GoutCAPTAINNCT05927688
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
An observational study of Gout and Rheumatoid Arthritis, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout, Rheumatoid Arthritis, Sjogren's Syndrome
- What is being tested?
- Therapeutic management following access by the physician to his patient's ePROs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 352 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2023to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Gout, Rheumatoid arthritis, Sjogren's syndrome or Systemic lupus erythematosus
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jacques-Eric GOTTENBERG, Professor contact
Jacques-Eric GOTTENBERG, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Strasbourg
Strasbourg, 67000
Jacques-Eric GOTTENBERG, MD, PhD, 3 88 12 79 53 ext. +33, jacques-eric.gottenberg@chru-strasbourg.fr
About this study
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
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.
- Being tested
- Therapeutic management following access by the physician to his patient's ePROs
- Medical subject headings
- Gout, Arthritis, Rheumatoid, Sjogren's Syndrome, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic management following access by the physician to his patient's ePROsBehavioural
Therapeutic management following access by the physician to his patient's ePROs
| Study group | Role | What they receive |
|---|---|---|
| Patients whose physician used the electronic platform to access ePRO | Not described Receives: 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 | Not described Receives: Behavioral: Therapeutic management following access by the physician to his patient's ePROs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (28)
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.
Measured: 6 months
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.
Measured: 24 months
Frequency of flares and exacerbation
To assess the fluctuation of disease activity and flares - as perceived by the patient
Measured: Day 1
Frequency of flares and exacerbation
To assess the fluctuation of disease activity and flares - as perceived by the patient
Measured: 6 months
Frequency of flares and exacerbation
To assess the fluctuation of disease activity and flares - as perceived by the patient
Measured: 12 months
Frequency of flares and exacerbation
To assess the fluctuation of disease activity and flares - as perceived by the patient
Measured: 24 months
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
To assess the overall health of patients
Measured: Day 1
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
To assess the overall health of patients
Measured: 6 months
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
To assess the overall health of patients
Measured: 12 months
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
To assess the overall health of patients
Measured: 24 months
HAQ score (Health Assessment Questionnaire) for health assessment
To assess the overall health of patients
Measured: Day 1
HAQ score (Health Assessment Questionnaire) for health assessment
To assess the overall health of patients
Measured: 6 months
HAQ score (Health Assessment Questionnaire) for health assessment
To assess the overall health of patients
Measured: 12 months
HAQ score (Health Assessment Questionnaire) for health assessment
To assess the overall health of patients
Measured: 24 months
IPAQ score (International Physical Activity Questionnaire) to measure physical activity
To assess patient's physical activity over time
Measured: Day 1
IPAQ score (International Physical Activity Questionnaire) to measure physical activity
To assess patient's physical activity over time
Measured: 6 months
IPAQ score (International Physical Activity Questionnaire) to measure physical activity
To assess patient's physical activity over time
Measured: 12 months
IPAQ score (International Physical Activity Questionnaire) to measure physical activity
To assess patient's physical activity over time
Measured: 24 months
PEPPI score (Perceived efficacy in patient-physician interactions)
To assess the patient-physician relationship
Measured: 6 months
PEPPI score (Perceived efficacy in patient-physician interactions)
To assess the patient-physician relationship
Measured: 12 months
PEPPI score (Perceived efficacy in patient-physician interactions)
To assess the patient-physician relationship
Measured: 18 months
PEPPI score (Perceived efficacy in patient-physician interactions)
To assess the patient-physician relationship
Measured: 24 months
Number of times patients logged in to the platform
To assess the use of the patient portal by patients and associated satisfaction
Measured: 6 months
Number of times patients logged in to the platform
To assess the use of the patient portal by patients and associated satisfaction
Measured: 12 months
Number of times patients logged in to the platform
To assess the use of the patient portal by patients and associated satisfaction
Measured: 24 months
Number of times physicians logged in to the platform
To assess the viewing of patient-reported data by physicians
Measured: 6 months
Number of times physicians logged in to the platform
To assess the viewing of patient-reported data by physicians
Measured: 12 months
Number of times physicians logged in to the platform
To assess the viewing of patient-reported data by physicians
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start18 Jul 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927688
- Sponsor's protocol ID
- 8546
- Acronym
- CAPTAIN
- Status last verified
- Mar 2025
- First submitted
- 22 Jun 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05927688
- Acronym / sponsor ID
- CAPTAIN / 8546
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Gout, Rheumatoid arthritis, Sjogren's syndrome or Systemic lupus erythematosus
Key inclusion criteria (10 listed)
- Men or women of at least 18 years of age
- Diagnosed with (at least) one of the following autoimmune diseases:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic management following access by the physician to his patient's ePROsTherapeutic management following access by the physician to his patient's ePROs | Behavioural | Patients whose physician did not used the electronic platform and did not access ePRO, Patients whose physician used the electronic platform to access ePRO |
Primary outcome
Frequency of therapeutic adjustments
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.
28 secondary outcomes
Frequency of therapeutic adjustments
Time frame: 6 months
Frequency of therapeutic adjustments
Time frame: 24 months
Frequency of flares and exacerbation
Time frame: Day 1
Frequency of flares and exacerbation
Time frame: 6 months
Frequency of flares and exacerbation
Time frame: 12 months
Frequency of flares and exacerbation
Time frame: 24 months
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
Time frame: Day 1
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
Time frame: 6 months
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
Time frame: 12 months
RAPID 3 (Routine Assessment of Patient Index Data 3) questionnaire to measure the disease score
Time frame: 24 months
HAQ score (Health Assessment Questionnaire) for health assessment
Time frame: Day 1
HAQ score (Health Assessment Questionnaire) for health assessment
Time frame: 6 months
HAQ score (Health Assessment Questionnaire) for health assessment
Time frame: 12 months
HAQ score (Health Assessment Questionnaire) for health assessment
Time frame: 24 months
IPAQ score (International Physical Activity Questionnaire) to measure physical activity
Time frame: Day 1
IPAQ score (International Physical Activity Questionnaire) to measure physical activity
Time frame: 6 months
IPAQ score (International Physical Activity Questionnaire) to measure physical activity
Time frame: 12 months
IPAQ score (International Physical Activity Questionnaire) to measure physical activity
Time frame: 24 months
PEPPI score (Perceived efficacy in patient-physician interactions)
Time frame: 6 months
PEPPI score (Perceived efficacy in patient-physician interactions)
Time frame: 12 months
PEPPI score (Perceived efficacy in patient-physician interactions)
Time frame: 18 months
PEPPI score (Perceived efficacy in patient-physician interactions)
Time frame: 24 months
Number of times patients logged in to the platform
Time frame: 6 months
Number of times patients logged in to the platform
Time frame: 12 months
Number of times patients logged in to the platform
Time frame: 24 months
Number of times physicians logged in to the platform
Time frame: 6 months
Number of times physicians logged in to the platform
Time frame: 12 months
Number of times physicians logged in to the platform
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacques-Eric GOTTENBERG, Professor contact
Jacques-Eric GOTTENBERG, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout and Rheumatoid Arthritis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacques-Eric GOTTENBERG, Professor (3 88 12 79 53 ext. +33, jacques-eric.gottenberg@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of therapeutic adjustments (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.