<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/NCT03269500</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2016/51</org_study_id>
    <nct_id>NCT03269500</nct_id>
  </id_info>
  <brief_title>Evaluation of the Applicability of Personalized Tools About Nutrition Education for Malnourished Older People</brief_title>
  <acronym>AlimAge</acronym>
  <official_title>Evaluation of the Applicability of Personalized Tools About Nutrition Education for Malnourished Older People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      Describe the frequency of use of nutrition education tools for undernourished older people&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The description of the population will identify the characteristics of patients who use the&#xD;
      tools and guide their use in patient care. To realize an impact assessment, It necessary to&#xD;
      identify specific criteria for inclusion. It is important initially to assess the use of the&#xD;
      nutritional tools. The assessment of performance (obstacles and understanding), will be used&#xD;
      to improve tools to optimize their use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">August 7, 2018</completion_date>
  <primary_completion_date type="Actual">August 7, 2018</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>Frequency of use of the booklet and platelets</measure>
    <time_frame>Day 14</time_frame>
    <description>number of use per week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the knowledge following the delivery of the tools</measure>
    <time_frame>Day 14</time_frame>
    <description>Number of response &quot;Yes&quot; for 24 items about the tools</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instrumental Activities of Daily Living</measure>
    <time_frame>Day 1</time_frame>
    <description>Score of Instrumental Activities of Daily Living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of quality of life scale</measure>
    <time_frame>Day 1</time_frame>
    <description>Score of EQ-5D</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Malnutrition of Mild Degree</condition>
  <arm_group>
    <arm_group_label>malnourished older people</arm_group_label>
    <description>The hospitalized elderly with swallowing and/or Mastication problems.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>use of nutrition education tools</intervention_name>
    <description>Use of different nutrition education tools :&#xD;
General advice: feeding seniors&#xD;
Oral supplementation: instructions for use&#xD;
Information about enriched food&#xD;
Food modified in texture: chopped masticatory disorders, chopped swallowing disorders, co-mingled&#xD;
How should I drink? : With stimulus, texture syrup / nectar, velvety texture, texture compote / cream&#xD;
Recipe booklets for people to easily eat (chewing disorders) or recipe with molded texture (swallowing disorders)</description>
    <arm_group_label>malnourished older people</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        malnourished elderly present on hospital day care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject of 75 years or more.&#xD;
&#xD;
          -  Hospitalized geriatric day hospital.&#xD;
&#xD;
          -  Living at home, within a radius of 40 km around the hospital Xavier Arnozan.&#xD;
&#xD;
          -  Subject or caregiver (s) read, understand and speak the french.&#xD;
&#xD;
          -  Undernutrition (criteria of the French high authority for health (HAS) 2007)&#xD;
&#xD;
          -  Agreed to participate in the study: compendium of the opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject not wishing to participate in the study,&#xD;
&#xD;
          -  MMSE (Mini Mental State Examination) &lt; 20, without presence of a caregiver with no&#xD;
             cognitive problems scoring.&#xD;
&#xD;
          -  Identified palliative care.&#xD;
&#xD;
          -  Presenting a contraindication to oral feeding.&#xD;
&#xD;
          -  Presence of supply of enteral or parenteral.&#xD;
&#xD;
          -  Presence with a diagnosis of severe psychiatric pathology.&#xD;
&#xD;
          -  Already participating in a study on undernutrition.&#xD;
&#xD;
          -  One against medical advice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ornella SARRY</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bordeaux University Hospital</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</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>
  </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/NCT03269500
org study id: CHUBX 2016/51
nct id: NCT03269500
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Describe the frequency of use of nutrition education tools for undernourished older people
The description of the population will identify the characteristics of patients who use the
      tools and guide their use in patient care. To realize an impact assessment, It necessary to
      identify specific criteria for inclusion. It is important initially to assess the use of the
      nutritional tools. The assessment of performance (obstacles and understanding), will be used
      to improve tools to optimize their use.
observational model: Cohort
time perspective: Prospective
measure: Frequency of use of the booklet and platelets
time frame: Day 14
description: number of use per week
measure: Evaluation of the knowledge following the delivery of the tools
time frame: Day 14
description: Number of response "Yes" for 24 items about the tools
measure: Instrumental Activities of Daily Living
time frame: Day 1
description: Score of Instrumental Activities of Daily Living
measure: Assessment of quality of life scale
time frame: Day 1
description: Score of EQ-5D
arm group label: malnourished older people
description: The hospitalized elderly with swallowing and/or Mastication problems.
intervention type: Other
intervention name: use of nutrition education tools
description: Use of different nutrition education tools :
General advice: feeding seniors
Oral supplementation: instructions for use
Information about enriched food
Food modified in texture: chopped masticatory disorders, chopped swallowing disorders, co-mingled
How should I drink? : With stimulus, texture syrup / nectar, velvety texture, texture compote / cream
Recipe booklets for people to easily eat (chewing disorders) or recipe with molded texture (swallowing disorders)
arm group label: malnourished older people
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Ornella SARRY
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No