Cognate Patient Care Insight Scale (EIPSP)
Pilot Study of a New Insight Assessment Tool
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Bron Cedex, Frankrijk, 69678
- Centre Hospitalier Le Vinatier
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Diagnosis of schizophrenia
- Age from 18 to 50 years old
- Stabilized clinical condition (without therapeutic modification during the month prior to inclusion)
- French language read, spoken and understood (patient and family member)
- Having given his consent
- Agreement of the guardian for persons under guardianship
- Consent of the relative
Exclusion Criteria:
- Refusal of patient or legal guardian
- Refusal of the loved one
- Patient and / or neurological disorder of neurological origin of vascular, infectious or neurodegenerative origin
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: patients with schizophrenia and their designated relatives
Evaluation of the patient's insight (an inclusion phase, followed by two evaluation phases on D0 and D7) by the patient, his / her close and two caregivers (inter-judicial fidelity)
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This study will evaluate the insight of the patient, something carried out in common practice within the Eastern Pole (CH Le Vinatier). This assessment will take place in the specific services where patients are cared for. It will make it possible to evaluate insight more closely by comparing the opinions of the three actors. There is no risk in this study. The study will be carried out over 2 years with a recruitment of 119 patients responding to the diagnosis of schizophrenia, taken care of within the Eastern Pole (Intra and Extrahospital services). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Concurrent validity of the hetero-evaluation scale by studying its correlation with the results obtained, for the same persons, on the SUMD scale (Scale to Assess Unawareness of Mental Disorder)
Tijdsspanne: two years
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Correlation higher than 0.40 in the Bravais-Pearson test between the caregiver's hetero-evaluation scale and the Scale to Assess Understanding of Mental Disorder (SUMD)
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two years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Correlation greater than 0.40 to inter-judge fidelity to Cohen's Kappa test
Tijdsspanne: two years
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Inter-judicial fidelity will be measured with Cohen's Kappa test, which is a coefficient to measure the agreement between two qualitative variables with the same modalities. Conventionally, it is used to measure the degree of concordance between the stages Awarded by two judges. It can also be applied to measure an intra-observer agreement. The closer the ratio is to 1, the closer the gap between the observed chord proportion and the theoretical proportion of "random" chords approaches the gap between the perfect tuning of the two observers and their random match. The coefficient is always between -1 and 1 (maximum agreement). |
two years
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Cronbach's alpha coefficient with a value of 0.7 measuring internal consistency
Tijdsspanne: two years
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Internal consistency will be measured with the Cronbach alpha coefficient, sometimes referred to simply as the coefficient. Which is a statistic used especially in psychometrics to measure the internal consistency (or reliability) of the questions asked during a test (the answers to the questions on the same subject to be correlated). Its value is between 0 and 1, being considered "acceptable" from 0.7. It therefore allows estimation of the fidelity of the score to a test. |
two years
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Correlation greater than 0.40 at the Bravais-Pearson test measuring test fidelity, re-testing
Tijdsspanne: two years
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This coefficient makes it possible to detect the presence or absence of a linear relationship between two continuous quantitative characters.
To calculate this coefficient, one must first calculate the covariance.
Covariance is the mean of the product of deviations from the mean.
The linear correlation coefficient of two characters X and Y is equal to the covariance of X and Y divided by the product of the standard deviations of X and Y.
It can be shown that this coefficient varies between -1 and +1
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two years
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: MAGES Nicolas, MDPH, Centre Hospitalier Le Vinatier
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2016-A01716-45
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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