Assessing how patient feedback affects treatment adjustments for autoimmune diseases
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
This study is testing if regular feedback from patients with autoimmune diseases like gout and rheumatoid arthritis can help doctors make better treatment decisions and improve patient care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 352 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05927688 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the impact of electronic Patient Reported Outcomes (ePROs) on the management of patients with gout, rheumatoid arthritis, Sjogren's syndrome, or systemic lupus erythematosus. By collecting regular feedback from patients through ePROs, physicians can make informed therapeutic adjustments based on the latest patient data. The study aims to determine if this approach leads to more effective treatment strategies and improved patient outcomes. The data collected will be communicated to physicians without interpretation, allowing for timely adjustments in therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with gout, rheumatoid arthritis, Sjogren's syndrome, or systemic lupus erythematosus.
Not a fit: Patients with neurodegenerative diseases that impair cognitive function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment personalization and improve health outcomes for patients with autoimmune diseases.
How similar studies have performed: Other studies have shown promise in using patient-reported outcomes to inform treatment adjustments, suggesting this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men or women of at least 18 years of age * Diagnosed with (at least) one of the following autoimmune diseases: * Rheumatoid arthritis (RA) according to the 2010 EULAR/ACR classification criteria, * Gout according to the 2015 EULAR/ACR classification criteria, * Systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria * Sjogren's Syndrome according to the 2016 EULAR/ACR classification criteria * According to local regulations, patient has expressed his/her non-opposition (for France) or has provided written informed consent (for Switzerland and Germany) to participate in the study * Patient has access to the internet, a functioning email address and a mobile phone number * Patient physically and mentally able to use a computer tool connected to the Internet * Only in Switzerland \& Germany : patient is covered by a health insurance plan Exclusion Criteria: * Any neurodegenerative disease that alters cognitive faculties * Refractory cancer * Patients who do not have access to the Internet and/or do not master its use in the context of this protocol * Unwillingness or inability to adhere to study protocol (language barriers, cognitive disorders…) Subject who is compulsorily detained for psychiatric treatment * Patient who cannot be followed for 2 years by the investigating physician * Patient over the age of legal majority who is protected, or deprived of liberty by judicial or administrative decision (vulnerable subject) * Patient with an estimated life expectancy shorter than 1 year
Where this trial is running
Strasbourg
- University Hospital of Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Jacques-Eric GOTTENBERG, Professor
- Email: jacques-eric.gottenberg@chru-strasbourg.fr
- Phone: 3 88 12 79 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.