Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05036590
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2021-08-05
Brief Title:
Efficiency Assessment of BREFORM A Multicentric Stepped-wedge Randomized Control Trial
Sponsor:
Hôpital le Vinatier
Organization:
Hôpital le Vinatier
Study Overview
Official Title:
Efficiency Assessment of a Mental Health Professionals Training Course for a Short Psychoeducational Program BREF for Families and Caregivers of Patients With Schizophrenia or First Psychotic Episode
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREFORM
Brief Summary:
In psychiatry caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment For single-family psychoeducation the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3 For caregivers psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies Therefore international recommendations recommend that psychoeducation for caregivers be systematic early and integrated into routine care
Currently the organization of the French care system does not allow these recommendations to be met In order to increase the use of psychoeducation in France early interventions for caregivers must be offered systematically The effectiveness of early psychoeducation for caregivers needs to be evaluated only three randomized controlled trials are available in the literature and none have been conducted in France
Currently the organization of the French care system does not allow these recommendations to be met In order to increase the use of psychoeducation in France early interventions for caregivers must be offered systematically The effectiveness of early psychoeducation for caregivers needs to be evaluated only three randomized controlled trials are available in the literature and none have been conducted in France
Detailed Description:
The BREFORM project proposes to train health professionals in an early psychoeducation program the BREF program in order to implement it in their structure and to evaluate its impact on the burden of caregivers of users living with a first psychotic episode or a schizophrenic disorder
Regarding caregivers outcomes
outcome measures will be assessed at baseline visit 1 V1 6 weeks Visit 2 V2 6 months Visit 3 V3 12 months Visit 4 V4 after baseline in the active group and in the treatment as usual group
Regarding patients outcomes
outcome measures will be assessed at baseline and 12 months after baseline in the active group and in the treatment as usual group
Regarding mental health professionals outcomes
outcome measures will be assessed before after and 16 months after the training course
Regarding the psychiatric departments outcomes
outcome measures will be assessed at baseline and 36 months after baseline
Regarding caregivers outcomes
outcome measures will be assessed at baseline visit 1 V1 6 weeks Visit 2 V2 6 months Visit 3 V3 12 months Visit 4 V4 after baseline in the active group and in the treatment as usual group
Regarding patients outcomes
outcome measures will be assessed at baseline and 12 months after baseline in the active group and in the treatment as usual group
Regarding mental health professionals outcomes
outcome measures will be assessed before after and 16 months after the training course
Regarding the psychiatric departments outcomes
outcome measures will be assessed at baseline and 36 months after baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None