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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gout, Rheumatoid Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus

Intervention / Treatment
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* Behavioral: Therapeutic management following access by the physician to his patient's ePROs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients whose physician used the electronic platform to access ePRO<br> | Behavioral: Therapeutic management following access by the physician to his patient's ePROs<br>* Therapeutic management following access by the physician to his patient's ePROs<br>|
| Patients whose physician did not used the electronic platform and did not access ePRO<br> | Behavioral: Therapeutic management following access by the physician to his patient's ePROs<br>* Therapeutic management following access by the physician to his patient's ePROs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of therapeutic adjustments | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of therapeutic adjustments | To assess the relationship between the frequency of therapeutic adjustments over a 6-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. | 6 months | 
| Frequency of therapeutic adjustments | 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. | 24 months | 
| Frequency of flares and exacerbation | To assess the fluctuation of disease activity and flares - as perceived by the patient | Day 1 | 
| Frequency of flares and exacerbation | To assess the fluctuation of disease activity and flares - as perceived by the patient | 6 months | 
| Frequency of flares and exacerbation | To assess the fluctuation of disease activity and flares - as perceived by the patient | 12 months | 
| Frequency of flares and exacerbation | To assess the fluctuation of disease activity and flares - as perceived by the patient | 24 months | 
| RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score | To assess the overall health of patients | Day 1 | 
| RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score | To assess the overall health of patients | 6 months | 
| RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score | To assess the overall health of patients | 12 months | 
| RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score | To assess the overall health of patients | 24 months | 
| HAQ score (Health Assessment Questionnaire) for health assessment | To assess the overall health of patients | Day 1 | 
| HAQ score (Health Assessment Questionnaire) for health assessment | To assess the overall health of patients | 6 months | 
| HAQ score (Health Assessment Questionnaire) for health assessment | To assess the overall health of patients | 12 months | 
| HAQ score (Health Assessment Questionnaire) for health assessment | To assess the overall health of patients | 24 months | 
| IPAQ score (International Physical Activity Questionnaire) to measure physical activity | To assess patient's physical activity over time | Day 1 | 
| IPAQ score (International Physical Activity Questionnaire) to measure physical activity | To assess patient's physical activity over time | 6 months | 
| IPAQ score (International Physical Activity Questionnaire) to measure physical activity | To assess patient's physical activity over time | 12 months | 
| IPAQ score (International Physical Activity Questionnaire) to measure physical activity | To assess patient's physical activity over time | 24 months | 
| PEPPI score (Perceived efficacy in patient-physician interactions) | To assess the patient-physician relationship | 6 months | 
| PEPPI score (Perceived efficacy in patient-physician interactions) | To assess the patient-physician relationship | 12 months | 
| PEPPI score (Perceived efficacy in patient-physician interactions) | To assess the patient-physician relationship | 18 months | 
| PEPPI score (Perceived efficacy in patient-physician interactions) | To assess the patient-physician relationship | 24 months | 
| Number of times patients logged in to the platform | To assess the use of the patient portal by patients and associated satisfaction | 6 months | 
| Number of times patients logged in to the platform | To assess the use of the patient portal by patients and associated satisfaction | 12 months | 
| Number of times patients logged in to the platform | To assess the use of the patient portal by patients and associated satisfaction | 24 months | 
| Number of times physicians logged in to the platform | To assess the viewing of patient-reported data by physicians | 6 months | 
| Number of times physicians logged in to the platform | To assess the viewing of patient-reported data by physicians | 12 months | 
| Number of times physicians logged in to the platform | To assess the viewing of patient-reported data by physicians | 24 months |