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Trial record 27 of 2833 for:    "Schizophrenia"

Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry

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ClinicalTrials.gov Identifier: NCT01611337
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Danielle Bourlot, Centre Hospitalier Esquirol

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Other: insight variation measure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
Study Start Date : June 2012
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
insight evaluation
insight evaluation using the Q8 scale
Other: insight variation measure
insight variation between the firt week of hospitalization and 1 month later



Primary Outcome Measures :
  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 [ Time Frame: first month after hospitalization ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611337


Locations
France
Centre Hospitalier Esquirol
Limoges, France, 87000
Centre Hospitalier La Vallette
Saint-Vaury, France, 23320
Sponsors and Collaborators
Centre Hospitalier Esquirol
Investigators
Principal Investigator: Danielle Bourlot, MD Centre Hospitalier Esquirol

Responsible Party: Danielle Bourlot, MD, Head of Esquirol Hospital Medical Council, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT01611337     History of Changes
Other Study ID Numbers: 2012-A00155-38
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by Danielle Bourlot, Centre Hospitalier Esquirol:
schizophrenia, insight

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders