Clinical trial NCT06667505: To Test an e-Health Educational Intervention Patients With an ICD
Official title: To Co-develop and Test an eHealth Intervention to Improve Knowledge, Attitude and Experience in Patients Living With an Implantable Cardioverter Defibrillator
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Implantable Cardioverter Defibrillator (ICD)
Keywords: Implantable cardioverter defibrillatior
e-Health intervention
patient education
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
name: Golden Jubilee National Hospital
First posted: 2024-10-31
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients, meeting the inclusion criteria of either awaiting or with a recently implanted ICD, will be invited to participate by a member of the clinical team in Belfast Health and Social care Trust (BHSCT) or Golden Jubilee National Hospital (Clydebank). If the patient is interested in participating, they will be invited to nominate a family member.

Once patients and family member / caregiver provides written informed consent will be randomly allocated to receive the intervention (Choice ICD APP and BHF booklet) or usual care.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

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

Primary outcomes:
measure: Feasibility, acceptability and usability of the Choice-ICD intervention
timeFrame: 3 and 6 months after recruitment.
Secondary outcomes:
measure: Patients' perceptions pre and post intervention
timeFrame: Baseline, 3 months and 6 months.
measure: Patients' concerns regarding the ICD pre and post intervention
timeFrame: Baseline, 3 months and 6 months.
measure: Patients' knowledge, experience and attitudes pre and post intervention
timeFrame: Baseline, 3 months and 6 months.
measure: Patients' anxiety pre and post intervention
timeFrame: Baseline, 3 months and 6 months.
measure: Patients' acceptance of the ICD pre and post intervention
timeFrame: Baseline, 3 months and 6 months.
measure: Patients' quality of life pre and post intervention
timeFrame: Baseline, 3 months and 6 months.
measure: Caregiver burden pre and post intervention
timeFrame: Baseline, 3 months and 6 months.
Other outcomes:
Locations:
Study officials:
affiliation: Ulster University
name: Loreena M Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References: