Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Longitudinal Observational Study

NCT06654284 | Enrolling By Invitation

• 1 other identifier: S69418
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Implantable Cardioverter Defibrillator (ICD)

Keywords

quality of life; Implantable Cardioverter Defibrillator (ICD)

Outcome Measures

Primary Outcomes (1)

• General QoL assessed using the Short Form Health Survey (SF-12)

  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.

  baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years

Secondary Outcomes (5)

• - 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

Interventions

quality of life questionnaires OTHER

All patients will receive a combination of quality of life questionnaires aimed at predeifined time points (baseline, 3 months, 1 year, 3 year, 6 year, 9 year and 12 year) collecting a complete overview of different aspects of quality of life, including: - Florida patient acceptance score (FPAS) - Short Form Health Survey (SF-12) - Kansas City Cardiomyopathy Questionnaire (KCCQ-12) - Hospital Anxiety and Depression Scale (HADS) - Florida Shock Acceptance score (FSAS) - Steinke Sexual Concerns Inventory - the "Good Death" questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with any type of implantable cardioverter-defibrillator implanted and followed at UZ Leuven.

You may qualify if:

• 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.

You may not qualify if:

• Patients with a mental disability

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Belgium

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: September 18, 2025
• Primary Completion (Estimated): December 1, 2042
• Study Completion (Estimated): December 1, 2042
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

BE (1)