To Investigate the Correlation of Stroke Patients and Demoralized

Completed

• Conditions: Post-stroke Depression

• Registration Number: NCT03829397
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2019-02-18
• Status Verified: 2019-05
• Primary Completion: 2020-03-24
• Study Completion: 2020-03-24
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
demoralization Scale-Mandarin Version (DS-MV) total score	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

Name	Time	Method
Patient Health Questionnaire (PHQ-9) total score	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.
demoralization Scale-Mandarin Version (DS-MV) total score criterion-related validity	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.
demoralization Scale-Mandarin Version (DS-MV) total score split-half reliability	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.

Trial Locations

Locations (1)

Tao-Yuan General Hospital; 🇨🇳 Taoyuan City, Zhongshan Rd., Taoyuan Dist, Taiwan