Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Mini International Neuropsychiatric Interview score
研究概览
简要总结
This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.
详细描述
The implantation of an ICD in primary prevention is known to increase the rates of anxiety and depression, which can reach up to 45% and 35% respectively in this patient population. Several studies have reported that psychological accompaniment for these patients can alleviate the symptoms of anxiety and/or depression. Therefore, we aim to investigate the utility of psychological follow-up for a period of 1 year after first implantation of an ICD for primary prevention.
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
- None
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
- •adult patients (aged 18 years or over)
- •indication for implantation of an ICD for primary prophylaxis
- •written informed consent provided
- •patients with social security coverage
排除标准
- •patients under legal tutorship or guardianship
- •patients with no social security coverage
- •patients still within the exclusion period after participation in another clinical trial, as indicated by the national registry of clinical trial volunteers
- •patients unable to complete the questionnaires (language barriers, mentally deficient, illiteracy or dementia)
- •patients awaiting heart transplant
- •patients who refuse to provide written informed consent
研究组 & 干预措施
Psychological follow-up
Patients undergoing implantation of an ICD for primary prevention will have an individual interview with a qualified psychologist in addition to standard medical follow-up.
干预措施: Individual interview with a qualified psychologist (Other)
Control
Patients undergoing implantation of an ICD for primary prevention will have standard medical follow-up.
结局指标
主要结局
Mini International Neuropsychiatric Interview score
时间窗: 12 months after implantation
Mini International Neuropsychiatric Interview score
时间窗: 2 weeks after implantation
Mini International Neuropsychiatric Interview score
时间窗: 48 hours after implantation
Mini International Neuropsychiatric Interview score
时间窗: 2 months after implantation
Mini International Neuropsychiatric Interview score
时间窗: 4 months after implantation
Mini International Neuropsychiatric Interview score
时间窗: 6 months after implantation
次要结局
- Quality of life(12 months after implantation)
- State-Trait Anxiety Inventory(12 months after implantation)
- Minnesota Living with Heart Failure questionnaire(12 months after implantation)
- Quality of life(48 hours after implantation)
- Quality of life(2 weeks after implantation)
- Quality of life(2 months after implantation)
- Quality of life(4 months after implantation)
- Quality of life(6 months after implantation)
- State-Trait Anxiety Inventory(48 hours after implantation)
- State-Trait Anxiety Inventory(2 weeks after implantation)
- State-Trait Anxiety Inventory(2 months after implantation)
- State-Trait Anxiety Inventory(4 months after implantation)
- State-Trait Anxiety Inventory(6 months after implantation)
- Minnesota Living with Heart Failure questionnaire(48 hours after implantation)
- Minnesota Living with Heart Failure questionnaire(2 weeks after implantation)
- Minnesota Living with Heart Failure questionnaire(2 months after implantation)
- Minnesota Living with Heart Failure questionnaire(4 months after implantation)
- Minnesota Living with Heart Failure questionnaire(6 months after implantation)