Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Cross-Sectional Observational Study (QoL-ICD I)

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.

Study Overview

• Status: Completed
• Conditions: Implantable Cardioverter Defibrillator (ICD)
• Intervention / Treatment: Other: quality of life questionnaires

• Study Type: Observational
• Enrollment (Actual): 731

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Age ≥ 18 years of age
• Patients with any type of ICD followed in UZ Leuven
• Willing and able to provide signed written informed consent

Exclusion Criteria:

• Patients who are hospitalized
• Patients with a mental disability
• Patients already included in another interventional study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS)	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.	Cross-sectional at time of inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- General QoL, including physical and emotional components, 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.	Cross-sectional at time of inclusion
- Cardiac-specific QoL assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12).	Cardiac-specific QoL assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The KCCQ-12 is a shortened, but validated version of the KCCQ-23, and measures symptoms, physical and social limitations, and quality of life in patients with heart failure.3 The 12 questions have variable answer options, but all are based on a Likert scale. KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.	Cross-sectional at time of inclusion
Florida Shock Acceptance score (FSAS)	Florida Shock Acceptance score (FSAS) The FSAS is intended to measure ICD shock anxiety.4 The measure was designed by an interdisciplinary team including electrophysiology and clinical psychology. Items were based on clinical experience with ICD patients. The scale itself consists of 10 items which respondents rate on a five-point Likert scale ranging from 1 (not at all) to 5 (all of the time). The score of the FSAS is determined by summing the items with higher values representing greater shock anxiety and lower values representing lower shock anxiety.	Cross-sectional at time of inclusion
Steinke Sexual Concerns Inventory	Steinke Sexual Concerns Inventory (SSCI, general cardiac version) The SSCI is an instrument that consists of 9 items reflecting change in the sexual relationship, sexual fears, change in sexual interest, symptoms associated with sexual activity, sexual dysfunction and any other sexual concerns.5 The items are rated on a scale of 0 to 3, where 0 indicates 'never' and 3 indicates 'frequently'. Higher scores indicate greater sexual concerns. Based on previous research, three potential subscales (sexual fears, symptoms, sexual dysfunction) were identified among the items.	Cross-sectional at time of inclusion
"Concept of a Good Death" questionnaire	The Concept of a Good Death measures three distinct domains, reflecting the psychosocial/spiritual, physical, and clinical aspects of a good death. The surveys comprises 17 questions on a 4-point Likert scale ranging from 'not at all' to 'essential'.	Cross-sectional at time of inclusion

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; implantable cardioverter defibrillator
• Other Study ID Numbers: S69417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No