<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/NCT03806634</url>
  </required_header>
  <id_info>
    <org_study_id>2018-09-001A-2</org_study_id>
    <nct_id>NCT03806634</nct_id>
  </id_info>
  <brief_title>Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 2)</brief_title>
  <official_title>Department of Physical Medicine &amp; Rehabilitation, Taipei Veterans General Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</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 research is aimed to asses the validity of the communication system improving the quality&#xD;
      of life and the degree of sanctification of clinical patients and their caregiver.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>2019.04.01~2019.06.30</time_frame>
    <description>It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. And also we can know the sanctification of the patient with ALS and their caregiver.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, ALSSQOL-R</measure>
    <time_frame>2019.04.01~2019.06.30</time_frame>
    <description>ALSSQOL-R is a 50 item instrument that measures overall quality of life (QOL) and six specific domains for individuals with ALS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taiwanese Depression Questionnaire, TDQ</measure>
    <time_frame>2019.04.01~2019.06.30</time_frame>
    <description>The TDQ is a culturally relevant questionnaire, which is adaptable for screening depressive people in the local communities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden Scale</measure>
    <time_frame>2019.04.01~2019.06.30</time_frame>
    <description>The burden experienced by family caregivers is the most important caregiver-related variable in care at home of a chronically-ill person. The extent of subjective burden has significant impact on the emotional and physical health of the family caregiver, and even influences the mortality of spouse caregivers. It affects the way the family caregiver deals with the care-receiver and determines the time of institutionalization.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Amyotrophic Lateral Sclerosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with ALS were recruited from ALS clinics(Taipei Veterans General Hospital,&#xD;
        Taiwan, R.O.C),20 participants. Participants were eligible for this study if they were&#xD;
        diagnosed with definite, probable, probable laboratory-supported, or possible ALS according&#xD;
        to the criteria (Brooks et al., 2000).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Escorial revised criteria (Brooks et al., 2000),The diagnosis of ALS requires:&#xD;
&#xD;
        (A) the presence of:&#xD;
&#xD;
          -  (A:1) evidence of lower motor neuron (LMN) degeneration by clinical,&#xD;
             electrophysiological or neuropathologic examination (A:2) evidence of upper motor&#xD;
             neuron (UMN) degeneration by clinical examination, and&#xD;
&#xD;
          -  (A:3) progressive spread of symptoms or signs within a region or to other regions, as&#xD;
             determined by history or examination, together with: (B) the absence of (B:1)&#xD;
             electrophysiological or pathological evidence of other disease processes that might&#xD;
             explain the signs of LMN and/or UMN degeneration, and (B:2) neuroimaging evidence of&#xD;
             other disease processes that might explain the observed clinical and&#xD;
             electrophysiological signs.&#xD;
&#xD;
               -  If they were Taiwanese and used traditional Chinese(Mandarin).&#xD;
&#xD;
               -  If they were older than age 20 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If they had been diagnosed with frontotemporal dementia, severe depression, or&#xD;
             schizophrenia.&#xD;
&#xD;
          -  If they cannot see the communication board after correction.&#xD;
&#xD;
          -  If they cannot complete the questionnaire with researchers or family members help.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Si Huei Li</last_name>
    <phone>886-2871-2121</phone>
    <phone_ext>2931</phone_ext>
    <email>lableesihuei@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cheng Liang Chou</last_name>
    <phone>886-2871-2121</phone>
    <phone_ext>7361</phone_ext>
    <email>cl_chou@vghtpe.gov.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <state>TW</state>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Amyotrophic lateral sclerosis, ALS, communication, needs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03806634
org study id: 2018-09-001A-2
nct id: NCT03806634
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research is aimed to asses the validity of the communication system improving the quality
      of life and the degree of sanctification of clinical patients and their caregiver.
observational model: Cohort
time perspective: Retrospective
measure: System Usability Scale
time frame: 2019.04.01~2019.06.30
description: It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. And also we can know the sanctification of the patient with ALS and their caregiver.
measure: Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, ALSSQOL-R
time frame: 2019.04.01~2019.06.30
description: ALSSQOL-R is a 50 item instrument that measures overall quality of life (QOL) and six specific domains for individuals with ALS.
measure: Taiwanese Depression Questionnaire, TDQ
time frame: 2019.04.01~2019.06.30
description: The TDQ is a culturally relevant questionnaire, which is adaptable for screening depressive people in the local communities.
measure: Caregiver Burden Scale
time frame: 2019.04.01~2019.06.30
description: The burden experienced by family caregivers is the most important caregiver-related variable in care at home of a chronically-ill person. The extent of subjective burden has significant impact on the emotional and physical health of the family caregiver, and even influences the mortality of spouse caregivers. It affects the way the family caregiver deals with the care-receiver and determines the time of institutionalization.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Si Huei Li
phone: 886-2871-2121
phone ext: 2931
email: lableesihuei@gmail.com
last name: Cheng Liang Chou
phone: 886-2871-2121
phone ext: 7361
email: cl_chou@vghtpe.gov.tw
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided