ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder
研究概览
简要总结
Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will decrease the number of hospitalizations in patients with schizophrenia or schizoaffective disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction of the total number of hospitalizations due to relapse of psychosis at the end of the 12-months follow-up period in the active ITAREPS group compared to the control (treatment-as-usual) group.
详细描述
Title of Study:
ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia.
Estimated Number of Study Centers and Countries:
30-40 outpatient psychiatrists in the Czech Republic and in the Slovak Republic.
Research Hypothesis:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women, ages 18 to 60 years, inclusive. Earliest inclusion day is the 18th birthday and the latest is the day before the 61st birthday.
- •A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
- •Increased risk for relapse, defined as having at least 1 psychiatric hospitalization for psychosis within the past 3 years and at least 2 psychiatric hospitalizations for psychosis in total (i.e. ≥ 2 hospitalizations).
- •Clinical Global Impression scale - Severity (CGI-S) ≤ 3 at study Visit
- •All patients must be on stable doses of antipsychotic medication during the study entry.
- •Absence of organic mental disorder, mental disorder due to psychoactive substance use or mental retardation.
- •Presence of a cooperating family member, caregiver or other person who is in frequent contact with the patient (at least 4 times a week) and who is willing to participate in the trial.
- •Signed written informed consent. The informed consent process must be documented by signing the informed consent form prior to any study-related procedures.
- •Eligibility for mobile phone communicating.
排除标准
- •Participation in another relapse prevention program or another interventional clinical trial will be prohibited during the entire participation in the study. Subjects enrolled in observational (non-interventional) trials are not excluded from this study.
- •Hayward compliance rating scale score < 2 at Visit 1.
研究组 & 干预措施
A
In the active-ITAREPS group, the e-mail ALERT message feedback to the investigator will be activated. The core study intervention was 20% antipsychotic dose increase within 24 hours in response to a Pharmacological Intervention Requiring Event (PIRE) defined as either: A) the receipt of any INITIAL ALERT (IA) e-mail. A dose increase was obligatory in such cases regardless of the current clinical status of the patient; or B) the receipt of an ALERT EMERGENCY (AE) e-mail after which the investigator confirmed clinical worsening via phone contact with the patient. AE is defined as further worsening in EWSQ scores during 3 week period after announcement of IA.
干预措施: antipsychotic dose increase (Drug)
TAU
In the treatment-as-usual study arm (control, non-active ITAREPS), the e-mail ALERT message feedback will not be activated. In this group, even in the presence of early warning sings, the investigators will be kept blinded to the EWSQ scores, will receive no ALERT message and thus no early pharmacologic intervention based on the ITAREPS program will be prompted. Treatment in the control group will consist of routine clinical and medication management with the frequency of visits common in the outpatient clinical settings. There will be no intevention based on ITAREPS.
干预措施: no intervention (Other)
结局指标
主要结局
The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder
时间窗: November 2008-November 2009
次要结局
- EWSQ 10P and 10FM sensitivity, specificity, positive predictive value(November 2008-November 2009)
- No. of hospitalization days(November 2008-November 2009)
- Assessment of the natural course of the psychotic illness(November 2008-November 2009)
- Correlation between baseline CGI and the No. of hospitalizations at the endpoint(November 2008-November 2009)
研究者
Filip Spaniel, M.D., Ph.D
MD
Prague Psychiatric Center