Prospective, Randomized, Open, Controlled Study With Information and Telecommunication Technology-aided Relapse Prevention Program in Schizophrenia.
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group.
研究概览
简要总结
THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for schizophrenia and schizoaffective disorder by means of simple, highly cost-effective information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study duration, patients in the active group enrolled in ITAREPS will demonstrate statistically significantly reduced risk of hospitalization, decreased number of hospitalization days and reduced direct inpatient costs in comparison to control group not using the program.
详细描述
The ITAREPS 2.0 program employs telecommunication and information technologies in order to detect fluctuations in longitudinal mental health status of patient with schizophrenia and thus signalize the very early stages of prodromes preceding relapse. This approach opens an avenue towards early pharmacological intervention. Subjects (150 patients with diagnosis of schizophrenia and schizoaffective disorder and their family members) will be randomized at a 1:1 ratio into the active or control group. Participants from the active group will be completing two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request generated automatically by the system during 18 months study duration. In this group, automatically generated e-mail alert message feedback to the investigator will be activated in case of prodrome detection, prompting investigator to antipsychotic dose increase by 20%. The control (treatment-as-usual) group will not use ITAREPS system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For entry into the study, the following criteria MUST be met:
- •Men and women, ages 18 to 60 years, inclusive.
- •A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
- •Having at least TWO psychiatric hospitalization for psychosis before the study enrollment.
- •Severity (CGI-S) ≤ 3 at study Visit
- •All patients must be on stable doses of antipsychotic medication during the study entry.
排除标准
- •Organic mental disorder,
- •mental disorder due to psychoactive substance use or mental retardation.
- •Participation in another relapse prevention program.
- •Hayward compliance rating scale score < 2 at Visit 1.
结局指标
主要结局
Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group.
时间窗: 18 months
次要结局
- Number of psychiatric hospitalization days(18months)
- Direct impatient costs(18months)
- Direct cost of outpatient antipsychotic medication(18months)
- Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups(18months)
研究者
Filip Spaniel, M.D., Ph.D
MD
Prague Psychiatric Center