To Investigate the Correlation of Stroke Patients and Demoralized

March 27, 2020 updated by: Taoyuan General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Zhongshan Rd., Taoyuan Dist
      • Taoyuan City, Zhongshan Rd., Taoyuan Dist, Taiwan, No. 1492
        • Tao-Yuan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

infarct stroke or hemorrhagic stroke within three years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taoyuan General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2019

Primary Completion (Actual)

March 24, 2020

Study Completion (Actual)

March 24, 2020

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYGH107037

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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