The Effect of add-on Tele Medicine Monitoring of Medication Adherence, on the Risk of Re-hospitalisation of Ambulatory Schizophrenic Patients. an Open, Prospective, Randomised Controled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Time to re-hospitalisation
研究概览
简要总结
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse.
详细描述
Schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. Although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. This study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse. The study is an uni center, open, prospective, randomised and controlled.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM 4 diagnosis of schizophrenia or schizoaffective
- •able to give written informed consent
- •Have a telephone line
排除标准
- •Are not discharged to a place with routine medication monitoring
- •Are not discharged under forced ambulatory treatment order
- •Are not homeless
- •Are not admitted due to drug intoxication or withdrawal.
- •Are not admitted due to severe self harm.
结局指标
主要结局
Time to re-hospitalisation
时间窗: 1 year
Time to re-hospitalisation will be compared in the study group and in the control group during the follow-up period of up to one year
次要结局
- number of re-hospitalisations(1 year)