Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-09 @ 2:35 AM
Study NCT ID:
NCT07258602
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-02
First Post:
2025-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-depth Interviews of Patients With ICDs
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
In-depth Interviews to Explore Patient and Partner/Caregiver Experiences, Unmet Needs, and Care Barriers in Patients With Implantable Cardioverter-defibrillators
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QoLICD-INSIGHT
Brief Summary:
Although ICDs are effective in preventing sudden cardiac death, they can also profoundly affect patients' and partner/caregivers' emotional well-being, social relationships, and daily functioning. Previous phases of the QoL-ICD project used patient-reported outcome measures (PROMs) and support group discussions to identify key domains affecting quality of life: patient education, physical health, psychological and social well-being, and end-of-life awareness. However, these methods have limitations in capturing the full depth and context of lived experience.
To complement and expand on these findings, this study uses in-depth, semi-structured interviews to explore how ICD patients and their partners interpret and navigate these challenges in their own words. Interviews provide a richer understanding of personal experiences, unmet needs, and barriers to care that are not easily measurable through questionnaires alone. Including both patients and their partners offers insight into relational dynamics and caregiving perspectives.
The primary objective of this study is to explore the lived experiences of ICD patients and their partners across four key domains:
* Patient education and information provision
* Physical health and activity
* Psychological and social well-being
* End-of-life considerations
To complement and expand on these findings, this study uses in-depth, semi-structured interviews to explore how ICD patients and their partners interpret and navigate these challenges in their own words. Interviews provide a richer understanding of personal experiences, unmet needs, and barriers to care that are not easily measurable through questionnaires alone. Including both patients and their partners offers insight into relational dynamics and caregiving perspectives.
The primary objective of this study is to explore the lived experiences of ICD patients and their partners across four key domains:
* Patient education and information provision
* Physical health and activity
* Psychological and social well-being
* End-of-life considerations
Detailed Description:
The investigators will ensure purposive sampling across key demographic and clinical variables which are available after a participant has expressed interest in the trial, with a minimum of 15 participants with ICD per subgroup (e.g., sex, age category, underlying cardiac condition). Data collection will continue until thematic saturation is reached within the overall cohort, followed by at least 5 additional interviews to confirm stability of themes. Subgroup representation is intended to capture relevant variation in lived experience and ensure applicability of findings across the ICD population. There is no subgroup analysis scheduled for partners as this cohort is considered secondary.
Predefined subgroups of interest:
* Sex
* Age: \<35 years; 35 to 65 years; and \> 65 years
* Underlying cardiac condition: congenital heart disease, hypertrophic cardiomyopathy, primary arrhythmia syndromes, Ischemic cardiomyopathy, Non-ischemic cardiomyopathy
* ICD shock history: appropriate ICD shock; inappropriate ICD shock; none
* Time since implantation: cut-off at 2 years
* ICD indication: primary vs secondary prevention
* Device type: single/dual/S-ICD vs cardiac resynchronization therapy
Predefined subgroups of interest:
* Sex
* Age: \<35 years; 35 to 65 years; and \> 65 years
* Underlying cardiac condition: congenital heart disease, hypertrophic cardiomyopathy, primary arrhythmia syndromes, Ischemic cardiomyopathy, Non-ischemic cardiomyopathy
* ICD shock history: appropriate ICD shock; inappropriate ICD shock; none
* Time since implantation: cut-off at 2 years
* ICD indication: primary vs secondary prevention
* Device type: single/dual/S-ICD vs cardiac resynchronization therapy
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: