Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
1 other identifier
interventional
205
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Jun 2012
Longer than P75 for not_applicable schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedSeptember 19, 2017
September 1, 2017
5.1 years
May 29, 2012
September 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
first month after hospitalization
Study Arms (1)
insight evaluation
OTHERinsight evaluation using the Q8 scale
Interventions
insight variation between the firt week of hospitalization and 1 month later
Eligibility Criteria
You may qualify if:
- Diagnosis of schizophrenia,
- Persons requiring psychiatric care in one of the participating care unit
- I1 \< 6 (absent or bad consciousness of the trouble).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Hospitalier Esquirol
Limoges, 87000, France
Centre Hospitalier La Vallette
Saint-Vaury, 23320, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Bourlot, MD
Centre Hospitalier Esquirol
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Head of Esquirol Hospital Medical Council
Study Record Dates
First Submitted
May 29, 2012
First Posted
June 4, 2012
Study Start
June 1, 2012
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
September 19, 2017
Record last verified: 2017-09