Cognate Patient Care Insight Scale

NCT ID: NCT03071939

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2020-04-02

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

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Assessment of the insight of schizophrenic patients by themselves, their relatives and caregivers

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MAGES Nicolas, MDPH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier le Vinatier

Locations

Centre Hospitalier Le Vinatier

Bron, , France

Countries

France

Other Identifiers

2016-A01716-45

Identifier Type: -

Identifier Source: org_study_id