To Co-develop and Test an eHealth Intervention to Improve Knowledge, Attitude and Experience in Patients Living With an Implantable Cardioverter Defibrillator
Phase: NA
Conditions: Implantable Cardioverter Defibrillator (ICD)
Sponsor: University of Ulster

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
 
FULL/LONG TITLE OF THE TRIAL: To Co-develop and test an eHealth Intervention tO 
improve knowledge, attItude and experienCE in patients living with an Implantable Cardioverter 
Defibrillator  
 
SHORT TRIAL TITLE / ACRONYM: CHOICE-ICD 
 
RESEARCH REFERENCE NUMBERS:  
 
IRAS Number: 
IRAS ID 343944 
ISRCTN Number / Clinical 
trials.gov Number: 
 
 
SPONSORS Number: 
B24/05 
FUNDERS Number: 
BHF Case Reference FS/CDRF/22/21048 
 
 
PROTOCOL VERSION NUMBER AND DATE: Version 2.3     6th June2024  
 
SPONSOR: Queen’s University Belfast  
 
 
For and on behalf of the Trial Sponsor: 
Name (please print): 
Kathryn Taylor  
 
Date: 
....../....../...... 
Research Governance, Ethics & Integrity, at Queen’s 
University, Belfast  
 
 
 
Chief Investigator: 
Signature:     
 
Date:  
Name: (please print): 
 
 
 
 
 
 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
LIST of CONTENTS 
GENERAL INFORMATION 
Page No. 
TITLE PAGE  
1 
RESEARCH REFERENCE NUMBERS  
1 
SIGNATURE PAGE 
1 
i. LIST of CONTENTS 
2 
ii. FUNDING  
3 
iii. TRIAL FLOW CHART  
3 
SECTION  
1: ABSTRACT  
4 
2: BACKGROUND AND PILOT WORK   
4-7 
3. AIM & OBJECTIVES   
7 
4. TRIAL DESIGN   
8-9 
5: POWER CALCULATION & PARTICIPANT ELIGIBILITY CRITERIA   
9-10 
6. INTERVENTION  
10 
7. DATA COLLECTION & OUTCOME MEASURES 
11 
8. DATA ANALYSIS 
11-12 
9. TRIAL MONITORING  
12 
10. TRIAL MANAGEMENT  
12 
11. ETHICS   
12 
12. DISSEMINATION POLICY 
13 
13. REFERENCES 
13-16 
14. APPENDICES 
17 &18 
 
 
 
FUNDING AND SUPPORT IN KIND 
FUNDER(S) 
 
FINANCIAL AND NON FINANCIALSUPPORT 
GIVEN 
British Heart Foundation  
£315,794.50 over 36 months  
 
 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
Trial Flow Chart (Figure 1)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients eligible for participation 
(n = 732) 
N = 57 
•
1-month follow-up (n = 64) 
•
3 months follow-up (n = 64) 
•
6 months follow-up (n = 57) 
10% attrition rate expected overall   
Allocated to intervention (n = 64) 
•
Patients awaiting implantation (n = 32) 
•
Patients with pre-existing ICD (n = 32) 
•
1-month follow-up (n = 64) 
•
3-months follow-up (n = 64) 
•
6 months follow-up (n = 57) 
     10% attrition rate expected overall 
Allocated to usual care (n = 64) 
•
Patients awaiting implantation (n = 32) 
•
Patients with pre-existing ICD (n = 32) 
N = 57 
Allocation 
Assessment 
Follow-Up 
Randomised (n = 128) 
Enrollment 
N = 114 provides an accurate representation of the patient population (90% 
confidence level, 10% margin of error) 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
1: Abstract  
Implantable cardioverter defibrillator (ICD) is cornerstone in the treatment of life-threatening 
arrhythmias, yet 25% of patients report poor quality of life following implantation.   
Aim: To co-design, optimize and establish feasibility and acceptability of eHealth intervention: 
CHOICE-ICD website, to reduce anxiety and improve patient involvement in future palliative 
decisions.  
Methods: Phase 1: Underpinned by theory and research, core components of an intervention 
was co-designed according to a six-step process, in collaboration with stakeholders. 
Components included ICD written information, educational animations, virtual reality (VR) 
application, patient and care videos and a communication “prompt” for consultations. An expert 
advisory group oversaw the iterative development, user testing (n=10) and optimization. Phase 
2: CHOICE-ICD is a prospective study, recruiting 128 patients awaiting or recently implanted 
ICD or cardiac resynchronisation therapy with ICD (CRTd) from Northern Ireland and Glasgow 
Participants will use the intervention for 3 months. Data will be analyzed to determine feasibility 
and acceptability.       
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.  
Conclusions: First UK eHealth intervention that will provide information to patients with an 
ICD, tailored to their needs. According to outcomes, plans will be initiated for future 
effectiveness trial.    
 
2: Background to the project and pilot data  
Identification of the problem: Unmet psycho-educational needs 
Implantable Cardioverter Defibrillators (ICDs) are recognised as an effective treatment for life-
threatening arrhythmias (1), contributing to a worldwide rise in implantation rates. Within the 
United Kingdom (UK) over 6 thousand ICDs were implanted in 2015 (2), with Northern Ireland 
(NI) health service implanting a total of 156 devices per million population annually 
(2016/2017(3)). The combination of Cardiac Resynchronisation Therapy, which is a 3-lead 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
pacemaker and ICD (CRTd) has transformed heart failure treatment over the last decade, 
resulting in improved symptoms and quality of life, along with a reduction in hospitalisations 
and mortality (4, 5). Referral for implantation or battery/generator replacement remains 
guideline-driven (5, 6), with clinical indicators informing the decision (1, 7, 8). Clinical trials show 
a short-term improvement in patients’ quality of life (9, 10) following ICD implantation, however 
for some people, the device has a detrimental impact on their psychological well-being and 
quality of life (11-13), particularly patients who receive frequent ICD shocks. Factors found to 
contribute to poor outcomes include Type D personality (14), poor illness perceptions (15), 
unrealistic expectations of treatment and underlying disease progression. Insufficient 
information can cause patients to misunderstand the functionality of their ICD, overestimating 
its benefits and prompting maladaptive coping strategies (16). American and Irish studies found 
37% to 65% of patients with a recently implanted ICD, were unable to recall or inaccurately 
recalled the information professionals provided (17, 18). Similar results were noted in NI and 
Denmark regarding ICD deactivation (19, 20) as nearly half of patients surveyed (48%) reported 
they received no information. International guidelines state that providing patients with 
comprehensive information at the implantation stage is critical for ensuring the validity of 
informed consent (16, 18) as it facilitates an accurate understanding of the device capability 
and functionality now, and as the clinical condition progresses.   
Identifying the evidence: Interventions to inform & support patients with ICD 
Effective pre-implantation education has been shown to improve knowledge, psychological 
acceptance and adaptation to living with the device (11, 21). International guidance 
recommends patients receive ongoing education and support to facilitate active involvement 
and improve adherence to measures for long-term health (5, 22, 23). Published guidelines 
provide healthcare professionals with the necessary knowledge to optimally manage patients 
with an ICD near the end-of-life (24, 25). Nevertheless, all too often patients reach the palliative 
stages, unprepared both educationally and psychologically to make informed choices 
concerning their device. Many professionals working across all clinical settings, in an effort to 
preserve the patient’s hope, are reluctant to initiate a discussion about deactivation(19, 26). 
Deactivation is a non-invasive process, whereby the shock function of the device is ‘turned off’, 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
while remaining functions remain active. At the palliative stage of care patients and family 
members should be fully informed and involved in decisions concerning future treatment and 
care provision (27, 28).  
In general, patients receive information about their device from professionals, information 
booklets, device manufacturer brochures or by accessing the internet (29). As a consequence 
of the Covid pandemic, nearly all adults in the UK now have internet access, with the proportion 
of those aged over 75 years increasing from 29% (2013) to 54% in 2020 (30). Technological 
innovation that provides personalised education and support to empower self-management has 
grown in acceptability with patients (31). Audio-visual aids (32) and an interest in educational 
virtual reality platforms are wide-reaching, sustainable and cost-effective, and can effectively 
provide information in a format, and at a time and place convenient to the user. Predictive 
modelling offered by Artificial Intelligence now makes it possible to personalise educational 
strategies, in accordance with, for example informational wishes, cognitive ability and clinical 
status of the patient (33).  
A recent systematic review  and meta-synthesis, on the perceptions and experiences of patients 
living with an ICD concluded that interventions should be patient-centric and tailored to patients’ 
holistic needs (34). ACQUIRE-ICD, is an ongoing Danish randomised control trial (35) of a 
supportive intervention, incorporating cognitive behavioural therapy and psychologist input over 
a 12-month period. Its primary outcome is device acceptability with secondary outcomes being 
clinical and cost effectiveness. The CHOICE-ICD study will compliment this study, by co-
designing and testing a psycho-educational intervention that integrates practical information, 
visual aids, patient stories and gamification. In addition to the acceptability and feasibility of the 
intervention, a composite outcome - knowledge, attitudes and experience, will be measured. 
This study has developed an intervention to provide tailored information and support, which will 
require wider testing to enable patients be better equipped and empowered to live well with 
their device. Therefore, a modern solution for what is increasingly a common clinical problem.     
Theory and pilot work: A New approach for ICD patients  
Psycho-educational interventions are `complex interventions' consisting of multiple interacting 
components (36). Exploratory work by this research team has identified the importance of 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
personalized information and support, beginning at pre-implantation and continuing throughout 
the illness trajectory (19, 37-39). A stakeholder meeting held in September 2021 with 
cardiologists, electro-physiologists, nurses, software developers, researchers and patients, 
confirmed the need for eHealth/website delivery, and discussed potential topics of information. 
The illness representation or “Common Sense model of Self-Regulation” (CSM) focuses on 
how an individual’s behaviour is influenced by his/her perceptions (40). Perceptions, in the case 
of the patient with an ICD, may be influenced by the reason for device implantation (41); short 
and long-term daily adaptations living with the device (42); receiving a shock (18); and the 
unpredictability of advanced heart failure (43). This model offers a sound theoretical framework 
to address the psychological and informational needs of patients with an ICD. Using the six-
stage ‘experience-based co-design’ approach, professionals and service users worked in 
partnership (44-47) to select and optimize the composition of these components. Lessons 
learned from the development of a supportive intervention within the field of cancer care (48, 
49) was implemented. The ‘added’ value of CHOICE-ICD is that it is a ‘state-of-the-art’ web-
based intervention, made possible by an interdisciplinary team including software developers, 
patients and family members, with the patient remaining a central partner (50) in decisions. The 
finalized prototype of the intervention will now be pilot tested by patients within Northern Ireland 
and Glasgow, optimized based on feedback, before a clinical feasibility trial.  
     
 3: Aim & Objectives  
An eHealth intervention co-designed by patients, family members and professionals will be 
feasible and acceptable, enabling progression to an effectiveness trial.     
Aim of this study  
Co-design and test an eHealth intervention for patients’ pre-implantation and those recently 
implanted an ICD, together with family members and professionals. 
Objectives of this study  
1. To co-develop and pilot test a prototype of an eHealth intervention with patients with an 
ICD, their family members and professionals.     

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
2. To optimise and deliver the intervention to patients awaiting and those with an implanted 
ICD, with data collected to determine recruitment/demand, engagement with the 
intervention (System Usability Scale-SUS) & attrition.  
3. To explore the acceptability of the intervention through a questionnaire and focus groups 
with patients, family members and healthcare professionals. 
4. To undertake a process evaluation identifying methodological issues, face and 
psychometric validity and the primary outcome for a future trial. Self-reported data from 
validated questionnaires delivered pre- and post-intervention will measure patients’ 
knowledge, attitudes and experiences (EOL-ICD), device acceptance and concerns 
(ICDc and Florida Patient Acceptance Survey), quality of life (EuroQol-5D), anxiety (BAI) 
and illness perceptions. Caregivers will complete the carer strain index (CSI)  
 
4: Trial design: 
This CHOICE-ICD methodology is framed according to the Medical Research Council (MRC) 
framework (36), and in accordance with the Common Sense model of Self-regulation and 
previous research conducted by the experienced research team (19, 27, 37, 51-54). 
Methods: 
This study comprises of two phases, outlined in the Consort diagram (Figure 1) (55) and Gantt 
chart (Appendix 1) .  
Phase 1: Co-design the intervention (Objective 1) 
The co-design of the intervention involved a number of iterative steps (48). Previous work 
conducted by this research team developed the concept of an eHealth intervention. The first 
integrated workshop stakeholders (n=18; patients with an ICD, family members, cardiologists, 
heart failure nurses, cardiac physiologists, and software developers) was held on the 8th 
September 2023. Interaction focused on balancing technical, holistic and practical details, with 
the provision of clinical facts without evoking fear, in order to create a patient-centred learning 
environment. Unstructured meetings (online) were held with 10 stakeholders (patient, family 
members and professionals) who tested and provided feedback on the prototype of the APP, 
which was conveyed at the forthcoming stakeholder meeting. The prototype was tested at each 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
iterative stage for two weeks. Within the second stakeholder workshop (n=16), on the 22nd 
May, feedback from testers (n=8) informed the components of the APP, including content, 
patient videos, VR option, ease of use and navigation. The intervention was further optimised 
and the testers, over a 2-week period, invited to provide feedback.    
Field notes were recorded, with the discussion digitally recorded, transcribed verbatim and 
thematically analysed (LH). A consensus approach and agreement was sought on the 
development of the prototype of the intervention, in terms of content and presentation. Data 
analysis outlining the key components of the intervention was discussed and confirmed 
throughout, by the international advisory team. The web-based intervention was developed 
through an expert software developer- ProPeer solutions. This established company has 
successfully collaborated on a number of projects. Here are a few examples:- Treatment of 
patients suffering with Post Traumatic Stress Disorder https://youtu.be/6D5sNgjHtko Exercise 
Solution 
with 
Parkinson’s 
https://drive.google.com/file/d/1j5kPbDEJ95qK1RyHCuvKFVoXwewaLYF-/view?usp=sharing 
.The intervention was optimised through repeated discussions and agreement between 
research team, software developers and patients.  
        
Phase 2: Clinical study of the web-based intervention (Objectives 2-4) 
Patients attending routine outpatient appointments at the Belfast Health and Social Care Trust 
(BHSCT) and Golden Jubilee National Hospital (GJNH), Clydebank will be identified and invited 
to participate by the Cardiologist or Heart Failure Nurse according to inclusion/exclusion criteria 
(See Table 1). The BHSCT and GJNH are busy tertiary centres, implanting collectively over 
700 devices per annum (2019/2020). Written consent to pass on contact details to the 
researchers (LH or Research Assistant - RA) will be obtained. Patients will be asked to 
nominate a family member or caregiver, to participate in the study. Only when the patient has 
spoken to the family member/caregiver will their contact details be passed onto the researcher. 
Written information detailing the study will be provided and interested patients and family 
members will be offered one week to consider participation. The researcher (LH or RA) will 
make contact with the patient and family member to ensure both are agreeable to participate, 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
before obtaining written consent, baseline data is collected and 1:1 randomisation. Baseline 
questionnaires will be completed in all patients and caregivers recruited to the study. A 
convenience sample of n=64 patients will be randomised to the intervention and usual care, 
with n=64 receiving usual care alone, across Northern Ireland and Scotland. Patients and 
caregivers will be followed up at 3 months and 6 months’ post intervention.  Patients who 
received the Choice-ICD intervention, along with their caregivers and members of their clinical 
team (i.e heart failure nurse, cardiologist or cardiac physiologists) will be invited to participate 
in a focus group. Members of the clinical team (8-10) will be invited by the local collaborator (Dr 
Dixon or Prof Gardner) and if agreeable, contact details will be passed to the researcher to 
provide information on the study and obtain consent. Focus group will be conducted separately 
(Focus group 1: patients and caregivers Focus group 2: healthcare professionals) within each 
clinical site. Any patients, caregivers or healthcare professionals involved in Phase 1 (Co-
design of the APP) will be excluded.    
 
 5: Power calculations: 
Unpublished audit data show that in 2019/2020: 482 ICD/CRTD were implanted in NI and 250 
implanted in Scotland. Given the total population size of 732 patients, we need to recruit 128 
patients in total to account for an expected 10% attrition rate. This would leave a sample size 
of n = 114 (intervention, n = 57; control, n = 57) that enables us to estimate a recruitment rate 
of 50% to within a 90% confidence interval of +/- 10%, which should provide an accurate 
representation of the patient population. These statistics have been deemed suitable as higher 
precision would warrant a larger sample size, with the required resources being unsuitable for 
a feasibility study. Co-applicant (MD) will provide statistical support throughout. The results of 
the proposed study will enable the planning of a future definitive trial. 
 
Table 1: Eligibility Criteria  
Patient 
Caregiver 
Healthcare Professional 
Patients with heart failure 
awaiting or with an ICD (no 
Have 
contact 
with 
the 
patient at least 5 times per 
week.  
Daily care of patients with 
heart 
failure 
and 
an 
implantable 
cardioverter 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
time 
restriction 
on 
implantation)  
 
defibrillator  
Aged 18 years and over 
 
Aged 18 and over. 
 
Willing 
to 
provide 
written 
informed consent 
No cognitive impairment  
 
Be nominated by the patient.  
 
Involved in the care of a patient 
using the Choice-ICD App  
Willing 
to 
provide 
written 
informed consent 
Be physically and mentally 
capable 
of 
participation 
(self-assessment) 
 
 
 
Willing to provide written 
informed consent.  
 
 
 
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   
 
6: Intervention:  
Patients and family members will receive the online intervention (accessed via a password 
protected link) and British Heart Foundation (BHF) booklet: “Implantable Cardioverter 
Defibrillators” (2018- HIS19/1117) or the BHF booklet only (usual care group). The eHealth 
intervention is theoretically driven, interactive and provides personalised information to patients 
and family members when and where they wish to access it.  Topics include: “How does an 
ICD work? How will it affect my daily activities? What do I do if I experience a shock? Do I have 
choices ahead when my health declines?” Each topic will have a link to a printable fact sheet 
with a prompt card that patients can take with them to their next professional consultation. Five 
short (2-3 minutes) videos, involving patients, caregivers and professionals, developed with 
MacMillen Media, will be uploaded onto the APP, alongside animation clips and useful links to 
online resources (56). A discussion forum will be accessible for participants using the APP, 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
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. This detail will not be collected, but 
rather is for the patient’s use only. The intervention is both an informational support resource 
as well as a “prompt” for patients and professionals to engage in complex discussions. Patients 
and family members will engage with the intervention for 3 months.  
Patients recruited from the Belfast Health and Social care Trust and randomised to receive the 
Choice -ICD intervention, will be invited to access the virtual reality (VR) enhanced intervention. 
Participants  attending during their visit 1 or 2 to the BHSCT, will be invited to access the 
optional VR aspect. . The VR enhanced intervention will be carried out within Queen’s 
University premises at the time in which focus groups have been arranged. Interested patients 
will receive instructions on the use of the headset (Meta Quest 3) and supervised by the 
researcher while it is in place The session will last for a maximum of 10 minutes, therefore 
minimising risk of adverse effects. A protocol to ensure the safety and tolerability of the VR 
session has been developed. No data will be collected from the headset. Anonymised data 
linked to recruitment to the VR option will be collected.        
7: Data collection & Outcome Measures:  
Descriptive data including recruitment/demand, participants’ engagement/adherence with the 
intervention (i.e., number of log-ins and screens viewed), and attrition will be collected, in line 
with the standards for feasibility studies (57). Patients will complete a paper copy of the 
validated patient reported outcome measures and short demographic questionnaire (i.e., age, 
education, New York Heart Association (NYHA), and indication for device) at baseline. They 
will also complete paper versions of validated questionnaires, including the ICD concerns 
questionnaire (ICDC) (58), Experiences, Attitudes and Knowledge of End-of-Life issues in 
Implantable Cardioverter Defibrillator Questionnaire (EOL-ICDQ) (59), Beck Anxiety Inventory 
(BAI) (60), Brief Illness perception questionnaire (15), Florida Patient Acceptance Survey 
(FPAS) (61) and the Kansas City Cardiomyopathy questionnaire (KCCQ- 12) quality of life tool 
(62). Family members will complete the Carer Strain Index (CSI) (63). Questionnaires, at 
baseline, 3 and 6 months will be disseminated by the QUB researcher (LH) or research nurse 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
if the patient lives in Clydebank. Data will be collected month 3, including system usability scale, 
and again at month 6 (post intervention). Questionnaires will be disseminated in paper copy. At 
3 and 6 months, a stamped addressed envelope will be provided to promote return of the 
questionnaires to the researcher at QUB  (LH). Reasons regarding loss to follow-up will be 
monitored. Primary outcome measures are the feasibility, acceptability and usability (according 
to SUS) of the intervention. Secondary outcome measures are effect of the eHealth intervention 
on patients’ knowledge, anxiety and device related quality of life as measured by the 
questionnaires. (Appendix 2)  
All data collected will be monitored by the Chief Investigator to ensure ethical, legal or 
management issues arising are addressed promptly. The researcher (LH) alongside her team, 
have experience and publications in this area (LD, DF, MD, OS). Results from the study will be 
reported back to participants and inform the intervention in preparation for a larger future trial. 
 
     8: Data Analysis   
Descriptive and inferential data analysis will be conducted by LH using SPSS (IDM Statistics 
22), which will focus on calculating effect sizes that describe the differences between pre- and 
post-intervention. Sub-group analysis will be undertaken between patients implanted with an 
ICD for the first time and those with a pre-existing device. Qualitative data will be collected from 
two focus groups with patients and family members (n=20) at 3 months by the RA. Results will 
enrich understanding of the perceptions of patients and family members towards the 
intervention and its acceptability, the validated tools used and how the intervention may 
facilitate future deactivation conversations. Barriers and facilitators of the intervention will be 
openly discussed. A brief acceptability questionnaire will be completed (64). Two separate 
focus group with healthcare professionals (n=20) will enable an insight into their perspectives 
towards the intervention. Each focus group will be audio-recorded, transcribed verbatim and 
thematically analysed. The transcript will be independently analysed to improve rigour and 
consistency.  
 
         9: Trial Monitoring:  

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
The study will also be monitored periodically by members of the International steering group, 
who will assess the progress of the study, verify adherence to the protocol and national 
requirements, and review the completeness, accuracy and consistency of the data. 
International experts (Debra Moser, USA, Ingela Thylen, Sweden, Susanne Pedersen, 
Denmark), high volume device implanter and heart failure specialists (Nick McKeag, Kat 
McCreary) and cardiologists Stephen Pettit & Karen Hogg, two patient representatives from 
Patient support group and BHF representative will advise on all aspects of the study. Advice 
and support is also available from Dr Paul Best from the Centre of Technological Innovation, 
Mental health and Education (TIME).      
The Research Governance Office at Queen's University Belfast, as lead sponsor, audits 
research studies conducted by University staff to make sure that they are being carried out in 
accordance with the Research Governance Framework and with the highest standards of 
integrity. Staff from the Research Governance Office may review the data collected in this study 
as part of their annual audit programme 
 
    10: Trial Management: 
 The study will be managed by an expert team of researchers and clinicians. The researcher 
(LH) will be supervised by Prof Donna Fitzsimons, Prof Martin Dempster Dr Olinda Santin, Dr 
Lana Dixon and Prof Roy Gardner to ensure research integrity and that the project is completed 
on time.  (Gantt chart- Appendix 1)     
 
   11: Ethics 
The protocol will be submitted to an NHS/HSC Research Ethics Commitee. Governance 
approval will be sought through the New HSC Approvals system New Research Approvals 
Service for HSC R&D in Northern Ireland | Public Health Agency - Research & Development in 
Northern Ireland (hscni.net) as well as approval within Golden Jubilee  hospital, Clydebank and 
the Belfast HSC Trust. The Ethics Committees will be informed of all changes to the study 
 

 
 
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Choice-ICD: IRAS 343944 Version 2.4, 30th July 2024       This protocol has regard for the HRA guidance. 
12: Dissemination 
The results will be published in peer review journal, as well presented at national and 
international congresses. Patients will have the opportunity to receive a copy of the results. 
Dissemination will also include regional meetings with patients and healthcare professionals.  
13: References  
1. 
Connolly SJ, Hallstrom AP, Cappato R, Schron EB, Kuck KH, Zipes DP, et al. Meta-analysis of the 
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Heart J. 2000;21(24):2071-8--8. 
2. 
Raatikainen MJP, Arnar DO, Zeppenfeld K, Merino JL. Statistics on the use of cardiac electronic devices 
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European Heart Rhythm Association. Europace. 2015;17:1-175. 
3. 
Programme NCA. National Audit of Cardiac Rhythm management devices and ablation: 2016/2017 
Summary Report London; 2019 11th July 2019. 
4. 
Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B, et al. Combined cardiac 
resynchronization and implantable cardioverter defibrillation in advanced chronic heart failure: the MIRACLE ICD 
Trial  JAMA. 2003;289(20):2985-694. 
5. 
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, et al. 2021 ESC Guidelines for 
the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599-726. 
6. 
Priori SG, Blomstrom- Lundqvist C, Mazzanti A, Bloma N, Borggrefe M, Camm J, et al. 2015 ESC Guidelines 
for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death The 
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Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and 
Congenital Cardiology (AEPC. European Heart Journal. 2015;36:2793-867. 
7. 
Nauffal V, Zhang Y, Tanawuttiwat T, Blasco-Colmenares E, Rickard J, Marine JE, et al. Clinical decision tool 
for CRT-P vs. CRT-D implantation: Findings from PROSE-ICD. Plos One. 2017;12(4):17520. 
8. 
Saxon LA, Bristow MR, Boehmer J, Krueger S, Kass DA, De Marco T, et al. Predictors of sudden cardiac 
death and appropriate shock in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure 
(COMPANION) Trial. Circulation. 2006;114:2766-72. 
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Irvine J, Dorian P, Baker B, O'Brien BJ, Roberts R, Gent M, et al. Quality of life in the Canadian Implantable 
Defibrillator study (CIDS)   AmHeart J. 2002;144:282-9. 
10. 
Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al. Amiodarone or an implantable 
cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225-37. 
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Thylen I, Dekker RL, Jaarsma T, Stromberg A, Moser D. Characteristics associated with anxiety, depressive 
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14: Appendices  
 
Appendix 1: Gantt chart of the project  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Appendix 2: 
Feasibility outcomes & Progression rules: description and target  
Measure 
Description of outcome 
Target: a priori 
Criteria for 
success 
Recruitment Rate  
Proportion of eligible participants identified who 
participated in the study   
60% 
Completion of data 
collection measures 
(baseline, 3 & 6 
months)   
Proportion of consented participants who 
completed all questionnaires at baseline and 
post-intervention   
60% 
Patient engagement  Proportion of participants who completed all 
topics  
60% 
Participant 
acceptability  
Proportion of patients accessing the 
intervention found it clear and understandable  
80% 
Intervention 
acceptability  
Proportion of patients, caregivers and 
professionals who accessed the intervention 
and would use it again  
80% 
If the number is within 5% points of the progression target, a discussion would occur 
regarding progression to future trial within the research team