NCT01611337

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

5.1 years

First QC Date

May 29, 2012

Last Update Submit

September 18, 2017

Conditions

Keywords

schizophrenia, insight

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

OTHER

insight evaluation using the Q8 scale

Other: insight variation measure

Interventions

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

insight evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Centre Hospitalier La Vallette

Saint-Vaury, 23320, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Danielle Bourlot, MD

    Centre Hospitalier Esquirol

    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
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

Locations