CABIN (CArdiac Brief INtervention): A Feasibility Study to Promote Engagement With Cardiac Rehabilitation Through an Early, Personalised, Holistic Intervention
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Sponsor: Queen's University, Belfast

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CABIN: A Feasibility Study to Promote Engagement with CR: Study Protocol. V2 – 20/01/23. 
Cover Page 
 
CABIN – (CArdiac Brief INtervention): a feasibility study to promote engagement with 
cardiac rehabilitation through an early, personalised, and holistic intervention. 
 
NCT05848674 
 
20/01/23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CABIN: A Feasibility Study to Promote Engagement with CR: Study Protocol. V2 – 20/01/23. 
 
 
 
 
 
 
 
CABIN – (CArdiac Brief INtervention): a 
feasibility study to promote engagement 
with cardiac rehabilitation through an 
early, personalised, and holistic 
intervention. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CABIN: A Feasibility Study to Promote Engagement with CR: Study Protocol. V2 – 20/01/23. 
Study Title 
CABIN – (CArdiac Brief INtervention): a feasibility study to promote engagement with cardiac 
rehabilitation through an early, personalised, and holistic intervention. 
Contact  
 
Name: Dr Gareth Thompson 
Post: Research Fellow 
Address: Room No. 05.310, School of Nursing Midwifery, Queen’s University Belfast, Medical 
Biology Centre, 97 Lisburn Road, Belfast, BT9 7BL. 
Tel: 02890972696 (work), 07714198795 (mobile) 
Email: gareth.thompson@qub.ac.uk 
Research Team 
 
Professor Donna Fitzsimons (Principal Investigator), Head of School of Nursing and Midwifery, 
Queen’s University Belfast. 
Professor Judy Bradley (Alternative Principal Investigator), Director of Clinical Research 
Facility, School of Medicine, Dentistry, and Biomedical Sciences, Queen’s University Belfast.  
Dr Gareth Thompson (Research Fellow), School of Nursing and Midwifery, Queen’s University 
Belfast. 
Gemma Caughers (Alternative Research Fellow), Lecturer (Education), School of Nursing and 
Midwifery, Queen’s University Belfast. 
Dr Patrick Donnelly (Clinical Contact), Consultant Cardiologist, Ulster Hospital, South Eastern 
Health and Social Care Trust.  
Dr Clare McKeaveney (Expert Advisor – Statistics), Lecturer, School of Nursing and Midwifery, 
Queen’s University Belfast.  
Professor Mike Clarke (Expert Advisor – Research Methodology), Director of MRC 
Methodology Hub, School of Medicine, Dentistry, and Biomedical Sciences, Queen’s 
University Belfast. 
Maria Mooney (Research Assistant), Royal Victoria Hospital, Belfast Health and Social Care 
Trust.  
 
 
 
 
 
 
 
 

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Abstract 
Background 
An ST-elevation myocardial infarction (STEMI) is a specific type of heart attack, following 
which cardiac rehabilitation (CR) is indicated to save lives and prevent recurrence. Patients 
often struggle to comprehend the cardiac event and hold erroneous beliefs regarding STEMI. 
These issues can impede recovery, including willingness to attend CR, with less than 50% 
uptake rates locally. Previous research identified the need for more psychological support after 
STEMI, which informed the co-production of a relevant intervention (CABIN – CArdiac Brief 
INtervention) with patients and clinicians.  
Aim  
To assess the feasibility of delivering CABIN and explore associated outcomes following 
STEMI.  
Methods 
A mixed-methods study based on the Medical Research Council framework for developing 
complex interventions will be conducted. Patients who had STEMI (number = 40) from 2 
hospital centres in Northern Ireland will be recruited to a feasibility randomised controlled trial. 
CABIN will constitute a brief leaflet that provides personalised education on coronary artery 
disease (CAD) and CR, along with facilitating psychological and emotional support 
discussions with a nurse. It will be delivered to the intervention group prior to discharge from 
a Coronary Care Unit. Data collection will be conducted across both groups (intervention and 
control) at baseline, post-intervention, 3-4 weeks from diagnosis, and 14 weeks from diagnosis 
(in line with the start and end of CR). Feasibility measurements and process evaluation 
(quantitative and qualitative) will assess the viability of the research design and CABIN 
delivery. Attendance data will be collected to examine participant engagement with CR. 
Participants will complete questionnaires to evaluate intervention effect on psychological and 
emotional well-being, along with knowledge of CAD and CR.  Quantitative data will be reported 
with descriptive statistics and qualitative data will be analysed using framework analysis.  
Anticipated Impact  
If feasible and acceptable, effectiveness of CABIN will be assessed in a multi-centre trial. This 
intervention could lead to greater CR uptake and improved outcomes for cardiac patients 
including prevention of recurrent cardiac events, reduced anxiety, improved health literacy, 
and better engagement with local support networks. 
 

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Study Protocol  
 
Background 
This project seeks to develop and test an innovative intervention for patients who have 
suffered a specific type of myocardial infarction / heart attack called an ST-elevation 
myocardial infarction (STEMI) and have subsequently been referred to cardiac rehabilitation 
(CR). There are two types of heart attack: 1) STEMI and 2) Non-ST elevation myocardial 
infarction (NSTEMI). A STEMI occurs secondary to a complete blockage of one or more of the 
coronary arteries responsible for supplying the myocardium with blood and oxygen, with 
treatment involving a visit to a Coronary Catheterisation Laboratory for an emergency 
angiography (stent insertion +/- clot removal). After STEMI, patients are invited to attend CR 
following discharge from hospital. Importantly, these patients often perceive their condition as 
serious and life threatening (1). The project will only include patients who had STEMI at this 
stage of testing to remove confounding variables, such as: illness misperception, which can 
strongly influence decision to attend CR (1–3).  
 
CR is an evidence-based intervention delivered after cardiac patients have been discharged, 
which has proven to be successful in decreasing mortality rate, preventing recurrent cardiac 
events, and enhancing quality of life (4). Along with the risk reduction and physical benefits 
offered by CR, there are psychological advantages, with completing the programme potentially 
improving quality of life (5). Over the past two decades, CR has been delivered using a variety 
of methods, for example, face to face, digital, telephone and self-directed study (6–9). Despite 
the wide range of delivery options available, patient engagement with CR programmes 
remains low and in Northern Ireland (NI) only 49% of eligible patients will take their place in 
CR (10). This is a global problem impacting Western and developed nations alike and remains 
a priority for the World Heart Foundation (11). Despite the benefits of completing a CR 
programme, there are still many reasons for patients not to engage, including: family 
responsibilities, work commitments, social issues, and logistical challenges (12–14). It is well 
established that patients often hold erroneous beliefs, known as cardiac misconceptions, 
regarding their heart attack and treatment, which can impede recovery (15), with psychological 
factors also strongly influencing their decisions (16,17). In a 2015 study by members of the 
research team (GC, PD, and DF), patients who experienced STEMI or NSTEMI discussed 
fear, guilt, anxiety, and low mood during the first days following their heart attack (2). More 
recently, local patients have highlighted a need for more psychological support after their heart 
attack (18). These findings are extensively corroborated in the literature, with patients being 
physically and emotionally shaken by their experience; they are shocked and afraid and often 
just want to go home and put it behind them (19). Importantly, patients, staff, and Northern 

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Ireland Chest, Heart, and Stroke (NICHS) representatives informed us that a brief 
personalised intervention prior to discharge may provide the opportunity to correct 
misconceptions, emotionally support the patient, and help patients prepare for the next phase 
of their treatment, including CR (18). This study will test if the suggested intervention is feasible 
and explore associated outcomes. 
 
Within standard practice, the multidisciplinary team focus on a safe patient discharge from the 
ward; discussing diagnosis and medication; and directing patients towards the CR 
programme. In some NI hospitals, CR nurses can attend Coronary Care Units (CCUs) to 
inform patients about CR and discuss practical concepts, such as: risk factors and lifestyle 
changes for the period between discharge and commencing the core CR programme. Factors 
including fast patient turnover, weekend discharges, staff shortages, and more recently, 
COVID-19 restrictions, all impact the ability of CR nurses to undertake this first meeting. In 
addition to these matters, time constraints result in limited opportunities to discuss the 
emotional and psychological impact on the patient and their family. Patients report that they 
are not psychologically ready to start this stage of their recovery, as they are still processing 
what has happened to them (12). CCU Nurses are ideally placed and suitably qualified to 
provide additional support to patients through brief, reassuring, and compassionate 
discussions. This study seeks to formalise this discussion process by facilitating consistent, 
personalised information for patients with STEMI, and providing them with access to essential 
psychological and emotional support. Iterations of this approach have been tested elsewhere 
with varying results (19). However, this project is novel as the intervention has been identified 
as necessary by local patients and subsequently co-designed by staff and patients. Thus, 
CABIN aims to formalise psychological and emotional support discussions using a 
personalised approach and provides a safe space for patients to discuss concerns. 
 
Development of CABIN  
 
The research team have acquired considerable knowledge of local patients’ needs through a 
Public Health Agency funded doctoral research fellowship study (GC), which focused on 
strategies to increase engagement with CR and was a multi-centre, co-design project with an 
exploratory phase of interviewing and focus groups with patients and staff involved in CR (12). 
The data from this exploratory phase informed a series of co-design workshops attended by 
previous participants and Patient and Public Involvement (PPI) representatives including 
NICHS and British Heart Foundation staff. Participants contributed from each of the five Health 
and Social Care Trusts. Multiple outcomes that focused on improving engagement with CR 
were produced. This study relates to one of these outcomes (CABIN), which constitutes a brief 

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leaflet that provides patients with personalised education on coronary artery disease (CAD) 
and CR, along with psychological and emotional support discussions facilitated by a nurse 
(18). Across four sessions between September and December 2021, a working group of staff 
and patients developed the content and wording of CABIN based on their experience of the 
patient journey, which aligns with Phase 1 of the Medical Research Council (MRC) framework 
for developing complex interventions (20). The working group also provided the following 
input:  
 
1) To minimise bias, participants of the control group should receive a refined version of 
CABIN (excluding supportive discussion), which details some standard discharge information 
(information about CAD and stenting / stent placement).   
 
2) The immediate effect of the intervention should be assessed with the Coronary Artery 
Disease Education Questionnaire, Short Version (CADE-Q SV) (21), which is a validated 
instrument for evaluating patients’ knowledge of CAD and core components of CR.  
 
3) Implement a distress management protocol in the event of a participant experiencing 
emotional upset.  
 
The formatting (i.e., colour scheme, graphic style, text positioning, and spacing) of CABIN was 
informed by PPI members (patients with CAD) from the Cardiac Research Group within the 
School of Nursing and Midwifery at Queen’s University Belfast (QUB). Subsequently, 
formatting requirements were supplied to Morrow Communications (a Graphic Design 
Company) to produce CABIN. As such, funding has been secured from NICHS for this study 
to progress CABIN to feasibility testing, in line with Phase 2 of the MRC framework for 
developing complex interventions (20). 
 
Research Question  
Is the delivery of CABIN to patients with STEMI, prior to discharge, feasible, and does the 
intervention increase engagement with CR and improve psychological and emotional well-
being in comparison to standard care?  
 
Aim 
To assess the feasibility of delivering CABIN to patients with STEMI, prior to discharge, and 
to explore a range of associated outcomes.  
 

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Objectives 
1) Evaluate the research design and CABIN implementation through a process evaluation and 
feasibility measurements, which focus on:  
i. 
Reach, dose, fidelity, data completeness, and acceptability.  
ii. 
Context (how external factors influence the delivery and functioning of the study / 
intervention). 
iii. 
Possible mechanisms of impact for the intervention.  
2) Preliminary exploration of the impact of CABIN on CR attendance; knowledge of CAD and 
CR; and psychological and emotional well-being.  
 
Methods  
The study is based on the MRC framework for designing complex interventions (20) and 
implements a mixed-methods design. This will involve utilising process evaluation and 
feasibility measurements that integrate quantitative and qualitative methods to achieve 
triangulation of findings and generate improvements in the feasibility, theory, design, methods, 
and implementation of CABIN (20,22).  
 
Theoretical Framework 
This study will be guided by the ‘Common Sense Model of Self-regulation of Health and Illness’ 
by Leventhal et al. (23). This theoretical framework was selected as it facilitates a dynamic 
understanding of complex behavioural responses to events such as illness (23). This 
framework asserts that in response to an illness or health threat, people develop their own 
common-sense beliefs or illness perceptions about their illness and treatment (23). These 
illness perceptions impact the types of healthy behaviours and coping strategies employed by 
patients for managing their illness, which may influence disease outcomes (23). This highlights 
the complex relationship between interpretation of disease and subsequent lifestyle choices, 
which is applicable to the setting of this study.  
 
Study Design 
CABIN will be assessed with a feasibility randomised controlled trial (RCT). The study will be 
guided by the CONSORT extension for reporting pilot and feasibility studies (24). Ensuring 
patient inclusion and preference is a priority for the research team, therefore, this study 
protocol has been designed in accordance with NIHR INVOLVE guidance (25). 
 

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PPI Group  
A PPI Group has been established to advise on the strategic management / delivery of all 
project elements (i.e., commenting on study material, voicing the preferences of patients / 
public, and providing feedback on study updates / objectives), which will maximise research 
impact and ensure the interests of patients / public are met. This group comprises patient 
representatives (4 patients with history of STEMI) and academic experts. Quarterly meetings 
will be held via Microsoft Teams or a hybrid approach (Microsoft Teams and in person) 
depending on preference of members. Communication between meetings will occur as 
required.  
 
Operational Research Team 
The Operational Research Team (DF, JB, GT, and GC) will cooperate to provide the Research 
Fellow (GT) with oversight and guidance for the daily management and delivery of CABIN. 
Monthly meetings will be held via Microsoft Teams or a hybrid approach (Microsoft Teams and 
in person) depending on preference of members. Communication between meetings will occur 
as required.  
 
General Research Team 
The General Research Team (DF, JB, GT, GC, PD, CMcK, MC, and MM) will oversee project 
management / delivery, research methodology, and procedures for CABIN (i.e., discussing 
and agreeing on protocols, research methodology, and procedures for implementation). 
Meetings will be held every two months via Microsoft Teams or a hybrid approach (Microsoft 
Teams and in person) depending on preference of members. Communication between 
meetings will occur as required. 
 
Setting 
Two CCUs in NI:  
 
1) Royal Victoria Hospital, Belfast Health and Social Care Trust (BHSCT). 
2) Ulster Hospital, South Eastern Heath and Social Care Trust (SEHSCT). 
 
Population  
Cardiac patients diagnosed with a STEMI and admitted to a CCU.  
 
Inclusion criteria 
1) Aged 18 and over. 

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2) Confirmed diagnosis of STEMI. 
3) Physically and mentally capable of participation (judged by Cardiologist or Nurse). 
4) Willing to provide informed consent. 
 
Exclusion criteria 
1) Lacking capacity to give consent (judged by Cardiologist or Nurse).  
2) Under the age of 18. 
 
Intervention Design 
There are eight components that form the basis of CABIN, as shown in Figure 1. 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Components of CABIN.  
 
CABIN is designed as a brief intervention with a facilitated discussion between a patient and 
a nurse, with the provision of a short leaflet (see Appendix 1) that summarises information and 
acts as an aide memoire. The discussion takes place in a quiet area and is intended to last 
15-20 minutes. It addresses the eight components in Figure 1 by listening to the patient and 
recognising any concerns he / she may have or identifying erroneous beliefs. It also provides 
the patient with personalised education on CAD and CR (i.e., information about stenting, stent 
placement, medication, and purpose / potential benefits of CR), along with facilitating 
psychological and emotional support discussions with a nurse (i.e., explaining causes of a 
STEMI, discussing support / treatment options, and exploring methods of improving health).  
 
Comparator  
 
Control Group 
In collaboration with our working group, we have considered the needs of the control group 
and agreed that a short educational session should be conducted to minimise bias and 
achieve ethical best practice. The control group will receive a refined version of CABIN (see 
Appendix 2), which excludes psychological and emotional support discussions with a nurse 
and details some standard discharge information (information about CAD and stenting / stent 

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placement).  This will prevent participants of the control group from feeling disadvantaged by 
lack of any intervention.  
 
Both forms of CABIN will not replace standard care or discharge information routinely 
delivered by clinical staff.  
 
Sample Size 
40 patients diagnosed with a STEMI will be recruited in total (intervention group, number (n) 
= 20; control group, n = 20). Whilst a formal sample size is not required for a feasibility study 
(26), the stated sample size was based on similar studies within a cardiac population (27,28), 
and aims to balance feasibility of study delivery within available timescale and resources, 
whilst having a sufficient number of participants to appropriately evaluate feasibility and 
acceptability. Nonetheless, we will recruit beyond this figure if feasible within time and 
resources available.  
 
Recruitment  
The study will comply with all regulatory requirements. Prior to study initiation, ethical and 
governance approvals will be sought from QUB, National Health Service (NHS) / Health and 
Social Care (HSC) Research Ethics Committee (REC), and local HSC R&D offices using the 
Integrated Research Application System (IRAS). Patients will be enrolled once all required 
agreements are in place. Approximate figures for 2019 / 2020 indicate that 4,300 patients were 
admitted to hospitals with a heart attack in NI, with 40% of these patients having a STEMI (n 
= 1,720). 75% of these patients who had STEMI (n = 1,290) were treated in the Belfast region 
within the CCUs that will serve as the study centres (29,30). Thus, approximately 107 patients 
with STEMI will be available for recruitment across both study centres per month. Given the 
small sample size required, we have judged a 6-month period for recruitment to be sufficient 
(recruiting at least 7% of potential participants per month).  
 
Recruitment procedure 
A member of the clinical team (Nurse or Doctor) at each CCU will review the records of 
admitted patients with a screening questionnaire (see Appendix 3) to identify patients who 
satisfy the eligibility criteria for the study. Eligible patients will be approached by a member of 
the clinical team who will provide an information pack including an invitation to participate and 
patient information sheets (see Appendix 4). The member of the clinical team will verbally 
discuss the information sheets with the eligible patient and answer any questions before 
asking if the patient is willing to participate. The typical ‘cooling-off’ period (i.e., one week) 
before making a decision regarding participation is not possible in this study as recruitment, 

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intervention delivery, and data collection must occur before patient discharge from the CCU, 
which will ensure patients receive the intervention as soon as possible following the STEMI, 
and limit participant burden (i.e., travelling to a recruitment appointment). A member of the 
clinical team will contact the Research Fellow to inform him of an interested potential 
participant.  The Research Fellow will attend the ward to further discuss the study (i.e., 
explaining the nature of an RCT and the potential for allocation to the control group) and 
answer any questions. If the patient is willing to participate, the Research Fellow will obtain 
informed consent (see Appendix 5) before randomising the participant and conducting 
baseline data collection. To set the results in context, informed consent will also be requested 
from participants for the extraction of information related to clinical characteristics (cardiac 
intervention received, prescribed medication, and co-morbidities) from their medical records. 
This study will seek adoption by the Northern Ireland Clinical Research Network (NICRN), 
which will involve research nurses extracting the required information from medical records of 
consenting participants. The research team will not have access to the medical records of 
patients. A private space will be used for recruitment and baseline data collection, such as an 
empty, private room at the CCU or a quiet area with a privacy screen. These procedures 
should take approximately 30 minutes. 
 
i. Access and Generalisability 
This study has broad eligibility criteria and a simple recruitment strategy to allow ease of 
access for participants. A study log will be used by members of the clinical team and the 
Research Fellow to identify any bias or complications with screening and recruitment (see 
Appendix 6). Participant identification training will be delivered by the Research Fellow to the 
clinical team, with updates provided on any changes to the study protocol and eligibility criteria. 
A poster diagram of the recruitment procedure (see Appendix 7) will be displayed on each 
ward for reference by members of the clinical team. A £20 voucher will be provided to 
participants upon completion of the study as compensation for their time and any 
inconvenience caused by participation. 
 
ii. Study Advertising and Accessibility of Participant Recruitment Information 
The PPI Group will advise on the development of all study documentation to ensure 
accessibility and adherence to plain English guidelines. We will accommodate potential 
participants with visual impairments by providing audio versions of documents as required. 
Study material will be translated from English if necessary.  
 

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iii. Randomisation Procedure 
An online randomisation service (random permuted blocks) provided by Sealed Envelope Ltd 
(31) will be used by the Research Fellow (GT) to randomise (1:1) patients to the intervention 
or control group. Randomisation will be conducted during the recruitment appointment after 
informed consent is obtained.   
 
Intervention Delivery 
 
Intervention Group 
CABIN (see Appendix 1) will be delivered in a single session to each participant (one-to-one) 
of the intervention group by the Research Assistant (MM) who is a cardiac nurse with over 20 
years of clinical experience in CR. Following recruitment and randomisation, the Research 
Fellow will contact the Research Assistant to inform her of a participant who requires the 
intervention, his / her CCU location (Royal Victoria Hospital or Ulster Hospital), and planned 
discharge date. Subsequently, the Research Assistant will contact the clinical team at the 
relevant CCU to arrange a time to deliver the intervention to the participant when he / she is 
clinically stable, prior to discharge. The Research Assistant will use a staff-facing CABIN 
document (see Appendix 8) to guide intervention delivery, which will provide prompts (i.e., 
relevant questions and actions) and space for notes. A private space will be used for 
intervention delivery, such as an empty, private room at the CCU or a quiet area with a privacy 
screen. Intervention delivery should take approximately 20 minutes.  
 
Control Group 
As previously discussed, participants of the control group will receive a refined version of 
CABIN (see Appendix 2), which excludes psychological and emotional support discussions 
with a nurse and details some standard discharge information (information about CAD and 
stenting / stent placement). The Research Fellow will deliver (one-to-one) this refined version 
of CABIN prior to patient discharge from the CCU. He has a PhD in the area of CAD and CR, 
which provides him with the knowledge required to discuss the relevant information with 
control group participants.  A private space will be used for intervention delivery, such as an 
empty, private room at the CCU or a quiet area with a privacy screen. Intervention delivery 
should take approximately 10 minutes.  
 
Outcome Measures 
 

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Feasibility Measurements and Process Evaluation (Objective 1) 
The primary objective of this study is to test the feasibility of the research design and CABIN 
delivery, which will inform the suitability of methods and procedures for a future effectiveness 
trial on a larger scale.  Thus, the feasibility assessments and process evaluation discussed in 
the following sections represent processes that are key to the success of a larger study 
(32,33). 
 
i. Reach (Recruitment Rate) 
The measurement of recruitment rate will allow the efficiency of the recruitment strategy to be 
assessed, with this information enabling the identification of potential issues and informing the 
required duration of the recruitment period for a larger study (34). The Research Fellow will 
maintain a record (see Appendix 9) of the number of patients screened for eligibility; the 
number eligible and invited to participate; and the number of patients who consented to 
participate per centre. When possible, the reasons for not entering the study will be recorded. 
Recruitment rate will be reported as the percentage of eligible patients who agreed to 
participate in the study, and the number of patients recruited monthly per centre over the 
recruitment period.  
 
ii. Dose  
Dose will assess the completeness of intervention delivery, which will inform the feasibility of 
CABIN implementation. This information will be collected via an intervention checklist (see 
Appendix 10) that is completed by the Research Assistant following each intervention session.  
 
iii. Fidelity  
Fidelity will be represented by adherence to the study protocol and procedures, which will 
identify any modifications required or issues to be resolved. This information will be collected 
via a study log (see Appendix 6) completed by the Research Fellow, Research Assistant, and 
members of the clinical team. 
 
iv. Data Completeness  
The completeness of baseline and outcome measures will be determined as missing data may 
jeopardise the power of a future study (33). The Research Fellow will record details about data 
collection in the study log (see Appendix 6), which will highlight any problems or required 
changes to improve data collection for a future study (33). Data completeness will be reported 
as the percentage of recruited participants providing data for each baseline and outcome 
measure, with reasons for any missing data stated.   

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v. Acceptability, Context, and Possible Mechanisms of Impact  
A process evaluation of the research design / CABIN implementation will be conducted 
through measures of 1) Acceptability of intervention (i.e., issues for development, required 
corrections, additional areas for inclusion, aspects enjoyed by participants, and barriers and 
facilitators to participation); 2) Context (i.e., factors influencing study / intervention delivery and 
functioning, for instance, time and resources); and 3) Possible mechanisms of impact (i.e., 
exploring how intervention activities may trigger change for participants). These 
measurements will be primarily assessed with qualitative data collected from exit interviews 
with participants and focus groups with CCU and CR staff. Information from study documents 
(i.e., intervention checklist (Appendix 10), study log (Appendix 6), and post-study evaluation 
questionnaire (Appendix 11)) will supplement this qualitative data.  
 
Protocol for Exit Interviews with Participants 
 
Design 
All participants (intervention and control group) will be eligible to complete a semi-structured 
interview (approximately 30 – 60 minutes in duration) at the final Time Point (TP) for data 
collection. A core set of questions in a “laddered style approach” will be used, which will ensure 
emerging ideas are explored (35). Interview questions for the intervention group participants 
(see Appendix 12) will focus on acceptability, context, and possible mechanisms of impact for 
intervention implementation and study delivery. As control group participants will not receive 
the full version of CABIN, their interview questions (see Appendix 13) will focus on 
acceptability of study delivery (i.e., barriers and facilitators to participation / any 
recommendations or concerns).  
 
Procedure  
As part of the original consent process (see Appendix 5), patients will either agree or refuse 
to participate in the exit interview. For those who agree, the Research Fellow will conduct each 
interview individually with participants at the final TP for data collection, which will be held 
virtually (i.e., Microsoft Teams) or face-to-face (i.e., the participant’s home or a quiet meeting 
room at QUB) at the participant’s preference. All interviews will be audio-recorded before being 
transcribed verbatim by an external service. Data analysis of the transcripts will be performed 
iteratively (after each interview).    
 

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Protocol for Focus Groups with Staff 
 
Design 
CCU and CR staff will be invited to participate in virtual (i.e., Microsoft Teams) focus groups 
(approximately 60 minutes in duration) at the end of the study. A core set of questions in a 
“laddered style approach” will be used, which will ensure emerging ideas are explored (35). 
These questions (see Appendix 14) will focus on acceptability, context, and possible 
mechanisms of impact for intervention implementation and study delivery.  
 
Participants 
CCU and CR staff at the collaborating hospital centres (Royal Victoria Hospital and Ulster 
Hospital) will be recruited.  
 
Inclusion Criteria 
1) Aged 18 and over. 
2) Willing to provide informed consent. 
 
Exclusion Criteria  
1) Under the age of 18.  
 
Sample Size 
Four virtual focus groups across both centres (Royal Victoria Hospital, n = 2; Ulster Hospital, 
n = 2) will be conducted. Each focus group will consist of CCU (n = 3) and CR staff (n = 3).  
This sample size is based on recommendations in the literature for a study of this scope (38).  
 
Procedure 
The Research Fellow will conduct the focus groups at the end of the study. The Research 
Fellow will verbally discuss the focus groups with members of the research team who are 
clinical staff. These members will be asked to supply interested colleagues (CCU and CR 
staff) with an information pack including an invitation to participate and participant information 
sheets (see Appendix 15) for the focus groups. The participant information sheets will advise 
potential participants to consider their willingness to participate for one week (cooling-off 
period) before contacting the Research Fellow who will then answer any questions and inform 

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the participant of the date for the virtual focus group. Informed consent (see Appendix 16) will 
be obtained electronically via Qualtrics from all participants before focus groups are 
conducted. Subsequently, participants will be asked to provide demographic details (age, 
gender, education level, marital status, occupation, and postcode (measure of socioeconomic 
background)) via Qualtrics (see Appendix 17), which will set the findings in context. All focus 
groups will be audio-recorded before being transcribed verbatim by an external service.  
 
Preliminary Exploration of CABIN Impact (Objective 2) 
The secondary objective of this study is to perform a preliminary assessment of intervention 
effect on relevant outcomes, which will inform the selection of appropriate outcome measures 
for a larger, definitive study.  
 
i. Questionnaires 
All participants will be asked to complete four short, validated questionnaires at each TP, 
which will provide information on the impact of CABIN on knowledge of CAD and CR; and 
psychological and emotional well-being: 
 
1) CADE-Q SV (21): evaluates patients’ knowledge of CAD and core components of CR.  
2) Brief Illness Perception Questionnaire (39): rapidly assesses the cognitive and emotional 
representations of illness.  
3) The Hospital Anxiety and Depression Scale (40): detects states of depression and anxiety.  
4) Personal Wellbeing Score (41): subjectively measures health status and health confidence. 
 
These outcome measures were specifically chosen to minimise participant burden, whilst 
providing reliable data. As per advice from the PPI Group, the Research Fellow or Research 
Assistant will clearly explain the questionnaires to all participants before completion, and will 
be present to provide assistance, if required. The questionnaires will be compiled in a booklet 
(see Appendix 18), which will include a short cover sheet comprising questions concerning 
demographic details (age, gender, education level, employment status, marital status, and 
postcode (measure of socioeconomic background)). This demographic information will assist 
with setting the results in context. The cover sheet will be removed from the questionnaire 
booklet for the follow-up TPs. If a TP for data collection is held virtually, the participant will 
complete the questionnaire booklet via Qualtrics under the guidance of the Research Fellow. 
The completion of the questionnaire booklet will take approximately 20 minutes.   
 

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ii. CR Attendance  
The impact of CABIN on CR attendance will be investigated. Participants will be asked to 
provide informed consent (see Appendix 5) for the Research Fellow to be supplied with their 
CR attendance figures by the CR teams.  
 
Success Criteria 
A feasibility study should possess clearly defined a priori success criteria that are based on 
the outcome measures (32). These criteria serve as the basis for interpreting the results to 
ascertain the viability of conducting a larger, definitive study and / or to identify required 
modifications to promote success (33).  
 
i. Reach (Recruitment Rate) 
Approximate figures for 2019 / 2020 indicate that 1,720 patients were admitted to hospitals 
with a STEMI in NI (29,30). Accordingly, for a future, multi-centre study including patients with 
STEMI across NI, a sample size of 315 would be required for a 5% margin of error, 95% 
confidence level, and a response distribution of 50%. Assuming a recruitment period of one 
year and five centres across the Health and Social Care Trusts in NI, the required monthly 
recruitment rate per centre would be approximately 6 participants. Therefore, for this study, a 
monthly recruitment rate of 6 participants per centre will be the success criterion.  
 
ii. Data Completeness  
Missing data for > 20% of participants may pose a serious threat to validity (42). Therefore, 
data completeness will be deemed successful if data is received from ≥ 80% of participants 
at each TP (excluding qualitative data as sample sizes will be different).   
 
iii. Acceptability of the Study Protocol and CABIN Implementation  
Acceptability of the study protocol and CABIN implementation (i.e., issues for development, 
required corrections, aspects enjoyed by participants, and factors influencing study / 
intervention delivery) will be predominantly informed by the qualitative data collected form 
participants and staff. Success will constitute the provision of positive feedback on the study 
protocol and intervention delivery, along with no infeasible / major revisions being identified.  
 
Time Points for Data Collection 
Four TPs for data collection were chosen to provide detail of illness perception and emotional 
/ psychological wellbeing for patients between discharge from the CCU and engagement with 
CR (see Table 1). All timing is from the point of STEMI diagnosis. TP-1 represents face-to-

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face recruitment and baseline data collection at the CCU before discharge, which will be 
conducted by the Research Fellow. TP-2 will constitute post-intervention data collection at the 
CCU before discharge, which will be performed by the Research Assistant (for intervention 
group) or Research Fellow (for control group) immediately following intervention delivery. Data 
collection at TP-3 and TP-4 coincides with the start and end of CR attendance, respectively. 
We will use these data points to assess engagement with CR across the duration of the 
programme. If a participant does not attend CR, the Research Fellow will calculate the same 
timescales and conduct data collection accordingly, with the same process occurring for those 
who reschedule their CR assessment. Data collection at TP-3 and TP-4 will be conducted 
virtually (i.e., Microsoft Teams) or face-to-face (i.e., the participant’s home or a private meeting 
room at QUB) depending on the participant’s preference. CCU and CR staff will be invited to 
participate in focus groups after data collection from patients has concluded.  
 
Case Report Form  
The Research Fellow will record data collected at each TP on an pseudonymised Case Report 
Form (see Appendix 19), which will serve as a consolidated resource that outlines the data 
collected for each participant.  

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Table 1. Time Points for Data Collection.  
Time 
Point 
Time after diagnosis 
Trigger  
Location 
Data collected 
Duration 
(minutes) 
Performed by 
TP-1 
(Baseline) 
12-96 hours 
Pre-intervention 
(recruitment session) 
CCU 
1) Clinical characteristics from 
medical records. 
2) Questionnaire booklet 
(including demographic details). 
20  
NICRN Research Nurse 
(extracting clinical characteristics 
from medical records) and 
Research Fellow (questionnaire 
booklet) 
TP-2 
< 96 hours (before discharge from 
CCU) 
Post-intervention 
CCU 
1) Questionnaire booklet. 
20 
Research 
Assistant 
Intervention 
Group 
Research 
Fellow 
Control Group 
TP-3 
3-4 weeks (may be different time 
frame depending on date of 1st CR 
assessment)  
1st CR assessment 
Virtual or 
in-person 
1) Questionnaire booklet. 
20 
Research Fellow 
TP-4 
13-14 weeks 
Final CR assessment 
Virtual or 
in-person 
1) Questionnaire booklet. 
2) Post-study evaluation 
questionnaire. 
3) Exit interview.  
4) CR attendance.  
60 
Research Fellow 

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TP = Time Point; CCU = Coronary Care Unit; NICRN = Northern Ireland Clinical Research Network; CR = Cardiac Rehabilitation; and N/A = Not Applicable.  
Focus 
groups 
with staff 
N/A 
Completion of data 
collection from patients 
Virtual 
1) Demographic details. 
2) Qualitative data. 
60 
Research Fellow 
 
 
 
 

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CABIN: A Feasibility Study to Promote Engagement with CR: Study Protocol. V2 – 20/01/23. 
Data Analysis 
 
Quantitative Data Analysis 
Quantitative data will be organised and collated into one dataset in Microsoft Excel before 
being transferred to the Statistical Package for the Social Sciences (IBM SPSS Statistics, 
Version 28). Inferential statistics will not be performed as this study is not formally powered to 
detect statistical significance. The data will be reported with descriptive statistics. In terms of 
numerical data, continuous data will be presented as mean ± standard deviation, with discrete 
data reported as absolute numbers and percentages. Categorical data will be displayed as 
frequency / percentages. Within and between-group mean differences and 95% confidence 
intervals will be reported at each TP for the questionnaire data, with results interpreted 
according to minimum clinically important differences, if available.  
 
Qualitative Data Analysis  
The audio-recordings of semi-structured interviews and focus groups will be transcribed 
verbatim by an external service, with identifying information removed.  Qualitative data will be 
analysed using the stages of the framework method of analysis; familiarisation, identifying a 
thematic framework, indexing, charting, mapping, and interpretation (43). The data in each 
group will be analysed separately to obtain an account for each experience. The research 
team will read and re-read transcripts for familiarity, with key issues and themes identified and 
a thematic framework developed. This framework will be applied to the transcripts and themes 
will be coded and charted, which will enable the refined themes to be mapped and interpreted 
to give a full account of the investigated phenomena. The accounts from each group will be 
compared to find similarities and differences between the groups. To enhance rigour, a 
process of member checking will be implemented, whereby the Research Fellow will give a 
descriptive summary and discuss the respective findings of each group with corresponding 
participants to ensure the analysis adequately reflects their accounts (44). Qualitative data 
analysis will be managed on NVivo (QSR International Pty Ltd. Release 1).  
 
Integration of Quantitative and Qualitative data 
The quantitative and qualitative data will be integrated to achieve triangulation of findings 
(convergence of quantitative and qualitative data), which may generate a multidimensional 
understanding of the feasibility, theory, design, methods, implementation, and impact of 
CABIN (22). A triangulation protocol will be implemented according to the recommendations 
of Farmer et al. (45). The findings from the quantitative and qualitative data will be sorted and 
listed on the same page to ascertain if there is agreement, partial agreement, discrepancy / 

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dissonance, or silence between them. Silence will represent a theme occurring in only one 
dataset. This assessment will be displayed in a convergence coding matrix, with the 
triangulated results being discussed by the research team for review and clarification. The 
reporting of this integrated data will comply with the ‘Good Reporting of a Mixed Methods 
Study’ framework (46).  
 
Ethical Considerations 
This study will be conducted in accordance with Good Clinical Practice guidelines and adhere 
to the Declaration of Helsinki statement (1964). Ethical and governance approvals will be 
sought from QUB, NHS / HSC REC, and local HSC R&D offices (BHSCT and SEHSCT) using 
IRAS. The research team have prior experience with successful ethical applications and 
understand the regulations and timescales involved. This is a low-risk intervention delivered 
by an experienced team who are familiar with the processes required to obtain ethical and 
governance approvals, with no difficulties anticipated. We have consulted with Professor Mike 
Clarke (methodological expert), along with patients and staff in the development of this 
protocol to mitigate any areas of ethical concern. The intervention has been designed by 
patients and Cardiac Nurses who have provided their experience and expertise. We will liaise 
with NICHS if any significant changes to the protocol are required.  
 
Study Publicity   
To improve reach and exposure, we will advertise the study at ward-level. We will endeavour 
to maximise the profile of the study through publications and presentations, which will also 
raise awareness of NICHS and the support they provide.  
 
CCU Staff Training  
Medical and nursing staff will adhere to Trust Governance Requirements for Research 
Conduct and Procedure. The research team will provide training to all staff for identifying 
potential participants and the process for contacting the Research Fellow. We will equip 
clinical staff with a factsheet to answer commonly asked questions (see Appendix 20) and a 
visual representation of the recruitment process (see Appendix 7), which will assist with the 
implementation of the recruitment protocol. NICRN research nurses will receive a dedicated 
data collection form to facilitate extraction of clinical characteristics from medical records of 
consenting patients (see Appendix 21).  
 
Recruitment  

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PPI input suggested that the research team need to spend time discussing the use of 
questionnaires to obtain measurements of emotional and psychological health. The Research 
Fellow will be explicit during the consent process to ensure the patient has fully understood 
the requirements of the study, which will equip him / her with the knowledge required to provide 
informed consent. This may include translating material for non-English speakers. The 
Research Fellow will explain the nature of an RCT and the potential for the participant to be 
randomised to the control group and receive only a limited version of the CABIN intervention. 
For those patients recruited to the control group, the Research Fellow will give them time to 
ask questions and refer any specific issues to the ward-based clinical team via the nurse in 
charge.   
 
CABIN  
Co-design methodology identified the need for more personalised information and 
psychological support in the acute phase following STEMI. The workshops were subsequently 
used to develop and refine CABIN based on patient experience, requirements, current 
scientific evidence, and guidance from the British Association for Cardiovascular Prevention 
and Rehabilitation (BACPR).  
 
Anonymity  
The identification of eligible patients will be completed by professional gatekeepers (Nurse or 
Doctor). These individuals will make primary contact with the patient about the study and 
determine their willingness to be involved. As such, the research team will not see any records 
or have any contact with patients before the Research Fellow meets with them to obtain 
informed consent. Medical records will only be assessed by the NICRN research nurses to 
obtain clinical characteristics if written informed consent is obtained from participants. Each 
participant will be assigned a Personal Identification Number (PIN), which will replace 
identifying information within datasets, such as: name and hospital Health & Care Numbers. 
 
Burden 
Study materials have been chosen / created to minimise participant burden. All patient 
information sheets and informed consent forms are user friendly in design and have been 
evaluated by the PPI Group. All study procedures will be conducted at a private space, for 
instance, in a quiet room at a CCU or QUB, the participant’s home, or virtually (i.e., Microsoft 
Teams). The questionnaires selected take a short time to complete and are validated, which 
aims to reduce participant burden. The location of data collection in the later stages of the 
study will be determined by participant preference. We will provide a £20 voucher to each 

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participant upon study completion as compensation for data usage, time commitment, and any 
inconvenience caused. 
 
Distress 
Participant distress may occur during the study (i.e., when completing questionnaires or 
discussing sensitive topics in an interview). As such, a distress protocol (see Appendix 22) 
has been developed by the research team, which will be implemented in the event of a 
participant becoming upset. Moreover, to support distressed participants, the research team 
will request for NICHS to provide additional information if required, for instance, lifestyle 
leaflets. This technique was used in previous research, which the participants found helpful.  
 
Safeguarding  
Patient participants who demonstrate low overall scores on the included questionnaires and 
scales will be immediately highlighted by the Research Fellow to the healthcare team. This 
will constitute an effort to identify those patients in need of additional support or follow-up. It 
will then be at the discretion of the healthcare team as to what extra support is provided to 
these individuals. If an interview occurs at a participant’s home, the Research Fellow will 
comply with the Lone Working policy at QUB for his safety.  
 
Study Withdrawal 
Participants will be informed of the voluntary nature of their inclusion in this research and their 
ability to withdraw at any point, without compromising their current clinical care. As stated in 
the patient information sheets, if a participant withdraws 2 weeks after the time of initial data 
collection, his / her data may be used for analysis (with the participant’s consent). The reason 
for withdrawal will be noted for review.  
 
Data Protection and Management 
The requirements of the General Data Protection Regulation and Data Protection Act (2018) 
will be adhered to, as per the QUB Data Protection Policy. All information will be stored in a 
secure manner in compliance with local Trust governance requirements. We will only acquire 
information that is required to undertake the study. All paper data will be stored in a Master 
File and Site Files in locked filing cabinets, inside locked offices within the School of Nursing 
and Midwifery, QUB and the collaborating centres (BHSCT and SEHSCT), respectively. All 
electronic data will be stored on an encrypted and password protected computer, inside a 
locked office within the School of Nursing and Midwifery, QUB. Individual data files will also 

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be password protected. All audio-recordings will be destroyed after the transcripts have been 
checked for accuracy.  
 
Personal data will be pseudonymised. A PIN system will be used, whereby each participant is 
allocated a unique number. This number will replace identifying information within datasets, 
such as: name and Health & Care Number (used within the hospital). This will help preserve 
anonymity when the data is reviewed by the research team. A master list that links PINs to 
patients’ personal information (i.e., name and contact details) will be stored securely and 
separately from other data in a locked office within the School of Nursing and Midwifery, QUB. 
The researcher will endeavour to use a participant’s first name only during audio-recordings 
of interviews and focus groups. Transcriptions of audio-recordings will be redacted and 
transferred through secure processes (i.e., linked with PIN). We will only use trusted staff who 
have completed a Data Sharing Agreement with the University for transcribing audio-
recordings. All data presented in publications will be anonymised to protect participant 
confidentiality.  
 
Consent will be obtained from participants for data preservation and sharing in an anonymised 
format. As per the QUB Research Data Management Policy, data will be retained in an 
anonymised format for a minimum of 5 years following publication if they are of continuing 
value to the researcher and the wider research community. Upon project completion, data sets 
will be allocated a DOI and transferred to the University’s research information management 
system (Pure) for long-term preservation, which will contain links to the project and relevant 
publications. All data that may identify participants will be destroyed following University 
procedures. Data will be exclusive to the research team until the completion of the study and 
publication of findings. Data generated by the project may be shared in an anonymised format 
after completion. The Principal Investigator (PI, Professor Donna Fitzsimons) will make the 
decision about whether to supply research data to a potential new user. Before data is shared, 
a data-sharing agreement will be issued and signed by appropriate authorities, which will 
prohibit any attempt by external users to (a) identify study participants form the released data 
or otherwise breach confidentiality and (b) make unapproved contact with any study 
participants. The MRC Policy and Guidance on Sharing of Research Data from Population 
and Patient Studies will be adhered to. The PI will be the first point of contact for all queries in 
relation to the data and will also have overall responsibility for the production and maintenance 
of metadata. The Research Fellow will have responsibility for study-wide data management, 
metadata creation, data security, and quality assurance of data. Preparation and upload of the 

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data will be carried out by the research team with the support of QUB Information Services 
staff. 
 
Dissemination  
The protocol / methods and results of this study will be disseminated via publications in peer-
reviewed journals and scientific conferences (European Society of Cardiology - Preventative 
Cardiology Congress, EuroHeartCare, Irish Cardiac Society, and BACPR). We will link with 
NICHS to publicise the study and increase awareness of both NICHS and the research it 
supports. We will also produce posters possessing lay terminology in relation to the study 
purpose and methodology (during data collection phase) and similar posters displaying the 
results, impact, and future plans. These posters will be suitable for online viewing whilst 
ensuring accessibility for those with disabilities. We will utilise opportunities within QUB to 
disseminate the study methods and results, for instance, post-doc events and the School of 
Nursing Annual Conference. Members of the PPI Group (i.e., patients) will be involved with 
dissemination of results and co-authorship of papers/abstracts where possible. 
 
Potential Impact 
If feasible and acceptable, this research will progress to ‘Evaluation’, which is the next phase 
of the MRC framework for developing complex interventions (20). This will involve performing 
a definitive, multi-centre RCT to assess the effectiveness of CABIN in a real-world setting. 
Ultimately, this research could lead to the implementation of CABIN in routine clinical practice,  
which may increase uptake to CR and improve outcomes for cardiac patients, such as: a 
reduction in recurrent cardiac events and lower readmission rates for anxiety-related chest 
pain. This intervention may also be replicated for other cardiac conditions and beyond the 
specialty into respiratory or stroke patients who face similar psychological challenges post-
diagnosis. Importantly, the high degree of personalisation within CABIN may enhance the 
health literacy of patients and empower self-management of their conditions in partnership 
with local support network and agencies (i.e., NICHS).  
 
Management Plan 
Abbreviations: DF = Donna Fitzsimons, JB= Judy Bradley, PD = Patrick Donnelly, GC = 
Gemma Caughers, GT = Gareth Thompson, MM = Maria Mooney, MC = Mike Clarke, and 
CMcK = Clare McKeaveney.  
 

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• 
DF is the PI and is an experienced cardiovascular nurse and researcher who will 
provide oversight and be primarily responsible for study delivery (alternative PI to 
deputise if and when required). 
• 
JB is the alternative PI and has co-authored the proposal and is an intrinsic member 
of the team. JB can assume the responsibility of PI if required with no negative impact 
to the study. Her role is also to provide additional oversight and link with clinical teams 
in the BHSCT.  
• 
PD has contributed to the proposal and as a clinical cardiologist will advise on the 
delivery of the study. PD will assist in identifying potential participants and support with 
raising the study profile within the Cardiology clinical teams at the SEHSCT.  
• 
GT is the Research Fellow who will conduct the daily running of the study, such as: 
training staff for potential participant identification, recruiting patients, data collection, 
administrative tasks, analysis, write-up, and dissemination of findings.   
• 
GC led the completion of the protocol and is an experienced cardiovascular nurse and 
researcher. GC can assume the responsibility of the Research Fellow or Research 
Assistant if required with no negative impact to the study.  
• 
MM is the Research Assistant and is a cardiac nurse with over 20 years of clinical 
experience. MM will be responsible for the safe delivery of the intervention and 
conducting post-intervention measurements on the intervention group.   
• 
MC and CMcK are methodological and statistical experts who will provide guidance 
and advice over the course of the study.   
• 
The team will meet regularly for updates and quarterly reports will be sent to NICHS. 
NICHS will also be updated at key points within the study, for instance, starting 
recruitment and achieving desired sample size. The Research Fellow will immediately 
report any safety issues or concerns to the team and escalate where appropriate.  
 
Contingency Plan 
All members of the team have full understanding of the study and associated requirements. 
GC will be trained in all aspects of study / intervention delivery should the Research Fellow or 
Research Assistant be unavailable in emergency circumstances. The analysis and writing of 
results can be transferred within the team, if necessary. We will inform NICHS if there are any 
potential or actual difficulties in delivering the project. 
 
 
 
 

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Project Milestones 
 
Table 2. Project Milestones 
 
Date 
Milestone 
Project 
Month 
Person Responsible 
November 2022 - March 2023 
Ethics and Governance 
Approval. 
0 
Research Fellow 
April 2023 
Publicising Study Initiation. 
1 
Entire Team 
April 2023 and May 2023 
CCU Staff Training. 
1 & 2 
Research Fellow 
April 2023 – June 2023 
Writing Methodology Paper. 
1 - 3 
Entire Team 
May 2023 
Recruitment Start. 
2 
Research Fellow 
May 2023 – October 2023 
Recruitment Open. 
2 - 7 
Research Fellow 
May 2023 – October 2023 
Baseline Data Collection (TP-
1) and Intervention Delivery. 
2 - 7 
Research Fellow (data 
collection) and Research 
Assistant (intervention 
delivery) 
May 2023 – October 2023 
Post-Intervention Data 
Collection (TP-2). 
2-7 
Research Assistant 
June 2023 – November 2023 
TP-3 Data Collection (Start of 
CR). 
3 - 8 
Research Fellow 
July 2023 – January 2024 
TP-4 Data Collection (End of 
CR). 
4 - 9 
Research Fellow 
January 2024 – February 2024 
Focus Groups with Staff. 
9 & 10 
Research Fellow 
July 2023 – August 2023 
Conference Abstract Writing. 
4 & 5 
Entire Team 
February 2024 – April 2024 
Refinement of CABIN for 
Further Testing. 
10 - 12 
Entire Team 
February 2024 – April 2024 
Results Papers. 
10 - 12 
Entire Team 
April 2024 
Conference Presentations. 
12 
Entire Team 
 
CCU = Coronary Care Unit, TP = Time Point, CR = Cardiac Rehabilitation, and CABIN = 
Cardiac brief intervention.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Project Deliverables 
 
Table 3. Project Deliverables.  
 
Deliverable 
Context 
Month 
of 
Delivery 
Person Responsible 
Methodology / Protocol Paper Publication in peer-reviewed 
scientific journal. 
3 
Research 
Fellow 
and 
review by team.  
Abstract 
Submission 
(2 
European Conferences)  
Abstract for conference poster / 
presentation.  
6 
Research 
Fellow 
and 
review by team. 
Abstract Submission (1 local 
conference) 
Abstract for conference poster / 
presentation. 
8 
Research 
Fellow 
and 
review by team. 
Results Paper 
Publication 
in 
peer-reviewed 
scientific journal. 
12 
Research 
Fellow 
and 
review by team. 
Abstract 
Submission 
(BACPR) 
Abstract for conference poster / 
presentation. 
12 
Research 
Fellow 
and 
review by team. 
Dissemination of results via 
NICHS, social media, HSC 
trust research departments, 
and print media. 
Dissemination of findings.  
11 - 12 
Research Fellow.  
 
BACPR = British Association for Cardiovascular Prevention and Rehabilitation, NICHS = 
Northern Ireland Chest, Heart, and Stroke, and HSC = Health and Social Care.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Project Timeline 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Reference List 
1. 
Dullaghan L, Lusk L, McGeough M, Donnelly P, Herity N, Fitzsimons D. ‘I am still a bit 
unsure how much of a heart attack it really was!’ Patients presenting with non ST 
elevation myocardial infarction lack understanding about their illness and have less 
motivation for secondary prevention. European Journal of Cardiovascular Nursing. 
2014;13(3):270–6. 
Available 
from: 
https://academic.oup.com/eurjcn/article/13/3/270/5933197  
2. 
McAnirn G, Lusk L, Donnelly P, McKenna N, Hamill C, Fitzsimons D. Shocked and 
guilty, but highly motivated: Younger patients’ experience post MI. British Journal of 
Cardiac 
Nursing. 
2015;10(12):610–5. 
Available 
from: 
https://www.magonlinelibrary.com/doi/10.12968/bjca.2015.10.12.610  
3. 
Herber OR, Smith K, White M, Jones MC. ‘Just not for me’ – contributing factors to 
nonattendance/noncompletion at phase III cardiac rehabilitation in acute coronary 
syndrome patients: a qualitative enquiry. J Clin Nurs. 2017;26(21–22):3529–42. 
Available from: https://onlinelibrary.wiley.com/doi/full/10.1111/jocn.13722  
4. 
Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015;351. Available from: 
https://www.bmj.com/content/351/bmj.h5000  
5. 
McGrady A, Burkes R, Badenhop D, McGinnis R. Effects of a Brief Intervention on 
Retention of Patients in a Cardiac Rehabilitation Program. Applied Psychophysiology 
Biofeedback. 
2014;39(3–4):163–70. 
Available 
from: 
https://link.springer.com/article/10.1007/s10484-014-9252-y  
6. 
Clark M, Kelly T, Deighan C. A Systematic Review of the Heart Manual Literature. 
European Journal of Cardiovascular Nursing. 2011;10(1):3–13. Available from: 
https://academic.oup.com/eurjcn/article/10/1/3/5929316  
7. 
Wakefield B, Drwal K, Scherubel M, Klobucar T, Johnson S, Kaboli P. Feasibility and 
Effectiveness of Remote, Telephone-Based Delivery of Cardiac Rehabilitation. 
Telemedicine 
and 
e-Health. 
2013;20(1):32–8. 
Available 
from: 
https://www.liebertpub.com/doi/10.1089/tmj.2013.0079  
8. 
Neubeck L, Redfern JU, Fernandez R, Briffa T, Bauman A, Freedman S ben. Telehealth 
interventions for the secondary prevention of coronary heart disease: a systematic 
review. European Journal of Cardiovascular Prevention and Rehabilitation. 
2009;16(3):281–9. 
Available 
from: 
https://academic.oup.com/eurjpc/article/16/3/281/5931930  

33 
 
Page 33 of 37 
 
CABIN: A Feasibility Study to Promote Engagement with CR: Study Protocol. V2 – 20/01/23. 
9. 
Wongvibulsin S, Habeos EE, Huynh PP, Xun H, Shan R, Porosnicu Rodriguez KA, et 
al. Digital Health Interventions for Cardiac Rehabilitation: Systematic Literature Review. 
J 
Med 
Internet 
Res. 
2021;23(2):e18773. 
Available 
from: 
https://www.jmir.org/2021/2/e18773  
10. 
National Audit of Cardiac Rehabilitation. NACR Quality and Outcomes Report 2019. 
https://www.bhf.org.uk/informationsupport/publications/statistics/national-audit-of-
cardiac-rehabilitation-quality-and-outcomes-report-2019#. 2019.  
11. 
Hendriks JML, Gallagher C, Astley C, Linz D, Gallagher R. Cardiac rehabilitation 
services: A global perspective on performance and barriers. Int J Cardiol Heart Vasc. 
2019;24:100410. Available from: https://doi.org/10.1016/j.ijcha.2019.100410 
12. 
Caughers G, Bradley J, Donnelly P, Fitzsimons D. Co-design of cardiac rehabilitation 
delivery in the aftermath of COVID-19, putting the patient view back in the picture. 
European Journal of Cardiovascular Nursing. 2021;20(Supplement_1). Available from: 
https://academic.oup.com/eurjcn/article/20/Supplement_1/zvab060.068/6330374  
13. 
Chindhy S, Taub PR, Lavie CJ, Shen J. Current challenges in cardiac rehabilitation: 
strategies 
to 
overcome 
social 
factors 
and 
attendance 
barriers.  
Expert Review of Cardiovascular Therapy. 2020 ;18(11):777–89. Available from: 
https://www.tandfonline.com/doi/abs/10.1080/14779072.2020.1816464  
14. 
Daly J, Sindone AP, Thompson DR, Hancock K, Chang E, Davidson P. Barriers to 
participation in and adherence to cardiac rehabilitation programs: a critical literature 
review. 
Prog 
Cardiovasc 
Nurs. 
2002;17(1):8–17. 
Available 
from: 
https://pubmed.ncbi.nlm.nih.gov/11872976/  
15. 
Figueiras MJ, Maroco J, Monteiro R, Caeiro R, Dias Neto D. Randomized controlled 
trial of an intervention to change cardiac misconceptions in myocardial infarction 
patients.  
Psychology, 
Health 
& 
Medicine. 
2016;22(3):255–65. 
Available 
from: 
https://www.tandfonline.com/doi/abs/10.1080/13548506.2016.1153677  
16. 
McPhillips R, Salmon P, Wells A, Fisher P. Cardiac Rehabilitation Patients’ Accounts 
of Their Emotional Distress and Psychological Needs: A Qualitative Study. J Am Heart 
Assoc. 
2019;8(11). 
Available 
from: 
https://www.ahajournals.org/doi/abs/10.1161/JAHA.118.011117  
17. 
Michie S, O’Connor D, Bath J, Giles M, Earll L. Cardiac rehabilitation: The psychological 
changes 
that 
predict 
health 
outcome 
and 
healthy 
behaviour.  

34 
 
Page 34 of 37 
 
CABIN: A Feasibility Study to Promote Engagement with CR: Study Protocol. V2 – 20/01/23. 
Psychology, 
Health 
& 
Medicine. 
2010;10(1):88–95. 
Available 
from: 
https://www.tandfonline.com/doi/abs/10.1080/13548500512331315398  
18. 
Caughers G, Bradley J, Fitzsimons D, Donnelly P. Rejuvenating Rehabilitation – 
Outcomes from an Experience Based Co-Design approach to improve engagement 
with Cardiac Rehabilitation. Poster session presented at British Association of 
Cardiovascular Prevention and Rehabilitation, Belfast, United Kingdom. Available from: 
https://pure.qub.ac.uk/en/publications/rejuvenating-rehabilitation-outcomes-from-an-
experience-based-co-  
19. 
Richards SH, Anderson L, Jenkinson CE, Whalley B, Rees K, Davies P, et al. 
Psychological interventions for coronary heart disease: Cochrane systematic review 
and meta-analysis. Eur J Prev Cardio. 2018;25(3):247–59. Available from: 
https://academic.oup.com/eurjpc/article/25/3/247/5926174  
20. 
Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. Framework 
for the development and evaluation of complex interventions: gap analysis, workshop 
and consultation-informed update. Health Technol Assess. 2021;25(57):1–132. 
Available from: https://doi.org/10.3310/hta25570 
21. 
Ghisi GL de M, Sandison N, Oh P. Development, pilot testing and psychometric 
validation of a short version of the coronary artery disease education questionnaire: 
The CADE-Q SV. Patient Educ Couns. 2016;99(3):443–7. Available from: 
https://doi.org/10.1016/j.pec.2015.11.002 
22. 
Dickson VV, Page SD. Using mixed methods in cardiovascular nursing research: 
Answering the why, the how, and the what’s next. European Journal of Cardiovascular 
Nursing. 
2021;20(1):82–9. 
Available 
from: 
https://academic.oup.com/eurjcn/article/20/1/82/6132767  
23. 
Cameron LD, Leventhal H. The self-regulation of health and illness behaviour. London: 
Routledge; 2003. 
24. 
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. 
CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 
2016;355. Available from: https://www.bmj.com/content/355/bmj.i5239  
25. 
National Institute for Health and Care Research. Being Inclusive in Public Involvement 
in Health and Care Research. https://www.nihr.ac.uk/documents/being-inclusive-in-
public-involvement-in-health-and-care-research/27365#What_is_public_involvement?. 
2021.  

35 
 
Page 35 of 37 
 
CABIN: A Feasibility Study to Promote Engagement with CR: Study Protocol. V2 – 20/01/23. 
26. 
Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and 
feasibility trials being undertaken in the United Kingdom registered in the United 
Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013;13(1):1–
6. Available from: https://link.springer.com/articles/10.1186/1471-2288-13-104  
27. 
Murphy PJ, Sharry JM, Casey D, Doherty S, Gillespie P, Jaarsma T, et al. Sexual 
counselling for patients with cardiovascular disease: protocol for a pilot study of the 
CHARMS sexual counselling intervention. BMJ Open. 2016;6(6):e011219. Available 
from: https://bmjopen.bmj.com/content/6/6/e011219  
28. 
Higgins RO, Rogerson M, Murphy BM, Navaratnam H, Butler M v., Barker L, et al. 
Cardiac Rehabilitation Online Pilot: Extending Reach of Cardiac Rehabilitation. Journal 
of 
Cardiovascular 
Nursing. 
2017;32(1):7–13. 
Available 
from: 
https://journals.lww.com/jcnjournal/Fulltext/2017/01000/Cardiac_Rehabilitation_Online
_Pilot__Extending.3.aspx  
29. 
British Heart Foundation. Heart and Circulatory Disease Statistics: Chapter 2 – 
Morbidity. 
https://www.bhf.org.uk/what-we-do/our-research/heart-statistics/heart-
statistics-publications/cardiovascular-disease-statistics-2021. 2021.  
30. 
Myocardial 
Ischaemia 
National 
Audit 
Project. 
2019 
Summary 
Report. 
https://www.hqip.org.uk/resource/myocardial-ischaemia-national-audit-project-minap-
2019-summary-report/#.Y0_rYPzMK3B. 2019.  
31. 
Sealed 
Envelope 
Ltd. 
Simple 
Randomisation 
Service. 
https://www.sealedenvelope.com/simple-randomiser/v1/. 2022.  
32. 
Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: 
The what, why and how. BMC Med Res Methodol. 2010;10(1):1–10. Available from: 
https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-10-1  
33. 
Avery KNL, Williamson PR, Gamble C, Francischetto EOC, Metcalfe C, Davidson P, et 
al. Informing efficient randomised controlled trials: exploration of challenges in 
developing 
progression 
criteria 
for 
internal 
pilot 
studies. 
BMJ 
Open. 
2017;7(2):e013537. Available from: https://bmjopen.bmj.com/content/7/2/e013537  
34. 
Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for Planning Pilot 
Studies in Clinical and Translational Research. Clin Transl Sci. 2011;4(5):332–7. 
Available 
from: 
https://onlinelibrary.wiley.com/doi/full/10.1111/j.1752-
8062.2011.00347.x  

36 
 
Page 36 of 37 
 
CABIN: A Feasibility Study to Promote Engagement with CR: Study Protocol. V2 – 20/01/23. 
35. 
Price B. Laddered questions and qualitative data research interviews. J Adv Nurs. 
2002;37(3):273–81. 
Available 
from: 
https://onlinelibrary.wiley.com/doi/full/10.1046/j.1365-2648.2002.02086.x  
36. 
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 
2006;3(2):77–101. DOI: 10.1191/1478088706qp063oa 
37. 
Braun V, Clarke V. Successful qualitative research: A practical guide for beginners. 
London (UK): SAGE Publications Limited; 2013.  
38. 
Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic 
review of empirical tests. Soc Sci Med. 2022;292:114523. Available from: 
https://doi.org/10.1016/j.socscimed.2021.114523 
39. 
Broadbent E, Petrie KJ, Main J, Weinman J. The Brief Illness Perception Questionnaire. 
J 
Psychosom 
Res. 
2006;60(6):631–7. 
Available 
from: 
https://doi.org/10.1016/j.jpsychores.2005.10.020 
40. 
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr 
Scand. 
1983;67(6):361–70. 
Available 
from: 
https://onlinelibrary.wiley.com/doi/full/10.1111/j.1600-0447.1983.tb09716.x  
41. 
Benson T, Sladen J, Liles A, Potts HWW. Personal Wellbeing Score (PWS)—a short 
version of ONS4: development and validation in social prescribing. BMJ Open Qual. 
2019;8(2):e000394. 
Available 
from: 
https://bmjopenquality.bmj.com/content/8/2/e000394  
42. 
Higgins JPT, Savović J, Page MJ, Elbers RG, Sterne JAC. Assessing risk of bias in a 
randomized trial. Cochrane Handbook for Systematic Reviews of Interventions. 
2019;205–28. 
Available 
from: 
https://onlinelibrary.wiley.com/doi/full/10.1002/9781119536604.ch8  
43. 
Pope C. Qualitative research in health care: Analysing qualitative data. BMJ. 
2000;320(7227):114–6. Available from: https://doi.org/10.1136/bmj.320.7227.114  
44. 
Polit D, Beck C. Nursing research: Generating and assessing evidence for nursing 
practice. 9th ed. London (UK): Lippincott Williams & Wilkins; 2012.  
45. 
Farmer T, Robinson K, Elliott SJ, Eyles J. Developing and Implementing a Triangulation 
Protocol for Qualitative Health Research. Qual Health Res. 2006;16(3):377–94. 
Available from: https://doi.org/10.1177/1049732305285 

37 
 
Page 37 of 37 
 
CABIN: A Feasibility Study to Promote Engagement with CR: Study Protocol. V2 – 20/01/23. 
46. 
O’Cathain A, Murphy E, Nicholl J. The Quality of Mixed Methods Studies in Health 
Services Research. J Health Serv Res Policy. 2008;13(2):92–8. Available from: 
https://doi.org/10.1258/jhsrp.2007.007074