Clinical trial NCT03829397: To Investigate the Correlation of Stroke Patients and Demoralized
Official title: To Investigate the Correlation of Stroke Patients and Demoralized
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-stroke Depression
Keywords: Demoralization Scale-Mandarin Version
Demoralization syndrome
Lead sponsor: Taoyuan General Hospital
Sponsor class: OTHER_GOV
First posted: 2019-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: infarct stroke or hemorrhagic stroke within three years

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.

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.

Eligibility 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.

Primary outcomes:
measure: demoralization Scale-Mandarin Version (DS-MV) total score
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: demoralization Scale-Mandarin Version (DS-MV) total score split-half reliability
timeFrame: through study completion, an average of 1 year
measure: Patient Health Questionnaire (PHQ-9) total score
timeFrame: through study completion, an average of 1 year
measure: demoralization Scale-Mandarin Version (DS-MV) total score criterion-related validity
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Tao-Yuan General Hospital
state: Zhongshan Rd., Taoyuan Dist
Study officials:
References:
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