Cognate Patient Care Insight Scale

NCT03071939 | Withdrawn

• 1 other identifier: 2016-A01716-45
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (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)

  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

Secondary Outcomes (3)

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

  two years

• Cronbach's alpha coefficient with a value of 0.7 measuring internal consistency

  two years

• Correlation greater than 0.40 at the Bravais-Pearson test measuring test fidelity, re-testing

  two years

Study Arms (1)

patients with schizophrenia and their designated relatives

OTHER

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

Interventions

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

patients with schizophrenia and their designated relatives

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia
• Age from 18 to 50 years old
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, 69678, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• MAGES Nicolas, MDPH

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One arm in this study comprising 119 patients and one of their relatives

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 7, 2017
• Study Start: January 2, 2018
• Primary Completion: January 2, 2020
• Study Completion: April 2, 2020
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)