CHOICE-ICD: online education and support for people with an implantable cardioverter defibrillator
To Co-develop and Test an eHealth Intervention to Improve Knowledge, Attitude and Experience in Patients Living With an Implantable Cardioverter Defibrillator
This project will test an online education and support program (CHOICE-ICD) for people awaiting or recently fitted with an ICD and their families to help lower anxiety and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulster Academic / other |
| Locations | 2 sites (Belfast, County Antrim and 1 other locations) |
| Trial ID | NCT06667505 on ClinicalTrials.gov |
What this trial studies
CHOICE-ICD is a co-designed eHealth intervention that combines written information, short patient videos, animations, games/quizzes and a virtual reality application to teach people about living with an ICD. The program was developed with patients, family members, clinicians and an international advisory group, then optimized through user testing. In a pilot randomized design, about 128 patients awaiting or recently implanted with an ICD (or CRT-D) in Belfast and Glasgow will be offered the resource to use for three months alongside usual care. Key outcomes are feasibility and acceptability, including recruitment, consent and randomization rates, and questionnaire completion at baseline, 3 and 6 months to inform a future effectiveness trial.
Who should consider this trial
Good fit: Ideal candidates are adults with heart failure who are awaiting or have recently received an ICD (or CRT-D) and have no cognitive impairment and capacity to consent.
Not a fit: Patients judged by their cardiologist as physically or mentally unsuitable, those lacking capacity to consent, or those without regular caregiver contact or internet access may not benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could reduce ICD-related anxiety and improve patients' confidence and quality of life by providing accessible, tailored education and support.
How similar studies have performed: Previous education interventions for ICD patients have shown reductions in anxiety and improved quality of life, but the fully integrated eHealth package with VR and interactive elements is novel and has not been tested at scale.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with heart failure awaiting or with an ICD (no time restriction on implantation) * No cognitive impairment Caregivers: * Have contact with the patient at least 5 times per week. * Be physically and mentally capable of participation (self-assessment) Healthcare professionals: * Daily care of patients with heart failure and an implantable cardioverter defibrillator * Involved in the care of a patient using the Choice-ICD intervention Exclusion Criteria: * 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 who's patient is unwilling to take participate
Where this trial is running
Belfast, County Antrim and 1 other locations
- Belfast Health and Social Care Trust — Belfast, County Antrim, United Kingdom (Not_yet_recruiting)
- Golden Jubilee National Hospital — Glasgow, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Loreena M Hill, PhD — Ulster University
- Study coordinator: Loreena M Prof Loreena M Hill, PhD
- Email: l.hill@ulster.ac.uk
- Phone: +44 7841037404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.