<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/NCT03829397</url>
  </required_header>
  <id_info>
    <org_study_id>TYGH107037</org_study_id>
    <nct_id>NCT03829397</nct_id>
  </id_info>
  <brief_title>To Investigate the Correlation of Stroke Patients and Demoralized</brief_title>
  <official_title>To Investigate the Correlation of Stroke Patients and Demoralized</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taoyuan General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taoyuan General Hospital</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>
      This study aim to clarify the participants's mental state with Demoralization Scale- Mandarin&#xD;
      Version(DS-MV). Based on clinical observations and literature review, investigators assume&#xD;
      participants's DS-MV score high correlation with PHQ-9 score.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Chinese version of Demoralization Scale-Mandarin Version (DS-MV) was used to assess the&#xD;
      mental state of patients with stroke after debridement. The statistical analysis test of&#xD;
      correlation is carried out, and the reliability and validity test and the norm establishment&#xD;
      of the Chinese version are further tested. Convenient sampling will be performed at a single&#xD;
      medical facility. The planned implementation period is 2019/01/01 ~ 2019/12/31, and the&#xD;
      location of the case is the rehabilitation ward and outpatient clinic of Taoyuan Hospital.&#xD;
      The diagnosis must be: intensive stroke or hemorrhagic brain within three years. In the case&#xD;
      of a 20- to 100-year-old clinical patient with stroke, the subject should explain the content&#xD;
      of the case, and the subject will complete the test consent form after informed consent, and&#xD;
      then begin the evaluation process of the self-assessment questionnaire. The assessment&#xD;
      procedure is preceded by a clinical psychologist conducting with MMSE test to determine the&#xD;
      cognitive function. When the patient's consciousness is blurred, the simple intelligent state&#xD;
      test (MMSE) score less than 24 points, aphasia can not be effectively communicated, the&#xD;
      diagnosis of mental illness or mental disorder has been recorded on the medical record, or&#xD;
      the patient or family member is unwilling to sign the informed consent form. If the above&#xD;
      situation is met, subjects will be excluded. The self-assessment questionnaire will obtain&#xD;
      the scores of the subjects in the Chinese version of the Demoralization Scale-Mandarin&#xD;
      Version (DS-MV) and the Patient Health Questionnaire (PHQ-9). Statistical analysis, as well&#xD;
      as the Chinese version of the loss of the scale of the reliability and validity of the test&#xD;
      and the establishment of clinical norm scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">March 24, 2020</completion_date>
  <primary_completion_date type="Actual">March 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>demoralization Scale-Mandarin Version (DS-MV) total score</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>When participants was included, investigators get on one-time assessment use the demoralization Scale-Mandarin Version (DS-MV). The demoralization Scale-Mandarin Version (DS-MV) minimum score are 0, and maximum score are 96, cut-off point are 30. No subscale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>demoralization Scale-Mandarin Version (DS-MV) total score split-half reliability</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Divide the demoralization Scale-Mandarin Version (DS-MV) into half, and then test the items of the previous half (item 1-12) and the second half (item 13-24) of the questionnaire. Then the two half questionnaire scores were test of correlation coefficient.Then If the degree of correlation is high, the reliability is very high.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9) total score</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>When participants was included, investigators get on one-time assessment use the Patient Health Questionnaire (PHQ-9) .Patient Health Questionnaire (PHQ-9) minimum score are 0, and maximum score are 27. No subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>demoralization Scale-Mandarin Version (DS-MV) total score criterion-related validity</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Correlation test between demoralization Scale-Mandarin Version (DS-MV) total score and Patient Health Questionnaire(PHQ-9) total score.</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Post-stroke Depression</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Questionnaire</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        infarct stroke or hemorrhagic stroke within three years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatient and outpatient of rehabilitation department in Taoyuan General Hospital,&#xD;
             patients diagnosis : who have an infarct stroke or hemorrhagic stroke within three&#xD;
             years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conscious state confusion, the MMSE score less than 24.&#xD;
&#xD;
          -  Unable to understand information, speech disorders, dementia, aphasia.&#xD;
&#xD;
          -  The diagnosis of mental illness or mental disorder has been recorded on the medical&#xD;
             history.&#xD;
&#xD;
          -  The patient or family unwilling to sign an informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tao-Yuan General Hospital</name>
      <address>
        <city>Taoyuan City</city>
        <state>Zhongshan Rd., Taoyuan Dist</state>
        <zip>No. 1492</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Nanni MG, Caruso R, Travado L, Ventura C, Palma A, Berardi AM, Meggiolaro E, Ruffilli F, Martins C, Kissane D, Grassi L. Relationship of demoralization with anxiety, depression, and quality of life: A Southern European study of Italian and Portuguese cancer patients. Psychooncology. 2018 Nov;27(11):2616-2622. doi: 10.1002/pon.4824. Epub 2018 Aug 6.</citation>
    <PMID>29943491</PMID>
  </reference>
  <reference>
    <citation>Tang PL, Wang HH, Chou FH. A Systematic Review and Meta-Analysis of Demoralization and Depression in Patients With Cancer. Psychosomatics. 2015 Nov-Dec;56(6):634-43. doi: 10.1016/j.psym.2015.06.005. Epub 2015 Jun 19.</citation>
    <PMID>26411374</PMID>
  </reference>
  <reference>
    <citation>Juliao M, Nunes B, Barbosa A. Prevalence and factors associated with demoralization syndrome in patients with advanced disease: Results from a cross-sectional Portuguese study. Palliat Support Care. 2016 Oct;14(5):468-73. doi: 10.1017/S1478951515001364. Epub 2016 Jan 6.</citation>
    <PMID>26732616</PMID>
  </reference>
  <reference>
    <citation>Wu YC, Tung HH, Wei J. Quality of life, demoralization syndrome and health-related lifestyle in cardiac transplant recipients - a longitudinal study in Taiwan. Eur J Cardiovasc Nurs. 2019 Feb;18(2):149-162. doi: 10.1177/1474515118800397. Epub 2018 Sep 18.</citation>
    <PMID>30226074</PMID>
  </reference>
  <results_reference>
    <citation>Clarke DM, Kissane DW. Demoralization: its phenomenology and importance. Aust N Z J Psychiatry. 2002 Dec;36(6):733-42. doi: 10.1046/j.1440-1614.2002.01086.x.</citation>
    <PMID>12406115</PMID>
  </results_reference>
  <results_reference>
    <citation>Mangelli L, Semprini F, Sirri L, Fava GA, Sonino N. Use of the Diagnostic Criteria for Psychosomatic Research (DCPR) in a community sample. Psychosomatics. 2006 Mar-Apr;47(2):143-6. doi: 10.1176/appi.psy.47.2.143.</citation>
    <PMID>16508026</PMID>
  </results_reference>
  <results_reference>
    <citation>Robinson S, Kissane DW, Brooker J, Burney S. A systematic review of the demoralization syndrome in individuals with progressive disease and cancer: a decade of research. J Pain Symptom Manage. 2015 Mar;49(3):595-610. doi: 10.1016/j.jpainsymman.2014.07.008. Epub 2014 Aug 15.</citation>
    <PMID>25131888</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Demoralization Scale-Mandarin Version</keyword>
  <keyword>Demoralization syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03829397
org study id: TYGH107037
nct id: NCT03829397
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aim to clarify the participants's mental state with Demoralization Scale- Mandarin
      Version(DS-MV). Based on clinical observations and literature review, investigators assume
      participants's DS-MV score high correlation with PHQ-9 score.
The Chinese version of Demoralization Scale-Mandarin Version (DS-MV) was used to assess the
      mental state of patients with stroke after debridement. The statistical analysis test of
      correlation is carried out, and the reliability and validity test and the norm establishment
      of the Chinese version are further tested. Convenient sampling will be performed at a single
      medical facility. The planned implementation period is 2019/01/01 ~ 2019/12/31, and the
      location of the case is the rehabilitation ward and outpatient clinic of Taoyuan Hospital.
      The diagnosis must be: intensive stroke or hemorrhagic brain within three years. In the case
      of a 20- to 100-year-old clinical patient with stroke, the subject should explain the content
      of the case, and the subject will complete the test consent form after informed consent, and
      then begin the evaluation process of the self-assessment questionnaire. The assessment
      procedure is preceded by a clinical psychologist conducting with MMSE test to determine the
      cognitive function. When the patient's consciousness is blurred, the simple intelligent state
      test (MMSE) score less than 24 points, aphasia can not be effectively communicated, the
      diagnosis of mental illness or mental disorder has been recorded on the medical record, or
      the patient or family member is unwilling to sign the informed consent form. If the above
      situation is met, subjects will be excluded. The self-assessment questionnaire will obtain
      the scores of the subjects in the Chinese version of the Demoralization Scale-Mandarin
      Version (DS-MV) and the Patient Health Questionnaire (PHQ-9). Statistical analysis, as well
      as the Chinese version of the loss of the scale of the reliability and validity of the test
      and the establishment of clinical norm scores.
observational model: Case-Only
time perspective: Other
measure: demoralization Scale-Mandarin Version (DS-MV) total score
time frame: through study completion, an average of 1 year
description: When participants was included, investigators get on one-time assessment use the demoralization Scale-Mandarin Version (DS-MV). The demoralization Scale-Mandarin Version (DS-MV) minimum score are 0, and maximum score are 96, cut-off point are 30. No subscale.
measure: demoralization Scale-Mandarin Version (DS-MV) total score split-half reliability
time frame: through study completion, an average of 1 year
description: Divide the demoralization Scale-Mandarin Version (DS-MV) into half, and then test the items of the previous half (item 1-12) and the second half (item 13-24) of the questionnaire. Then the two half questionnaire scores were test of correlation coefficient.Then If the degree of correlation is high, the reliability is very high.
measure: Patient Health Questionnaire (PHQ-9) total score
time frame: through study completion, an average of 1 year
description: When participants was included, investigators get on one-time assessment use the Patient Health Questionnaire (PHQ-9) .Patient Health Questionnaire (PHQ-9) minimum score are 0, and maximum score are 27. No subscale.
measure: demoralization Scale-Mandarin Version (DS-MV) total score criterion-related validity
time frame: through study completion, an average of 1 year
description: Correlation test between demoralization Scale-Mandarin Version (DS-MV) total score and Patient Health Questionnaire(PHQ-9) total score.
intervention type: Diagnostic Test
intervention name: Questionnaire
description: Questionnaire
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Taiwan
citation: Nanni MG, Caruso R, Travado L, Ventura C, Palma A, Berardi AM, Meggiolaro E, Ruffilli F, Martins C, Kissane D, Grassi L. Relationship of demoralization with anxiety, depression, and quality of life: A Southern European study of Italian and Portuguese cancer patients. Psychooncology. 2018 Nov;27(11):2616-2622. doi: 10.1002/pon.4824. Epub 2018 Aug 6.
PMID: 29943491
citation: Tang PL, Wang HH, Chou FH. A Systematic Review and Meta-Analysis of Demoralization and Depression in Patients With Cancer. Psychosomatics. 2015 Nov-Dec;56(6):634-43. doi: 10.1016/j.psym.2015.06.005. Epub 2015 Jun 19.
PMID: 26411374
citation: Juliao M, Nunes B, Barbosa A. Prevalence and factors associated with demoralization syndrome in patients with advanced disease: Results from a cross-sectional Portuguese study. Palliat Support Care. 2016 Oct;14(5):468-73. doi: 10.1017/S1478951515001364. Epub 2016 Jan 6.
PMID: 26732616
citation: Wu YC, Tung HH, Wei J. Quality of life, demoralization syndrome and health-related lifestyle in cardiac transplant recipients - a longitudinal study in Taiwan. Eur J Cardiovasc Nurs. 2019 Feb;18(2):149-162. doi: 10.1177/1474515118800397. Epub 2018 Sep 18.
PMID: 30226074
citation: Clarke DM, Kissane DW. Demoralization: its phenomenology and importance. Aust N Z J Psychiatry. 2002 Dec;36(6):733-42. doi: 10.1046/j.1440-1614.2002.01086.x.
PMID: 12406115
citation: Mangelli L, Semprini F, Sirri L, Fava GA, Sonino N. Use of the Diagnostic Criteria for Psychosomatic Research (DCPR) in a community sample. Psychosomatics. 2006 Mar-Apr;47(2):143-6. doi: 10.1176/appi.psy.47.2.143.
PMID: 16508026
citation: Robinson S, Kissane DW, Brooker J, Burney S. A systematic review of the demoralization syndrome in individuals with progressive disease and cancer: a decade of research. J Pain Symptom Manage. 2015 Mar;49(3):595-610. doi: 10.1016/j.jpainsymman.2014.07.008. Epub 2014 Aug 15.
PMID: 25131888
responsible party type: Sponsor
mesh term: Stroke