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

Rheumatoid Arthritis Clinical Trial

— CAPTAIN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927688
• Other study ID #: 8546
• Status: Recruiting
• Start date: July 18, 2023
• Est. completion date: July 2027

Study information

• Verified date: February 2024
• Source: University Hospital, Strasbourg, France
• Contact: Jacques-Eric GOTTENBERG, Professor
• Phone: 3 88 12 79 53
• Email: jacques-eric.gottenberg[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

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