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Post-stroke DepressionNCT03829397

To Investigate the Correlation of Stroke Patients and Demoralized

An observational study of Post-stroke Depression, run by Taoyuan General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 100 years
Conditions the study is for
Post-stroke Depression
What is being tested?
Questionnaire
How many people
40 participants
Where
1 siteTaiwan
Study dates
18 Feb 2019to 24 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: infarct stroke or hemorrhagic stroke within three years

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Tao-Yuan General Hospital

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

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
Questionnaire
Keywords
Demoralization Scale-Mandarin Version, Demoralization syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireDiagnostic test

    Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)

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

    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.

    Measured: through study completion, an average of 1 year

  2. Patient Health Questionnaire (PHQ-9) total score

    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.

    Measured: through study completion, an average of 1 year

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

    Correlation test between demoralization Scale-Mandarin Version (DS-MV) total score and Patient Health Questionnaire(PHQ-9) total score.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2019
  2. Study start18 Feb 2019
  3. Primary completion24 Mar 2020
  4. Study completion24 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03829397
Sponsor's protocol ID
TYGH107037
Status last verified
May 2019
First submitted
30 Jan 2019
Last updated
31 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 29943491

  • 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.

    PubMed 26411374

  • 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.

    PubMed 26732616

  • 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.

    PubMed 30226074

  • 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.

    PubMed 12406115

  • 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.

    PubMed 16508026

  • 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.

    PubMed 25131888

Questions about this trial

What is this clinical trial studying?

An observational study of Post-stroke Depression, run by Taoyuan General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

demoralization Scale-Mandarin Version (DS-MV) total score (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03829397, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.

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