Assertive Community Treatment (ACT) as Part of Integrated Care Versus Standard Care: a 12-month Trial in Patients With First- and Negatively Selected Multiple-episode Schizophrenia-spectrum Disorders Treated With Quetiapine IR
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Time to Service Disengagement
研究概览
简要总结
The study examined the 12-month effectiveness of continuous therapeutic assertive community treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with quetiapine IR.
详细描述
Two catchment areas in Hamburg, Germany with similar population size and health care structures were assigned to offer 12-month ACT (& IC; Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf) or SC (Asklepios Hospital, Department of Psychiatry and Psychotherapy) to 120 first-episode and negatively selected multiple-episode patients with SSD. Primary outcome was the time to Service Disengagement. Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, satisfaction with care from patients and relatives perspectives, and service use data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18-65 years
- •Met the diagnostic criteria of a first- or multiple episode of a schizophrenia spectrum disorders, i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder NOS
- •New initiation or current treatment with quetiapine Immediate Release (IR)
排除标准
- •Other psychotic disorders (e.g., due to medical condition)
- •Mental retardation (IQ lower than 70 points)
结局指标
主要结局
Time to Service Disengagement
时间窗: 12 months
The primary outcome of the study was the time to service disengagement (SD). This primary aim was chosen because the assertive approach of ACT is to prevent service disengagement3 and because service disengagement is a major predictor for relapse and thereby poor long-term outcome.16,17 Service disengagement was present, if a patient repeatedly refuses further treatment despite several attempts of reengagement (phone calls of patient and family in both treatment arms and potentially home visits in the ACT group).
次要结局
- Improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives(12 months)