University Hospital of Strasbourg
Strasbourg, 67000, France
Location status: Recruiting
NCT Number: NCT05927688
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Strasbourg, 67000, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Therapeutic management following access by the physician to his patient's ePROs
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
To assess the fluctuation of disease activity and flares - as perceived by the patient
Time frame: 6 months
To assess the fluctuation of disease activity and flares - as perceived by the patient
Time frame: 12 months
To assess the fluctuation of disease activity and flares - as perceived by the patient
Time frame: 24 months
To assess the fluctuation of disease activity and flares - as perceived by the patient
Time frame: Day 1
To assess the overall health of patients
Time frame: 6 months
To assess the overall health of patients
Time frame: 12 months
To assess the overall health of patients
Time frame: 24 months
To assess the overall health of patients
Time frame: Day 1
To assess the overall health of patients
Time frame: 6 months
To assess the overall health of patients
Time frame: 12 months
To assess the overall health of patients
Time frame: 24 months
To assess the overall health of patients
Time frame: Day 1
To assess patient's physical activity over time
Time frame: 6 months
To assess patient's physical activity over time
Time frame: 12 months
To assess patient's physical activity over time
Time frame: 24 months
To assess patient's physical activity over time
Time frame: 6 months
To assess the patient-physician relationship
Time frame: 12 months
To assess the patient-physician relationship
Time frame: 18 months
To assess the patient-physician relationship
Time frame: 24 months
To assess the patient-physician relationship
Time frame: 6 months
To assess the use of the patient portal by patients and associated satisfaction
Time frame: 12 months
To assess the use of the patient portal by patients and associated satisfaction
Time frame: 24 months
To assess the use of the patient portal by patients and associated satisfaction
Time frame: 6 months
To assess the viewing of patient-reported data by physicians
Time frame: 12 months
To assess the viewing of patient-reported data by physicians
Time frame: 24 months
To assess the viewing of patient-reported data by physicians
Contact information is provided by the study sponsor or research team.
Jacques-Eric GOTTENBERG, MD, PhD
CONTACT
Jacques-Eric GOTTENBERG, Professor
CONTACT
3 88 12 79 53 ext. +33
University Hospital, Strasbourg, France
Other
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
Acronym: CAPTAIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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