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

NCT06667505 | Recruiting DMC

• 2 other identifiers: 24/NI/0094FS/CDRF/22/21048
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

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.

Conditions

Implantable Cardioverter Defibrillator (ICD)

Keywords

Implantable cardioverter defibrillatior; e-Health intervention; patient education

Outcome Measures

Primary Outcomes (1)

• Feasibility, acceptability and usability of the Choice-ICD intervention

  System Usability Scale and focus group. The system usability scale has 10 questions, with responses on a Likert scale 1(strongly disagree) to 5 (strongly agree). The higher the score the more feasible. The focus group will be completed at 6 months.

  3 and 6 months after recruitment.

Secondary Outcomes (7)

• Patients' perceptions pre and post intervention

  Baseline, 3 months and 6 months.

• Patients' concerns regarding the ICD pre and post intervention

  Baseline, 3 months and 6 months.

• Patients' knowledge, experience and attitudes pre and post intervention

  Baseline, 3 months and 6 months.

• Patients' anxiety pre and post intervention

  Baseline, 3 months and 6 months.

• Patients' acceptance of the ICD pre and post intervention

  Baseline, 3 months and 6 months.

Study Arms (2)

CHOICE-ICD

ACTIVE COMPARATOR

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

Behavioral: Choice-ICD

Control

NO INTERVENTION

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

Interventions

Choice-ICD 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.

CHOICE-ICD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead
• Belfast Health and Social Care Trust: collaborator
• Golden Jubilee National Hospital: collaborator

Study Sites (2)

Belfast Health and Social Care Trust

Belfast, County Antrim, BT53 6UE, United Kingdom

NOT YET RECRUITING

Golden Jubilee National Hospital

Glasgow, United Kingdom

RECRUITING

Study Officials

• Loreena M Hill, PhD

  Ulster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loreena M Prof Loreena M Hill, PhD

CONTACT

+44 7841037404; l.hill@ulster.ac.uk

Lana Dr Lana Dixon, MD

CONTACT

lana.dixon@belfasttrust.hscni.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 31, 2024
• Study Start: August 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)