Clinical trial NCT05927688: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gout
Rheumatoid Arthritis
Sjogren's Syndrome
Systemic Lupus Erythematosus
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with Gout, Rheumatoid arthritis, Sjogren's syndrome or Systemic lupus erythematosus

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of therapeutic adjustments
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of therapeutic adjustments
timeFrame: 6 months
measure: Frequency of therapeutic adjustments
timeFrame: 24 months
measure: Frequency of flares and exacerbation
timeFrame: Day 1
measure: Frequency of flares and exacerbation
timeFrame: 6 months
measure: Frequency of flares and exacerbation
timeFrame: 12 months
measure: Frequency of flares and exacerbation
timeFrame: 24 months
measure: RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
timeFrame: Day 1
measure: RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
timeFrame: 6 months
measure: RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
timeFrame: 12 months
measure: RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
timeFrame: 24 months
measure: HAQ score (Health Assessment Questionnaire) for health assessment
timeFrame: Day 1
measure: HAQ score (Health Assessment Questionnaire) for health assessment
timeFrame: 6 months
measure: HAQ score (Health Assessment Questionnaire) for health assessment
timeFrame: 12 months
measure: HAQ score (Health Assessment Questionnaire) for health assessment
timeFrame: 24 months
measure: IPAQ score (International Physical Activity Questionnaire) to measure physical activity
timeFrame: Day 1
measure: IPAQ score (International Physical Activity Questionnaire) to measure physical activity
timeFrame: 6 months
measure: IPAQ score (International Physical Activity Questionnaire) to measure physical activity
timeFrame: 12 months
measure: IPAQ score (International Physical Activity Questionnaire) to measure physical activity
timeFrame: 24 months
measure: PEPPI score (Perceived efficacy in patient-physician interactions)
timeFrame: 6 months
measure: PEPPI score (Perceived efficacy in patient-physician interactions)
timeFrame: 12 months
measure: PEPPI score (Perceived efficacy in patient-physician interactions)
timeFrame: 18 months
measure: PEPPI score (Perceived efficacy in patient-physician interactions)
timeFrame: 24 months
measure: Number of times patients logged in to the platform
timeFrame: 6 months
measure: Number of times patients logged in to the platform
timeFrame: 12 months
measure: Number of times patients logged in to the platform
timeFrame: 24 months
measure: Number of times physicians logged in to the platform
timeFrame: 6 months
measure: Number of times physicians logged in to the platform
timeFrame: 12 months
measure: Number of times physicians logged in to the platform
timeFrame: 24 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
Study officials:
References: