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Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia (SePaRIC)

29. mars 2021 oppdatert av: University Hospital, Limoges

Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia Through an Innovative Organizational Strategy

The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk

Studieoversikt

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

918

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Limoges, Frankrike, 87000
        • Service de Rhumatologie, CHu de Limoges

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with chronic inflammatory rheumatism

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.
Tidsramme: 2 months
Number of request for advice from the referring Rheumatologist by the student and/or the patient
2 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 2 months
Numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
2 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Pascale PV Vergne-Salle, MD-PhD, University Hospital, Limoges

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2020

Primær fullføring (Faktiske)

1. juli 2020

Studiet fullført (Faktiske)

31. juli 2020

Datoer for studieregistrering

Først innsendt

9. desember 2020

Først innsendt som oppfylte QC-kriteriene

18. mars 2021

Først lagt ut (Faktiske)

19. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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