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Checks whether doctors change treatment after reading patients' electronic symptom reports

Studies doctors' treatment changes after reviewing reports from adults with gout or lupus.

Key facts

Who runs it
University Hospital, Strasbourg, France
Where
Strasbourg, FranceSee the site
Trial code
Registry 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
Status
Recruiting
People taking part
352 people, planned
Started
18 Jul 2023
Expected to end
Jul 2027
Type of study
Observational, 2 groups
Treatments tested
  • Therapeutic management following access by the physician to his patient's ePROs
Record updated
12 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with gout, rheumatoid arthritis, Sjogren's syndrome or systemic lupus erythematosus. They fill in health forms online, and their doctor can see the answers.

Age
18 years or older
Sex
Men and women
Disease stage
Diagnosed with at least one of: rheumatoid arthritis, gout, systemic lupus erythematosus or Sjogren's syndrome, according to the EULAR/ACR classification criteria named in the record.

Main reasons for not taking part

  • A brain disease that harms thinking (neurodegenerative disease)
  • Refractory cancer
  • No internet access, or cannot use the online tool
  • Cannot be followed by the investigating physician for 2 years
  • Estimated life expectancy shorter than 1 year

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Any neurodegenerative disease that alters cognitive faculties
  • Refractory cancer
  • Unwillingness or inability to adhere to study protocol (language barriers, cognitive disorders…) Subject who is compulsorily detained for psychiatric treatment
  • Patient over the age of legal majority who is protected, or deprived of liberty by judicial or administrative decision (vulnerable subject)
  • Patients who do not have access to the Internet and/or do not master its use in the context of this protocol
  • Patient who cannot be followed for 2 years by the investigating physician
  • Patient with an estimated life expectancy shorter than 1 year

Where in France

  • University Hospital of StrasbourgStrasbourg, FranceContact: Jacques-Eric GOTTENBERG, MD, PhDTaking people

About the trial

What the trial wants to find out

Inflammatory rheumatic diseases affect 1% of the population. Treatment of such diseases should be based on disease activity, safety issues and other patient characteristics such as comorbidities (EULAR, 2022), leading to a higher risk of cardiovascular diseases. To this end, the general treat-to-target approach, as recommended in the EULAR guidance, may require several successive treatment lines based on updates to the patients' profile and close monitoring as the keystone of its implementation.

Read full original descriptionShow less

Regular feedback from patients could be used to fuel such strategies. This feedback can be collected using an ePRO (electronic Patient Reported Outcome). The purpose of this study is therefore to assess patient management using the information provided by patients through e-PROs, which will transfer the data provided by the patient to the physician and will notify the investigators via email when a patient has completed a form (no data interpretation or alerts).

The hypothesis is that the more physicians are provided with insights into their patients' health, the more they will function in a treat-to-target approach and the more often they will tend to adjust their patients' treatments.

The 2 groups in the trial

  • Patients whose physician used the electronic platform to access ePRO

    Treatment: Therapeutic management following access by the physician to his patient's ePROs

  • Patients whose physician did not used the electronic platform and did not access ePRO

    Treatment: Therapeutic management following access by the physician to his patient's ePROs

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Checks whether doctors change treatment after reading patients' electronic symptom reportsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 March 2025