Cognate Patient Care Insight Scale (EIPSP)
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|ClinicalTrials.gov Identifier: NCT03071939|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2017
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Other: Assessment of the insight of schizophrenic patients by themselves, their relatives and caregivers||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||119 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||One arm in this study comprising 119 patients and one of their relatives|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of a New Insight Assessment Tool|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||January 5, 2019|
|Estimated Study Completion Date :||February 15, 2019|
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)
Other: Assessment of the insight of schizophrenic patients by themselves, their relatives and caregivers
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).
- 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) [ Time Frame: 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)
- Correlation greater than 0.40 to inter-judge fidelity to Cohen's Kappa test [ Time Frame: 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).
- Cronbach's alpha coefficient with a value of 0.7 measuring internal consistency [ Time Frame: 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.
- Correlation greater than 0.40 at the Bravais-Pearson test measuring test fidelity, re-testing [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071939
|Contact: MAGES Nicolas, MDPH||0033 4 37 91 50 email@example.com|
|Contact: SAUCOURT Guillaume, Nurses||0033 4 37 91 50 firstname.lastname@example.org|
|Centre Hospitalier Le Vinatier||Not yet recruiting|
|Bron Cedex, France, 69678|
|Contact: Thierry D'AMATO, PH 04 37 91 51 00 email@example.com|
|Principal Investigator:||MAGES Nicolas, MDPH||Centre Hospitalier Le Vinatier|