CHU Lille | MentCovRMD | COVID-19 | e-cohorte
MentCovRMD is a cross-sectional observational RIPH3 study aiming to assess the socio-psychological consequences in patients with chronic rheumatism, systemic autoimmune or autoinflammatory diseases who have experienced COVID-19.
The COVID-19 pandemic and the associated lockdown measures quickly raised concerns about their mental health impact on affected populations. Recent data suggest that individuals who experienced COVID-19 are particularly at risk of developing post-traumatic stress disorder (PTSD). This risk may be even higher for those who already suffered from chronic illnesses before contracting the virus, as they represent a high-risk group for complications related to the infection.
Patients with inflammatory rheumatic diseases, systemic autoimmune diseases, and autoinflammatory diseases (SAIDs) are treated with immunosuppressants, biologics, corticosteroids, or non-steroidal anti-inflammatory drugs. These medications are essential for patients, but they carry a significant risk of infection. In June 2020, the French RMD COVID-19 cohort study (ClinicalTrials.gov Identifier: NCT04353609) recorded 843 cases of patients with SAIDs who had COVID-19, and identified certain immunosuppressive treatments associated with a higher risk of severe COVID-19 forms.
Thus, the chronic nature of these diseases and the risks related to their treatments lead clinicians to question the psychosocial impact of COVID-19 infection in these patients. The objective of the study is to compare RMD patients (rheumatic musculoskeletal diseases) who had COVID-19 (RMD-Cohort COVID+) with RMD patients who did not (RMD Non-COVID Control) in terms of mental health outcomes.
Study completed, with approximately 300 participants enrolled.
Role of Alsinova: Regulatory support, data preparation for interoperability between RMD-Cohort and MentCovRMD, setup of an eCRF platform for rapid data collection and patient surveys with SMS/email reminders (MR-003 compliance), performance monitoring dashboard, and coordination of investigator meetings.