NCT06667505 To Test an e-Health Educational Intervention Patients With an ICD
| NCT ID | NCT06667505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ulster |
| Condition | Implantable Cardioverter Defibrillator (ICD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2025-08-11 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2025-08-11 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Role of the implantable cardioverter defibrillator (ICD) is to monitor heart rate and discharge a small electrical discharge or shock if the heart rate becomes life threatening. Patients and family members have requested more information about their ICD, how it works and how to live well with the device. This study will build on previous research by designing, in collaboration with patients, family members and professionals, an online resource to provide important information that can lower anxiety and concerns, and improve quality of life. The CHOICE-ICD resource will be easy to use, incorporating games and quizzes to encourage engagement, up to date information appropriate to each patient's needs, as well as animation clips, virtual reality, and short patient videos. CHOICE-ICD will be made available to 64 patients, in addition to normal care, awaiting or with a recently implanted ICD in Belfast and Glasgow. Patients will use the resource for 3 months. Patients and family members will then be asked to complete questionnaires and participate in semi-structured interviews. This study will develop 1st UK online resource providing information to enable patients to have greater choice and control in their care.
Eligibility 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
Contact & Investigator
Loreena M Hill, PhD
PRINCIPAL INVESTIGATOR
Ulster University
Frequently Asked Questions
Who can join the NCT06667505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Implantable Cardioverter Defibrillator (ICD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06667505 currently recruiting?
Yes, NCT06667505 is actively recruiting participants. Contact the research team at l.hill@ulster.ac.uk for enrollment information.
Where is the NCT06667505 trial being conducted?
This trial is being conducted at Belfast, United Kingdom, Glasgow, United Kingdom.
Who is sponsoring the NCT06667505 clinical trial?
NCT06667505 is sponsored by University of Ulster. The principal investigator is Loreena M Hill, PhD at Ulster University. The trial plans to enroll 256 participants.