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

November 28, 2025 updated by: Universitaire Ziekenhuizen KU Leuven
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
731

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS)
Time Frame: Cross-sectional at time of inclusion
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
- General QoL, including physical and emotional components, assessed using the Short Form Health Survey (SF-12)
Time Frame: Cross-sectional at time of inclusion

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).
Time Frame: Cross-sectional at time of inclusion
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)
Time Frame: Cross-sectional at time of inclusion
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
Time Frame: Cross-sectional at time of inclusion
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
Time Frame: Cross-sectional at time of inclusion
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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