In-depth Interviews of Patients With ICDs

NCT07258602 | Enrolling By Invitation

• 1 other identifier: S71109
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Implantable Cardioverter Defibrillator (ICD)

Keywords

quality of life; implantable cardioverter defibrillator (ICD)

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with any type of implantable cardioverter-defibrillator followed at UZ Leuven and their partners or primary caregivers.

You may qualify if:

• Adult (≥18 years) with an implanted ICD for either primary or secondary prevention of sudden cardiac death.
• At least 3 months have passed since ICD implantation.
• Sufficient cognitive ability and fluency in Dutch to provide informed consent and actively participate in the interview.
• Willing and able to participate in a one-time, individual in-depth interview of 30 to 60 minutes.

You may not qualify if:

• Current active severe psychiatric disorder or cognitive impairment that would interfere with meaningful participation as based on the medical history..
• Inability to provide informed consent due to legal, cognitive, or communicative limitations.
• Medical instability or terminal illness that, in the opinion of the treating physician or research team, precludes participation.
• Participation in another interventional trial that may influence psychological or behavioral outcomes relevant to this study.
• Participation in the QoL-ICD II trial with longitudinal QoL assessment.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 2, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

BE (1)