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Recruiting 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

— Observational Gout Rheumatoid Arthritis Sjogren's Syndrome Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Therapeutic management following access by the physician to his patient's ePROs.
Who it may be relevant to
Registry conditions: Gout, Rheumatoid Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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

Primary outcome measures

  • Frequency of therapeutic adjustments [Time frame: 12 months]
Secondary outcome measures (12)
  • Frequency of therapeutic adjustments [Time frame: 6 months]
  • Frequency of therapeutic adjustments [Time frame: 24 months]
  • Frequency of flares and exacerbation [Time frame: Day 1]
  • Frequency of flares and exacerbation [Time frame: 6 months]
  • Frequency of flares and exacerbation [Time frame: 12 months]
  • Frequency of flares and exacerbation [Time frame: 24 months]
  • RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score [Time frame: Day 1]
  • RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score [Time frame: 6 months]
  • RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score [Time frame: 12 months]
  • RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score [Time frame: 24 months]
  • HAQ score (Health Assessment Questionnaire) for health assessment [Time frame: Day 1]
  • HAQ score (Health Assessment Questionnaire) for health assessment [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • University Hospital of Strasbourg — Strasbourg

Identifiers

NCT: NCT05927688 · 8546

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗