Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Longitudinal Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Implantable Cardioverter Defibrillator (ICD)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- General QoL assessed using the Short Form Health Survey (SF-12)
- Status
- Enrolling By Invitation
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients with a mental disability
Outcomes
Primary Outcomes
General QoL assessed using the Short Form Health Survey (SF-12)
Time Frame: 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.
Secondary Outcomes
- - 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)