 28, 2025

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: NIS
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Vascular; Chronic Urticaria; Urticaria
• Other Study ID Numbers: CLOU064ADE01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com