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NCT Number: NCT05349513

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Henri Laborit

Poitiers, 86000, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESSME questionnaire

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.

Primary outcomes

  1. Correlation coefficient between the total ecological questionnaire (ESSME) score and the total score of the social autonomy scale.

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carole WANGERMEZ

CONTACT

[email protected]

+33 5 49 38 00 19

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Laborit

Other

Registry information

Acronym: IEvaEcoSchi

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2022
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.