To Test an e-Health Educational Intervention Patients With an ICD (CHOICE-ICD)

Ulster University

Status

Not yet enrolling

Conditions

Implantable Cardioverter Defibrillator (ICD)

Treatments

Behavioral: Choice-ICD

Study type

Interventional

Funder types

Other

Identifiers

NCT06667505

FS/CDRF/22/21048 (Other Grant/Funding Number)

24/NI/0094

Details and patient eligibility

About

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.

Full description

Implantable cardioverter defibrillator (ICD) is cornerstone in treatment of life-threatening arrhythmias, yet 25% of patients express concerns following implantation.

Aim: To co-design, optimize and establish feasibility and acceptability of eHealth intervention: CHOICE-ICD, providing information to reduce patients' concerns and improve quality of life.

Methods: Phase 1 has been completed: Underpinned by theory and research, core components of an intervention has been co-designed according to six-step process, and in collaboration with stakeholders. Components include ICD written information, educational animations, virtual reality application and patient videos. International advisory group will oversee iterative development, user testing and optimization.

Phase 2 ongoing: CHOICE-ICD is pilot trial, recruiting 128 patients awaiting/recently implanted ICD or cardiac resynchronisation therapy with ICD from Northern Ireland and Glasgow. Participants will use the intervention for 3 months. Data will be analyzed to determine feasibility and acceptability of intervention, and trial methods for future effectiveness trial.

Outcomes: Recruitment, consent and randomization rates, and completion of questionnaires at baseline, 3 and 6 months. Acceptability of intervention delivery and suitability of outcome measures.

Enrollment

256 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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