Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Longitudinal Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- General QoL assessed using the Short Form Health Survey (SF-12)
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 longitudinal observational cohort studies will provide detailed insights in the change of patient-reported QoL after ICD impalntation. The aim is to study the change in time of 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
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age
- •Patients either scheduled for a new ICD implantation or scheduled for an elective generator change
- •Willing and able to provide signed written informed consent.
排除标准
- •Patients with a mental disability
结局指标
主要结局
General QoL assessed using the Short Form Health Survey (SF-12)
时间窗: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
General QoL assessed using the Short Form Health Survey (SF-12) The SF-12 measures the experienced health or health-related quality of life. The SF-12 is a shortened version of the longer SF-36. This questionnaire consists of twelve items, divided into eight subcategories: \- General Health * Physical Functioning * Role Physical * Role Emotional * Bodily Pain * Mental Health * Vitality * Social functioning For each subcategory, a score between 0 and 100 is calculated using an available key. This score can then be compared to an available normative population. Average values below 50 indicate poorer physical/mental health compared to that normative population, while values above 50 indicate better health.
次要结局
- - Cardiac-specific QoL assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years)
- Florida Shock Acceptance score (FSAS)(baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years)
- ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS)(baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years)
- Steinke Sexual Concerns Inventory(baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years)
- "Concept of a Good Death" questionnaire(baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years)