Heart-focused Anxiety in Patients With Implantable Cardioverter Defibrillator (ICD) and/or Mechanical Cardiovascular Assist Device (AD) (Anxiety-CHF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Extent of heart-focused anxiety before and change after ICD implantation
研究概览
简要总结
The aim of the present study is to measure heart-focused anxiety, general anxiety, depression, PTSD and quality of life as well as type D personality in patients with heart failure before and after the implantation of a cardioverter defibrillator (ICD) and/or assist device (AD).
详细描述
In patients with heart failure and implantable Cardioverter Defibrillator (ICD) psychological comorbidities such as heart focused anxiety and depression often occur. These psychological factors may have negative effects on compliance as well as on the development of the cardiac disease and therefore on rehospitalization and mortality rates.
A personality structure where negative affect is paired with social inhibition (the inability to communicate ones feelings to others) can often be found in patients with cardiovascular disease. This so-called type D personality is also associated with a worse prognosis.
It is of interest whether, and if so in what way, the implantation of an ICD can affect the psychological well-being and through that the prognosis of the heart failure patient.
The goal of this study is therefore to investigate the effect of ICD implantation on heart-focused anxiety, depression, possible traumatization and quality of life in patients with heart failure with consideration of a possible moderating effect of the type D personality.
Furthermore, the impact of the above stated psychological factors on rehospitalization and mortality, as well as on frequency of shocks shall be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heart failure, indication for an implantable Cardioverter Defibrillator
排除标准
- •psychosis; advanced dementia; drug abuse
结局指标
主要结局
Extent of heart-focused anxiety before and change after ICD implantation
时间窗: From baseline before ICD implantation to 24 months after implantation
Heart-focused anxiety is measured through the use of the Cardiac Anxiety Questionnaire. All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.
Extent of general anxiety and depression before and change after ICD implantation
时间窗: From baseline before ICD implantation to 24 months after implantation
General anxiety and depression are recorded with the Hospital Anxiety and Depression Scale. All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.
Number of patients affected by PTSD before and after ICD implantation
时间窗: From baseline before ICD implantation to 24 months after implantation
The Impact of Event Scale (revised) is used to evaluate the possibility of a post-traumatic stress disorder (PTSD). All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.
Quality of life before and change after ICD implantation
时间窗: From baseline before ICD implantation to 24 months after implantation
Quality of life is documented through the Minnesota Living With Heart Failure Questionnaire. All questionnaires will be filled out at baseline (before device implantation) as well as 5, 12 and 24 months after implantation.
次要结局
- Impact of type D personality on heart-focused anxiety(For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation)
- Influence of general anxiety and depression in rehospitalization and morbidity(Baseline to 24 months after implantation.)
- Influence of quality of life on rehospitalization and morbidity(Baseline to 24 months after implantation.)
- Effect of ICD-shocks on heart-focused anxiety and effect of heart-focused anxiety on frequency of shocks(Baseline to 24 months after implantation.)
- Effect of ICD-shocks on general anxiety and depression and effect of general anxiety and depression on frequency of shocks(Baseline to 24 months after implantation.)
- Impact of type D personality on numbers of shocks.(For type D: Baseline and for number of shocks: from ICD implantation to 24 months after implantation.)
- Impact of type D Personality on rehospitalization and morbidity.(For type D: Baseline and for rehospitalization and morbidity: from implantation until 24 months after implantation..)
- Effect of ICD-shocks on quality of life and effect of quality of life on frequency of shocks(Baseline to 24 months after implantation.)
- Impact of type D personality on quality of life.(For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation.)
- Impact of type D personality on general anxiety and depression(For type D: Baseline and for the psychological variables: from baseline before ICD implantation to 24 months after implantation.)
- Impact of type D personality on PTSD.(For type D: Baseline and for the psychological variable: from baseline before ICD implantation to 24 months after implantation.)
- Influence of heart-focused anxiety on rehospitalization and morbidity(Baseline to 24 months after implantation.)
研究者
Ingird Kindermann (PD Dr. med)
Prof. Dr. med.
University Hospital, Saarland