Rehabilitation Needs After COVID-19 Hospital Treatment
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 06/09/2020 |
| Estimated Enrollment Submitted: | 06/16/2020 |
| First Posted: | 06/17/2020 |
| Last Update Submitted: | 07/08/2020 |
| Last Update Posted: | 07/12/2020 |
| Actual Study Start Date: | 06/29/2020 |
| Estimated Primary Completion Date: | 12/30/2020 |
| Estimated Study Completion Date: | 12/30/2020 |
Condition or disease
Intervention/treatment
Other: Covid-19 discharged
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Covid-19 discharged Patients affected by COVID-19 and discharged from hospital wards of the Azienda USL- IRCCS Of Reggio Emilia (Italy). | Other: Covid-19 discharged none, this study is observational |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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 . |
Outcome
Primary Outcome Measures
1. number of participants with considerable dyspnea: Medical Research Council (MRC, 0-4, lower score better outcome) [2-months after hospital discharge]
2. number of participants with fatigue [2-months after hospital discharge]
3. number of participants with anxiety [2-months after hospital discharge]
4. number of participants with depression [2-months after hospital discharge]
Secondary Outcome Measures
1. level of independence in B-ADL [2-months after hospital discharge]
2. level of participation in social [2-months after hospital discharge]
3. description of qualitative data about patients' experience [2-months after hospital discharge]
