NCT02976961已完成不适用
A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and CaRE of Patients with an Implantable Cardioverter Defibrillator
Susanne Schmidt Pedersen5 个研究点 分布在 1 个国家目标入组 478 人开始时间: 2017年2月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 478
- 试验地点
- 5
- 主要终点
- Device acceptance
研究概览
简要总结
This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Patients with a first-time ICD or CRT-D
- •≥18 years of age
排除标准
- •Subcutaneous ICD
- •Upgrade from a pacemaker to ICD or CRT
- •History of psychiatric illness other than affective/anxiety disorders
- •Cognitive impairments (e.g. dementia)
- •Left ventricular assist device (LVAD) or upcoming LVAD implant
- •Under evaluation or on the waiting list for heart transplantation
- •No e-mail address
- •Inability to manage or cope with computer technology
- •Insufficient knowledge of the Danish language
- •Participation in other randomized controlled trials unless of a technical nature
- •Irresponsible to ask patient to participate according to GCP
研究组 & 干预措施
Intervention
Experimental
Implantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge
干预措施: Supportive care (Other)
Usual care
No Intervention
Implantable cardioverter defibrillator implant + usual care
结局指标
主要结局
Device acceptance
时间窗: 12 months
Measured with the Florida Patient Acceptance Survey (FPAS)
次要结局
- Time to mortality(12 and 24 months)
- Health status (generic)(12 and 24 months)
- ICD patient concerns (ICDC)(12 and 24 months)
- Symptoms of depression(12 and 24 months)
- Health status (heart failure specific)(12 and 24 months)
- Return to work(12 and 24 months)
- Time to first hospitalization due to a cardiac cause(12 and 24 months)
- Patient empowerment (ICD-EMPOWER)(12 and 24 months)
- Symptoms of anxiety(12 and 24 months)
- Time to first ICD therapy(12 and 24 months)
- Cost-effectiveness(12 and 24 months)
研究者
Susanne Schmidt Pedersen
Professor
University of Southern Denmark
研究点 (5)
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