<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/NCT03835455</url>
  </required_header>
  <id_info>
    <org_study_id>40715</org_study_id>
    <nct_id>NCT03835455</nct_id>
  </id_info>
  <brief_title>Acceptability and Feasibility of Finger Foods</brief_title>
  <official_title>A Mixed Methods Study to Determine the Acceptability and Feasibility of Providing Finger Foods as Nutritional Support for Patients After Stroke in Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southampton</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 study will investigate the feasibility of using a finger food menu on an acute stroke&#xD;
      rehabilitation ward. This study has a mixed methods design, with quantitative, qualitative&#xD;
      and economic components which will be used to inform a future randomised control trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Eligibility rate</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients eligible for study based on inclusion and exclusion criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients approached vs number of patients recruited to the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition rate</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants without fully completed outcome measures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary intake of participants over 3 mealtimes</measure>
    <time_frame>3 mealtimes</time_frame>
    <description>Estimation of dietary intake over 3 mealtimes. This will include a standard mealtime and 2 meals when the finger menu is offered. This will be measured as energy and protein intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs of implementing a finger food menu</measure>
    <time_frame>6 months</time_frame>
    <description>A cost consequence analysis will be used to describe direct and indirect costs associated with providing a finger food menu.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fidelity of intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Fidelity determined through observation field notes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient experience</measure>
    <time_frame>6 months</time_frame>
    <description>Semi-structured interviews with participants to determine patient experience</description>
  </other_outcome>
  <other_outcome>
    <measure>Staff experience</measure>
    <time_frame>6 months</time_frame>
    <description>Semi-structured interviews with staff to determine facilitators and barriers to using the menu on the ward</description>
  </other_outcome>
  <enrollment type="Actual">31</enrollment>
  <condition>Stroke, Acute</condition>
  <eligibility>
    <study_pop>
      <textblock>
        On stroke rehabilitation ward&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current patient on stroke rehabilitation ward&#xD;
&#xD;
          -  65 years or older&#xD;
&#xD;
          -  Normal textured food&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On the end of life pathway&#xD;
&#xD;
          -  Partial or full enteral feeding&#xD;
&#xD;
          -  Significant food allergies, intolerances or other dietary restrictions that could not&#xD;
             be catered for by the finger food menu.&#xD;
&#xD;
          -  Unable to give consent or no consultee able to consent on behalf of patient&#xD;
&#xD;
          -  In a side room on the ward&#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>Milly Heelan</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southampton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Southampton NHS trust</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>July 24, 2021</last_update_submitted>
  <last_update_submitted_qc>July 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Finger food</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03835455
org study id: 40715
nct id: NCT03835455
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will investigate the feasibility of using a finger food menu on an acute stroke
      rehabilitation ward. This study has a mixed methods design, with quantitative, qualitative
      and economic components which will be used to inform a future randomised control trial.
observational model: Other
time perspective: Prospective
measure: Eligibility rate
time frame: 6 months
description: Number of patients eligible for study based on inclusion and exclusion criteria
measure: Recruitment rate
time frame: 6 months
description: Number of patients approached vs number of patients recruited to the study
measure: Attrition rate
time frame: 6 months
description: Number of participants without fully completed outcome measures
measure: Dietary intake of participants over 3 mealtimes
time frame: 3 mealtimes
description: Estimation of dietary intake over 3 mealtimes. This will include a standard mealtime and 2 meals when the finger menu is offered. This will be measured as energy and protein intake.
measure: Costs of implementing a finger food menu
time frame: 6 months
description: A cost consequence analysis will be used to describe direct and indirect costs associated with providing a finger food menu.
measure: Fidelity of intervention
time frame: 6 months
description: Fidelity determined through observation field notes
measure: Patient experience
time frame: 6 months
description: Semi-structured interviews with participants to determine patient experience
measure: Staff experience
time frame: 6 months
description: Semi-structured interviews with staff to determine facilitators and barriers to using the menu on the ward
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Milly Heelan
role: Principal Investigator
affiliation: University of Southampton
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stroke