<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/NCT03762941</url>
  </required_header>
  <id_info>
    <org_study_id>SHS-ED-06-2018</org_study_id>
    <nct_id>NCT03762941</nct_id>
  </id_info>
  <brief_title>Quality of Life Among Acute Admitted Elderly</brief_title>
  <official_title>Is There a Difference in the Definition and Rating of Quality of Life Among Acute Admitted Elderly i) With and ii) Without Homecare Background: A Cross Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern Denmark</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>
      Elderly dependent on homecare, admitted acutely, are fragile. The aim of this study is to&#xD;
      investigate the difference in the definition and rating of Quality of Life (QoL) among acute&#xD;
      admitted elderly i) with and ii) without homecare background.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed as a cross sectional study and will be conducted at three Emergency&#xD;
      Departments (ED) within the Region of Southern Denmark; Hospital of Southern Jutland,&#xD;
      Hospital of Southwest Jutland and Hospital Lillebaelt. The study method is based on a QoL&#xD;
      questionnaire preformed as a structured interview with elderly who are acutely admitted in an&#xD;
      ED.&#xD;
&#xD;
      Elderly persons who meet the inclusion criteria will be invited to participate during their&#xD;
      admission. Written information about this study will be handed from the nurse in the ED. If&#xD;
      the elderly accept she/he will get further oral information from the researcher. Written&#xD;
      consent will be obtained if the elderly wish to participate.&#xD;
&#xD;
      Including patients from three different EDs will presumably provide a broad selection, with&#xD;
      elderly persons who live both in the city and in rural areas and thereby representing a&#xD;
      general sample of the Danish population.There may be a variation in cause of hospitalization&#xD;
      related to seasonal changes. To present a broad selection, the inclusion period will involve&#xD;
      summer, fall, and winter. Inclusion and all structured interviews will be performed during&#xD;
      admission by two persons: the responsible researcher and a research assistant.&#xD;
&#xD;
      Primary Outcome:&#xD;
&#xD;
      The primary outcome QoL will be accessed and evaluated by the Schedule for the Evaluation of&#xD;
      Individual Quality of Life - direct weighting (SEIQoL-DW).&#xD;
&#xD;
      Exposure:&#xD;
&#xD;
      Homecare: Receiving &quot;personal&quot; homecare for more than 2 hours per week. Furthermore numbers&#xD;
      of hours of homecare a week will be registered for each participant to see if there is any&#xD;
      difference in QoL connected to number of hours.&#xD;
&#xD;
      Readmission: Readmissions 30 days after discharge from the primary index admission (yes/no).&#xD;
      Readmission is defined as; an unscheduled hospitalization for any reason and where the&#xD;
      patient has stayed at the hospital overnight within 30 days after discharge from the index&#xD;
      admission.&#xD;
&#xD;
      The outcomes and variables will be collected through;&#xD;
&#xD;
      At a structured interview during hospitalization; The Ph.D student and the research assistant&#xD;
      are responsible for conducting the interviews. The patients will at the interview be asked&#xD;
      about; Aspect and index score of QoL, cognitive functioning (OMC score), marital status,&#xD;
      length of education and social support.&#xD;
&#xD;
      In the patients' records during hospitalization; The Ph.D student is responsibility for&#xD;
      collecting following information in the patients' record; Last admission, hours of homecare,&#xD;
      use of home nursing, primary reason for hospitalization and comorbidities. Patients will be&#xD;
      asked specific for permission to access journal data. Variables from the patients' record&#xD;
      will be extracted after the informed consent for participation is obtained. The information&#xD;
      from the journal will be handled from health professionals in the ED.&#xD;
&#xD;
      In the patients' record 30 days after discharge; Variables after 30 days will be counted from&#xD;
      the discharge form the index admission. The Ph.D student is responsibility for collecting the&#xD;
      information in the patient record about readmission and length of hospital stay under the&#xD;
      same terms as described above.&#xD;
&#xD;
      Instrument&#xD;
&#xD;
      The primary outcome QoL are accessed and evaluated by SEIQoL-DW which are assessed in a&#xD;
      structured interview. First the interviewer elicits five areas of life considered most&#xD;
      important by the participant. Secondly, the participant rates the level each of these areas&#xD;
      from worst possible to best possible on a visual analogue scale (SEIQoL - VAS) and thirdly&#xD;
      the participant is asked for the relative importance of each area by a direct weighting (DW)&#xD;
      procedure. The DW procedure uses a pie chart consisting of five coloured segments. Each&#xD;
      colour represents an area chosen by the respondent. The areas can be adjusted in size to&#xD;
      reflect the relative importance of each area (greatest importance is the largest pie area).&#xD;
      The total value of all five segments equals 100. To calculate the participants QoL at the&#xD;
      moment, each area will be divided by 100. By multiplying the level of the area by the weight&#xD;
      for each area and adding up the values for each area, a SEIQoL-DW index score will be&#xD;
      calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Individual Quality of life accessed and evaluated by a structured interview</measure>
    <time_frame>d) QoL are measured during admission(expected inclusions period: 1 year). Data are reported ½ year after the end of inclusion.</time_frame>
    <description>The primary outcome is QoL measured as an index score (range from 0 [lowest QoL] to 100 [highest QoL]).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">406</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Elderly patients acutely admitted</arm_group_label>
    <description>Elderly patients (aged ≥ 65 year) admitted to emergency departments at the Hospital of Southern Jutland or Odense University</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly persons who meet the inclusion criteria will be invited to participate during their&#xD;
        admission.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients (aged ≥ 65 year) admitted to EDs at the Hospital of Southern Jutland,&#xD;
             Hospital of Southwest Jutland or Hospital Lillebaelt&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give informed consent to participate&#xD;
&#xD;
          -  Patients known or believed to be cognitively impaired as assessed by the OMC test&#xD;
             (score &gt; 18 point).&#xD;
&#xD;
          -  Patients who only receive outpatient treatment in the ED will be excluded&#xD;
&#xD;
          -  Patients with an inadequate understanding of written and spoken Danish (assessed by&#xD;
             the health professionals at the ED).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mette Elkjær</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of Southern Jutland</name>
      <address>
        <city>Aabenraa</city>
        <state>The Region Of Southern Denmark</state>
        <zip>6200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elderly patients</keyword>
  <keyword>Emergency Department</keyword>
  <keyword>Homecare</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/NCT03762941
org study id: SHS-ED-06-2018
nct id: NCT03762941
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Elderly dependent on homecare, admitted acutely, are fragile. The aim of this study is to
      investigate the difference in the definition and rating of Quality of Life (QoL) among acute
      admitted elderly i) with and ii) without homecare background.
The study is designed as a cross sectional study and will be conducted at three Emergency
      Departments (ED) within the Region of Southern Denmark; Hospital of Southern Jutland,
      Hospital of Southwest Jutland and Hospital Lillebaelt. The study method is based on a QoL
      questionnaire preformed as a structured interview with elderly who are acutely admitted in an
      ED.

      Elderly persons who meet the inclusion criteria will be invited to participate during their
      admission. Written information about this study will be handed from the nurse in the ED. If
      the elderly accept she/he will get further oral information from the researcher. Written
      consent will be obtained if the elderly wish to participate.

      Including patients from three different EDs will presumably provide a broad selection, with
      elderly persons who live both in the city and in rural areas and thereby representing a
      general sample of the Danish population.There may be a variation in cause of hospitalization
      related to seasonal changes. To present a broad selection, the inclusion period will involve
      summer, fall, and winter. Inclusion and all structured interviews will be performed during
      admission by two persons: the responsible researcher and a research assistant.

      Primary Outcome:

      The primary outcome QoL will be accessed and evaluated by the Schedule for the Evaluation of
      Individual Quality of Life - direct weighting (SEIQoL-DW).

      Exposure:

      Homecare: Receiving "personal" homecare for more than 2 hours per week. Furthermore numbers
      of hours of homecare a week will be registered for each participant to see if there is any
      difference in QoL connected to number of hours.

      Readmission: Readmissions 30 days after discharge from the primary index admission (yes/no).
      Readmission is defined as; an unscheduled hospitalization for any reason and where the
      patient has stayed at the hospital overnight within 30 days after discharge from the index
      admission.

      The outcomes and variables will be collected through;

      At a structured interview during hospitalization; The Ph.D student and the research assistant
      are responsible for conducting the interviews. The patients will at the interview be asked
      about; Aspect and index score of QoL, cognitive functioning (OMC score), marital status,
      length of education and social support.

      In the patients' records during hospitalization; The Ph.D student is responsibility for
      collecting following information in the patients' record; Last admission, hours of homecare,
      use of home nursing, primary reason for hospitalization and comorbidities. Patients will be
      asked specific for permission to access journal data. Variables from the patients' record
      will be extracted after the informed consent for participation is obtained. The information
      from the journal will be handled from health professionals in the ED.

      In the patients' record 30 days after discharge; Variables after 30 days will be counted from
      the discharge form the index admission. The Ph.D student is responsibility for collecting the
      information in the patient record about readmission and length of hospital stay under the
      same terms as described above.

      Instrument

      The primary outcome QoL are accessed and evaluated by SEIQoL-DW which are assessed in a
      structured interview. First the interviewer elicits five areas of life considered most
      important by the participant. Secondly, the participant rates the level each of these areas
      from worst possible to best possible on a visual analogue scale (SEIQoL - VAS) and thirdly
      the participant is asked for the relative importance of each area by a direct weighting (DW)
      procedure. The DW procedure uses a pie chart consisting of five coloured segments. Each
      colour represents an area chosen by the respondent. The areas can be adjusted in size to
      reflect the relative importance of each area (greatest importance is the largest pie area).
      The total value of all five segments equals 100. To calculate the participants QoL at the
      moment, each area will be divided by 100. By multiplying the level of the area by the weight
      for each area and adding up the values for each area, a SEIQoL-DW index score will be
      calculated.
observational model: Cohort
time perspective: Prospective
measure: Individual Quality of life accessed and evaluated by a structured interview
time frame: d) QoL are measured during admission(expected inclusions period: 1 year). Data are reported ½ year after the end of inclusion.
description: The primary outcome is QoL measured as an index score (range from 0 [lowest QoL] to 100 [highest QoL]).
arm group label: Elderly patients acutely admitted
description: Elderly patients (aged ≥ 65 year) admitted to emergency departments at the Hospital of Southern Jutland or Odense University
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
last name: Mette Elkjær
role: Principal Investigator
affiliation: University of Southern Denmark
facility: 
country: Denmark
responsible party type: Sponsor
sharing ipd: No