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 (CAPTAIN)

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Sjogren's Syndrome; Systemic Lupus Erythematosus; Rheumatoid Arthritis; Gout

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

Study type: Observational

Funder types: Other

Identifiers

NCT05927688

8546

Details and patient eligibility

About

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.

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.

Enrollment: 352 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

352 participants in 2 patient groups

Patients whose physician used the electronic platform to access ePRO

Treatment:

Behavioral: 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:

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