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

29 marzo 2021 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

918

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with chronic inflammatory rheumatism

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.
Lasso di tempo: 2 months
Number of request for advice from the referring Rheumatologist by the student and/or the patient
2 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 2 months
Numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied
2 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Limoges

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2020

Completamento primario (Effettivo)

1 luglio 2020

Completamento dello studio (Effettivo)

31 luglio 2020

Date di iscrizione allo studio

Primo inviato

9 dicembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

18 marzo 2021

Primo Inserito (Effettivo)

19 marzo 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 aprile 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 87RI20_0044 (SePaRIC)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Covid19

Prove cliniche su SePaRIC-Covid19 cohort

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Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Finland

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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