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NCT Number: NCT06667505

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

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.

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Key information

Conditions

Implantable Cardioverter Defibrillator (ICD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belfast Health and Social Care Trust, Belfast, County Antrim, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility, acceptability and usability of the Choice-ICD intervention

    Time frame: 3 and 6 months after recruitment.

    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.

Secondary outcomes

  1. Patients' perceptions pre and post intervention

    Time frame: Baseline, 3 months and 6 months.

    Brief Illness perception questionnaire. The Brief Illness questionnaire has 8 questions, with responses on a Likert scale 1 to 10 Likert Scale (the higher the score (maximum 30) the more positive the patient's view.

  2. Patients' concerns regarding the ICD pre and post intervention

    Time frame: Baseline, 3 months and 6 months.

    Implantable Cardioverter Defibrillator concerns questionnaire (ICDC).The validated questionnaire has 20 questions, with responses ranging from not at all to very much. The more worried the patient is, the higher the score ( maximum 100).

  3. Patients' knowledge, experience and attitudes pre and post intervention

    Time frame: Baseline, 3 months and 6 months.

    Experiences, Attitudes and Knowledge of End-of-Life issues in Implantable Cardioverter Defibrillator Questionnaire (EOL-ICDQ). Validated questionnaire with 17 questions, the higher the score indicates the lower level of knowledge on the device

  4. Patients' anxiety pre and post intervention

    Time frame: Baseline, 3 months and 6 months.

    Beck Anxiety Inventory (BAI). Validated questionnaire with 21 questions, with responses from "not at all anxious" to "severely anxious", therefore the higher the scoring the more anxiety.

  5. Patients' acceptance of the ICD pre and post intervention

    Time frame: Baseline, 3 months and 6 months.

    Florida Patient Acceptance Survey (FPAS). Validated questionnaire with 18 questions, responses on a Likert scale of 1-5, with lower score indicating higher level of acceptance of device

  6. Patients' quality of life pre and post intervention

    Time frame: Baseline, 3 months and 6 months.

    Kansas City Cardiomyopathy questionnaire (KCCQ- 12) quality of life tool. Validated questionnaire with 8 key questions, scores are 0-100, where 0 notes lowest health status and 100 highest possible health status

  7. Caregiver burden pre and post intervention

    Time frame: Baseline, 3 months and 6 months.

    Carer Strain Index (CSI). Validated questionnaire with 12 questions and responses as Yes or No. A score of 7 or higher indicates a high level of stress.

Study contacts

Contact information is provided by the study sponsor or research team.

Lana Dr Lana Dixon, MD

CONTACT

[email protected]

Loreena M Prof Loreena M Hill, PhD

CONTACT

[email protected]

+44 7841037404

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Belfast Health and Social Care Trust
  • Golden Jubilee National Hospital

Registry information

Official study title

To Co-develop and Test an eHealth Intervention to Improve Knowledge, Attitude and Experience in Patients Living With an Implantable Cardioverter Defibrillator

Acronym: CHOICE-ICD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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