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

NCT05927688 | Recruiting

• 1 other identifier: 8546
• Study Type: observational
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout; Rheumatoid Arthritis; Sjogren's Syndrome; Systemic Lupus Erythematosus

Outcome Measures

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.

  12 months

Secondary Outcomes (28)

• Frequency of therapeutic adjustments

  6 months

• Frequency of therapeutic adjustments

  24 months

• Frequency of flares and exacerbation

  Day 1

• Frequency of flares and exacerbation

  6 months

• Frequency of flares and exacerbation

  12 months

Study Arms (2)

Patients whose physician used the electronic platform to access ePRO

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

Patients whose physician did not used the electronic platform and did not access ePRO

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

Interventions

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

Patients whose physician did not used the electronic platform and did not access ePRO; Patients whose physician used the electronic platform to access ePRO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Hospital of Strasbourg

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Jacques-Eric GOTTENBERG, Professor

CONTACT

3 88 12 79 53; jacques-eric.gottenberg@chru-strasbourg.fr

Jacques-Eric GOTTENBERG, MD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: July 18, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

FR (1)