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

NCT06654232 | Completed

• 1 other identifier: S69417
• Study Type: observational
• Target: 731
• 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 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.

Conditions

Implantable Cardioverter Defibrillator (ICD)

Keywords

implantable cardioverter defibrillator; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• - 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

Interventions

quality of life questionnaires OTHER

All patients will receive a combination of quality of life questionnaires aimed at 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: all
• 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 followed at UZ Leuven.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Study Design

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

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: November 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

BE (1)