Implantation Sur Cinq Centres Médico-Psychologiques Franciliens du Parcours Socio-Sanitaire orienté Vers le Rétablissement (PASSVers2)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Patient self rating of recovery support by caregivers T12
研究概览
简要总结
Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures evolution during the implementation of recovery based intervention.
详细描述
This is a hybrid efficacy-implementation Type I recovery based interventional study based on a multicenter follow-up of a cohort of 300 patients with severe and persistent mental disorders (60 patients per center). The evolution of concepts and means of evaluation now allow a precise description of the mechanisms of recovery in all the diversity of its expression among patients, their entourages and the psychiatric facilities.
In the present study, the investigators aim to characterize simultaneously the patients' trajectories and the evolution of the care facilities and their professionals with respect to the principles of recovery. This double exploration should allow to build theoretical and practical references for the extension of this approach to other centers in France.
The study considers a dual timeline for data collection:
- The timeline associated with patients defined by the inclusion of each patient and extending to 24 months after, punctuated by an assessment at 12 months;
- The timeline of the inclusion centers and professionals involved in the rehabilitation projects defined by the beginning of the study and extending beyond the end of inclusion of the last patient, punctuated by annual intermediate evaluations of the means allocated by the structure and the positioning of the personnel in terms of recovery.
The intervention consists in a follow-up of the patients and their relatives by a psychiatric nurse and a social worker during 12 months. Both professionals, trained to rehabilitation and recovery principles, will focus on the patient's needs and goals in order to improve the outcome, quality-of-life and clinical status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a severe and persistent mental disorder among the following ICD10 compliant diagnostic categories:
- •Schizophrenia spectrum disorder (F2x)
- •Recurrent or persistent mood disorders (F30.x, F31.x, F33.x, F34.x, F38.x)
- •Psychological developmental disorders including autism spectrum disorders (F8x) and childhood and adolescent onset disorders (F9x)
- •Presence of an indication for inclusion in the rehabilitation project identified by the treating psychiatrist and endorsed in the inclusion session by the PASSVers staff.
- •Written consent from the patient or his/her legal representative to participate in the study.
排除标准
- •Presence of an not stabilized or progressive organic neurological pathology, neurodegenerative disease
- •Psychological or behavioral disorders mainly related to addictions with substances
- •Psychiatric disorders secondary to an organic pathology that is not stabilized or that is evolving
- •The following psychiatric situations are reasons for non-inclusion in the absence of an argued and collegial reassessment (the reason being that, although PASSVers2 must be considered as a first intention proposal in many situations meeting the inclusion criteria, it cannot intervene or be thought of as a "solution" to certain complex situations):
- •Psychiatric disorders caused by pregnancy or immediate postpartum
- •Severe borderline personality disorder
- •Current suicidal crisis
- •Extreme fragility of the patient with respect to changes that may be induced by the project, associated with a high risk of self or hetero-aggression.
- •Patient under justice constraint
- •Foreseeable departure from the geographic area, not allowing for certainty of further evaluation
- •Refusal of the patient to be followed by a social-health team (i.e. refusal of care or refusal of a dialogue on social aspects and projects).
结局指标
主要结局
Patient self rating of recovery support by caregivers T12
时间窗: 1 year
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Patient self rating of recovery support by caregivers and structure T12
时间窗: 1 year
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Patient self rating of recovery support by caregivers T0
时间窗: baseline
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Patient self rating of recovery support by caregivers and structure T0
时间窗: baseline
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Patient functioning T0
时间窗: baseline
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Psychotic symptoms T0
时间窗: baseline
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Psychotic symptoms T12
时间窗: 1 year
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Depression T12
时间窗: 1 year
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Clinical outcome T0: Clinically significant events
时间窗: baseline
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Patient self rating of recovery T24
时间窗: 2 years
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Patient functioning T12
时间窗: 1 year
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Patient self rating of quality of life T12
时间窗: 1 year
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Patient functioning T24
时间窗: 2 years
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Patient self rating of quality of life T0
时间窗: baseline
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Clinical outcome T12: Clinically significant events
时间窗: 1 year
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Patient self rating of recovery T12
时间窗: 1 year
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Patient self rating of quality of life T24
时间窗: 2 years
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Depression T0
时间窗: baseline
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Patient self rating of recovery T0
时间窗: baseline
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
次要结局
- Perceived needs T0(baseline)
- Sleep T0(baseline)
- Professional's Recovery opinions on patients T12(1 year)
- Stigmatization T0(baseline)
- Perceived needs T12(1 year)
- Cognitive disability T0(baseline)
- Professional's Recovery knowledge on patients T12(1 year)
- Professional's Recovery opinions on patients T0(baseline)
- Goal achievement T12(1 year)
- Metacognitive strategies T0(baseline)
- Entourage assessment of structure recovery orientation T0(baseline)
- Stigmatization T12(1 year)
- Sleep T12(1 year)
- Medication adherence T12(1 year)
- Illness severity T0(baseline)
- Illness severity T12(1 year)
- Entourage assessment of structure recovery orientation T12(1 year)
- Professional's Recovery knowledge on patients T0(baseline)
- Medication adherence T0(baseline)
- Cognitive disability T12(1 year)
研究者
Dr Christine PASSERIEUX
Principal Investigator
Versailles Hospital