- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Limoges, Francia, 87000
- Service de Rhumatologie, CHu de Limoges
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.
Periodo de tiempo: 2 months
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Number of request for advice from the referring Rheumatologist by the student and/or the patient
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2 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied
Periodo de tiempo: 2 months
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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
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COVID-19 infection evaluation in the monitored patient population
Periodo de tiempo: 2 months
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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.
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2 months
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Proportion of patients informed about COVID-19
Periodo de tiempo: 2 months
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Evaluate the proportion of patients having received medical information about the Covid-19 pandemic.
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2 months
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Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied
Periodo de tiempo: 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
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2 months
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Evaluate the association between pain increase perceived by patients and the factors studied
Periodo de tiempo: 2 months
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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)
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2 months
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Evaluate the association between rheumatologist advice asked by student and the factors studied
Periodo de tiempo: 2 months
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request for an advice from the referring rheumatologist by the student and the factors studied
|
2 months
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Evaluate the association between rheumatologist advice asked by patient and the factors studied
Periodo de tiempo: 2 months
|
request for an advice from the referring rheumatologist by the patient and the factors studied.
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2 months
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To evaluate the satisfaction of the telephone call with patients and students. Time Frame: phone call day
Periodo de tiempo: 2 months
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Numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
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2 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Pascale PV Vergne-Salle, MD-PhD, University Hospital, Limoges
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Neumonía Viral
- Neumonía
- Enfermedades pulmonares
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades del tejido conectivo
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones estreptocócicas
- Infecciones por bacterias grampositivas
- Enfermedades de la columna
- Enfermedades óseas
- Enfermedades De Los Huesos Infecciosas
- COVID-19
- Artritis
- Enfermedades reumáticas
- Enfermedades del colágeno
- Espondilitis
- Espondiloartritis
- Fiebre reumática
Otros números de identificación del estudio
- 87RI20_0044 (SePaRIC)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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