NCT05349513

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

April 21, 2022

Last Update Submit

January 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

interventionnal arm

EXPERIMENTAL

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

Other: ESSME questionnaire

Interventions

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.

interventionnal arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Henri Laborit

Poitiers, 86000, France

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 27, 2022

Study Start

February 23, 2022

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations