Clinical trial Recruiting at 1 site Interventional Ages 18 and up

CHOICE-ICD: online education and support for people with an implantable cardioverter defibrillator

Official title: To Co-develop and Test an eHealth Intervention to Improve Knowledge, Attitude and Experience in Patients Living With an Implantable Cardioverter Defibrillator

Run by University of Ulster · NCT06667505 · Data updated 2026-11-12

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.

More Implantable Cardioverter Defibrillator (ICD) trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment256 (estimated)
SponsorUniversity of Ulster
Academic / other
Locations2 sites (Belfast, County Antrim and 1 other locations)
StatusRecruiting
StartedAugust 11, 2025
Main results expectedDecember 1, 2026
Study endsDecember 1, 2026
Registry record updatedMay 5, 2026
Trial IDNCT06667505 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Golden Jubilee National Hospital
    Glasgow, United Kingdom
    Recruiting
  • Belfast Health and Social Care Trust
    Belfast, County Antrim, United Kingdom
    Not yet 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.