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To Investigate the Correlation of Stroke Patients and Demoralized

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ClinicalTrials.gov Identifier: NCT03829397
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Taoyuan General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Post-stroke Depression Diagnostic Test: Questionnaire

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Investigate the Correlation of Stroke Patients and Demoralized
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Questionnaire
    Questionnaire


Primary Outcome Measures :
  1. demoralization Scale-Mandarin Version (DS-MV) total score [ Time Frame: through study completion, an average of 1 year ]
    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.


Secondary Outcome Measures :
  1. demoralization Scale-Mandarin Version (DS-MV) total score split-half reliability [ Time Frame: through study completion, an average of 1 year ]
    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.

  2. Patient Health Questionnaire (PHQ-9) total score [ Time Frame: through study completion, an average of 1 year ]
    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.

  3. demoralization Scale-Mandarin Version (DS-MV) total score criterion-related validity [ Time Frame: through study completion, an average of 1 year ]
    Correlation test between demoralization Scale-Mandarin Version (DS-MV) total score and Patient Health Questionnaire(PHQ-9) total score.



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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
infarct stroke or hemorrhagic stroke within three years
Criteria

Inclusion Criteria:

  • Inpatient and outpatient of rehabilitation department in Taoyuan General Hospital, patients diagnosis : who have an infarct stroke or hemorrhagic stroke within three years.

Exclusion Criteria:

  • Conscious state confusion, the MMSE score less than 24.
  • Unable to understand information, speech disorders, dementia, aphasia.
  • The diagnosis of mental illness or mental disorder has been recorded on the medical history.
  • The patient or family unwilling to sign an informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829397


Locations
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Taiwan
Tao-Yuan General Hospital Recruiting
Taoyuan City, Zhongshan Rd., Taoyuan Dist, Taiwan, No. 1492
Contact: Hu Chiachin, staff    912555306    h.alice1980@gmail.com   
Sponsors and Collaborators
Taoyuan General Hospital

Publications of Results:
Other Publications:
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Responsible Party: Taoyuan General Hospital
ClinicalTrials.gov Identifier: NCT03829397     History of Changes
Other Study ID Numbers: TYGH107037
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taoyuan General Hospital:
Demoralization Scale-Mandarin Version
Demoralization syndrome

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases