SchizophreniaNCT01611337
Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
A study testing insight variation measure in people with Schizophrenia, run by Centre Hospitalier Esquirol at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- insight variation measure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2012to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia,
- Persons requiring psychiatric care in one of the participating care unit
- I1 < 6 (absent or bad consciousness of the trouble).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Esquirol
Limoges, 87000
Centre Hospitalier La Vallette
Saint-Vaury, 23320
About this study
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.
- Conditions
- Schizophrenia
- Being tested
- insight variation measure
- Keywords
- schizophrenia, insight
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insight variation measureOther
insight variation between the firt week of hospitalization and 1 month later
| Study group | Role | What they receive |
|---|---|---|
| insight evaluation | Other | insight evaluation using the Q8 scale Receives: Other: insight variation measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first month after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Bourlot, Centre Hospitalier Esquirol
- Investigators
- Danielle Bourlot, MD, Principal investigator, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611337
- Sponsor's protocol ID
- 2012-A00155-38
- Status last verified
- Sep 2017
- First submitted
- 29 May 2012
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
- ClinicalTrials.gov ID
- NCT01611337
- Acronym / sponsor ID
- 2012-A00155-38
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, insight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insight evaluation | Other | Other: insight variation measureinsight evaluation using the Q8 scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia,
- Persons requiring psychiatric care in one of the participating care unit
- I1 < 6 (absent or bad consciousness of the trouble).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insight variation measureinsight variation between the firt week of hospitalization and 1 month later | Other | insight evaluation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Bourlot, MD principal investigator
Centre Hospitalier Esquirol
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insight variation measure in people with Schizophrenia, run by Centre Hospitalier Esquirol at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.