<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/NCT04414319</url>
  </required_header>
  <id_info>
    <org_study_id>20_RIPH3-02</org_study_id>
    <nct_id>NCT04414319</nct_id>
  </id_info>
  <brief_title>Severe Acute Respiratory Syndrome-Coronavirus-2 and Loss of Autonomy in the Elderly</brief_title>
  <acronym>CovAged</acronym>
  <official_title>Impact of SARS-CoV-2 Infection in a Population Aged 70 Years or Older on Loss of Autonomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Center of Martinique</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>
      In most diseases, older people have less typical symptomatology than that described for&#xD;
      younger people. The investigators therefore hypothesize that within the framework of&#xD;
      coronavirus disease 19, the clinical pictures in the elderly will present specificities that&#xD;
      will need to be described. Moreover, since infection by the severe acute respiratory syndrome&#xD;
      (SARS-CoV-2) virus is new to humans, the investigators do not yet have sufficient information&#xD;
      on the fate of the elderly, in terms of loss of autonomy, rehospitalization,&#xD;
      institutionalization, mortality, etc. the investigators therefore assume that the clinical&#xD;
      pictures in the elderly will present specificities that will need to be described. The&#xD;
      investigators hypothesize that an acute infection of this type will have short-, medium-, and&#xD;
      long-term repercussions in the elderly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The question of the outcome of elderly populations in the immediate aftermath of the epidemic&#xD;
      and at a distance from it are essential to measure the effectiveness of the medical care that&#xD;
      has been undertaken, but also to adapt the response to the specific problems of the elderly&#xD;
      population. It is likely that the older, more fragile population will take longer to recover&#xD;
      from the epidemic than the younger population because their functional reserves prior to&#xD;
      coronavirus disease 19 are lower. In addition, the possible consequences of containment must&#xD;
      be added to the burden of co-morbidities and dependence prior to the epidemic. Containment is&#xD;
      synonymous with a restriction in social relationship, and sometimes a reduction in the&#xD;
      support provided on a daily basis to frail or even dependent elderly people. Moreover,&#xD;
      containment alone may be responsible for the onset or worsening of pathologies.&#xD;
&#xD;
      In most diseases, older people have less typical symptomatology than that described for&#xD;
      younger people. The investigators therefore hypothesize that within the framework of&#xD;
      coronavirus disease 19, the clinical pictures in the elderly will present specificities that&#xD;
      will need to be described. Moreover, since infection by the SARS-CoV-2 virus is new to&#xD;
      humans, the investigators do not yet have sufficient information on the fate of the elderly,&#xD;
      in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. The&#xD;
      investigators therefore assume that the clinical pictures in the elderly will present&#xD;
      specificities that will need to be described. The investigators hypothesize that an acute&#xD;
      infection of this type will have short-, medium-, and long-term repercussions in the elderly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of time to realize the research&#xD;
  </why_stopped>
  <start_date type="Actual">April 15, 2020</start_date>
  <completion_date type="Actual">April 13, 2023</completion_date>
  <primary_completion_date type="Actual">April 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>Loss of autonomy</measure>
    <time_frame>36 months</time_frame>
    <description>Loss of autonomy (based on the variation of activity of daily living and instrumental activities of daily living score, and new formal or informal help)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital readmission</measure>
    <time_frame>1 month follow-up</time_frame>
    <description>Any new hospitalization not scheduled during follow-up. We we will also study early re-hospitalizations (occurring within 30 days or less).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nursing home admission</measure>
    <time_frame>36 months</time_frame>
    <description>for non-institutionalized persons at inclusion) by a change of residence, from the usual place of residence to a lodging establishment for people dependent elderly, or to a long-term care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Inclusion and 36 months</time_frame>
    <description>Death considered will be those occurring between inclusion and the end of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in self-rated health</measure>
    <time_frame>36 months</time_frame>
    <description>Self-rated health will be rated as: very good, good bad, very bad. The transition during monitoring to a less favorable modality than that announced at inclusion will be considered as a perceived deterioration in health</description>
  </secondary_outcome>
  <enrollment type="Actual">170</enrollment>
  <condition>SARS-CoV 2</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A cohort of covid-19 patients aged 70 years or older, admitted in a short stay or a&#xD;
        rehabilitation geriatric wards.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  70 years of age or older;&#xD;
&#xD;
          -  Hospitalized in a short stay or a rehabilitation geriatric wards at one of the&#xD;
             participating centers;&#xD;
&#xD;
          -  Positive by Reverse Transcriptase-Polymerase Chain Reaction for severe acute&#xD;
             respiratory syndrome (SARS-CoV-2) coronavirus or be considered to have SARS-CoV-2&#xD;
             coronavirus based on lung CT data and physician opinion;&#xD;
&#xD;
          -  Formal consent to answer the questionnaire or, in the event of inability to give&#xD;
             consent, consent obtained from the trusted third party;&#xD;
&#xD;
          -  Affiliation to a social security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under formal guardianship or trusteeship.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Moustapha DRAME, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Unversity hospital of Martinique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital of Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Va de Lys-Ramsay Gds group Clinic</name>
      <address>
        <city>Tourcoing</city>
        <zip>59200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopsital of Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <zip>59300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospital of Guadeloupe</name>
      <address>
        <city>Les Abymes</city>
        <zip>97139</zip>
        <country>Guadeloupe</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospital of Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Guadeloupe</country>
    <country>Martinique</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04414319
org study id: 20_RIPH3-02
nct id: NCT04414319
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In most diseases, older people have less typical symptomatology than that described for
      younger people. The investigators therefore hypothesize that within the framework of
      coronavirus disease 19, the clinical pictures in the elderly will present specificities that
      will need to be described. Moreover, since infection by the severe acute respiratory syndrome
      (SARS-CoV-2) virus is new to humans, the investigators do not yet have sufficient information
      on the fate of the elderly, in terms of loss of autonomy, rehospitalization,
      institutionalization, mortality, etc. the investigators therefore assume that the clinical
      pictures in the elderly will present specificities that will need to be described. The
      investigators hypothesize that an acute infection of this type will have short-, medium-, and
      long-term repercussions in the elderly.
The question of the outcome of elderly populations in the immediate aftermath of the epidemic
      and at a distance from it are essential to measure the effectiveness of the medical care that
      has been undertaken, but also to adapt the response to the specific problems of the elderly
      population. It is likely that the older, more fragile population will take longer to recover
      from the epidemic than the younger population because their functional reserves prior to
      coronavirus disease 19 are lower. In addition, the possible consequences of containment must
      be added to the burden of co-morbidities and dependence prior to the epidemic. Containment is
      synonymous with a restriction in social relationship, and sometimes a reduction in the
      support provided on a daily basis to frail or even dependent elderly people. Moreover,
      containment alone may be responsible for the onset or worsening of pathologies.

      In most diseases, older people have less typical symptomatology than that described for
      younger people. The investigators therefore hypothesize that within the framework of
      coronavirus disease 19, the clinical pictures in the elderly will present specificities that
      will need to be described. Moreover, since infection by the SARS-CoV-2 virus is new to
      humans, the investigators do not yet have sufficient information on the fate of the elderly,
      in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. The
      investigators therefore assume that the clinical pictures in the elderly will present
      specificities that will need to be described. The investigators hypothesize that an acute
      infection of this type will have short-, medium-, and long-term repercussions in the elderly.
observational model: Cohort
time perspective: Prospective
measure: Loss of autonomy
time frame: 36 months
description: Loss of autonomy (based on the variation of activity of daily living and instrumental activities of daily living score, and new formal or informal help)
measure: Hospital readmission
time frame: 1 month follow-up
description: Any new hospitalization not scheduled during follow-up. We we will also study early re-hospitalizations (occurring within 30 days or less).
measure: Nursing home admission
time frame: 36 months
description: for non-institutionalized persons at inclusion) by a change of residence, from the usual place of residence to a lodging establishment for people dependent elderly, or to a long-term care unit
measure: All-cause mortality
time frame: Inclusion and 36 months
description: Death considered will be those occurring between inclusion and the end of follow-up
measure: change in self-rated health
time frame: 36 months
description: Self-rated health will be rated as: very good, good bad, very bad. The transition during monitoring to a less favorable modality than that announced at inclusion will be considered as a perceived deterioration in health
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
last name: Moustapha DRAME, PHD
role: Study Director
affiliation: Unversity hospital of Martinique
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Guadeloupe
country: Martinique
responsible party type: Sponsor
sharing ipd: No