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Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients (PEPITS)

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PEPITS Programme
Usual care
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 65 years

  • Patient with a diagnosed and reported schizophrenic disorder announced :

    • Schizophrenia
    • Schizoaffective disorder
  • Or a diagnosed and reported Delusional Disorder
  • Express written consent by the participant after receiving information about the study
  • Be able to communicate verbally
  • Participant affiliated to a social security scheme

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Patient who does not speak French
  • Participation in a psycho-education group in the last 3 years
  • Patient under legal protection or guardianship

Sites / Locations

  • Serrvice de Psychiatrie
  • Service de psychiatrieRecruiting
  • Service de psychiatrie
  • Service de psychiatrie
  • Service de psychiatrieRecruiting
  • Service de psychiatrieRecruiting
  • Service de psychiatrieRecruiting
  • Service de psychiatrieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEPITS programme

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Evolution of insight
using the Introspection Self Assessment Questionnaire (IAQ)

Secondary Outcome Measures

Evolution of patient's quality of life
using the S-QOL (Subjective - Quality of Life)
Medication compliance
by the Medication Adherence Rating Scale (MARS)
Evolution of quality of life at work
Measured by the Quality of life at work scale (Elizur and Shye scale, validated in French by Delmas, 2001) for nurses. Score from 1 to 6 per question. Average of all scores.The higher the average, the higher the level of quality of life at work.
Evolution of psychological well-being at work
Scale of psychological well-being at work (Gilbert, Dagenais-Desmarais, & Savoie, 2011) for nurses. Score from 1 to 5 per question. Average of all scores.The higher the average, the higher the Psychological well-being at work.
Evolution of job satisfaction
Job satisfaction scale (Fouquereau & Rioux, 2002) for nurses. Score from 1 to 7 per question. Average of all scores. The higher the average, the higher the job satisfaction.
Evolution of sense of self-efficacy
Self-efficacy scale (Nagels, 2008). Score from 1 to 4 per question. Average of all scores. The higher the average, the higher the sense of self-efficacy .
Evolution of commitment to work
Work Engagement Scale (Scaufeli, Baker, & Salanova, 2006) for nurses. score from 1 to 6 per question. Average score. The higher the average, the higher the work vigour, dedication to work and absorption at work.

Full Information

First Posted
March 18, 2022
Last Updated
November 4, 2022
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT05329363
Brief Title
Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients
Acronym
PEPITS
Official Title
Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients: A Randomized, Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Schizophrenia affects about 0.7% of the population. Poor insight, which is common in this disease, linked to poor drug compliance is leads to rehospitalisation with major impact on quality of life. Indeed, many patients relapse with exacerbation of symptoms. Psychoeducation can improve therapeutic alliance and medication compliance. In this context, an individual psycho-education program (PEPITS) has been developed. PEPITS carried out by nurses during the initial stages of hospitalisation. The hypothesis is that PEPITS program will decrease relapse and improve the compliance and insight and and so the quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEPITS programme
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
PEPITS Programme
Intervention Description
The programme has three main phases: Phase I: Introduction phase (Session 1) Phase II: Pathology and care work phase (Sessions 2 - 3 - 4) Phase III: Recovery and "stepping stone" phase (Sessions 5 - 6 - 7) The programme provides information, keys and new skills to the patient through 3 phases focusing on pathology and recovery.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Patients will receive the same psychiatric care as the experimental group except of the PEPITS programme.
Primary Outcome Measure Information:
Title
Evolution of insight
Description
using the Introspection Self Assessment Questionnaire (IAQ)
Time Frame
From inclusion (T0) up to one year (T12) after randomisation
Secondary Outcome Measure Information:
Title
Evolution of patient's quality of life
Description
using the S-QOL (Subjective - Quality of Life)
Time Frame
From inclusion (T0) up to one year (T12) after randomisation
Title
Medication compliance
Description
by the Medication Adherence Rating Scale (MARS)
Time Frame
From inclusion (T0) up to one year (T12) after randomisation
Title
Evolution of quality of life at work
Description
Measured by the Quality of life at work scale (Elizur and Shye scale, validated in French by Delmas, 2001) for nurses. Score from 1 to 6 per question. Average of all scores.The higher the average, the higher the level of quality of life at work.
Time Frame
From prior to their training in the programme up to 6 months after their first inclusion
Title
Evolution of psychological well-being at work
Description
Scale of psychological well-being at work (Gilbert, Dagenais-Desmarais, & Savoie, 2011) for nurses. Score from 1 to 5 per question. Average of all scores.The higher the average, the higher the Psychological well-being at work.
Time Frame
From prior to their training in the programme up to 6 months after their first inclusion
Title
Evolution of job satisfaction
Description
Job satisfaction scale (Fouquereau & Rioux, 2002) for nurses. Score from 1 to 7 per question. Average of all scores. The higher the average, the higher the job satisfaction.
Time Frame
From prior to their training in the programme up to 6 months after their first inclusion
Title
Evolution of sense of self-efficacy
Description
Self-efficacy scale (Nagels, 2008). Score from 1 to 4 per question. Average of all scores. The higher the average, the higher the sense of self-efficacy .
Time Frame
From prior to their training in the programme up to 6 months after their first inclusion
Title
Evolution of commitment to work
Description
Work Engagement Scale (Scaufeli, Baker, & Salanova, 2006) for nurses. score from 1 to 6 per question. Average score. The higher the average, the higher the work vigour, dedication to work and absorption at work.
Time Frame
From prior to their training in the programme up to 6 months after their first inclusion

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: Age between 18 and 65 years Patient with a diagnosed and reported schizophrenic disorder announced : Schizophrenia Schizoaffective disorder Or a diagnosed and reported Delusional Disorder Express written consent by the participant after receiving information about the study Be able to communicate verbally Participant affiliated to a social security scheme Exclusion Criteria: Pregnant or breastfeeding woman Patient who does not speak French Participation in a psycho-education group in the last 3 years Patient under legal protection or guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud CHESSE
Phone
+33(0)2.34.37.89.68
Email
A.CHESSE@chu-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie LECLERC
Phone
+33(0)2.47.47.46.64
Email
m.leclerc@chu-tours.fr
Facility Information:
Facility Name
Serrvice de Psychiatrie
City
Blois
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Mieszkalski
First Name & Middle Initial & Last Name & Degree
Michael Mieszkalski
Facility Name
Service de psychiatrie
City
Chinon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle BODIN
Facility Name
Service de psychiatrie
City
Dreux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica PÉTÉ SARAROLS
First Name & Middle Initial & Last Name & Degree
Jessica PÉTÉ SARAROLS
Facility Name
Service de psychiatrie
City
Fleury-les-Aubrais
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélien BARRET
First Name & Middle Initial & Last Name & Degree
Aurélien BARRET
Facility Name
Service de psychiatrie
City
La Roche sur Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde JOUIN
First Name & Middle Initial & Last Name & Degree
Mathilde JOUIN
Facility Name
Service de psychiatrie
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Amélie DESCHENES
First Name & Middle Initial & Last Name & Degree
Marie-Amélie DESCHENES
Facility Name
Service de psychiatrie
City
Sainte-Gemmes-sur-Loire
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis RICHARD
First Name & Middle Initial & Last Name & Degree
Alexis RICHARD
Facility Name
Service de psychiatrie
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex MONDOULET
First Name & Middle Initial & Last Name & Degree
Alex MONDOULET

12. IPD Sharing Statement

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Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients

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