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Rehabilitation Needs After COVID-19 Hospital Treatment (REACT)

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ClinicalTrials.gov Identifier: NCT04438239
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Azienda Unità Sanitaria Locale Reggio Emilia

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.


Condition or disease Intervention/treatment
Covid-19 Other: none, this study is observational

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Rehabilitation Needs After COVID-19 Hospital Treatment (REACT): an Observational Study
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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: none, this study is observational
none, this study is observational




Primary Outcome Measures :
  1. number of participants with considerable dyspnea: Medical Research Council (MRC, 0-4, lower score better outcome) [ Time Frame: 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. number of participants with fatigue [ Time Frame: 2-months after hospital discharge ]
    Fatigue will be assessed with Fatigue Severity Scale (FSS), minimum value 9-maximum value 63, lower value=better outcome

  3. number of participants with anxiety [ Time Frame: 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

  4. number of participants with depression [ Time Frame: 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


Secondary Outcome Measures :
  1. level of independence in B-ADL [ Time Frame: 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. level of participation in social [ Time Frame: 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

  3. description of qualitative data about patients' experience [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438239


Contacts
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Contact: Stefania Fugazzaro, MD +39 0522522441 stefania.fugazzaro@ausl.re.it
Contact: Stefania Costi, PhD +39 0522522441 stefania.costi@unimore.it

Locations
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Italy
Azienda USL-IRCCS S.Maria Nuova Hospital Recruiting
Reggio Emilia, Italy, 42123
Sponsors and Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia
Investigators
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Principal Investigator: Stefania Fugazzaro, MD Azienda USL - IRCCS of Reggio Emilia (Italy)
Publications:
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Responsible Party: Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier: NCT04438239    
Other Study ID Numbers: 428/2020/OSS/AUSLRE
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Unità Sanitaria Locale Reggio Emilia:
Covid-19
Rehabilitation
patients' needs