Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ESSME questionnaire.
- Who it may be relevant to
- Registry conditions: Patients With Schizophrenia-like Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Other ESSME questionnaire
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.
Primary outcome measures
- Correlation coefficient between the total ecological questionnaire (ESSME) score and the total score of the social autonomy scale. [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Hospitalier Henri Laborit — Poitiers
Identifiers
NCT: NCT05349513 · 2022-A00080-43