Back to resultsInterest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders (IEvaEcoSchi)
Primary Purpose
Patients With Schizophrenia-like Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ESSME questionnaire
Sponsored by
About this trial
This is an interventional other trial for Patients With Schizophrenia-like Disorders
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.
Sites / Locations
- Centre Hospitalier Henri LaboritRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
interventionnal arm
Arm Description
Administration of the experimental questionnaire ESSME in patient's environment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05349513
First Posted
April 21, 2022
Last Updated
August 18, 2023
Sponsor
Centre Hospitalier Henri Laborit
1. Study Identification
Unique Protocol Identification Number
NCT05349513
Brief Title
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Acronym
IEvaEcoSchi
Official Title
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Schizophrenia-like Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventionnal arm
Arm Type
Experimental
Arm Description
Administration of the experimental questionnaire ESSME in patient's environment.
Intervention Type
Other
Intervention Name(s)
ESSME questionnaire
Intervention Description
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 Measure Information:
Title
Correlation coefficient between the total ecological questionnaire (ESSME) score and the total score of the social autonomy scale.
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carole WANGERMEZ
Phone
+33 5 49 38 00 19
Email
carole.wangermez@ch-poitiers.fr
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
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