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

N/AActive Not RecruitingNCT06991608

Novartis Pharmaceuticals116 enrolled

Overview

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.

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

116

Conditions

Chronic Spontaneous Urticaria

Interventions

Collection of patient dataOTHER

This non-interventional study and will not influence treatment decisions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (20)

Novartis Investigative Site

Hamburg, Free and Hanseatic City of Hamburg, Germany

Novartis Investigative Site

Lingen Ems, Lower Saxony, Germany

Outcomes

Primary Outcomes

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

Time frame: 52 weeks

Total number of contacts per patient

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

Time frame: 52 weeks

Time interval in between visits per patient

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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.