<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/NCT03252054</url>
  </required_header>
  <id_info>
    <org_study_id>Ger1-16</org_study_id>
    <nct_id>NCT03252054</nct_id>
  </id_info>
  <brief_title>Memory and Attention Disorders and Malnutrition in Hospital Setting</brief_title>
  <official_title>Prevalence of Memory and Attention Disorders and Malnutrition in Hospitalized Older Adults (Muistitoimintojen ja Tarkkaavaisuuden häiriöiden ja Vajaaravitsemuksen Yleisyys iäkkäillä Sairaalahoidossa Olevilla Potilailla [Finnish])</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coxa, Hospital for Joint Replacement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tampere University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tampere University Hospital</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>
      This is a cross-sectional observational study that investigates the prevalence of memory&#xD;
      disorders, attention disorders (suggesting delirium), and malnutrition in hospitalized older&#xD;
      adults (aged 70 years or over) in a tertiary care centre, using rapid screening toos&#xD;
      (Six-item screener for memory disorders, Months of the Year Backwards Test for delirium, and&#xD;
      NRS-2002 and Mini Nutritional Assessment Short Form for malnutrition).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of memory disorders</measure>
    <time_frame>day of recruitment</time_frame>
    <description>Abnormal result in Six-Item Screener</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of attention disorders</measure>
    <time_frame>day of recruitment</time_frame>
    <description>Abnormal result in Months of the Year Backwards Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of malnutrition and risk of malnutrition</measure>
    <time_frame>day of recruitment</time_frame>
    <description>Abnormal result based on nutritional status screening tools</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">151</enrollment>
  <condition>Dementia</condition>
  <condition>Delirium</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Patients aged 70 or over</arm_group_label>
    <description>Patients eligible for the study will undergo screening for memory disorders, attention disorders, and malnutrition</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Screening for memory disorders, attention disorders, and malnutrition</intervention_name>
    <description>Screening for memory disorders, attention disorders, and malnutrition, using Six-Item Screener, Months of the Year Backwards Test, and NRS-2002 and MNA-SF, respectively.</description>
    <arm_group_label>Patients aged 70 or over</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients born in 1946 or earlier hospitalized in somatic wards.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized in Tampere University Hospital (excl. psyciatry, pediatrics, ICU)&#xD;
&#xD;
          -  Able to communicate in Finnish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to communicate because of unconciuousness, critical health status, or&#xD;
             communication difficulties&#xD;
&#xD;
          -  Having a (surgical) procedure at the time of data collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esa Jämsen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>consultant</affiliation>
  </overall_official>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>June 7, 2018</last_update_submitted>
  <last_update_submitted_qc>June 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Cognition Disorders</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/NCT03252054
org study id: Ger1-16
nct id: NCT03252054
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a cross-sectional observational study that investigates the prevalence of memory
      disorders, attention disorders (suggesting delirium), and malnutrition in hospitalized older
      adults (aged 70 years or over) in a tertiary care centre, using rapid screening toos
      (Six-item screener for memory disorders, Months of the Year Backwards Test for delirium, and
      NRS-2002 and Mini Nutritional Assessment Short Form for malnutrition).
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of memory disorders
time frame: day of recruitment
description: Abnormal result in Six-Item Screener
measure: Prevalence of attention disorders
time frame: day of recruitment
description: Abnormal result in Months of the Year Backwards Test
measure: Prevalence of malnutrition and risk of malnutrition
time frame: day of recruitment
description: Abnormal result based on nutritional status screening tools
arm group label: Patients aged 70 or over
description: Patients eligible for the study will undergo screening for memory disorders, attention disorders, and malnutrition
intervention type: Diagnostic Test
intervention name: Screening for memory disorders, attention disorders, and malnutrition
description: Screening for memory disorders, attention disorders, and malnutrition, using Six-Item Screener, Months of the Year Backwards Test, and NRS-2002 and MNA-SF, respectively.
arm group label: Patients aged 70 or over
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Esa Jämsen, MD, PhD
role: Study Director
affiliation: consultant
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Cognition Disorders
sharing ipd: No