<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/NCT03806647</url>
  </required_header>
  <id_info>
    <org_study_id>2018-09-001A-1</org_study_id>
    <nct_id>NCT03806647</nct_id>
  </id_info>
  <brief_title>Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 1)</brief_title>
  <official_title>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 explore the needs of clinical patients and their caregiver,so as to&#xD;
      provide suggestions to the designer of the communication system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To promote and develop a smart communication system is helpful to patients with amyotrophic&#xD;
      lateral sclerosis (ALS),especially for stage 3 and stage 4 (late stage). Through the needs&#xD;
      assessment, the research is aimed to explore the needs of clinical patients and their&#xD;
      caregiver,so as to provide suggestions to the designer of the communication system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 1, 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>Amyotrophic Lateral Sclerosis Supportive Care Needs (ALSSCN)</measure>
    <time_frame>2018.10.01~2020.04.31</time_frame>
    <description>The ALSSCN consisted of 37 items with seven domains: physical, psychological, emotional, spiritual, social, informational, and practical needs.</description>
  </primary_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;
          -  Clinical diagnosis of ALS&#xD;
&#xD;
          -  Taiwanese and used traditional Chinese(Mandarin).&#xD;
&#xD;
          -  If they were older than age 20 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Frontotemporal dementia, severe depression, or schizophrenia.&#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>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</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 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 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/NCT03806647
org study id: 2018-09-001A-1
nct id: NCT03806647
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research is aimed to explore the needs of clinical patients and their caregiver,so as to
      provide suggestions to the designer of the communication system.
To promote and develop a smart communication system is helpful to patients with amyotrophic
      lateral sclerosis (ALS),especially for stage 3 and stage 4 (late stage). Through the needs
      assessment, the research is aimed to explore the needs of clinical patients and their
      caregiver,so as to provide suggestions to the designer of the communication system.
observational model: Cohort
time perspective: Retrospective
measure: Amyotrophic Lateral Sclerosis Supportive Care Needs (ALSSCN)
time frame: 2018.10.01~2020.04.31
description: The ALSSCN consisted of 37 items with seven domains: physical, psychological, emotional, spiritual, social, informational, and practical needs.
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: 
status: Recruiting
country: Taiwan
responsible party type: Sponsor
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided