A Randomized Controlled Trial Assessing the Efficacy of Remote Patient Monitoring in Patients Treated for a Moderate to Severe Major Depressive Episode
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 594
- 试验地点
- 6
- 主要终点
- Response rate over a 6-month period.
研究概览
简要总结
Mood disorders like depression and bipolar disorder are widespread and cause serious psychological, cognitive, and social impairments, with a high burden on healthcare systems. Edra PRO is a digital medical device developed to support clinical decision-making and remotely monitor symptoms in psychiatric patients. The EC-102 randomized controlled trial will evaluate its impact compared to usual care on symptoms, quality of life, healthcare costs, comorbidities, and user adherence and satisfaction.
详细描述
Mood disorders such as depression and bipolar disorder affect a large portion of the global population and cause significant psychological, cognitive, and functional impairments, along with high healthcare costs. Despite available treatments, sustained remission is hard to achieve, and many patients experience persistent symptoms and treatment side effects. Continuous remote monitoring could improve care and outcomes. Edra PRO is a digital medical device designed for remote symptom tracking and clinical decision support in psychiatry. The EC-102 randomized controlled trial will assess the impact of Edra PRO versus usual care on symptoms, quality of life, healthcare costs, comorbidities, and user satisfaction and adherence.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old) meeting ICD-11 criteria for a moderate to severe major depressive episode
- •Access to a personal smartphone and an internet connection, and cognitively able to use it independently
排除标准
- •Pregnant women
- •Individuals under legal guardianship or conservatorship
- •Ongoing alcohol or drug abuse considered likely to interfere with study participation, as judged by the investigator
- •Psychiatric or physical comorbidities (e.g., severe neurological or cardiovascular conditions) considered likely to interfere with participation or study results, at the discretion of the Principal Investigator
研究组 & 干预措施
Intervention
Edra PRO
干预措施: Edra PRO (Device)
Control
Standard care
结局指标
主要结局
Response rate over a 6-month period.
时间窗: Month 6
Difference in response rates (%) between the intervention group and the control group
次要结局
- Safety and absence of defects in Edra PRO over a 6-month period(Month 6)
- Impact of Edra PRO versus usual care on patients' quality of life(Month 6)
- Safety and absence of defects in Edra PRO over a 6-month period(Month 6)
- Impact of Edra PRO versus usual care on patients' quality of life(Month 6)
- Medico-economics impact of Edra PRO versus usual care(Month 6)