Health TrialsbyHealthPanel

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

ConditionImplantable Cardioverter Defibrillator (ICD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ulster

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with heart failure awaiting or with an ICD (no time restriction on implantation)

No cognitive impairment

Have contact with the patient at least 5 times per week.

Be physically and mentally capable of participation (self-assessment)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: CHOICE-ICDActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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.

Time frame
3 and 6 months after recruitment.

Secondary outcomes

1

Patients' perceptions pre and post intervention

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.

Time frame
Baseline, 3 months and 6 months.
2

Patients' concerns regarding the ICD pre and post intervention

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).

Time frame
Baseline, 3 months and 6 months.
3

Patients' knowledge, experience and attitudes pre and post intervention

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

Time frame
Baseline, 3 months and 6 months.
4

Patients' anxiety pre and post intervention

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.

Time frame
Baseline, 3 months and 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Ulster

Lead sponsor

Belfast Health and Social Care Trust

Collaborator

Golden Jubilee National Hospital

Collaborator

Source ClinicalTrials.gov
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