Chronic Spontaneous UrticariaDigiMocNCT06991608
A Study to Compare Digital Disease Monitoring of Patients With csU (Telemedicine to Face-to-Face Visits) in Germany
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 20 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Collection of patient data
- How many people
- 116 participants
- Where
- 20 sitesGermany
- Study dates
- 11 Jun 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Simultaneous participation in any clinical trial
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Germany20 sites
Novartis Investigative Site
Ahaus, 48683
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 13086
Novartis Investigative Site
Bremen, 28779
Novartis Investigative Site
Dortmund, 44143
Novartis Investigative Site
Dresden, 01109
Novartis Investigative Site
Freising, 85354
Novartis Investigative Site
Gelsenkirchen, 45879
Novartis Investigative Site
Gera, 07548
Novartis Investigative Site
Halle, Saxony-Anhalt, 06122
Novartis Investigative Site
Hamburg, Free and Hanseatic City of Hamburg, 22391
Novartis Investigative Site
Kamen, 59174
Novartis Investigative Site
Koblenz, Rhineland-Palatinate, 56068
Novartis Investigative Site
Leipzig, Saxony, 04103
Novartis Investigative Site
Lingen, Lower Saxony, 49809
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
München, 80377
Novartis Investigative Site
Nuremberg, 90402
Novartis Investigative Site
Remscheid, 42897
Novartis Investigative Site
Selters, 56242
About this study
Official title: 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.
Read the 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 .
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Collection of patient data
- Keywords
- NIS
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of patient dataOther
This non-interventional study and will not influence treatment decisions
| Study group | Role | What they receive |
|---|---|---|
| arm A: F2F | Monitoring via face to face (F2F) visits Receives: Other: Collection of patient data | |
| Arm B: Teledermatology | Monitoring via teledermatological visits Receives: Other: Collection of patient data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 52 weeks
Total number of contacts per patient
Total number of contacts per patient over the course of 52 weeks
Measured: 52 weeks
Time interval in between visits per patient
Time interval in between visits per patient over the course of 52 weeks
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Baseline, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start11 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991608
- Sponsor's protocol ID
- CLOU064ADE01
- Acronym
- DigiMoc
- Status last verified
- Jul 2025
- First submitted
- 16 May 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study to Compare Digital Monitoring of Patients With Chronic Spontaneous Urticaria by Telemedicine to Face-to-Face Visits in Germany (DigiMoc)
- ClinicalTrials.gov ID
- NCT06991608
- Acronym / sponsor ID
- DigiMoc / CLOU064ADE01
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- NIS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm A: F2F | – | Other: Collection of patient dataMonitoring via face to face (F2F) visits |
| Arm B: Teledermatology | – | Other: Collection of patient dataMonitoring via teledermatological visits |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Simultaneous participation in any clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of patient dataThis non-interventional study and will not influence treatment decisions | Other | Arm B: Teledermatology, arm A: F2F |
Primary outcome
Average number of UCT usage per patient
Time frame: 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
Time frame: 52 weeks
Total number of contacts per patient over the course of 52 weeks
Time interval in between visits per patient
Time frame: 52 weeks
Time interval in between visits per patient over the course of 52 weeks
Average number of visits in F2F arm
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 20 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of UCT usage per patient (time frame: 52 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.