- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03071939
Cognate Patient Care Insight Scale (EIPSP)
Pilot Study of a New Insight Assessment Tool
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Bron Cedex, Frankrig, 69678
- Centre Hospitalier Le Vinatier
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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)
|
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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: two years
|
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)
|
two years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation greater than 0.40 to inter-judge fidelity to Cohen's Kappa test
Tidsramme: two years
|
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
|
|
Cronbach's alpha coefficient with a value of 0.7 measuring internal consistency
Tidsramme: two years
|
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
|
|
Correlation greater than 0.40 at the Bravais-Pearson test measuring test fidelity, re-testing
Tidsramme: two years
|
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
|
two years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: MAGES Nicolas, MDPH, Centre Hospitalier Le Vinatier
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016-A01716-45
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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