Clinical Trial

In-depth Interviews of Patients With ICDs

Study acronym: QoLICD-INSIGHT
Enrolling by Invitation
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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
Trial Details
NCT Number NCT07258602
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Conditions Implantable Cardioverter Defibrillator (ICD)
Enrollment 250 participants
Start Date 2025-11-04
Primary Completion 2026-10 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-02