First Episode PsychosisCHECKLISTPEPNCT05737966
Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist
An observational study of First Episode Psychosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- First Episode Psychosis
- What is being tested?
- evaluation of professional practices
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Professional working in an early intervention center treating first episodes of psychosis
Who may be able to join
- Professional working in an early intervention center treating first episodes of psychosis
- Professional involved in the organization/management of the center or practicing case management.
Who cannot join
- Professional not working in the early intervention center
- Professional working in the early intervention center but not having a role in the organization or management of the center or as case manager
- Professional who does not take charge of people who have had a first psychotic episode
Trial locations and contacts
1 site in 1 country.
About this study
Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. It is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. For more than a decade, early intervention services (EIS) are opened in France over an increasingly large territory. Still too few studies assess the impact of these structures in France. These EIS offer a multimodal intervention (social, professional, psychotherapeutic). The intervention of case managers (or care coordinators in french) seems to be the core of EIS. The case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care.
The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of young people with a FEP.
Read more
A qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions.
Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate the practice of case management in the EIS in France. This check-list contains different 35 items. The final score between 1(poor) to 5 (good) is established to determine the quality of the case management. Qualitative data are also collected during the interview with the participants.
- Conditions
- First Episode Psychosis
- Being tested
- evaluation of professional practices
- Keywords
- first episode of psychosis assertive community treatment, early intervention in mental health, case management, assertive community treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of professional practicesOther
Evaluation of professional practices : evaluation of the case management carried out in a program for early psychosis in France using a checklist according good practices guidelines
What is being measured
The primary outcome is the main question the study is designed to answer.
conformity to TIDieR checklist in each center and for each case manager interviewed
TIDieR checklist Patient - Use of the case management manual (yes or no)
Measured: 1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
TIDieR checklist Patient - Use of specific and validated tools for Psychoeducation (yes or no)
Measured: 1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
TIDieR checklist Patient - Use of an information brochure on First Episode Psychosis (yes or no)
Measured: 1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
TIDieR checklist Patient - Use of specific and validated tools to support families (yes or no)
Measured: 1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
TIDieR checklist Patient - Use of specific and validated tools for Motivational Interviewing (yes or no)
Measured: 1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
TIDieR checklist Patient - Presence of Individualized Therapeutic Plan (ITP) supervision system (yes or no)
Measured: 1 year
conformity to TIDieR checklist in each center and for each case manager interviewed
TIDieR checklist Patient - Use of Individualized Therapeutic Plan (ITP) supervision system (yes or no)
Measured: 1 year
Secondary outcomes (2)
description of the global organisation of each center
Number of staff by trade
Measured: 1 year
description of their involvement in the early intervention center
number of years experience
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Feb 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Episode PsychosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737966
- Sponsor's protocol ID
- LOCAL/2022/RP
- Acronym
- CHECKLISTPEP
- Status last verified
- Sep 2023
- First submitted
- 22 Dec 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist
- ClinicalTrials.gov ID
- NCT05737966
- Acronym / sponsor ID
- CHECKLISTPEP / LOCAL/2022/RP
- Conditions
- First Episode Psychosis
- Keywords
- first episode of psychosis assertive community treatment, early intervention in mental health, case management, assertive community treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. It is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. For more than a decade, early intervention services (EIS) are opened in France over an increasingly large territory. Still too few studies assess the impact of these structures in France. These EIS offer a multimodal intervention (social, professional, psychotherapeutic). The intervention of case managers (or care coordinators in french) seems to be the core of EIS. The case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care.
The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of young people with a FEP.
A qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions.
Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate the practice of case management in the EIS in France. This check-list contains different 35 items. The final score between 1(poor) to 5 (good) is established to determine the quality of the case management. Qualitative data are also collected during the interview with the participants.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Professional working in an early intervention center treating first episodes of psychosis
Key inclusion criteria (2 listed)
- Professional working in an early intervention center treating first episodes of psychosis
- Professional involved in the organization/management of the center or practicing case management.
Key exclusion criteria (3 listed)
- Professional not working in the early intervention center
- Professional working in the early intervention center but not having a role in the organization or management of the center or as case manager
- Professional who does not take charge of people who have had a first psychotic episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of professional practicesEvaluation of professional practices : evaluation of the case management carried out in a program for early psychosis in France using a checklist according good practices guidelines | Other | – |
Primary outcome
conformity to TIDieR checklist in each center and for each case manager interviewed
Time frame: 1 year
TIDieR checklist Patient - Use of the case management manual (yes or no)
conformity to TIDieR checklist in each center and for each case manager interviewed
Time frame: 1 year
TIDieR checklist Patient - Use of specific and validated tools for Psychoeducation (yes or no)
conformity to TIDieR checklist in each center and for each case manager interviewed
Time frame: 1 year
TIDieR checklist Patient - Use of an information brochure on First Episode Psychosis (yes or no)
conformity to TIDieR checklist in each center and for each case manager interviewed
Time frame: 1 year
TIDieR checklist Patient - Use of specific and validated tools to support families (yes or no)
conformity to TIDieR checklist in each center and for each case manager interviewed
Time frame: 1 year
TIDieR checklist Patient - Use of specific and validated tools for Motivational Interviewing (yes or no)
conformity to TIDieR checklist in each center and for each case manager interviewed
Time frame: 1 year
TIDieR checklist Patient - Presence of Individualized Therapeutic Plan (ITP) supervision system (yes or no)
conformity to TIDieR checklist in each center and for each case manager interviewed
Time frame: 1 year
TIDieR checklist Patient - Use of Individualized Therapeutic Plan (ITP) supervision system (yes or no)
2 secondary outcomes
description of the global organisation of each center
Time frame: 1 year
description of their involvement in the early intervention center
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Episode Psychosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conformity to TIDieR checklist in each center and for each case manager interviewed (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.