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

Recruiting

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

• Registration Number: NCT05927688
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Study Start: 2023-07-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 352

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of therapeutic adjustments	12 months	To assess the relationship between the frequency of therapeutic adjustments over a 12-month period made by rheumatologists who were provided regular patient reported outcomes (PROs) and their use of an electronic platform providing them with these data.

Secondary Outcome Measures

Name	Time	Method
IPAQ score (International Physical Activity Questionnaire) to measure physical activity	24 months	To assess patient's physical activity over time
HAQ score (Health Assessment Questionnaire) for health assessment	24 months	To assess the overall health of patients
Number of times patients logged in to the platform	24 months	To assess the use of the patient portal by patients and associated satisfaction
Frequency of flares and exacerbation	24 months	To assess the fluctuation of disease activity and flares - as perceived by the patient
PEPPI score (Perceived efficacy in patient-physician interactions)	24 months	To assess the patient-physician relationship
Frequency of therapeutic adjustments	24 months	To assess the relationship between the frequency of therapeutic adjustments over a 24-month period made by rheumatologists who were provided regular patient reported outcomes (PROs) and their use of an electronic platform providing them with these data.
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score	24 months	To assess the overall health of patients
Number of times physicians logged in to the platform	24 months	To assess the viewing of patient-reported data by physicians

Trial Locations

Locations (1)

University Hospital of Strasbourg; 🇫🇷 Strasbourg, France