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Cognate Patient Care Insight Scale (EIPSP)

Primary Purpose

Schizophrenia

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of the insight of schizophrenic patients by themselves, their relatives and caregivers
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Le Vinatier

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with schizophrenia and their designated relatives

Arm Description

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)

Outcomes

Primary Outcome Measures

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)
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

Correlation greater than 0.40 to inter-judge fidelity to Cohen's Kappa test
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
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
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

Full Information

First Posted
February 28, 2017
Last Updated
April 19, 2019
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT03071939
Brief Title
Cognate Patient Care Insight Scale
Acronym
EIPSP
Official Title
Pilot Study of a New Insight Assessment Tool
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
the investigator left our institution
Study Start Date
January 2, 2018 (Anticipated)
Primary Completion Date
January 2, 2020 (Anticipated)
Study Completion Date
April 2, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One arm in this study comprising 119 patients and one of their relatives
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with schizophrenia and their designated relatives
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Assessment of the insight of schizophrenic patients by themselves, their relatives and caregivers
Intervention Description
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 Measure Information:
Title
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)
Description
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)
Time Frame
two years
Secondary Outcome Measure Information:
Title
Correlation greater than 0.40 to inter-judge fidelity to Cohen's Kappa test
Description
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).
Time Frame
two years
Title
Cronbach's alpha coefficient with a value of 0.7 measuring internal consistency
Description
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.
Time Frame
two years
Title
Correlation greater than 0.40 at the Bravais-Pearson test measuring test fidelity, re-testing
Description
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
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MAGES Nicolas, MDPH
Organizational Affiliation
Centre Hospitalier le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron Cedex
ZIP/Postal Code
69678
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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