<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/NCT03820791</url>
  </required_header>
  <id_info>
    <org_study_id>DYSPHAGIA</org_study_id>
    <nct_id>NCT03820791</nct_id>
  </id_info>
  <brief_title>Poster on Dysphagia-specific Food Procedures: Usability and Impact</brief_title>
  <acronym>DYSPHAGIA</acronym>
  <official_title>Using a Visual Poster Communicating Dysphagia-specific Food Procedures as a Complementary Means of Information to Caregivers in Inpatient Care: Usability and Impact</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Porto</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>
      The aim of this study is to evaluate the use of a poster containing information on&#xD;
      dysphagia-specific food procedures at two levels: utility from the point of view of patients'&#xD;
      caregivers, and impact on patients' health. Half the patients will have the poster placed in&#xD;
      their room, whereas the other half will not.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dysphagia is a swallowing disorder that can be associated with clinically relevant&#xD;
      complications, and caregivers can play a fundamental role in this process, namely because&#xD;
      they feed the patient. However, studies show a lack of professional-caregiver communication&#xD;
      in dysphagia, and caregivers' need for more information. Communicating dysphagia-specific&#xD;
      food procedures through a visual poster might bridge professional-caregiver communication&#xD;
      gaps, with consequences for the patient's health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patients' aspiration risk before and after placement of the poster in their rooms</measure>
    <time_frame>1 month</time_frame>
    <description>Change in patients' risk of aspiration in dysphagia (with the Gugging Swallowing Screen - GUSS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patients' capacity for oral intake before and after placement of the poster in their rooms</measure>
    <time_frame>1 month</time_frame>
    <description>Change in patients' oral intake capacity in dysphagia (with the Functional Oral Intake Scale - FOIS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patients' oral health before and after placement of the poster in their rooms</measure>
    <time_frame>1 month</time_frame>
    <description>Change in patients' oral health in dysphagia (with the Oral Health Assessment Tool - OHAT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patients' nutritional health before and after placement of the poster in their rooms</measure>
    <time_frame>1 month</time_frame>
    <description>Change in patients' nutritional status in dysphagia (with the Mini Nutritional Assessment - MNA)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dysphagia</condition>
  <arm_group>
    <arm_group_label>Poster</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A poster with pictorial information about dysphagia-specific food procedures placed in patients' rooms for one month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No poster</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No poster is placed in patients' room.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placement of a poster in patients' rooms</intervention_name>
    <description>Patients and their caregivers will be exposed to the poster for one month</description>
    <arm_group_label>Poster</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with post-acute dysphagia (lesion occurring at least six weeks prior,&#xD;
             approximately),&#xD;
&#xD;
          -  remaining in inpatient care for at least one month after the first moment of data&#xD;
             collection,&#xD;
&#xD;
          -  18 years of age or older,&#xD;
&#xD;
          -  receiving regular visits from their family members or caregivers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failing to meet inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene P Carvalho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade do Porto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Irene P Carvalho, PhD</last_name>
    <phone>225513622</phone>
    <email>irenec@med.up.pt</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>António Soares, PhD</last_name>
    <phone>225513622</phone>
    <email>ajasoares@med.up.pt</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CINTESIS - Faculty of Medicine of the University of Porto</name>
      <address>
        <city>Porto</city>
        <zip>4200-450</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</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>Deglutition 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/NCT03820791
org study id: DYSPHAGIA
nct id: NCT03820791
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the use of a poster containing information on
      dysphagia-specific food procedures at two levels: utility from the point of view of patients'
      caregivers, and impact on patients' health. Half the patients will have the poster placed in
      their room, whereas the other half will not.
Dysphagia is a swallowing disorder that can be associated with clinically relevant
      complications, and caregivers can play a fundamental role in this process, namely because
      they feed the patient. However, studies show a lack of professional-caregiver communication
      in dysphagia, and caregivers' need for more information. Communicating dysphagia-specific
      food procedures through a visual poster might bridge professional-caregiver communication
      gaps, with consequences for the patient's health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change in patients' aspiration risk before and after placement of the poster in their rooms
time frame: 1 month
description: Change in patients' risk of aspiration in dysphagia (with the Gugging Swallowing Screen - GUSS)
measure: Change in patients' capacity for oral intake before and after placement of the poster in their rooms
time frame: 1 month
description: Change in patients' oral intake capacity in dysphagia (with the Functional Oral Intake Scale - FOIS)
measure: Change in patients' oral health before and after placement of the poster in their rooms
time frame: 1 month
description: Change in patients' oral health in dysphagia (with the Oral Health Assessment Tool - OHAT)
measure: Change in patients' nutritional health before and after placement of the poster in their rooms
time frame: 1 month
description: Change in patients' nutritional status in dysphagia (with the Mini Nutritional Assessment - MNA)
arm group label: Poster
arm group type: Experimental
description: A poster with pictorial information about dysphagia-specific food procedures placed in patients' rooms for one month
arm group label: No poster
arm group type: No Intervention
description: No poster is placed in patients' room.
intervention type: Device
intervention name: Placement of a poster in patients' rooms
description: Patients and their caregivers will be exposed to the poster for one month
arm group label: Poster
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Irene P Carvalho, PhD
role: Principal Investigator
affiliation: Universidade do Porto
last name: Irene P Carvalho, PhD
phone: 225513622
email: irenec@med.up.pt
last name: António Soares, PhD
phone: 225513622
email: ajasoares@med.up.pt
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Deglutition Disorders
sharing ipd: No