<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/NCT03816098</url>
  </required_header>
  <id_info>
    <org_study_id>07-XD-080</org_study_id>
    <nct_id>NCT03816098</nct_id>
  </id_info>
  <brief_title>The Accuracy of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly</brief_title>
  <official_title>The Accuracy of Chinese Version of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</source>
  <oversight_info>
    <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 research was to examine the accuracy of translated Chinese version of&#xD;
      Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its&#xD;
      clinical manifestation in patients over 65 years old.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 11, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Swallowing Disturbance Questionnaire</measure>
    <time_frame>At the baseline</time_frame>
    <description>Chinese version of Swallowing Dysphagia Questionnaire consists of 15 questions regarding oral and pharyngeal stage of dysphagia. Subjects are asked to fill out the questionnaire concerning current state and during the past year using a 4-point scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Videofluroscopy Swallowing Study (VFSS)</measure>
    <time_frame>At the baseline</time_frame>
    <description>VFSS studies are conducted using 4 different consistencies: thin liquid, nectar-thick liquid, puree, and cookie. Subjects are asked to take 2 trials for each consistency to assess if any oral or pharyngeal dysphagia occurs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical water test</measure>
    <time_frame>At the baseline</time_frame>
    <description>Each subject takes 3 trials of 3cc-water using a dropper. Then sequential water drinking is assessed (about 60-70 ml). We assess: coughing, choking, voice changes. At least one symptom means dysphagia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination (MMSE)</measure>
    <time_frame>At the baseline</time_frame>
    <description>Mini-Mental State Examination was used to identify subjects' cognitive state.The following four cut-off levels should be employed to classify the severity of cognitive impairment: no cognitive impairment=24-30; mild cognitive impairment=19-23; moderate cognitive impairment=10-18; and severe cognitive impairment&lt;9.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Deglutition Disorders</condition>
  <arm_group>
    <arm_group_label>elderly patients with dysphagia</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>elderly patients without dysphagia</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        40 elderly inpatients age over 65 are included in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious&#xD;
             mental or cognitive conditions; no aphasia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or&#xD;
             cognitive conditions or aphasia (4) Allergy to barium sulfate suspension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</investigator_affiliation>
    <investigator_full_name>Hsiao-chan, Lai</investigator_full_name>
    <investigator_title>Speech-language therapist</investigator_title>
  </responsible_party>
  <keyword>elderly</keyword>
  <keyword>screening</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/NCT03816098
org study id: 07-XD-080
nct id: NCT03816098
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this research was to examine the accuracy of translated Chinese version of
      Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its
      clinical manifestation in patients over 65 years old.
observational model: Cohort
time perspective: Cross-Sectional
measure: Swallowing Disturbance Questionnaire
time frame: At the baseline
description: Chinese version of Swallowing Dysphagia Questionnaire consists of 15 questions regarding oral and pharyngeal stage of dysphagia. Subjects are asked to fill out the questionnaire concerning current state and during the past year using a 4-point scale.
measure: Videofluroscopy Swallowing Study (VFSS)
time frame: At the baseline
description: VFSS studies are conducted using 4 different consistencies: thin liquid, nectar-thick liquid, puree, and cookie. Subjects are asked to take 2 trials for each consistency to assess if any oral or pharyngeal dysphagia occurs.
measure: Clinical water test
time frame: At the baseline
description: Each subject takes 3 trials of 3cc-water using a dropper. Then sequential water drinking is assessed (about 60-70 ml). We assess: coughing, choking, voice changes. At least one symptom means dysphagia.
measure: Mini-Mental State Examination (MMSE)
time frame: At the baseline
description: Mini-Mental State Examination was used to identify subjects' cognitive state.The following four cut-off levels should be employed to classify the severity of cognitive impairment: no cognitive impairment=24-30; mild cognitive impairment=19-23; moderate cognitive impairment=10-18; and severe cognitive impairment<9.
arm group label: elderly patients with dysphagia
arm group label: elderly patients without dysphagia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
investigator full name: Hsiao-chan, Lai
investigator title: Speech-language therapist
mesh term: Deglutition Disorders