Идёт набор NCT05036590

Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.

Без фазы С лечением Schizophrenia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: control group, Intervention group.
Кому может быть актуально: Состояния в реестре: Schizophrenia. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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.

Обзор

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.

Подробное описание

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

Вмешательства

Другое control group
The control group consisted of caregivers included during the control period, before the intervention was deployed, i.e., before the BREF program was implemented by the centers.
Другое Intervention group
The intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.

Первичные конечные точки

Changes in the severity of caregiver burden between V1 and V4 by the Zarit Burden Inventory scale (ZBI) [Срок оценки: one year]

Вторичные конечные точки (12)

Changes in caregiver burden severity at V1,V2 and V3 by the Zarit Burden Inventory (ZBI) scale [Срок оценки: 8 months]
Evolution of the caregivers' perceived-stress between V1, V2, V3, V4 by the Perceived Stress Scale-14 (PSS-14) [Срок оценки: one year]
Evolution of the caregivers' mood between V1, V2, V3, V4 by the Center for Epidemiologic Studies-Depression Scale (CES-D) [Срок оценки: one year]
Evolution of the caregivers' family functioning between V1, V2, V3, V4 [Срок оценки: one year]
Evolution of the caregivers' quality of life between V1, V2, V3, V4 [Срок оценки: one year]
Evolution of the caregivers' sense of competence between V1, V2, V3, V4 [Срок оценки: one year]
Evolution of the caregivers' number of consultations with the general practitioner (GP) [Срок оценки: 12 months period before baseline assessment versus 12 months period after baseline assessment]
Evolution of the caregivers' number of days off work [Срок оценки: 12 months period before baseline assessment vs. 12 months period after baseline assessment]
Evolution of the caregivers' number of days on long-term leave or disability [Срок оценки: 12 months period before baseline assessment vs. 12 months period after baseline assessment]
Evolution of the caregivers' number of work days [Срок оценки: 12 months]
Evolution of the caregivers' willingness to pay someone to replace them in their caring activities during one hour [Срок оценки: 12 months]
Evolution of the caregivers' number of suicide attempts assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [Срок оценки: 12 months period before baseline assessment vs. 12 months period after baseline assessment]

Критерии участия

Критерии включения

people over 18yo
first-degree relatives (parents, siblings, children) or spouse of the patient
primary caregiver of a patient with schizophrenic disorders or first psychotic episode (DSM5)
consenting to participate to the study