Clinical trial NCT04438239: Rehabilitation Needs After COVID-19 Hospital Treatment
Official title: Rehabilitation Needs After COVID-19 Hospital Treatment (REACT): an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: Covid-19
Rehabilitation
patients' needs
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2020-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients hospitalized for COVID-19 and discharged from hospital wards of the Azienda USL- IRCCS Of Reggio Emilia (Italy) from April to June 2020

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 .

Primary outcomes:
measure: number of participants with considerable dyspnea: Medical Research Council (MRC, 0-4, lower score better outcome)
timeFrame: 2-months after hospital discharge
measure: number of participants with fatigue
timeFrame: 2-months after hospital discharge
measure: number of participants with anxiety
timeFrame: 2-months after hospital discharge
measure: number of participants with depression
timeFrame: 2-months after hospital discharge
Secondary outcomes:
measure: level of independence in B-ADL
timeFrame: 2-months after hospital discharge
measure: level of participation in social
timeFrame: 2-months after hospital discharge
measure: description of qualitative data about patients' experience
timeFrame: 2-months after hospital discharge
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda USL-IRCCS S.Maria Nuova Hospital
Study officials:
affiliation: Azienda USL - IRCCS of Reggio Emilia (Italy)
name: Stefania Fugazzaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.