Rehabilitation Needs After COVID-19 Hospital Treatment

NCT04438239 | Completed

• 1 other identifier: 428/2020/OSS/AUSLRE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19

Keywords

Covid-19; Rehabilitation; patients' needs

Outcome Measures

Primary Outcomes (4)

• number of participants with considerable dyspnea: Medical Research Council (MRC, 0-4, lower score better outcome)

  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

  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

  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

  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

Secondary Outcomes (3)

• level of independence in B-ADL

  2-months after hospital discharge

• level of participation in social

  2-months after hospital discharge

• description of qualitative data about patients' experience

  2-months after hospital discharge

Study Arms (1)

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

Interventions

none, this study is observational OTHER

none, this study is observational

Covid-19 discharged

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age\>18,
• positive at COVID-19
• manifesting symptoms that required hospitalization, that is history of fever or pneumonia or other symptoms COVID-19 related.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda USL-IRCCS S.Maria Nuova Hospital

Reggio Emilia, 42123, Italy

Location

Related Publications (3)

• 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.

  PMID: 32175719 BACKGROUND

• 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.

  PMID: 35584875 DERIVED

• 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.

  PMID: 35346138 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stefania Fugazzaro, MD

  Azienda USL - IRCCS of Reggio Emilia (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 18, 2020
• Study Start: June 22, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)