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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Men or women of at least 18 years of age

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

Disqualifiers

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

Trial population

Patient with Gout, Rheumatoid arthritis, Sjogren's syndrome or Systemic lupus erythematosus

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Behavioral

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

Treatment groups

352 Participants
are divided into 2 treatment groups
Group A: Patients whose physician used the electronic platform to access ePRO1 intervention
Group B: Patients whose physician did not used the electronic platform and did not access ePRO1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
24 months
3

Frequency of flares and exacerbation

To assess the fluctuation of disease activity and flares - as perceived by the patient

Time frame
Day 1
4

Frequency of flares and exacerbation

To assess the fluctuation of disease activity and flares - as perceived by the patient

Time frame
6 months

Other outcomes

Sponsors and contacts

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