Working... Menu

Cognate Patient Care Insight Scale (EIPSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03071939
Recruitment Status : Not yet recruiting
First Posted : March 7, 2017
Last Update Posted : July 6, 2018
Information provided by (Responsible Party):
Hôpital le Vinatier

Brief Summary:
Schizophrenia is a disease of young adults that affects 1% of the general population. According to numerous studies, it has been estimated that between 50% and 80% of patients with schizophrenia do not consider to have a mental disorder and are therefore not aware of their disorders. A poor degree of insight is associated with poor compliance, a higher number of re-hospitalizations, altered social and relational functioning, and a higher number of suicides and violent behaviors. This is why insight, which is an essential dimension of psychopathology, must be evaluated, as it depends to a large extent on the therapeutic alliance, adherence to treatment, likelihood of relapse and prognosis.

Condition or disease Intervention/treatment Phase
Schizophrenia Other: Assessment of the insight of schizophrenic patients by themselves, their relatives and caregivers Not Applicable

Detailed Description:
Evaluation (test, re-test) This new tool for assessing insight will allow for a discrepancy in assessment and a more refined assessment with a view to developing specific care for the patient and / or the relative with regard to the three dimensions Evaluated: disease, treatment and functional implications

Layout table for study information
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03071939

Layout table for location contacts
Contact: MAGES Nicolas, MDPH 0033 4 37 91 50 80
Contact: SAUCOURT Guillaume, Nurses 0033 4 37 91 50 80

Layout table for location information
Centre Hospitalier Le Vinatier Not yet recruiting
Bron Cedex, France, 69678
Contact: Thierry D'AMATO, PH    04 37 91 51 00   
Sponsors and Collaborators
Hôpital le Vinatier
Layout table for investigator information
Principal Investigator: MAGES Nicolas, MDPH Centre Hospitalier Le Vinatier

Layout table for additonal information
Responsible Party: Hôpital le Vinatier Identifier: NCT03071939     History of Changes
Other Study ID Numbers: 2016-A01716-45
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders