Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders (IEvaEcoSchi)

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Schizophrenia-like Disorders
• Intervention / Treatment: Other: ESSME questionnaire

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carole WANGERMEZ; Phone Number: +33 5 49 38 00 19; Email: carole.wangermez@ch-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • Centre Hospitalier Henri Laborit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventionnal arm; Administration of the experimental questionnaire ESSME in patient's environment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Laborit

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 2022-A00080-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No