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

NCT ID: NCT05349513

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2026-02-28

Brief 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 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.

Conditions

Patients With Schizophrenia-like Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

interventionnal arm

Administration of the experimental questionnaire ESSME in patient's environment.

Group Type: EXPERIMENTAL

ESSME questionnaire

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Henri Laborit

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Henri Laborit

Poitiers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Carole WANGERMEZ

Role: CONTACT

carole.wangermez@ch-poitiers.fr

+33 5 49 38 00 19

Other Identifiers

2022-A00080-43

Identifier Type: -

Identifier Source: org_study_id