Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
insight variation measure
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia focused on measuring schizophrenia, insight
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of schizophrenia,
- Persons requiring psychiatric care in one of the participating care unit
- I1 < 6 (absent or bad consciousness of the trouble).
Exclusion Criteria:
- I1≥6
- Expression capacities incompatible with Q8 scale quotation (delirium, no understanding of the french language, mutism, contention or therapeutic isolation)
- Age under 18, absence of health care insurance
Sites / Locations
- Centre Hospitalier Esquirol
- Centre Hospitalier La Vallette
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
insight evaluation
Arm Description
insight evaluation using the Q8 scale
Outcomes
Primary Outcome Measures
number of collected data explaining insight variation between the first week of hospitalization (I1) and 1 month later (I2) in a model of logistic regression
identification of the variables explaining insight variation when it is ≥ 1,5: social and demographic data : age, gender, marital status, study level clinical : disease duration, Positive and Negative Syndrome Scale (PANSS), type of trouble therapeutic : care and treatments received during hospitalization.
Secondary Outcome Measures
Full Information
NCT ID
NCT01611337
First Posted
May 29, 2012
Last Updated
September 18, 2017
Sponsor
Centre Hospitalier Esquirol
1. Study Identification
Unique Protocol Identification Number
NCT01611337
Brief Title
Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
Official Title
Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Esquirol
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Therapeutic alliance, and drug observance are major difficulties in the care of persons presenting schizophrenic symptomatology. They appear to be linked to insight, the consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it, but usually without using specific evaluation tool. Insight is usually not evaluated during care, and its evolution is also not known, although it is highly probable that a positive evolution of insight for a person in hospital correlated to an adapted and optimal care by the medical and nursing teams. The investigators do not know examples of insight evaluation during a sequence of hospital care, or any evidence of insight variation in relation to evolution abilities of some schizophrenic patients cared in hospital.
The investigators propose here to evaluate insight in people presenting schizophrenia or related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better characterize insight variations, and identify the sociodemographic, clinical and therapeutic variables linked to it.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, insight
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
insight evaluation
Arm Type
Other
Arm Description
insight evaluation using the Q8 scale
Intervention Type
Other
Intervention Name(s)
insight variation measure
Intervention Description
insight variation between the firt week of hospitalization and 1 month later
Primary Outcome Measure Information:
Title
number of collected data explaining insight variation between the first week of hospitalization (I1) and 1 month later (I2) in a model of logistic regression
Description
identification of the variables explaining insight variation when it is ≥ 1,5: social and demographic data : age, gender, marital status, study level clinical : disease duration, Positive and Negative Syndrome Scale (PANSS), type of trouble therapeutic : care and treatments received during hospitalization.
Time Frame
first month after hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of schizophrenia,
Persons requiring psychiatric care in one of the participating care unit
I1 < 6 (absent or bad consciousness of the trouble).
Exclusion Criteria:
I1≥6
Expression capacities incompatible with Q8 scale quotation (delirium, no understanding of the french language, mutism, contention or therapeutic isolation)
Age under 18, absence of health care insurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Bourlot, MD
Organizational Affiliation
Centre Hospitalier Esquirol
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Esquirol
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Centre Hospitalier La Vallette
City
Saint-Vaury
ZIP/Postal Code
23320
Country
France
12. IPD Sharing Statement
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Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
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