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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01611337
Other study ID # 2012-A00155-38
Secondary ID
Status Completed
Phase N/A
First received May 29, 2012
Last updated September 18, 2017
Start date June 2012
Est. completion date July 2017

Study information

Verified date September 2017
Source Centre Hospitalier Esquirol
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 205
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
insight variation measure
insight variation between the firt week of hospitalization and 1 month later

Locations

Country Name City State
France Centre Hospitalier Esquirol Limoges
France Centre Hospitalier La Vallette Saint-Vaury

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Esquirol

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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