NCT03829397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2020

Completed
Last Updated

March 31, 2020

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

January 30, 2019

Last Update Submit

March 27, 2020

Conditions

Post-stroke Depression

Keywords

Demoralization Scale-Mandarin VersionDemoralization syndrome

Outcome Measures

Primary Outcomes (1)

  • demoralization Scale-Mandarin Version (DS-MV) total score

    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 Outcomes (3)

  • demoralization Scale-Mandarin Version (DS-MV) total score split-half reliability

    through study completion, an average of 1 year

  • Patient Health Questionnaire (PHQ-9) total score

    through study completion, an average of 1 year

  • demoralization Scale-Mandarin Version (DS-MV) total score criterion-related validity

    through study completion, an average of 1 year

Interventions

QuestionnaireDIAGNOSTIC_TEST

Questionnaire

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

infarct stroke or hemorrhagic stroke within three years

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tao-Yuan General Hospital

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

Location

Related Publications (7)

  • 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.

    PMID: 29943491BACKGROUND

  • 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.

    PMID: 26411374BACKGROUND

  • Juliao 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.

    PMID: 26732616BACKGROUND

  • 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.

    PMID: 30226074BACKGROUND

  • Clarke DM, Kissane DW. Demoralization: its phenomenology and importance. Aust N Z J Psychiatry. 2002 Dec;36(6):733-42. doi: 10.1046/j.1440-1614.2002.01086.x.

    PMID: 12406115RESULT

  • 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. doi: 10.1176/appi.psy.47.2.143.

    PMID: 16508026RESULT

  • 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.

    PMID: 25131888RESULT

MeSH Terms

Interventions

Pain Measurement

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 4, 2019

Study Start

February 18, 2019

Primary Completion

March 24, 2020

Study Completion

March 24, 2020

Last Updated

March 31, 2020

Record last verified: 2019-05

Locations

TW(1)