<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/NCT04402307</url>
  </required_header>
  <id_info>
    <org_study_id>RHN_DMK_05</org_study_id>
    <nct_id>NCT04402307</nct_id>
  </id_info>
  <brief_title>Effect of Training of Patients With Dysphagia</brief_title>
  <official_title>Effect of Training of Patients With Dysphagia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vendsyssel Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vendsyssel 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>
      Effect of training of patients with dysphagia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomised controlled study in the effect of training in patients with dysphagia.&#xD;
&#xD;
      The patients are randomised for training or for usual care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Readmission</measure>
    <time_frame>6 months</time_frame>
    <description>Number of readmissions within 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>Level of quality of life - measured with Dysphagia Handicap Index questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness</measure>
    <time_frame>6 months</time_frame>
    <description>Economic evaluation of training compared to usual care, measured with EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>6 months</time_frame>
    <description>Mortality in patients with dysphagia within 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swallowing function</measure>
    <time_frame>3 months</time_frame>
    <description>Aspiration (yes/no) - measured with Volume Viscosity Swallow Test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Dysphagia</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care to patients with dysphagia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chin Tuck Against Resistance to patients with dysphagia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chin Tuck Against Resistance</intervention_name>
    <description>Training in 6 weeks 3 times a day.</description>
    <arm_group_label>Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with dysphaigia&#xD;
&#xD;
          -  Patients living in the participating locations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are linguistically or cognitively unable to participate&#xD;
&#xD;
          -  Patients who are unable to collaborate about the training&#xD;
&#xD;
          -  Palliative patients&#xD;
&#xD;
          -  Patients with a probe&#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>Dorte M Kristiansen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Denmark Regional Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jammerbugt municipality</name>
      <address>
        <city>Brovst</city>
        <zip>9460</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brøndby municipality</name>
      <address>
        <city>Brøndby</city>
        <zip>2605</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frederikshavn municipality</name>
      <address>
        <city>Frederikshavn</city>
        <zip>9900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hjørring municipality</name>
      <address>
        <city>Hjørring</city>
        <zip>9800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kolding municipality</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense municipality</name>
      <address>
        <city>Odense</city>
        <zip>5100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slagelse municipality</name>
      <address>
        <city>Slagelse</city>
        <zip>4200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tønder municipality</name>
      <address>
        <city>Tønder</city>
        <zip>6270</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>April 1, 2019</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vendsyssel Hospital</investigator_affiliation>
    <investigator_full_name>Dorte Melgaard Kristiansen</investigator_full_name>
    <investigator_title>Seniorresearcher, research coordinator, ph.d.</investigator_title>
  </responsible_party>
  <keyword>Training</keyword>
  <keyword>Effect</keyword>
  <keyword>Elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</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/NCT04402307
org study id: RHN_DMK_05
nct id: NCT04402307
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Effect of training of patients with dysphagia
A randomised controlled study in the effect of training in patients with dysphagia.

      The patients are randomised for training or for usual care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Readmission
time frame: 6 months
description: Number of readmissions within 6 months
measure: Change in Quality of life
time frame: 3 months
description: Level of quality of life - measured with Dysphagia Handicap Index questionnaire
measure: Cost effectiveness
time frame: 6 months
description: Economic evaluation of training compared to usual care, measured with EQ-5D
measure: Mortality
time frame: 6 months
description: Mortality in patients with dysphagia within 6 months
measure: Swallowing function
time frame: 3 months
description: Aspiration (yes/no) - measured with Volume Viscosity Swallow Test
arm group label: Usual care
arm group type: No Intervention
description: Usual care to patients with dysphagia
arm group label: Training
arm group type: Experimental
description: Chin Tuck Against Resistance to patients with dysphagia
intervention type: Other
intervention name: Chin Tuck Against Resistance
description: Training in 6 weeks 3 times a day.
arm group label: Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dorte M Kristiansen, PhD
role: Principal Investigator
affiliation: North Denmark Regional Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Vendsyssel Hospital
investigator full name: Dorte Melgaard Kristiansen
investigator title: Seniorresearcher, research coordinator, ph.d.
mesh term: Deglutition Disorders