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To Co-Develop And Test An EHealth Intervention To Improve Knowledge, Attitude And Experience In Patients Living With An Implantable Cardioverter Defibrillator

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Actively Recruiting
Phase Not Applicable
Age: 18 Years +
All Genders
ID: 06667505
To Co-develop and Test an eHealth Intervention to Improve Knowledge, Attitude and Experience in Patients Living With an Implantable Cardioverter Defibrillator
Led by University of Ulster
Updated on: 2026-05-05
Participants Needed: 256
Research Sites: 2
Total Duration: N/A
On this page
- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- Research Team
- How is the study designed?
- Similar Trials
- Frequently Asked Questions
- Sponsors
AI-Summary
What This Trial Is About
This research aims to co-develop and test an online educational resource called CHOICE-ICD for patients living with or awaiting an implantable cardioverter defibrillator (ICD). The study focuses on providing easy-to-understand information through games, quizzes, animations, virtual reality, and patient videos to reduce anxiety and improve quality of life. The study involves collaboration with patients, family members, and healthcare professionals to design a patient-centered resource. Participants will be randomly assigned to two groups: one group will receive access to the CHOICE-ICD app alongside an information booklet, and the other group will receive only the information booklet as part of usual care. The intervention lasts for 3 months, during which patients and family members will engage with the app's interactive features, including videos, animations, a discussion forum, and a diary function for appointments. The study includes an ongoing phase to optimize and test the feasibility and acceptability of the CHOICE-ICD resource. During the study, participants will complete questionnaires and participate in interviews at baseline, 3 months, and 6 months to evaluate their perceptions, concerns, knowledge, attitudes, anxiety, acceptance of the ICD, quality of life, and caregiver burden. Researchers will assess recruitment, consent, randomization rates, and intervention usability. The total participation spans at least 6 months, including follow-up assessments to measure the intervention's impact and trial feasibility.
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CONDITIONS
Brief Title
To Test an e-Health Educational Intervention for Patients With an ICD
Who Can Participate
Age: 18 Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with heart failure awaiting or with an implantable cardioverter defibrillator (no time restriction on implantation)
- No cognitive impairment
- Caregivers who have contact with the patient at least 5 times per week
- Caregivers who are physically and mentally capable of participation (self-assessment)
- Healthcare professionals involved in daily care of patients with heart failure and an implantable cardioverter defibrillator, and involved in care using the CHOICE-ICD intervention
You will not qualify if you...
- Patients judged by their Cardiologist as physically or mentally unsuitable to complete the study
- Patients or caregivers lacking capacity to give consent
- Patients who have known pregnancy
- Caregivers whose patient is unwilling to participate
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 3 months
Participants use the CHOICE-ICD eHealth intervention app and receive educational materials to improve their knowledge, attitude, and experience living with an implantable cardioverter defibrillator (ICD).
Baseline visit and follow-up visits at 3 and 6 months
Trial Site Locations
Total: 2 locations
-
Golden Jubilee National Hospital
- Glasgow, United Kingdom
- Actively Recruiting
-
Belfast Health and Social Care Trust
- Belfast, County Antrim, United Kingdom, BT53 6UE
- Not Yet Recruiting
Research Team
- Loreena M Prof Loreena M Hill, PhD
- Lana Dr Lana Dixon, MD
How is the study designed?
Study Type
- INTERVENTIONAL
Masking
- NONE
Allocation
- RANDOMIZED
Model
- PARALLEL
Primary Purpose
- HEALTH_SERVICES_RESEARCH
Number of Arms
- 2
Frequently Asked Questions
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On this page
- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- Research Team
- How is the study designed?
- Similar Trials
- Frequently Asked Questions
- Sponsors
Sponsors
- University of Ulster
- Lead Sponsor
- Belfast Health and Social Care Trust
- Collaborating Sponsor
- Golden Jubilee National Hospital
- Collaborating Sponsor
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