- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04438239
Rehabilitation Needs After COVID-19 Hospital Treatment (REACT)
Rehabilitation Needs After COVID-19 Hospital Treatment (REACT): an Observational Study
The onset of Coronavirus Disease 2019 (COVID-19) in the first months of 2020 had a huge impact on Italian population and Healthcare System, with more than 150.000 total confirmed cases1. SARS-CoV-2 is a highly contagious new virus, causing an influenza like illness and respiratory tract infection demonstrating fever (89%), cough (68%), fatigue (38%), sputum production (34%) and/or shortness of breath (19%).
The aim of this observational study is to detect symptoms, disabilities, participation and the lived experience of the disease in individuals affected by COVID-19 two months after the hospital discharge.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The onset of Coronavirus Disease 2019 (COVID-19) in the first months of 2020 had a huge impact on Italian population and Healthcare System, with more than 150.000 total confirmed cases. SARS-CoV-2 is a highly contagious new virus, causing an influenza like illness and respiratory tract infection demonstrating fever (89%), cough (68%), fatigue (38%), sputum production (34%) and/or shortness of breath (19%). The spectrum of disease severity ranges from an asymptomatic infection or mild upper respiratory tract illness (80% of cases), to 15% of cases with severe infection with fever, cough, fatigue and shortness of breath, requiring oxygen, and 5% are severe viral pneumonia with respiratory failure requiring ventilation and life support and/or death. At present, clinicians do not know the real impact of Coronavirus Disease on patients' performances, functional status and QoL. Patients admitted to hospital experience fever, cough, dyspnea, muscle soreness and/or acute respiratory distress syndrome but healthcare professionals observe also anxiety, depression and important functional limitations during hospital stay. This situation is expected to have a significant negative impact in the short term, mainly for patients affected by other medical conditions and it may lead to deconditioning, fatigue, isolation, poor functional status and QoL.
In the first months after COVID-19 outbreak, researchers focused their studies on infection epidemiology, transmission, COVID-19 diagnosis and medical treatments. As the epidemic progresses, a large part of patients is expected to come out of the acute phase, and they may need adequate rehabilitation to face functional limitations and return to previous levels of participation.
To date, the very few studies published on the rehabilitation of positive and symptomatic patients with COVID-19 focused on pulmonary rehabilitation guidelines or on implications for rehabilitation services. To our knowledge, no clinical trial on rehabilitation intervention for patients after COVID-19 is ongoing. Our research group set up an observational study to detect patients' rehabilitation needs after COVID-19, collecting data on symptoms, impairments, functional abilities and participations to social life in the first months after hospital discharge.
The aim of this observational study is to detect symptoms, disabilities, participation and the lived experience of the disease in individuals affected by COVID-19 two months after the hospital discharge.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Reggio Emilia, Italie, 42123
- Azienda USL-IRCCS S.Maria Nuova Hospital
-
-
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:
- age>18,
- positive at COVID-19
- manifesting symptoms that required hospitalization, that is history of fever or pneumonia or other symptoms COVID-19 related.
Exclusion Criteria:
- asymptomatic individuals COVID-19 positive that were hospitalized for reasons other than COVID-19;
- dementia;
- psychiatric disorders
- other diseases preventing people to participate to the rehabilitation assessments provided by this protocol;
- acute or post-acute clinical conditions causing disability itself (e.g.: major neurological disease, such as recent stroke, TBI, etc., or recent surgical intervention, or heart failure, etc.),
- previous complete dependence in ADLs .
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Autre
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Covid-19 discharged
Patients affected by COVID-19 and discharged from hospital wards of the Azienda USL- IRCCS Of Reggio Emilia (Italy).
|
none, this study is observational
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
number of participants with considerable dyspnea: Medical Research Council (MRC, 0-4, lower score better outcome)
Délai: 2-months after hospital discharge
|
Dyspnea will be measured with Medical Research Council (MRC), minimum value 0-maximum value 4, lower value= better outcome
|
2-months after hospital discharge
|
|
number of participants with fatigue
Délai: 2-months after hospital discharge
|
Fatigue will be assessed with Fatigue Severity Scale (FSS), minimum value 9-maximum value 63, lower value=better outcome
|
2-months after hospital discharge
|
|
number of participants with anxiety
Délai: 2-months after hospital discharge
|
anxiety will be assessed with Hospital Anxiety and Depression Scale (HADS), subscale 'Anxiety', minimum value 0-maximum value 24, lower score=better outcome, cut-off for clinically significant anxiety score>7
|
2-months after hospital discharge
|
|
number of participants with depression
Délai: 2-months after hospital discharge
|
depression will be assessed with Hospital Anxiety and Depression Scale (HADS), subscale 'Depression', minimum value 0-maximum value 24, lower score=better outcome, cut-off for clinically significant depression score>7
|
2-months after hospital discharge
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
level of independence in B-ADL
Délai: 2-months after hospital discharge
|
independence or disability will be assessed with Barthel Index (BI), minimum score 0- maximum score 100, higher score=better outcome
|
2-months after hospital discharge
|
|
level of participation in social
Délai: 2-months after hospital discharge
|
reintegration into normal social activities (e.g.
recreation, movement in the community, and interaction in family or other relationships) will be assessed with Reintegration to Normal Living Index (RNLI), minimum score 0-maximum score 100, higher score=better outcome
|
2-months after hospital discharge
|
|
description of qualitative data about patients' experience
Délai: 2-months after hospital discharge
|
open ended questions will be recorded, transcribed verbatim and analyzed (two questions addressed to symptoms and limitations in activities that patients may have experienced during hospitalization or after discharge)
|
2-months after hospital discharge
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Stefania Fugazzaro, MD, Azienda USL - IRCCS of Reggio Emilia (Italy)
Publications et liens utiles
Publications générales
- Boldrini P, Bernetti A, Fiore P; SIMFER Executive Committee, SIMFER Committee for International Affairs. Impact of COVID-19 outbreak on rehabilitation services and Physical and Rehabilitation Medicine physicians' activities in Italy. An official document of the Italian PRM Society (SIMFER). Eur J Phys Rehabil Med. 2020 Jun;56(3):316-318. doi: 10.23736/S1973-9087.20.06256-5. Epub 2020 Mar 16. No abstract available.
- Fugazzaro S, Denti M, Mainini C, Accogli MA, Bedogni G, Ghizzoni D, Bertolini A, Esseroukh O, Gualdi C, Schiavi M, Braglia L, Costi S. Sex differences and rehabilitation needs after hospital discharge for COVID-19: an Italian cross-sectional study. BMJ Open. 2022 May 18;12(5):e055308. doi: 10.1136/bmjopen-2021-055308.
- Schiavi M, Fugazzaro S, Bertolini A, Denti M, Mainini C, Accogli MA, Bedogni G, Ghizzoni D, Esseroukh O, Gualdi C, Costi S. "Like before, but not exactly": the Qualy-REACT qualitative inquiry into the lived experience of long COVID. BMC Public Health. 2022 Mar 28;22(1):599. doi: 10.1186/s12889-022-13035-w.
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 428/2020/OSS/AUSLRE
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
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Covid-19
-
PfizerActif, ne recrute pasCOVID-19 [feminine] | Maladie à coronavirus 2019 (COVID-19) | Infection par covid-19 | Vaccins contre le covid-19 | Infection par le SRAS-CoV-2, COVID19 | Vaccination COVID-19 | Infection par le SRAS-CoV-2, COVID-19 | COVID-19 (maladie à coronavirus 2019) | COVID-19 Infection par le SRAS-CoV-2États-Unis
-
Shanghai Public Health Clinical CenterPas encore de recrutement
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Complété
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RecrutementÉtat post-COVID-19 | Après COVID-19 | Syndrome post-COVID-19 | Syndrome long du COVID-19 | État post-COVID-19 (PCC)Allemagne
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRecrutementFatigue | Syndrome post-COVID-19 | État post-COVID-19 | Syndrome post-COVID | Longue COVID-19 | Long-COVID | État post-COVIDCanada
-
PfizerRecrutementMaladies des voies respiratoires | COVID-19 [feminine] | Pneumonie | Maladies pulmonaires | Maladie du coronavirus 2019 | Maladie à coronavirus 2019 (COVID-19) | Infection par covid-19 | Infections des voies respiratoires supérieures | Infection des voies respiratoires | COVID-19 (maladie à coronavirus... et d'autres conditionsBelgique
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkPas encore de recrutementSyndrome post-COVID-19 | Longue COVID | Longue Covid19 | État post-COVID-19 | Syndrome post-COVID | Condition post-COVID-19, non précisée | État post-COVIDPays-Bas
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlComplétéSéquelles post-aiguës de la COVID-19 | État post-COVID-19 | Long-COVID | Syndrome chronique du COVID-19Italie
-
Indonesia UniversityRecrutementSyndrome post-COVID-19 | Longue COVID | État post-COVID-19 | Syndrome post-COVID | Longue COVID-19Indonésie
-
ModeX Therapeutics, An OPKO Health CompanyRecrutementCOVID 19 | COVID-19 (Prévention)États-Unis