To Investigate the Correlation of Stroke Patients and Demoralized

• ClinicalTrials.gov Identifier: NCT03829397
• Recruitment Status: Completed
• First Posted: February 4, 2019
• Last Update Posted: March 31, 2020
• Sponsor: Taoyuan General Hospital
• Information provided by (Responsible Party): Taoyuan General Hospital

Study Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: To Investigate the Correlation of Stroke Patients and Demoralized
• Actual Study Start Date: February 18, 2019
• Actual Primary Completion Date: March 24, 2020
• Actual Study Completion Date: March 24, 2020

Groups and Cohorts

Intervention Details:

• Diagnostic Test: Questionnaire
  Questionnaire

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Taiwan

Tao-Yuan General Hospital

Taoyuan City, Zhongshan Rd., Taoyuan Dist, Taiwan, No. 1492

Sponsors and Collaborators

Taoyuan General Hospital

More Information

Publications of Results:

Clarke DM, Kissane DW. Demoralization: its phenomenology and importance. Aust N Z J Psychiatry. 2002 Dec;36(6):733-42. Review.

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.

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. Review.

Other Publications:

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.

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. Review.

Julião 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.

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.

• Responsible Party: Taoyuan General Hospital
• ClinicalTrials.gov Identifier: NCT03829397
• Other Study ID Numbers: TYGH107037
• First Posted: February 4, 2019
• Last Update Posted: March 31, 2020
• Last Verified: May 2019

• 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:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases