<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04438239</url>
  </required_header>
  <id_info>
    <org_study_id>428/2020/OSS/AUSLRE</org_study_id>
    <nct_id>NCT04438239</nct_id>
  </id_info>
  <brief_title>Rehabilitation Needs After COVID-19 Hospital Treatment</brief_title>
  <acronym>REACT</acronym>
  <official_title>Rehabilitation Needs After COVID-19 Hospital Treatment (REACT): an Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Unità Sanitaria Locale Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Unità Sanitaria Locale Reggio Emilia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The onset of Coronavirus Disease 2019 (COVID-19) in the first months of 2020 had a huge&#xD;
      impact on Italian population and Healthcare System, with more than 150.000 total confirmed&#xD;
      cases1. SARS-CoV-2 is a highly contagious new virus, causing an influenza like illness and&#xD;
      respiratory tract infection demonstrating fever (89%), cough (68%), fatigue (38%), sputum&#xD;
      production (34%) and/or shortness of breath (19%).&#xD;
&#xD;
      The aim of this observational study is to detect symptoms, disabilities, participation and&#xD;
      the lived experience of the disease in individuals affected by COVID-19 two months after the&#xD;
      hospital discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The onset of Coronavirus Disease 2019 (COVID-19) in the first months of 2020 had a huge&#xD;
      impact on Italian population and Healthcare System, with more than 150.000 total confirmed&#xD;
      cases. SARS-CoV-2 is a highly contagious new virus, causing an influenza like illness and&#xD;
      respiratory tract infection demonstrating fever (89%), cough (68%), fatigue (38%), sputum&#xD;
      production (34%) and/or shortness of breath (19%). The spectrum of disease severity ranges&#xD;
      from an asymptomatic infection or mild upper respiratory tract illness (80% of cases), to 15%&#xD;
      of cases with severe infection with fever, cough, fatigue and shortness of breath, requiring&#xD;
      oxygen, and 5% are severe viral pneumonia with respiratory failure requiring ventilation and&#xD;
      life support and/or death. At present, clinicians do not know the real impact of Coronavirus&#xD;
      Disease on patients' performances, functional status and QoL. Patients admitted to hospital&#xD;
      experience fever, cough, dyspnea, muscle soreness and/or acute respiratory distress syndrome&#xD;
      but healthcare professionals observe also anxiety, depression and important functional&#xD;
      limitations during hospital stay. This situation is expected to have a significant negative&#xD;
      impact in the short term, mainly for patients affected by other medical conditions and it may&#xD;
      lead to deconditioning, fatigue, isolation, poor functional status and QoL.&#xD;
&#xD;
      In the first months after COVID-19 outbreak, researchers focused their studies on infection&#xD;
      epidemiology, transmission, COVID-19 diagnosis and medical treatments. As the epidemic&#xD;
      progresses, a large part of patients is expected to come out of the acute phase, and they may&#xD;
      need adequate rehabilitation to face functional limitations and return to previous levels of&#xD;
      participation.&#xD;
&#xD;
      To date, the very few studies published on the rehabilitation of positive and symptomatic&#xD;
      patients with COVID-19 focused on pulmonary rehabilitation guidelines or on implications for&#xD;
      rehabilitation services. To our knowledge, no clinical trial on rehabilitation intervention&#xD;
      for patients after COVID-19 is ongoing. Our research group set up an observational study to&#xD;
      detect patients' rehabilitation needs after COVID-19, collecting data on symptoms,&#xD;
      impairments, functional abilities and participations to social life in the first months after&#xD;
      hospital discharge.&#xD;
&#xD;
      The aim of this observational study is to detect symptoms, disabilities, participation and&#xD;
      the lived experience of the disease in individuals affected by COVID-19 two months after the&#xD;
      hospital discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number of participants with considerable dyspnea: Medical Research Council (MRC, 0-4, lower score better outcome)</measure>
    <time_frame>2-months after hospital discharge</time_frame>
    <description>Dyspnea will be measured with Medical Research Council (MRC), minimum value 0-maximum value 4, lower value= better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of participants with fatigue</measure>
    <time_frame>2-months after hospital discharge</time_frame>
    <description>Fatigue will be assessed with Fatigue Severity Scale (FSS), minimum value 9-maximum value 63, lower value=better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of participants with anxiety</measure>
    <time_frame>2-months after hospital discharge</time_frame>
    <description>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&gt;7</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of participants with depression</measure>
    <time_frame>2-months after hospital discharge</time_frame>
    <description>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&gt;7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>level of independence in B-ADL</measure>
    <time_frame>2-months after hospital discharge</time_frame>
    <description>independence or disability will be assessed with Barthel Index (BI), minimum score 0- maximum score 100, higher score=better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of participation in social</measure>
    <time_frame>2-months after hospital discharge</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>description of qualitative data about patients' experience</measure>
    <time_frame>2-months after hospital discharge</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Covid-19 discharged</arm_group_label>
    <description>Patients affected by COVID-19 and discharged from hospital wards of the Azienda USL- IRCCS Of Reggio Emilia (Italy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>none, this study is observational</intervention_name>
    <description>none, this study is observational</description>
    <arm_group_label>Covid-19 discharged</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients hospitalized for COVID-19 and discharged from hospital wards of the Azienda&#xD;
        USL- IRCCS Of Reggio Emilia (Italy) from April to June 2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt;18,&#xD;
&#xD;
          -  positive at COVID-19&#xD;
&#xD;
          -  manifesting symptoms that required hospitalization, that is history of fever or&#xD;
             pneumonia or other symptoms COVID-19 related.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  asymptomatic individuals COVID-19 positive that were hospitalized for reasons other&#xD;
             than COVID-19;&#xD;
&#xD;
          -  dementia;&#xD;
&#xD;
          -  psychiatric disorders&#xD;
&#xD;
          -  other diseases preventing people to participate to the rehabilitation assessments&#xD;
             provided by this protocol;&#xD;
&#xD;
          -  acute or post-acute clinical conditions causing disability itself (e.g.: major&#xD;
             neurological disease, such as recent stroke, TBI, etc., or recent surgical&#xD;
             intervention, or heart failure, etc.),&#xD;
&#xD;
          -  previous complete dependence in ADLs .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefania Fugazzaro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda USL - IRCCS of Reggio Emilia (Italy)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda USL-IRCCS S.Maria Nuova Hospital</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <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>
    <PMID>32175719</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 22, 2021</last_update_submitted>
  <last_update_submitted_qc>January 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Covid-19</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>patients' needs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04438239
org study id: 428/2020/OSS/AUSLRE
nct id: NCT04438239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: number of participants with considerable dyspnea: Medical Research Council (MRC, 0-4, lower score better outcome)
time frame: 2-months after hospital discharge
description: Dyspnea will be measured with Medical Research Council (MRC), minimum value 0-maximum value 4, lower value= better outcome
measure: number of participants with fatigue
time frame: 2-months after hospital discharge
description: Fatigue will be assessed with Fatigue Severity Scale (FSS), minimum value 9-maximum value 63, lower value=better outcome
measure: number of participants with anxiety
time frame: 2-months after hospital discharge
description: 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
measure: number of participants with depression
time frame: 2-months after hospital discharge
description: 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
measure: level of independence in B-ADL
time frame: 2-months after hospital discharge
description: independence or disability will be assessed with Barthel Index (BI), minimum score 0- maximum score 100, higher score=better outcome
measure: level of participation in social
time frame: 2-months after hospital discharge
description: 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
measure: description of qualitative data about patients' experience
time frame: 2-months after hospital discharge
description: 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)
arm group label: Covid-19 discharged
description: Patients affected by COVID-19 and discharged from hospital wards of the Azienda USL- IRCCS Of Reggio Emilia (Italy).
intervention type: Other
intervention name: none, this study is observational
description: none, this study is observational
arm group label: Covid-19 discharged
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefania Fugazzaro, MD
role: Principal Investigator
affiliation: Azienda USL - IRCCS of Reggio Emilia (Italy)
facility: 
country: Italy
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.
PMID: 32175719
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No