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| ID | Type | Description | Link |
|---|---|---|---|
| FS/CDRF/22/21048 | Other Grant/Funding Number | British Heart Foundation |
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| Name | Class |
|---|---|
| Belfast Health and Social Care Trust | OTHER |
| Golden Jubilee National Hospital | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Control | No Intervention | Patients will receive information booklet, that they would have received if they had not been included in this research |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months and 6 months. |
| Patients' concerns regarding the ICD pre and post intervention |
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Inclusion Criteria:
Caregivers:
Healthcare professionals:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Loreena M Hill, PhD | Ulster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast Health and Social Care Trust | Not yet recruiting | Belfast | County Antrim | BT53 6UE | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 30, 2024 | Oct 14, 2024 | Prot_000.pdf |
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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.
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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). |
| Baseline, 3 months and 6 months. |
| 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 | Baseline, 3 months and 6 months. |
| 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. | Baseline, 3 months and 6 months. |
| Patients' acceptance of the ICD pre and post intervention | 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 | Baseline, 3 months and 6 months. |
| Patients' quality of life pre and post intervention | 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 | Baseline, 3 months and 6 months. |
| Caregiver burden pre and post intervention | 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. | Baseline, 3 months and 6 months. |
| Golden Jubilee National Hospital | Recruiting | Glasgow | United Kingdom |
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