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

NCT ID: NCT06654232

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

731 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Implantable Cardioverter Defibrillator (ICD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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quality of life questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S69417

Identifier Type: -

Identifier Source: org_study_id

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