Actively Recruiting
Assessment of Physician Consideration of Electronic Patient Reported Outcomes, from Patients with Gout, Rheumatoid Arthritis, Sjogren's Syndrome or Systemic Lupus Erythematosus, on the Frequency of Therapeutic Adjustments
Led by University Hospital, Strasbourg, France · Updated on 2025-03-12
352
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Inflammatory rheumatic diseases such as gout, rheumatoid arthritis, Sjogren's syndrome, and systemic lupus erythematosus affect about 1% of the population and often require treatment based on disease activity, safety, and patient characteristics including comorbidities. This research aims to assess how using electronic patient-reported outcomes (ePROs) to provide physicians with direct patient health feedback influences therapeutic decisions. The study hypothesizes that better physician access to patient health data will encourage a treat-to-target approach with more frequent treatment adjustments. Participants are divided into groups based on whether their physician uses an electronic platform to access the patient's ePRO data or not. The study tracks therapeutic management over time with no direct intervention but by monitoring the physician's use of patient-reported information. The platform notifies investigators when a patient completes a form but does not interpret the data or generate alerts. During the study, patients will provide regular health feedback through ePROs while researchers monitor treatment adjustments over 12 months as the primary outcome. Secondary outcomes include treatment changes at 6 and 24 months, flare frequency, disease activity measured by RAPID 3 questionnaires, health status via HAQ scores, physical activity levels, patient-physician interaction efficacy, and platform login frequency by both patients and physicians. The study involves ongoing assessments and data collection to understand how ePRO usage affects patient care over the course of up to 24 months.
CONDITIONS
Brief Title
Assessment of Physician Consideration of EPRO's, from Patients with Gout, Rheumatoid Arthritis, Sjogren's Syndrome or Systemic Lupus, on the Frequency of Therapeutic Adjustments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older
- Diagnosed with at least one of the following autoimmune diseases: rheumatoid arthritis, gout, systemic lupus erythematosus, or Sjogren's syndrome according to established classification criteria
- Provided written informed consent or expressed non-opposition according to local regulations
- Have access to the internet, a valid email address, and a mobile phone number
- Physically and mentally able to use an internet-connected computer tool
- In Switzerland and Germany, covered by a health insurance plan
You will not qualify if you...
- Diagnosis of any neurodegenerative disease affecting cognitive function
- Presence of refractory cancer
- Lack of access to or inability to use the internet as required by the study
- Unwillingness or inability to adhere to the study protocol due to language barriers or cognitive disorders
- Compulsory psychiatric detention
- Inability to be followed for 2 years by the investigating physician
- Being legally protected, deprived of liberty, or considered a vulnerable subject
- Estimated life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 24 months
Participants are observed over time to assess therapeutic adjustments and disease activity based on electronic patient reported outcomes (ePROs).
Assessments on Day 1, 6 months, 12 months, 18 months, and 24 months
Trial Site Locations
Total: 1 location
1
University Hospital of Strasbourg
Strasbourg, France, 67000
Actively Recruiting
Research Team
J
Jacques-Eric GOTTENBERG, Professor
J
Jacques-Eric GOTTENBERG, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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