To Test an e-Health Educational Intervention Patients With an ICD

NCT ID: NCT06667505

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-04-01

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.

Conditions

Implantable Cardioverter Defibrillator (ICD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CHOICE-ICD

Patients will receive access to the CHOICE-ICD App for 3 months. They will also be provided with the information booklet, similar to usual care group

Group Type: ACTIVE_COMPARATOR

Choice-ICD

Intervention Type: BEHAVIORAL

The eHealth intervention theoretically driven, interactive and provides personalised information to patients and family members when and where they wish to access it. Five short (2-3 minutes) videos, involving patients, caregivers and professionals, are uploaded onto the APP, alongside animation clips and useful links to online resources. A discussion forum will be accessible for participants using the APP, which will be closely moderated by the researcher, who will ensure any concerning posts or dialogue are promptly removed, and the necessary action is taken. The diary function will allow patients to record and be reminded of future appointments. Patients and family members will engage with the intervention for 3 months.

Control

Patients will receive information booklet, that they would have received if they had not been included in this research

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Choice-ICD

The eHealth intervention theoretically driven, interactive and provides personalised information to patients and family members when and where they wish to access it. Five short (2-3 minutes) videos, involving patients, caregivers and professionals, are uploaded onto the APP, alongside animation clips and useful links to online resources. A discussion forum will be accessible for participants using the APP, which will be closely moderated by the researcher, who will ensure any concerning posts or dialogue are promptly removed, and the necessary action is taken. The diary function will allow patients to record and be reminded of future appointments. Patients and family members will engage with the intervention for 3 months.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belfast Health and Social Care Trust

OTHER

Sponsor Role: collaborator

Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Loreena Hill

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Loreena M Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

Ulster University

Central Contacts

Loreena M Prof Loreena M Hill, PhD

Role: CONTACT

l.hill@ulster.ac.uk

+44 7841037404

Lana Dr Lana Dixon, MD

Role: CONTACT

lana.dixon@belfasttrust.hscni.net

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

FS/CDRF/22/21048

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24/NI/0094

Identifier Type: -

Identifier Source: org_study_id