<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/NCT02990520</url>
  </required_header>
  <id_info>
    <org_study_id>14-0527</org_study_id>
    <nct_id>NCT02990520</nct_id>
  </id_info>
  <brief_title>Prevalence of Malnutrition and/or Sarcopenia at Hospital Admission</brief_title>
  <acronym>MASS</acronym>
  <official_title>Prevalence of Malnutrition and/or Sarcopenia at Hospital Admission</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at&#xD;
      admission to the hospital in older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary outcome of this study is to determine the prevalence of malnutrition and/or&#xD;
      sarcopenia at admission to the hospital in older adults. The secondary outcome is to assess&#xD;
      the relationship between malnutrition/sarcopenia status and length of stay, comorbidity load,&#xD;
      polypharmacy, and 30-day readmission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2024</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>Prevalence of Malnutrition</measure>
    <time_frame>baseline</time_frame>
    <description>malnutrition measured with questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of sarcopenia</measure>
    <time_frame>baseline</time_frame>
    <description>Sarcopenia defined using the EWGSOP or IWGS or FNIH criteria</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Malnutrition</condition>
  <condition>Sarcopenia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized older adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to the UTMB ACE unit&#xD;
&#xD;
          -  Aged 65 years or older&#xD;
&#xD;
          -  Able to consent to participate in study (alert and oriented x3)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Because this study aims to determine prevalence of malnutrition and/or sarcopenia at&#xD;
             admission to the hospital, patients will be excluded if study measures are not able to&#xD;
             be taken within 72 hours of admission.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Volpi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTMB</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erin Hommel, MD</last_name>
    <email>erhommel@utmb.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>UTMB Hospitals</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Hommel, MD</last_name>
      <email>erhommel@utmb.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 3, 2015</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</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>Sarcopenia</mesh_term>
    <mesh_term>Malnutrition</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/NCT02990520
org study id: 14-0527
nct id: NCT02990520
lead sponsor: 
has dmc: No
The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at
      admission to the hospital in older adults.
The primary outcome of this study is to determine the prevalence of malnutrition and/or
      sarcopenia at admission to the hospital in older adults. The secondary outcome is to assess
      the relationship between malnutrition/sarcopenia status and length of stay, comorbidity load,
      polypharmacy, and 30-day readmission.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of Malnutrition
time frame: baseline
description: malnutrition measured with questionnaires
measure: Prevalence of sarcopenia
time frame: baseline
description: Sarcopenia defined using the EWGSOP or IWGS or FNIH criteria
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Volpi, MD, PhD
role: Principal Investigator
affiliation: UTMB
last name: Erin Hommel, MD
email: erhommel@utmb.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Sarcopenia
mesh term: Malnutrition
sharing ipd: No