Patients With Schizophrenia-like DisordersIEvaEcoSchiNCT05349513
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
A study testing ESSME questionnaire in people with Patients With Schizophrenia-like Disorders, run by Centre Hospitalier Henri Laborit at 1 site in France.
Trial summary
The study use a new ecological questionnaire called ESSME developed by a care team in order to evaluate ecological environment of patients with schizophrenia-like disorders. Indeed, evaluation in an ecological environment would make it possible to be as close as possible to the concerns of theses patients, which could… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients With Schizophrenia-like Disorders
- What is being tested?
- ESSME questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2022to Feb 2027
- Phase
- Interventional
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- man or woman aged 18 to 65 inclusive;
- diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders version number 5 (DSM-V) criteria;
- patient receiving care in a Center for Rehabilitation and Intersectoral Therapeutic Activities (CREATIV);
- person who consented to the study;
- affiliate or beneficiary of a social security scheme.
Who cannot join
- patient aged under 18 or over 65;
- pregnant or breastfeeding women;
- person unable or unwilling to receive a home visit;
- person not consenting to the study;
- presence of a diagnosis of an associated neurodevelopmental disorder;
- presence of a diagnosis of dementia or associated neurodegenerative process;
- person with a level of French language insufficient to understand the items.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Henri Laborit
Poitiers, 86000
About this study
The study use a new ecological questionnaire called ESSME developed by a care team in order to evaluate ecological environment of patients with schizophrenia-like disorders.
Indeed, evaluation in an ecological environment would make it possible to be as close as possible to the concerns of theses patients, which could improve the care of this population, by making it possible to set with the patient objectives anchored in their daily life.
Read the detailed description
The duration of patient's participation to the study is 6 months plus 7 to 14 days.
The study includes the following visits :
- V0: Inclusion visit (Day 0) with the administration of standard of care questionnaires;
- V1: visit at patient's home (Day 0 +7 to 14 days) with the administration of the experimental ESSME questionnaire;
- V2: follow-up visit at 6 months (M6) with the administration of the same standard of care questionnaires than at the inclusion visit;
- V3: visit at patient's home (M6 + 7 to 14 days) with the administration of the experimental ESSME questionnaire.
- Being tested
- ESSME questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESSME questionnaireOther
The experimental ecological questionnaire ESSME is administered 7 to 14 days after the inclusion visit and 7 to 14 days after the 6 months follow-up visit to the patient at their home.
| Study group | Role | What they receive |
|---|---|---|
| interventionnal arm | Experimental | Administration of the experimental questionnaire ESSME in patient's environment. Receives: Other: ESSME questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between the total ecological questionnaire (ESSME) score and the total score of the social autonomy scale.
The main judgment criterion is the correlation coefficient between the change in the total ESSME score and the change in the total score of the selected autonomy scale, the EAS over a period of 6 months.
The judgment criterion will be obtained by calculating a percentage variation between the initial total score and that obtained at 6 months for each of the scales: EAS and for the ESSME tool.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start23 Feb 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Schizophrenia-like DisordersStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349513
- Sponsor's protocol ID
- 2022-A00080-43
- Acronym
- IEvaEcoSchi
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No