- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04806867
Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia (SePaRIC)
Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia Through an Innovative Organizational Strategy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The COVID-19 pandemic led to the suspension of consultations and hospitalization of the majority of patients followed in the Rheumatology Department of the Limoges University Hospital.
The department therefore implemented a strategy for the management of patients with chronic inflammatory rheumatism (CIR) during this period, which allowed maintaining contact with patients in the patient database.
During this telephone call, an CIR-Covid19 questionnaire was fulfilled in order to prioritize patients requiring rapid management.
The strategy is based on the use of the available health reserve, i.e. volunteered medical students to provide patient management assistance. These students were trained with face-to-face learning in the rheumatology department given by residents on chronic inflammatory rheumatism to remind them of all the elements of diagnosis and management. They had an interview with a senior rheumatologist from the Department to present the questionnaire and its objectives , to give them advice regarding communication with patients, as well as information about the COVID-19 infection and recommendations of the French Rheumatology Society for CIR patients. The students were trained with quizzes on practical situations, with feedback on the answers.
The information's collected in the questionnaire were based on the patients' feelings. Telephone communication does not allow an assessment of disease activity according to validated criteria as it requires a clinical examination.
The opinion of the referring rheumatologist was requested by the patients or by the medical student at the end of the telephone call, depending on the information collected. At any time, the medical students could call upon to senior doctors from the department or residents in case of difficulties.
943 patients were thus contacted between 14/04/2020 and 28/04/2020. They were able to benefit from an optimized management according to the context of the COVID19 pandemic.
These questionnaires were analyze in order to assess the need for specialized follow-up during this period and to evaluate the impact of COVID19 on this population.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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-
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Limoges, France, 87000
- Service de Rhumatologie, CHu de Limoges
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients with chronic inflammatory rheumatism who answered the RIC-COVID19 survey during the telephone call set up by the Rheumatology Department of the Limoges University Hospital during the confinement.
Exclusion Criteria:
- Patients objecting to the use of their data
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.
Délai: 2 months
|
Number of request for advice from the referring Rheumatologist by the student and/or the patient
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2 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied
Délai: 2 months
|
Request for an advice from the referring rheumatologist by the student and/or the patient and the factors studied. Factors studied: Sex, age, department of residence, RA or AS COVID-19 symptoms, increase in CIR activity, increase in pain, discontinuation of treatment, increase in stress and anxiety, increase in depression, increase in fatigue, increase in sleep disorders, fear of coming to consultation or hospitalization, adaptability with their rheumatic disease, medical loneliness. |
2 months
|
COVID-19 infection evaluation in the monitored patient population
Délai: 2 months
|
Evaluate the proportion of COVID-19 infection in patients monitored in the Rheumatology department at Limoges University Hospital Proportion of COVID-19 serological tests performed and their positivity in this patient population.
|
2 months
|
Proportion of patients informed about COVID-19
Délai: 2 months
|
Evaluate the proportion of patients having received medical information about the Covid-19 pandemic.
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2 months
|
Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied
Délai: 2 months
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Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied using numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
|
2 months
|
Evaluate the association between pain increase perceived by patients and the factors studied
Délai: 2 months
|
Percentage increase in pain perceived by patients during the epidemic and factors studied, evaluated by numerical scale during the phone call 0% to 100% (0% represente no pain, and 100% maximal pain)
|
2 months
|
Evaluate the association between rheumatologist advice asked by student and the factors studied
Délai: 2 months
|
request for an advice from the referring rheumatologist by the student and the factors studied
|
2 months
|
Evaluate the association between rheumatologist advice asked by patient and the factors studied
Délai: 2 months
|
request for an advice from the referring rheumatologist by the patient and the factors studied.
|
2 months
|
To evaluate the satisfaction of the telephone call with patients and students. Time Frame: phone call day
Délai: 2 months
|
Numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
|
2 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pascale PV Vergne-Salle, MD-PhD, University Hospital, Limoges
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Pneumonie virale
- Pneumonie
- Maladies pulmonaires
- Maladies articulaires
- Maladies musculo-squelettiques
- Maladies du tissu conjonctif
- Infections bactériennes
- Infections bactériennes et mycoses
- Infections streptococciques
- Infections bactériennes à Gram positif
- Maladies de la colonne vertébrale
- Maladies osseuses
- Maladies osseuses, infectieuses
- COVID-19 [feminine]
- Arthrite
- Maladies rhumatismales
- Maladies du collagène
- Spondylarthrite
- Spondylarthrite
- Rhumatisme articulaire aigu
Autres numéros d'identification d'étude
- 87RI20_0044 (SePaRIC)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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