CAPTAIN: 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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05927688

Collaborator

(none)

352

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gout Rheumatoid Arthritis Sjogren's Syndrome Systemic Lupus Erythematosus	Behavioral: Therapeutic management following access by the physician to his patient's ePROs

Study Design

Study Type:

Observational

Anticipated Enrollment :

352 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2027

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Patients whose physician used the electronic platform to access ePRO	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
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 Therapeutic management following access by the physician to his patient's ePROs

Arm

Intervention/Treatment

Patients whose physician used the electronic platform to access ePRO

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

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
Frequency of therapeutic adjustments [24 months]
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.
Frequency of flares and exacerbation [Day 1]
To assess the fluctuation of disease activity and flares - as perceived by the patient
Frequency of flares and exacerbation [6 months]
To assess the fluctuation of disease activity and flares - as perceived by the patient
Frequency of flares and exacerbation [12 months]
To assess the fluctuation of disease activity and flares - as perceived by the patient
Frequency of flares and exacerbation [24 months]
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
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score [6 months]
To assess the overall health of patients
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score [12 months]
To assess the overall health of patients
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score [24 months]
To assess the overall health of patients
HAQ score (Health Assessment Questionnaire) for health assessment [Day 1]
To assess the overall health of patients
HAQ score (Health Assessment Questionnaire) for health assessment [6 months]
To assess the overall health of patients
HAQ score (Health Assessment Questionnaire) for health assessment [12 months]
To assess the overall health of patients
HAQ score (Health Assessment Questionnaire) for health assessment [24 months]
To assess the overall health of patients
IPAQ score (International Physical Activity Questionnaire) to measure physical activity [Day 1]
To assess patient's physical activity over time
IPAQ score (International Physical Activity Questionnaire) to measure physical activity [6 months]
To assess patient's physical activity over time
IPAQ score (International Physical Activity Questionnaire) to measure physical activity [12 months]
To assess patient's physical activity over time
IPAQ score (International Physical Activity Questionnaire) to measure physical activity [24 months]
To assess patient's physical activity over time
PEPPI score (Perceived efficacy in patient-physician interactions) [6 months]
To assess the patient-physician relationship
PEPPI score (Perceived efficacy in patient-physician interactions) [12 months]
To assess the patient-physician relationship
PEPPI score (Perceived efficacy in patient-physician interactions) [18 months]
To assess the patient-physician relationship
PEPPI score (Perceived efficacy in patient-physician interactions) [24 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 patients logged in to the platform [12 months]
To assess the use of the patient portal by patients and associated satisfaction
Number of times patients logged in to the platform [24 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
Number of times physicians logged in to the platform [12 months]
To assess the viewing of patient-reported data by physicians
Number of times physicians logged in to the platform [24 months]
To assess the viewing of patient-reported data by physicians

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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