Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Cross-Sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 731
- 试验地点
- 1
- 主要终点
- ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS)
研究概览
简要总结
Patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (ICD), which has repeatedly shown improved survival. However, living with an ICD may pose several challenges and affect quality of life (QoL). This prospective cross-sectional observational cohort studies will provide detailed insights in patient-reported QoL. The aim is to study the QoL perspective of patients who have an ICD, including physical and emotional health; ICD acceptance; concerns of ICD patients with regard to physical and sexual activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Age ≥ 18 years of age
- •Patients with any type of ICD followed in UZ Leuven
- •Willing and able to provide signed written informed consent
排除标准
- •Patients who are hospitalized
- •Patients with a mental disability
- •Patients already included in another interventional study
结局指标
主要结局
ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS)
时间窗: Cross-sectional at time of inclusion
The primary endpoint of the cross-sectional QoL-ICD study is the ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS). The FPAS began as a self-report survey with 47 items composed with the help of experts on psychosocial functioning in device patients, an expert in the field of psychometrics, and a cardiac electrophysiologist.2 Information obtained through surveys and interviews were used as guidelines for item construction. The result is an 18 question survey. Of these 18 questions, there are 3 filler items which are still relevant for ICD patients and the remaining questions cover 4 domains: (1) Return to Function; (2) Device-Related Distress; (3) Positive Appraisal; and (4) Body Image Concerns. Items are rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). Scale scores were calculated for each of the factors. By combining the scores for each question, a total FPAS score can be calculated.
次要结局
- - General QoL, including physical and emotional components, assessed using the Short Form Health Survey (SF-12)(Cross-sectional at time of inclusion)
- - Cardiac-specific QoL assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12).(Cross-sectional at time of inclusion)
- Florida Shock Acceptance score (FSAS)(Cross-sectional at time of inclusion)
- Steinke Sexual Concerns Inventory(Cross-sectional at time of inclusion)
- "Concept of a Good Death" questionnaire(Cross-sectional at time of inclusion)