Mental Health Consequences of COVID19 Infection in the French RMD Cohort (NCT04510467) | Clinical Trial Compass
TerminatedNot Applicable
Mental Health Consequences of COVID19 Infection in the French RMD Cohort
Stopped: inclusion number not reached during the period
France296 participantsStarted 2021-01-20
Plain-language summary
this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient case:
* Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease
* With confirmed COVID-19 infection (at least one month prior to study inclusion)
* Study information given to the patient
* Patient affiliated to social security
Patient control:
* Patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease.
* Not having had a confirmed COVID-19 infection
* Study information given to the patient
* Patient affiliated to social security
Exclusion Criteria:
* Opposition to participation in the study by the patient and/or his legal representative
* Adult patient not able to understand the implications and rules of the study
* Protected adults under guardianship or curatorship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID
Timeframe: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection