<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/NCT04408196</url>
  </required_header>
  <id_info>
    <org_study_id>FDG_socialdistancing_COVID-19</org_study_id>
    <nct_id>NCT04408196</nct_id>
  </id_info>
  <brief_title>QoL and the Emotional-affective Sphere in Rehabilitation Setting During COVID-19 Quarantine</brief_title>
  <official_title>Effects of Social Distancing on the Quality of Life and on the Emotional-affective Sphere of Caregivers and Patients Hospitalized in Residential Rehabilitation Departments: an Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Don Carlo Gnocchi Onlus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Don Carlo Gnocchi Onlus</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>
      Coronavirus disease (COVID-19) is caused by the Severe Acute Respiratory Syndrome CoronaVirus&#xD;
      2 (SARS-CoV-2) virus. This virus was identified in December 2019 in the Chinese city of&#xD;
      Wuhan, in the province of Hubei, where it determined a state of health emergency proclaimed&#xD;
      by China on January 30, 2020.&#xD;
&#xD;
      Since February 2020, Italy has been involved in the emergency of the COVID-19 infection, with&#xD;
      devastating consequences for the health of the population and the economy of our country. As&#xD;
      published by the Italian National Institute of Health, the starting date of the symptoms&#xD;
      dates back to the end of January, the first case diagnosed dates back to 21 February 2020&#xD;
      while the first cases of home isolation date back to March 1st, 2020. On March 30, 2020,&#xD;
      there were 101739 positive subjects and 11591 deaths (Civil Protection data).&#xD;
&#xD;
      According to data published by the World Health Organization, most people with COVID-19&#xD;
      develop a flu-like form, 14% develop a severe form that requires hospitalization and oxygen&#xD;
      therapy and 5% require an ICU admission.&#xD;
&#xD;
      The emergency from Covid19 made it necessary to provide institutional social distancing&#xD;
      conditions which resulted in rehabilitation departments being prohibited from visiting&#xD;
      patients by family members and/or caregivers. This event, although necessary, led to the&#xD;
      first moment of discomfort on the part of patients and family members; to overcome this&#xD;
      reaction &quot;technological&quot; solutions were found, trying to give continuity to the contact&#xD;
      between the patient and the family member through the use of video calls. Despite this, the&#xD;
      COVID-19 emergency and the limitations resulting from social distancing likely have an impact&#xD;
      on both patients and family members/caregivers that needs to be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims:&#xD;
&#xD;
      The study aims to measure the quality of life (QoL) and the emotional-affective sphere of&#xD;
      patients, currently hospitalized in residential structures, and their family members.&#xD;
&#xD;
      The study data will allow identifying (a) whether the social distancing between family&#xD;
      members/caregivers and patients undergoing rehabilitation for orthopedic or neurological&#xD;
      disabilities affects the quality of life and the emotional-affective sphere and (b) if these&#xD;
      conditions change over time. The data obtained will, therefore, allow identifying those&#xD;
      subjects who present a particular fragility of the emotional-affective sphere and who&#xD;
      therefore need attention and possibly psychological support that will be prescribed.&#xD;
&#xD;
      Procedures:&#xD;
&#xD;
      Demographic (for patients and caregivers) and anamnestic (only for patients) data will be&#xD;
      collected; moreover, disability will be assessed in patients using the modified Barthel&#xD;
      index.&#xD;
&#xD;
      Three questionnaires will be administered to patients and caregivers:&#xD;
&#xD;
        -  The Short Form (36) Health Survey (SF36), to evaluate the QoL;&#xD;
&#xD;
        -  The Beck Anxiety Inventory (BAI), to evaluate the emotional state;&#xD;
&#xD;
        -  The Beck Depression Inventory-II (BDI-II), to evaluate mood.&#xD;
&#xD;
      These questionnaires will be administered after one month of hospitalization (T0), and after&#xD;
      one (T1) and two (T2) months after T0. Finally, at time T1 and T2 it will be registered if&#xD;
      the patient is still hospitalized or discharged (and in the latter case the days between the&#xD;
      discharge and the compilation of the questionnaire will be recorded). Since the three&#xD;
      selected questionnaires provide for self-administration, to simplify the collection of data&#xD;
      relating to caregivers, the implementation and use of an online questionnaire will be&#xD;
      assessed. This questionnaire will also provide for the collection of consent to the use of&#xD;
      data by the subject and will guarantee their privacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">February 22, 2021</completion_date>
  <primary_completion_date type="Actual">February 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Short Form-36 Health Survey (SF36)</measure>
    <time_frame>After one month of hospitalisation (baseline, T0)</time_frame>
    <description>It is a questionnaire to evaluate the Quality of Life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form (36) Health Survey (SF36)</measure>
    <time_frame>One month after baseline (T1)</time_frame>
    <description>It is a questionnaire to evaluate the Quality of Life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form (36) Health Survey (SF36)</measure>
    <time_frame>Two months after baseline (T2)</time_frame>
    <description>It is a questionnaire to evaluate the Quality of Life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Anxiety Inventory (BAI)</measure>
    <time_frame>After one month of hospitalisation (baseline,T0)</time_frame>
    <description>It is a brief, criteria-referenced assessment for measuring anxiety severity and level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Anxiety Inventory (BAI)</measure>
    <time_frame>One month after baseline (T1)</time_frame>
    <description>It is a brief, criteria-referenced assessment for measuring anxiety severity and level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Anxiety Inventory (BAI)</measure>
    <time_frame>Two months after baseline (T2)</time_frame>
    <description>It is a brief, criteria-referenced assessment for measuring anxiety severity and level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>After one month of hospitalisation (baseline)</time_frame>
    <description>It is a brief, criteria-referenced assessment for measuring depression severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>One month after baseline (T1)</time_frame>
    <description>It is a brief, criteria-referenced assessment for measuring depression severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>Two months after baseline (T2)</time_frame>
    <description>It is a brief, criteria-referenced assessment for measuring depression severity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>modified Barthel Index (mBI)</measure>
    <time_frame>After one month of hospitalisation (baseline, T0)</time_frame>
    <description>It is a measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">121</enrollment>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>100 patients admitted to an inpatient rehabilitation facility</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers</arm_group_label>
    <description>100 caregivers of patients admitted to an inpatient rehabilitation facility</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to inpatients rehabilitation centers&#xD;
&#xD;
        Caregivers of patients admitted to inpatients rehabilitation centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients admitted to the centers of the Don Gnocchi Foundation participating in the&#xD;
             study and their caregivers will be recruited&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For patients: a score on the Mini-Mental State Examination (MMSE) scale lower than 24&#xD;
             which prevents the administration of SF36;&#xD;
&#xD;
          -  For patients and caregivers: failure to acquire informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene APRILE, MD,PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Fondazione Don Carlo Gnocchi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Don Gnocchi Foundation</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.</citation>
    <PMID>9817120</PMID>
  </reference>
  <reference>
    <citation>Aprile I, Piazzini DB, Bertolini C, Caliandro P, Pazzaglia C, Tonali P, Padua L. Predictive variables on disability and quality of life in stroke outpatients undergoing rehabilitation. Neurol Sci. 2006 Apr;27(1):40-6. doi: 10.1007/s10072-006-0563-5.</citation>
    <PMID>16688598</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione Don Carlo Gnocchi Onlus</investigator_affiliation>
    <investigator_full_name>Irene Giovanna Aprile</investigator_full_name>
    <investigator_title>Md, PhD, Principal Investigator, Head of Rehabilitation Unit</investigator_title>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <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/NCT04408196
org study id: FDG_socialdistancing_COVID-19
nct id: NCT04408196
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease (COVID-19) is caused by the Severe Acute Respiratory Syndrome CoronaVirus
      2 (SARS-CoV-2) virus. This virus was identified in December 2019 in the Chinese city of
      Wuhan, in the province of Hubei, where it determined a state of health emergency proclaimed
      by China on January 30, 2020.

      Since February 2020, Italy has been involved in the emergency of the COVID-19 infection, with
      devastating consequences for the health of the population and the economy of our country. As
      published by the Italian National Institute of Health, the starting date of the symptoms
      dates back to the end of January, the first case diagnosed dates back to 21 February 2020
      while the first cases of home isolation date back to March 1st, 2020. On March 30, 2020,
      there were 101739 positive subjects and 11591 deaths (Civil Protection data).

      According to data published by the World Health Organization, most people with COVID-19
      develop a flu-like form, 14% develop a severe form that requires hospitalization and oxygen
      therapy and 5% require an ICU admission.

      The emergency from Covid19 made it necessary to provide institutional social distancing
      conditions which resulted in rehabilitation departments being prohibited from visiting
      patients by family members and/or caregivers. This event, although necessary, led to the
      first moment of discomfort on the part of patients and family members; to overcome this
      reaction "technological" solutions were found, trying to give continuity to the contact
      between the patient and the family member through the use of video calls. Despite this, the
      COVID-19 emergency and the limitations resulting from social distancing likely have an impact
      on both patients and family members/caregivers that needs to be assessed.
Aims:

      The study aims to measure the quality of life (QoL) and the emotional-affective sphere of
      patients, currently hospitalized in residential structures, and their family members.

      The study data will allow identifying (a) whether the social distancing between family
      members/caregivers and patients undergoing rehabilitation for orthopedic or neurological
      disabilities affects the quality of life and the emotional-affective sphere and (b) if these
      conditions change over time. The data obtained will, therefore, allow identifying those
      subjects who present a particular fragility of the emotional-affective sphere and who
      therefore need attention and possibly psychological support that will be prescribed.

      Procedures:

      Demographic (for patients and caregivers) and anamnestic (only for patients) data will be
      collected; moreover, disability will be assessed in patients using the modified Barthel
      index.

      Three questionnaires will be administered to patients and caregivers:

        -  The Short Form (36) Health Survey (SF36), to evaluate the QoL;

        -  The Beck Anxiety Inventory (BAI), to evaluate the emotional state;

        -  The Beck Depression Inventory-II (BDI-II), to evaluate mood.

      These questionnaires will be administered after one month of hospitalization (T0), and after
      one (T1) and two (T2) months after T0. Finally, at time T1 and T2 it will be registered if
      the patient is still hospitalized or discharged (and in the latter case the days between the
      discharge and the compilation of the questionnaire will be recorded). Since the three
      selected questionnaires provide for self-administration, to simplify the collection of data
      relating to caregivers, the implementation and use of an online questionnaire will be
      assessed. This questionnaire will also provide for the collection of consent to the use of
      data by the subject and will guarantee their privacy.
observational model: Cohort
time perspective: Prospective
measure: Short Form-36 Health Survey (SF36)
time frame: After one month of hospitalisation (baseline, T0)
description: It is a questionnaire to evaluate the Quality of Life
measure: Short Form (36) Health Survey (SF36)
time frame: One month after baseline (T1)
description: It is a questionnaire to evaluate the Quality of Life
measure: Short Form (36) Health Survey (SF36)
time frame: Two months after baseline (T2)
description: It is a questionnaire to evaluate the Quality of Life
measure: Beck Anxiety Inventory (BAI)
time frame: After one month of hospitalisation (baseline,T0)
description: It is a brief, criteria-referenced assessment for measuring anxiety severity and level
measure: Beck Anxiety Inventory (BAI)
time frame: One month after baseline (T1)
description: It is a brief, criteria-referenced assessment for measuring anxiety severity and level
measure: Beck Anxiety Inventory (BAI)
time frame: Two months after baseline (T2)
description: It is a brief, criteria-referenced assessment for measuring anxiety severity and level
measure: Beck Depression Inventory-II (BDI-II)
time frame: After one month of hospitalisation (baseline)
description: It is a brief, criteria-referenced assessment for measuring depression severity
measure: Beck Depression Inventory-II (BDI-II)
time frame: One month after baseline (T1)
description: It is a brief, criteria-referenced assessment for measuring depression severity
measure: Beck Depression Inventory-II (BDI-II)
time frame: Two months after baseline (T2)
description: It is a brief, criteria-referenced assessment for measuring depression severity
measure: modified Barthel Index (mBI)
time frame: After one month of hospitalisation (baseline, T0)
description: It is a measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions.
arm group label: Patients
description: 100 patients admitted to an inpatient rehabilitation facility
arm group label: Caregivers
description: 100 caregivers of patients admitted to an inpatient rehabilitation facility
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Irene APRILE, MD,PHD
role: Principal Investigator
affiliation: IRCCS Fondazione Don Carlo Gnocchi
facility: 
country: Italy
citation: Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.
PMID: 9817120
citation: Aprile I, Piazzini DB, Bertolini C, Caliandro P, Pazzaglia C, Tonali P, Padua L. Predictive variables on disability and quality of life in stroke outpatients undergoing rehabilitation. Neurol Sci. 2006 Apr;27(1):40-6. doi: 10.1007/s10072-006-0563-5.
PMID: 16688598
responsible party type: Principal Investigator
investigator affiliation: Fondazione Don Carlo Gnocchi Onlus
investigator full name: Irene Giovanna Aprile
investigator title: Md, PhD, Principal Investigator, Head of Rehabilitation Unit
sharing ipd: No