Gout, Rheumatoid Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus
Conditions
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.
Interventions
BEHAVIORALTherapeutic management following access by the physician to his patient's ePROs
Therapeutic management following access by the physician to his patient's ePROs
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of flares and exacerbation | Day 1 | To assess the fluctuation of disease activity and flares - as perceived by the patient |
| RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score | Day 1 | To assess the overall health of patients |
| HAQ score (Health Assessment Questionnaire) for health assessment | Day 1 | To assess the overall health of patients |
| Frequency of therapeutic adjustments | 6 months | 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. |
| PEPPI score (Perceived efficacy in patient-physician interactions) | 6 months | To assess the patient-physician relationship |
| Number of times patients logged in to the platform | 6 months | To assess the use of the patient portal by patients and associated satisfaction |
| Number of times physicians logged in to the platform | 6 months | To assess the viewing of patient-reported data by physicians |
| IPAQ score (International Physical Activity Questionnaire) to measure physical activity | Day 1 | To assess patient's physical activity over time |
Countries
France
Contacts
Primary ContactJacques-Eric GOTTENBERG, Professor
Backup ContactJacques-Eric GOTTENBERG, MD, PhD
Outcome results
None listed