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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:
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semi-structured interview | Other | Patients with an ICD and partner/caregivers will be invited for semi-structured interviews interviews to explore how ICD patients and their partners/caregivers 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Thematic saturation across interviews of the 4 predefined domains | This qualitative study has descriptive and thematic endpoints, not statistical. The primary endpoint is defined as thematic saturation across interviews regarding 4 predefined domains: patient education and information provision, physical health and activity, psychological and social well-being, and end-of-life considerations. Thematic saturation indicates that the data collected sufficiently captures the full range of relevant experiences, perspectives, and needs of ICD patients and their partners. To track thematic saturation a saturation grid and theme tracking table will be used. A saturation grid tracks the appearance of themes and documents: (1) themes present in each interview; (2) when new themes emerge; (3) when previously identified themes are reinforced. Theme tracking tables summarize the progress by coding the number of new themes. Thematic saturation is reached when 5 consecutive interviews fail to produce any new themes after a minimum of 15 interviews per subgroup. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with any type of implantable cardioverter-defibrillator followed at UZ Leuven and their partners or primary caregivers.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
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