- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Limoges, Frankrijk, 87000
- Service de Rhumatologie, CHu de Limoges
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.
Tijdsspanne: 2 months
|
Number of request for advice from the referring Rheumatologist by the student and/or the patient
|
2 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied
Tijdsspanne: 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
Tijdsspanne: 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
|
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Proportion of patients informed about COVID-19
Tijdsspanne: 2 months
|
Evaluate the proportion of patients having received medical information about the Covid-19 pandemic.
|
2 months
|
|
Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied
Tijdsspanne: 2 months
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 2 months
|
Numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
|
2 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Pascale PV Vergne-Salle, MD-PhD, University Hospital, Limoges
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Coronavirus-infecties
- Coronaviridae-infecties
- Nidovirales-infecties
- RNA-virusinfecties
- Virusziekten
- Infecties
- Luchtweginfecties
- Ziekten van de luchtwegen
- Longontsteking, viraal
- Longontsteking
- Longziekten
- Gewrichtsziekten
- Musculoskeletale aandoeningen
- Bindweefselziekten
- Bacteriële infecties
- Bacteriële infecties en mycosen
- Streptokokkeninfecties
- Gram-positieve bacteriële infecties
- Spinale ziekten
- Botziekten
- Botziekten, besmettelijk
- COVID-19
- Artritis
- Reumatische aandoeningen
- Collageen Ziekten
- Spondylitis
- Spondylartritis
- Reumatische koorts
Andere studie-ID-nummers
- 87RI20_0044 (SePaRIC)
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
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