<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/NCT04481477</url>
  </required_header>
  <id_info>
    <org_study_id>2020664</org_study_id>
    <nct_id>NCT04481477</nct_id>
  </id_info>
  <brief_title>Results of Emotional Support Activities During Hospital Admission With a Diagnosis of COVID19</brief_title>
  <acronym>WW2COVID-19</acronym>
  <official_title>Impact on Patients of Nurses' Emotional Support Activities During Hospital Admission With a Diagnosis of COVID19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to find out what care patients affected by anxiety, fear or&#xD;
      loneliness have perceived and the perceived impact of this care. This knowledge will allow us&#xD;
      to design measures aimed at improving nursing care of these aspects in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional descriptive study to be carried out at the Consorci Corporació&#xD;
      Sanitària Parc Taulí (CCSPT). The results of this study will provide information on the care&#xD;
      received by patients admitted to COVID 19 affected by anxiety, fear or loneliness, the&#xD;
      perceived impact of this care and will enable measures to be implemented to improve nursing&#xD;
      care in the future. 450 patients, randomly selected from the Hospital de Sabadell database,&#xD;
      will be included. In the sample, we will ensure that the proportion of women and men is in&#xD;
      line with the distribution of the population to enable the incorporation of the gender&#xD;
      perspective in the analyses. The quantitative variables will be described by means of their&#xD;
      mean and standard deviation. Qualitative variables will be described in absolute and relative&#xD;
      frequencies. In order to evaluate the suitability of the intervention to the needs of the&#xD;
      patient, a table of concordance will be constructed between the actions proposed by the panel&#xD;
      of experts and the actions carried out as referred by the patient. The kappa concordance&#xD;
      index will be calculated and the degree of concordance will be classified according to the&#xD;
      Landis and Koch scale. As regards the effectiveness of the intervention, the patients who&#xD;
      were treated correctly and those who were not will be identified, and the percentage of&#xD;
      positive impacts according to Csq-8 between the two groups will be compared by means of the&#xD;
      Chi-square test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 27, 2020</start_date>
  <completion_date type="Anticipated">April 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The adequacy of nursing care to the needs of the patient</measure>
    <time_frame>6 months after care</time_frame>
    <description>kappa concordance rate between care provided and care needed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intervention effectiveness</measure>
    <time_frame>6 months after care</time_frame>
    <description>comparison of the percentage of positive impacts according to Csq-8 between the two groups using the Chi-square test</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Patients COVID-19</arm_group_label>
    <description>Patients over the age of 18 who were admitted with a diagnosis of COVID-19 to any CCSPT unit between March 13, 2020 and April 30, 2020 and were discharged with a recovery result</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nursing care to reduce anxiety, fear and loneliness</intervention_name>
    <description>Decreased anxiety Presence Emotional support Improved security Increasing coping capacity Presence Emotional support Facilitating visits</description>
    <arm_group_label>Patients COVID-19</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Residents in the CCSPT reference area&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 18 who were admitted with a diagnosis of COVID-19 to any&#xD;
             CCSPT unit between March 13, 2020 and April 30, 2020 and were discharged with a&#xD;
             recovery result&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Communication problems or inability to read and speak Spanish&#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>Montserrat Montaña, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporación Parc Taulí</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Montserrat Montaña, PhD</last_name>
    <phone>+34692617376</phone>
    <email>mmontana@tauli.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jordi Torralbas, MSc</last_name>
    <phone>+34937231010</phone>
    <email>jtorralbas@tauli.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CorporacionPT</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Montserrat Montaña, PhD</last_name>
      <phone>+34692617376</phone>
      <email>mmontana@tauli.cat</email>
    </contact>
    <contact_backup>
      <last_name>Jordi Torralbas, MSc</last_name>
      <phone>+34937231010</phone>
      <email>jtorralbas@tauli.cat</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Montserrat Montaña</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Research</investigator_title>
  </responsible_party>
  <keyword>Nursing care</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Loneliness</keyword>
  <keyword>Fear</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04481477
org study id: 2020664
nct id: NCT04481477
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to find out what care patients affected by anxiety, fear or
      loneliness have perceived and the perceived impact of this care. This knowledge will allow us
      to design measures aimed at improving nursing care of these aspects in the future.
This is a cross-sectional descriptive study to be carried out at the Consorci Corporació
      Sanitària Parc Taulí (CCSPT). The results of this study will provide information on the care
      received by patients admitted to COVID 19 affected by anxiety, fear or loneliness, the
      perceived impact of this care and will enable measures to be implemented to improve nursing
      care in the future. 450 patients, randomly selected from the Hospital de Sabadell database,
      will be included. In the sample, we will ensure that the proportion of women and men is in
      line with the distribution of the population to enable the incorporation of the gender
      perspective in the analyses. The quantitative variables will be described by means of their
      mean and standard deviation. Qualitative variables will be described in absolute and relative
      frequencies. In order to evaluate the suitability of the intervention to the needs of the
      patient, a table of concordance will be constructed between the actions proposed by the panel
      of experts and the actions carried out as referred by the patient. The kappa concordance
      index will be calculated and the degree of concordance will be classified according to the
      Landis and Koch scale. As regards the effectiveness of the intervention, the patients who
      were treated correctly and those who were not will be identified, and the percentage of
      positive impacts according to Csq-8 between the two groups will be compared by means of the
      Chi-square test.
observational model: Case-Only
time perspective: Cross-Sectional
measure: The adequacy of nursing care to the needs of the patient
time frame: 6 months after care
description: kappa concordance rate between care provided and care needed
measure: Intervention effectiveness
time frame: 6 months after care
description: comparison of the percentage of positive impacts according to Csq-8 between the two groups using the Chi-square test
arm group label: Patients COVID-19
description: Patients over the age of 18 who were admitted with a diagnosis of COVID-19 to any CCSPT unit between March 13, 2020 and April 30, 2020 and were discharged with a recovery result
intervention type: Other
intervention name: Nursing care to reduce anxiety, fear and loneliness
description: Decreased anxiety Presence Emotional support Improved security Increasing coping capacity Presence Emotional support Facilitating visits
arm group label: Patients COVID-19
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Montserrat Montaña, PhD
role: Principal Investigator
affiliation: Corporación Parc Taulí
last name: Montserrat Montaña, PhD
phone: +34692617376
email: mmontana@tauli.cat
last name: Jordi Torralbas, MSc
phone: +34937231010
email: jtorralbas@tauli.cat
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Montserrat Montaña
investigator title: Principal Investigator, Clinical Research
mesh term: COVID-19