Developing an Arts-based Intervention for Patients With End-stage Kidney Disease Whilst Receiving Haemodialysis
Phase: NA
Conditions: Feasibility Study, End Stage Renal Disease on Dialysis (Diagnosis)
Sponsor: Queen's University, Belfast

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Developing an arts-based intervention for patients with end-stage kidney disease whilst 
receiving haemodialysis 
Introduction 
Aim: To develop an arts-based intervention for patients with end-stage kidney disease 
receiving haemodialysis and conduct a feasibility randomised controlled trial. 
Objectives: 
 Develop an arts-based intervention for patients receiving haemodialysis, informed by 
a systematic literature review and an interdisciplinary advisory group.   
 Identify best practice for implementing an arts-based intervention in a haemodialysis 
unit. 
 Establish recruitment, retention and participation rates for a randomised controlled 
trial.  
 Identify time needed for recruitment, data collection and data analysis. 
 Explore the acceptability of an arts-based intervention for patients and staff on a 
haemodialysis unit.  
 Explore the suitability of outcome measures. 
 Identify estimated costs of delivering the arts-based intervention and methods for 
assessing cost-effectiveness in a full trial.  
 Develop the protocol for a definitive randomised controlled trial and economic 
evaluation of an arts-based intervention compared to usual care.  
Background 
End-stage kidney disease (ESKD) is the final stage of chronic kidney disease and is defined 
by an estimated glomerular filtration rate (eGFR) of <15 ml/min/1.73m2 (National Institute 
for Health and Care Excellence, 2014). The eGFR is the estimated rate of fluid filtration 
within the glomerulus of the kidney and is the main indicator of renal function. Patients with 
ESKD are poly-symptomatic and experience difficult symptoms including fatigue, pruritus, 
pain, nausea, sexual dysfunction and muscle weakness,  which can profoundly impact quality 
of life (QoL) (Raj et al., 2017). ESKD is treated with renal replacement therapies (RRT), 
such as haemodialysis. Haemodialysis is a difficult and time consuming treatment that 
requires patients to attend hospital up to three times a week for up to four hours each time. 
During treatment the patient is connected to a dialysing unit that filters their blood and 
removes waste products and excess fluid; replacing the role of the kidneys.  Patients 
receiving haemodialysis have lower health-related quality of life (HRQoL) than the general 
population (Lowney et al., 2015). Lower HRQoL is associated with increased morbidity and 
mortality in patients on haemodialysis (Liebman et al., 2016). Patients receiving 

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haemodialysis also have higher rates of anxiety and depression than the general population or 
patients with ESKD who receive a renal transplant (Cohen et al., 2007; Nabolsi et al., 2015; 
Chen et al., 2016; Kokoszka et al., 2016).  
Depression is an independent predictor of mortality in haemodialysis populations (Chilcot et 
al., 2011; Barros et al., 2016); this may result from poor treatment adherence (Ossareh et al., 
2014; Nabolsi et al.,2015), maladaptive health behaviours (Ziegelstein et al., 2000), self-harm 
and increased suicide risk (Pompili et al., 2013). Treatment for ESKD involves an extensive 
treatment regimen which includes adherence to dialysis sessions, medications, fluid 
restriction and a restrictive diet (Nabolsi et al., 2015). Non-adherence to this regimen can 
result in increased mortality risk – missing a single dialysis session each month increases the 
risk of death by 30% (Denhaerynck et al., 2007). Depression is a contributing factor to non-
adherence for patients receiving maintenance haemodialysis (Ossareh et al., 2014). Patients 
with depression are also less likely to follow guidance on healthy lifestyle behaviours in 
general, including recommendations on diet, exercise and stress reduction (Ziegelstein et al., 
2000). Fewer studies have explored the impact of anxiety alone on mortality and morbidity, 
with the majority of research considering depression and anxiety in combination (Preljevic et 
al., 2013). A prospective cohort study of 100 patients with ESKD in Holland found that 
symptoms of anxiety, as measured by the Beck’s Anxiety Inventory (Beck et al., 1988), had a 
statistically significant relationship with poorer clinical outcomes in chronic kidney disease 
patients who were not on dialysis (Loosman et al., 2015). Therefore symptoms of anxiety and 
depression have the potential to impact physical wellbeing of patients receiving 
haemodialysis. 
A strong relationship exists between HRQoL, anxiety and depression in patients receiving 
haemodialysis. A cross-sectional multi-centre study conducted by Bujang et al., (2015) in 
Malaysia sampled 1332 patients receiving haemodialysis or peritoneal dialysis and found 
depression, anxiety and stress correlated significantly with the WHOQOL-BREF, a brief 
questionnaire measuring HRQoL. This relationship was also found in a cross-sectional study 
conducted in Greece, where depression and anxiety were associated with HRQoL scores in 
patients on haemodialysis, after adjusting for confounding variables (Vasilopoulou et al., 
2015). Cohort studies within the United Kingdom and Ireland also report this association, 
where depression scores of patients receiving haemodialysis have been found to significantly 
correlate with the EQ-5D-5L, another valid HRQoL measure (Lowney et al., 2015). A 
systematic literature review by García-Llana et al., (2014) reviewed 38 articles exploring the 

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relationship between depression, anxiety, stress and HRQoL in relation to treatment 
adherence in patients receiving haemodialysis. Each of the identified articles found a 
statistically significant relationship between anxiety, depression and HRQoL. There are a 
number of different factors that contribute to this established relationship. Depression can 
influence QoL in a number of ways, including impacting mood and motivation (Mccann et 
al., 2000; Farragher et al., 2017). As previously mentioned depression can lead to poor 
treatment adherence in patients receiving haemodialysis (Nabolsi et al., 2015), which 
increases symptom burden. Symptoms of ESKD can impact mood and increase depressive 
symptoms (Cao et al., 2017; Maung et al., 2017; Wan Zukiman et al., 2017). A review by 
Farragher, et al (2017) found the relationship between fatigue and depression so robust that 
they recommend routine screening for depression in patients receiving haemodialysis who 
present with fatigue. The relationship between HRQoL, anxiety and depression is enmeshed, 
yet depression and anxiety remains underdiagnosed and under-treated in patients receiving 
haemodialysis (Watnick et al., 2003; Cohen et al., 2007; Cukor et al., 2008; Kokoszka et al., 
2016).  
One reason for this complex dynamic is the overlap between anxiety, depressive symptoms 
and the uremic state; many symptoms of depression and anxiety, such as fatigue, anorexia, 
sleep disturbances, appetite disturbances and sexual dysfunction are identical to symptoms of 
uraemia, rendering it be difficult to differentiate anxiety, depression from the clinical picture 
of ESKD (Cohen et al., 2007; Cohen et al., 2016).  Stigma surrounding depression also 
contributes to the rates of diagnosis and treatment. Wuerth et al., (2008) screened 380 
patients receiving haemodialysis or peritoneal dialysis using the Beck Depression Inventory 
(BDI) to identify who may be experiencing a depressive disorder. While 49% were identified 
to be at risk, 55% of those identified declined a mental health assessment. Some patients 
regarded this assessment as a sign of weakness, and were apprehensive of being stigmatised 
if they acknowledged symptoms of depression. Therefore HRQoL, anxiety and depression 
cannot be considered in isolation from each other when caring for patients with ESKD. This 
strong relationship results in a need for creative, holistic approaches to address these issues, 
in a way that is cognisant of the multiple contributing factors. 
The application of arts in health has received recent interest because of its potential to 
improve patient outcomes and reduce costs for the National Health Service (NHS) (All-Party 
Parliamentary Group on Arts Health and Wellbeing, 2017a). Arts-based interventions involve 
the implementation of arts activities in a healthcare context to deliver a creative experience 

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(Centre for Arts in Medicine, 2017). They have been shown to improve QoL, symptom 
burden and mental health (Staricoff and Clift, 2011; Bungay et al., 2014; Sonke et al., 2015) 
in a variety of settings, including medical-surgical units (Sonke et al., 2015), primary care 
(Crone et al., 2012) and cancer care (Kim et al., 2017), but there is a lack of research 
exploring their effect in renal populations. Emphasis across healthcare research remains on 
arts therapies which are a form of clinical intervention, administered by a professional 
therapist within a psychotherapeutic framework, to meet clinical objectives (Health & Care 
Professions Council, 2009), although even in this area, few studies have been published 
involving patients receiving haemodialysis. Less attention has been given to participatory 
arts-based interventions by funding bodies such as the National Institute of Health Research. 
As a result, research examining arts-based interventions tends to be small in scale (All-Party 
Parliamentary Group on Arts Health and Wellbeing, 2017b), lack longitudinal follow-up 
(Boyce et al., 2017) and often focus on receptive interventions such as music listening which 
are easier to implement than more complex arts in health programmes or artistic mediums 
(Staricoff and Clift, 2011; Bungay et al., 2014).There is also a lack of research examining the 
effect of arts-based interventions in patients with ESKD. While a systematic literature review 
by Kim et al. (2015) identified a number of randomised controlled trials using music-
listening interventions, other forms of arts-based interventions have not been explored using 
this methodology.  
In order to establish the effectiveness of arts-based interventions rigorous randomised 
controlled trials are the most robust method of evaluation. However there are difficulties 
associated with randomised controlled trials, particularly around recruitment and retention of 
participants (Donovan et al., 2014). This is exacerbated in palliative care trials where 
participation rates under 50% are common (Hanson et al., 2015). Trials in nephrology, the 
most under-researched field of internal medicine, also experience problems retaining 
participants (Palmer et al., 2011). The reasons for these low recruitment and retention rates 
are multi-factorial, including ethical implications of working with patients who have an end-
stage illness, the emotional distress and burden placed on participants who may experience 
severe symptoms such as fatigue, pain and nausea (Hanson et al., 2015).  
Methodology in arts-based intervention research needs to be considered due to the lack of 
randomised controlled trials conducted using non-music art forms as an intervention (Bungay 
et al., 2014; Boyce et al., 2017). Music-listening is a straightforward intervention that 
typically involves patients listening to personal Mp3 players through headphones 

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(Momennasab et al., 2018). It is difficult to apply research methods used in music-listening 
interventions to more dynamic arts-based interventions that require facilitation and mediums 
which may impact on the clinical environment (Sonke, 2017). These more dynamic arts-
based interventions meet the Medical Research Council’s description of a complex 
intervention (Medical Research Council, 2009), in that it involves several interacting 
components that can impact on implementation, evaluation and the context in which it is 
delivered. There is a tendency of complex interventions to fail to show a significant effect in 
randomised controlled trials (Levati et al., 2016). This absence of detectable effect may not 
result from an ineffective intervention, but instead could be a consequence of the logistical 
difficulties in standardising and evaluating complex health interventions in an experimental 
process (Medical Research Council, 2009). Consideration needs to be given to optimising the 
intervention and the trial process, such as recruitment procedures and randomisation, for the 
context in which the intervention will be delivered. To address these issues Levati et al. 
(2016) recommend feasibility studies. These focus on real world implementation during the 
development of the intervention and research design, by involving key stakeholders 
throughout each stage of the process and ‘in vivo’ exploration of problems that occur with 
implementation and trial processes during feasibility testing.  
When exploring the staff perceptions of arts-based interventions, the focus in the literature is  
on how the intervention impacts the patients, with fewer studies examining the effect of the 
intervention on healthcare staff themselves (Bungay et al., 2014; Boyce et al., 2017). It is 
particularly important to consider the potential positive and negative effects of arts-based 
interventions on healthcare staff, due to the unique nature of the clinical working 
environment. A critical review by Wilson et al., (2015) explored healthcare staff perceptions 
of arts-based interventions and identified numerous benefits of arts-based interventions 
including reductions in stress and improved working relationships. However the potential 
negative outcomes included interference with work flow, increased stress and restricted 
communication between healthcare staff. Any negative impact on the ability of healthcare 
staff to perform their job could have significant consequences for patient safety; therefore the 
acceptability of an intervention for healthcare staff is important to consider (May, 2013) . The 
acceptability for patients must also be taken into consideration. If an effective intervention is 
burdensome or non-engaging, patients will not participate and not experience the benefits 
(May, 2013). In order to evaluate whether an intervention is acceptable in practice, a process 
evaluation must be conducted. Process evaluations provide a detailed understanding of 

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complex interventions by examining their implementation, mechanism of impact and context 
(Moore et al., 2015).  
As already described, the All Party Parliamentary Group report on the Arts for Health and 
Wellbeing (All-Party Parliamentary Group on Arts Health and Wellbeing, 2017b) claimed 
that arts-based interventions have the potential to reduce costs within the NHS, however the 
only cost-effectiveness analysis cited within this comprehensive report was for a single to a 
community singing intervention for healthy older people (Skingley et al., 2011). The 
estimated savings within the report were predominantly based on the costs associated with 
disease and the assumption that the interventions are effective; this is not a rigorous method 
of economic evaluation. Markov models are needed to make long-term projections about the 
economic implications of an intervention. These models require disease progression rates and 
cost data obtained from economic evaluations within large-scale randomised controlled trials 
(Komorowski and Raffa, 2016). The Arts for Health and Wellbeing report reflects the lack of 
cost-effectiveness analysis and economic evaluations conducted for arts-based interventions 
(Craemer, 2009). Cost-effectiveness analyses are important as they are the basis of decision 
making for health intervention recommendations by NICE (Ogden, 2017). In order to ensure 
that the effectiveness of an intervention can guide healthcare policy, economic evaluations 
and cost-effectiveness analysis are needed to establish justification for funding. However, due 
to the total absence of economic evaluations for arts-based interventions implemented within 
hospital settings, it is important to explore the best methods for conducting such cost-
effectiveness analyses.  
As there are identified barriers to recruitment and retention of participations in  palliative care 
and nephrology research, arts-based interventions are complex and under-researched, and no 
formal cost-effectiveness analyses have been conducted a feasibility trial, process evaluation, 
and feasibility economic evaluation are necessary to inform optimal strategies and methods 
for a definitive randomised controlled trial (Bowen et al., 2009) 
Research design 
The study will consist of four phases and will utilise a mixed-method design. Phase 1 will 
consist of the development of the intervention, phase 2 will involve a quantitative feasibility 
randomised controlled trial, phase 3 will involve a qualitative process evaluation and phase 4 
will involve feasibility testing for an economic evaluation.  

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The RE-AIM mixed methods framework (Forman et al., 2017) will be used to guide the 
research process. The framework outlines the core aspects of a complex intervention that 
should be explored to enhance the generalisability of findings (Glasgow and Estabrooks, 
2018). The core aspects include the intervention’s reach, effectiveness, adoption, 
implementation and maintenance. Not all RE-AIM objectives can be met within a feasibility 
study, for example, the maintenance of the intervention over time. However the framework 
will be used to inform research questions, data collection and outcomes appropriate for a 
feasibility study.  
Plan of Investigation 
Research Setting 
The research will be conducted in the haemodialysis unit at Antrim Area Hospital in the 
Northern Health and Social Care Trust, Antrim, Northern Ireland.    
Phase 1 – Development of the intervention 
The development of the intervention will follow the comprehensive framework provided by 
Fancourt in 'Arts in Health' (2017). This framework provides an overview of seven steps 
following a problem-based solution approach for developing and evaluating arts-based 
interventions for use in healthcare. The steps include mapping the environment, gaining 
concrete 
experience, 
conducting 
reflective 
observation, 
undertaking 
abstract 
conceptualisation, active experimentation, reviewing and reconnecting.  
The intervention will be developed in conjunction with the inter-disciplinary Advisory Group 
for the research project. The Advisory Group will include healthcare staff representatives 
from the haemodialysis unit at Antrim Area Hospital, two artist representatives from Arts 
Care Northern Ireland, the CEO of Arts Care Northern Ireland, three patient representative 
from the Northern Ireland Kidney Patient Association, members of the Renal Arts Group at 
Queen’s University Belfast, a representative from University of Florida school of Arts in 
Medicine, the manager of Community Wellbeing in the Northern Trust and a statistician.  
This group will meet approximately every 3 months, both face to face and virtually, in order 
to provide guidance on the research project and the development of the intervention.  

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The Template for Intervention Description and Replication (TIDieR) checklist will provide 
an overview of the specific components to be considered when describing the intervention in 
any future publication  (Hoffmann et al., 2014). 
The development framework outlines the need to identify the existing evidence base 
(Fancourt, 2017), therefore a systematic literature review will be conducted. Searches will be 
undertaken in the following databases: MEDLINE, Embase, PsycINFO, CINAHL, Scopus, 
and Web of Science. Grey literature will be searched, including reports published by arts in 
health agencies and online theses databases. The literature review will aim to address specific 
research questions:  
1. 
What arts-based interventions have been used to support patients with ESKD? 
2. 
How have arts-based interventions been implemented in clinical settings? 
3. 
How have arts-based interventions impacted on patients with ESKD? 
4. 
What methods have been used to evaluate outcomes? 
5. 
What are the costs associated with implementing arts-based interventions in a 
clinical setting? 
The methodological standard of identified articles will be critically appraised using the 
Joanna Briggs Institute (JBI) critical appraisal checklists (The Joanna Briggs Institute, 2017). 
These were selected as they cover a wider variety of methodological approaches compared to 
other critical appraisal tools, such as Critical Appraisal Skills Programme (CASP) tools 
(CASP UK, 2017).  
Phase 2 – Feasibility Randomised Controlled Trial 
Participants 
Participants will include patients receiving haemodialysis in the outpatient haemodialysis unit 
at Antrim Area Hospital.  
Eligibility criteria for patients: 
 Age 18 or over  
 Able and willing to participate 
 Receiving haemodialysis 

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There is little consensus on the appropriate sample size for a feasibility study, with guidance 
ranging from 12 per arm (Julious, 2005) to 50 per arm (Sim and Lewis, 2012). A formal 
sample size calculation is not appropriate for feasibility studies as the objectives do not 
include establishing the effectiveness of an intervention. Feasibility studies should instead 
focus on the acceptability of trial processes or an intervention, including the willingness of 
participants to be randomised, the time needed to collect and analyse data and response rates 
to outcome measures (Eldridge et al., 2016). This inconsistency in sample size guidance 
could reflect the inconsistency in how pilot and feasibility studies are reported. A review of 
54 pilot and feasibility studies by Arain et al. (2010) concluded that pilot/feasibility studies 
were poorly reported and placed an inappropriate emphasis on hypothesis testing, with 81% 
of studies conducting hypothesis testing and a further 35% using a sample size calculation to 
ensure adequate statistical power for this purpose. Recent  reviews of pilot studies confirm 
that inappropriate hypothesis testing is a common issue (Kannan and Gowri, 2015). The 
report of statistically significant results tends to be opportunistic, in that the study may not 
have been initially designed to establish effectiveness but because a statistically significant 
result was found it was reported, which decreases the likelihood of a follow up definitive 
RCT. This calls into question the validity of the effect, as the study was not designed for the 
purpose of hypothesis testing, and therefore would not have the rigour of a definitive RCT 
(Eldridge et al., 2016).   
The justification for larger sample sizes in feasibility studies is to obtain narrow standard 
deviations on outcome measures to maximise precision in a future power calculation (Sim 
and Lewis, 2012; Teare et al., 2014). However there is disagreement over whether this is an 
appropriate method to inform power calculations, or whether it’s an appropriate objective at 
the feasibility and piloting stage, as to obtain a narrow standard error for a precise power 
calculation the sample within the feasibility study would need to approach the size of a fully 
powered randomised controlled trial (Kraemer et al., 2006). This would in turn increase the 
likelihood of identifying a statistically significant effect during the feasibility stage, which  
can be inappropriately reported, and reduce the likelihood of a follow up RCT (Lancaster et 
al., 2004) . A sample size of 30 is recommended by the NIHR’s Research Design Service for 
the estimation of a parameter, such as sample size, recruitment or attrition rate, for a 
definitive randomised controlled trial, although they recognise that advice varies from 24 to 
50 participants. Due to the increased risk of identifying a statistically significant result with 
larger sample sizes, and practical limitations of a small, single centre study, a sample size of 

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30 was selected for the feasibility RCT. A university statistician was consulted who 
confirmed that a sample of 30 was an appropriate sample size to meet the objectives of the 
study.   
Recruitment 
Eligible patients will be approached by a gatekeeper working on the haemodialysis unit. 
Posters will also be displayed in the waiting area of the haemodialysis unit. These posters will 
draw attention to the research taking place and will instruct the patient to speak to a member 
of their healthcare team, who will act as a gatekeeper, for more information on the study if 
they are interested in participation.  The gatekeeper will be provided with an initial approach 
script that will contain an overview of the study and important information about trial 
processes. The script will also outline how to respond if a patient expresses an interest in 
participating, or if they decline to take part. Screening logs will be used to measure the 
proportion of patients who are eligible and who are interested in the research. Patients who 
express interest and agree for their name to be passed on will receive an information sheet 
from the gatekeeper (Appendix 1), which will contain the contact details of the researcher. 
The gatekeeper will seek permission from the patient to pass their name on to the researcher. 
The patient will be provided a period of at least 48 hours to decide if they wish to participate, 
before the researcher will approach them with a consent form and provide the patient an 
opportunity to ask any further questions (Appendix 2).   
Randomisation  
The proportion of eligible participants willing to be randomised will be collected through the 
use of screening logs (Lancaster et al., 2004). Participants will be randomly allocated to a 
control group or experimental group following the collection of baseline data. Block 
randomisation at a ratio of 1:1 will be used to ensure both groups comprise the same number 
of participants (Suresh, 2011). Patients will be randomly allocated according to the days of 
the week they attend the unit for haemodialysis, as opposed to at an individual level. As the 
renal unit is an open environment allocation according to shift pattern will reduce the risk of 
participants within the control group viewing implementation of the intervention, which 
would introduce potential contamination (Mc Daid et al., 2006). Sealed envelopes will 
contain the allocation and these will be stored in a locked filing cabinet on site, and will be 
opened once consent and baseline data have been obtained. Participants who are randomly 
allocated to the control group will be instructed not to participate in any art activities during 

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their haemodialysis sessions throughout the study, but that once data collection is completed 
they will be provided with art supplies and participate in a facilitated session.  
Data Collection and Management 
Feasibility measures  
The main feasibility outcome of interest will be the recruitment, participation and retention 
rate of participants.  Assessing the ability to recruit and retain participants is a common issue 
explored in feasibility trials (Lancaster et al., 2004; Bugge et al., 2013; Arain et al., 2016; 
Avery et al., 2017). As barriers to recruitment exist in palliative care research (Hanson et al., 
2015), and nephrology research commonly experiences high attrition rates (Palmer et al., 
2011), it is important to establish the feasibility of recruiting and retaining the participants 
needed for a definitive randomised controlled trial. Baseline demographic and clinical data 
will be include age, gender, ethnicity, socio-economic status, education, kidney diagnosis,  
dialysis vintage, number of co-morbidities and frailty as measured by the Clinical Frailty 
Scale; these will be collected to explore factors that may influence participation in a full trial.  
Clinical outcome measures 
Arts-based interventions can improve depression, a common issue in patients receiving 
haemodialysis (Bujang et al., 2015). Improvements in depression have been reported in 
receptive arts groups; in a study by (Dowrick et al., 2012) depression scores were measured 
in patients clinically diagnosed with depressive disorders using the PHQ-9, and a statistically 
significant reduction in depression was found after engagement in a reading group. Arts-
based interventions have also been shown to impact anxiety, another common issue amongst 
patients receiving haemodialysis (Cohen et al., 2016). As discussed earlier depression and 
anxiety are highly prevalent and under-addressed amongst patients with ESKD receiving 
haemodialysis, therefore depression and anxiety will be measured as a clinical outcome. 
These will be collected through the use of the Hospital Anxiety and Depression Scale 
(HADS), which has been validated in patients with ESKD (Loosman et al., 2010). The scale 
measures depression and anxiety within the same tool, allowing independent exploration of 
two outcomes with a subscale analysis (Annunziata et al., 2011).  
Arts-based activities have also been found to contribute to QoL in clinical populations 
(Staricoff and Clift, 2011; Sturm et al., 2014; Boyce et al., 2017). As previously discussed 
patients receiving haemodialysis have lower HRQoL than the general population, and a 

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variety of factors contribute to this outcome. These include not only the physical symptoms 
patients experience, but psychological and social consequences of the disease and the 
associated treatments (Kang et al., 2015). The Kidney Disease Quality of Life (KDQoL-36) 
is a commonly used measure of HRQoL in renal literature, is valid and reliable, and has been 
identified as providing the most comprehensive overview of factors that contribute to QoL 
(Glover et al., 2011). Therefore the KDQoL-36 will be used to measure QoL. 
The clinical outcome measures will be collected at baseline and immediately after the 
intervention. A pre/post-test design is common in arts-based intervention research and allows 
researchers to evaluate improvements in health outcomes over a short time period (Bungay et 
al., 2014; Kim et al., 2017). However, arts-based intervention research has faced criticism 
due to lack of longitudinal follow up, which would be necessary to identify whether arts-
based interventions are sustainable in a clinical setting, and whether the benefits are lasting 
(Boyce et al., 2017). Participants who are lost to follow up in longitudinal RCTs concerning 
complex healthcare interventions tend to be older, diagnosed with a chronic illness and have 
higher co-morbidity (Peterson et al., 2012), common demographic factors in patients with 
ESKD (Zyoud et al., 2016). To establish the feasibility of follow up within a definitive 
randomised controlled trial and establish attrition rates over time, a longitudinal follow up 
will also occur. This period will be limited by the time frame of the PhD programme, and 
clinical outcome measures will be collected pre and post intervention and at 6 weeks and 3 
months after the intervention commences.  
 Data analysis  
Data analysis will be conducted using the Statistical Package for the Social Sciences (SPSS v 
24). Descriptive statistics will be used to present baseline demographic and clinical data 
Categorical data will be presented as frequencies and percentages, while continuous data will 
be presented as means and standard deviations. Recruitment, participation and retention rates 
will be reported and presented in a CONSORT flow diagram (Eldridge et al., 2016). The 
proportion of patients who were eligible for recruitment, who consented to participation and 
who completed the study will be calculated and presented with 95% confidence intervals.  
Exploratory inferential statistics will be conducted, but no conclusions on the effectiveness of 
the intervention will be made from the results. Independent t-tests (or the non-parametric 
equivalent Mann-Whitney U) will be conducted to compare the scores of the experimental 
group and control group. The majority of arts-based intervention research involves pre-and-

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post-test designs; therefore a repeated measures t-test (or the non-parametric equivalent 
Wilcoxon Matched Pairs test) will also be conducted to compare the mean scores of the 
experimental before and after receiving the intervention. An analysis of variance will be 
conducted to explore any potential sub-group analysis that may be relevant within a future 
RCT.  
Phase 3 – Process evaluation  
Participants 
Participants will include both patients who have been recruited into phase 2 of the study, and 
healthcare staff working on the unit during the implementation of the intervention. Healthcare 
staff from the unit will also be recruited into the process evaluation.  
Eligibility criteria for healthcare staff: 
 A member of the multidisciplinary team, including nurses, healthcare support 
workers, doctors, dietitians, social workers and counsellors.  
 Have had experience with the intervention. 
 Have worked in a clinical renal setting for more than 3 months 
Familiarity with the context of the clinical environment is needed to inform the acceptability 
of the intervention (May, 2013). Context includes the social system within in the work place, 
taking into consideration social norms, material resources, and collective commitment (May, 
2013). A qualitative study by Farnell and Dawson (2006) interviewed critical care nurses 
over 6 months after transferring from general medical wards. Up to 3 months after 
commencing their new post nurses continued to report experiences relating to their 
socialisation, including the setting feeling ‘so different’, feeling deskilled in the new 
environment and being unable to meet the high expectations they set for themselves. At 6 
months follow up these experiences were no longer reported. New staff and students require 
time to familiarise themselves with the clinical environment, the expectations involved in 
their role and the social structure of the unit (Valdez, 2008). Therefore healthcare staff who 
have worked in a renal setting for less than 3 months and students on placement during the 
intervention will be excluded from the evaluation. 
Recruitment 

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During data collection for phase 2 patients will be offered with the opportunity to participate 
in the process evaluation. A separate information sheet (Appendix 3) will be provided to 
interested participants by the researcher, participants will be given a minimum of 48 hours 
(time between dialysis sessions) to consider participation and a consent form (Appendix 4) 
will be provided for completion at the start of each interview.   
Healthcare staff will be recruited for the process evaluation by purposive sampling. During 
the feasibility trial the ward manager, who will act as a gatekeeper, will approach healthcare 
staff and provide them with a participant information sheet containing contact details for the 
researcher (Appendix 5). Due to managerial and social hierarchies within hospitals 
healthcare, staff may feel pressure to participate; therefore the staff will be asked to contact 
the researcher if interested, so the gatekeeper will not be aware of who is participating.   
Data Collection and Management 
Approximately 13 patients will be recruited into the process evaluation. Simulations have 
shown that this sample size of 10 should identify 80% of problems within a complex 
intervention (O’Cathain et al., 2014), while data saturation is likely to be reached at 12 
interviews on average (Guest et al., 2006). The principle of  10 + 3 for data saturation 
outlines that a minimum of 10 interviews should be conducted, followed by at least 3 
consecutive interviews  that present no new findings (Francis et al., 2010), therefore a sample 
of 13 patients will be recruited for semi-structured interviews.  Approximately 5 healthcare 
staff will be recruited into each focus group, with a proposed total of 3 focus groups  
(Schneider et al., 2009). The  dialysis unit in which the study is taking place is relatively 
small, therefore the focus groups will be limited by the amount of staff available who meet 
the eligibility criteria and the requirement to produce a manageable amount of data for the 
time limitations of the study (Carlsen and Glenton, 2011; O’Cathain et al., 2014). However, 
these are approximate sample sizes, and data collection will continue until data saturation is 
reached. The researcher will provide the participants with a consent form prior to 
commencement of the focus group (Appendix 6). Data saturation will be determined when 
there is no new data being found from which additional themes can be developed (Guest et 
al., 2006). 
Data collection for the process evaluation will occur in parallel to the feasibility randomised 
controlled trial, during implementation of the intervention and follow up (Moore et al., 2014). 
The semi-structured interviews will be conducted with patients in their own home to maintain 

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15 
 
confidentiality and avoid the power dynamic present in a clinical setting (Green and 
Thorogood, 2004). This approach will be flexible and patients can request that interviews 
occur during the haemodialysis session or on the unit if this is their preferred location. The 
focus groups with staff will take place in a private room on the haemodialysis unit. The 
process evaluation will follow the MRC guidance on process evaluations for complex 
evaluations (Moore et al., 2014). It will therefore focus on the acceptability of the 
intervention, barriers and facilitators to implementation, the appropriateness of outcome 
measures, motivations for participation, reasons for continued engagement and potential 
mechanism of impact of the intervention.   
The semi-structured interviews and focus groups will use interview guides consisting of open 
questions informed by the RE-AIM QuEST framework (Forman et al., 2017). The interview 
guide will be flexible to ensure that participants can express and explore perspectives that 
they consider relevant to implementation, and will be reviewed by the advisory group and 
supervisory team who are responsible for providing objective oversight.  
Data Analysis 
The semi-structured interviews and focus groups will be recorded and transcribed verbatim. 
Inductive thematic analysis will be used to analyse the data collected. Thematic analysis 
involves identifying and coding central themes within qualitative data through an iterative 
process (Braun and Clarke, 2006). Themes are conceptualised as ideas that reflect some level 
of meaning within the data (Jugder, 2016). The first step will involve descriptive coding of 
the data line by line, identifying words or phrases that capture salient components in the data. 
During the second step, interpretive codes will be synthesized from the descriptive codes. 
The interpretive codes will then be arranged into hierarchical categories, forming final 
overarching themes. (Tracy, 2013). The purpose of a process evaluation is to develop an 
understanding of the intervention, trial, context and mechanisms of change, therefore data 
analysis must be focused on answering these research questions (Grant et al., 2013). Themes 
will be identified at a semantic level, in that they will develop from the explicit content 
contained within the data. This is different to identifying themes at a latent level, which 
requires a more hermeneutic approach (Braun and Clarke, 2006). Semantic themes are 
appropriate for a process evaluation as the aim is to gather explicit information on the 
implementation of an intervention and trial processes (Forman et al., 2017).   

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16 
 
Investigator triangulation will be used to ensure validity of the identified themes. This will 
involve regular review of the analysis and themes by the supervisory team to ensure that 
subjective bias is controlled for during the analysis of the data (Steinke, 2004). Method 
triangulation will also be used by comparing the quantitative data collected during phase two 
and comparing semi-structured interviews, focus groups and field notes (for example, 
comparing demographic or clinical data and recruitment rates with themes related to 
participation). Data source triangulation will also be used in the process evaluation. This 
involves collecting data from a variety of sources, and will be achieved by collecting 
information from a wide variety of participants, including participants from phase two, 
participants who declined to take part in the trial, and healthcare staff working on the unit 
(Carter et al., 2014). The importance of objective oversight has been highlighted in the MRC 
guidance on process evaluations, due to potential bias that researchers involved in the 
development of an intervention may bring when evaluating its acceptability (Moore et al., 
2015).  
 
Phase 4 – Economic evaluation 
Data collection and management 
Feasibility studies do not have the sample size required for the statistical power needed to 
establish effectiveness, therefore conducting a full cost-effectiveness evaluation within a 
feasibility study is not recommended (Hounsome and Shearer, 2015). However the feasibility 
of data collection methods and the appropriateness of outcome measures can be evaluated 
during a feasibility study to inform a full economic evaluation within a definitive randomised 
controlled trial.  
Health and social care costs of participants will be collected using Patient Service Use Logs 
previously used in the Palliative Care in Chronic Kidney Disease study (PACKS) (Agus et al. 
(2017). These logs will collect information on health and social care service use during the 
intervention.  The logs will be collected post-intervention and at six weeks and three months 
follow up. The outcome of interest will be the feasibility of using a Patient Service Use Log 
in a full economic evaluation according to proportion of participants who complete the 
Patient Service Use Log.  

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17 
 
The EQ-5D-5L will be administered to patients in conjunction with the clinical outcome 
measures, pre/post-intervention and at 6 weeks and 3 months follow up. The EQ-5D-5L is 
recommended by NICE for deriving utility values for the calculation of quality adjusted life 
years in cost-effectiveness analysis within definitive economic evaluations (National Institute 
for Health and Care Excellence, 2012) and has been shown to be a valid measurement of 
health status in patients with ESKD (Cleemput et al., 2004). However it is important to 
consider the burden of questionnaires on participants during a randomised controlled trial. 
The acceptability of administering the EQ-5D-5L to patients in conjunction with the KDQoL-
SF 36 and the HADS will be explored by examining the completion rates and proportion of 
missing data for the EQ-5D-5L. 
Data analysis 
A cost-consequence analysis is recommended by the National Institute of Health Research for 
both complex interventions and feasibility studies where the outcomes of interest are not 
clear (Hunter and Shearer, 2014). Costs and outcome measure data for both the intervention 
and control group will be presented using means and 95% confidence intervals in order to 
show a general overview of the economic costs of the intervention, and differences in 
resource use and outcome measures between groups. Completion rates and missing data for 
the Patient Service Use Log and the EQ-5D-5L will be presented as frequencies to assess the 
feasibility of data collection. 
Progression Criteria 
Progression to a definitive RCT will be determined by recruitment rates and the acceptability 
of the intervention for patients and staff.  
 75-100% of the target sample size recruited will result in progression to a definitive 
RCT. 
 50-74% of the target sample size recruited will result in progression to a definitive 
trial after reviewing the protocol and data from the process evaluation, and making 
appropriate amendments to address barriers to recruitment. 
 25-49% of the target sample size recruited will result in progression to a definitive 
trial after reviewing the protocol with input from potential co-applicants to ensure that 
the protocol is modified to enhance recruitment rates.  

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18 
 
 Less than 25% of the target sample size recruited will probably result in the trial not 
progressing, unless a significant modifiable barrier is identified within the process 
evaluation.   
 Progression to a full trial will be contingent on the acceptability of the intervention for 
both patients and staff regardless of recruitment rates. This will be assessed within the 
qualitative process evaluation (Forman et al., 2017). Any necessary modifications 
identified within the process evaluation to improve the intervention will be made prior 
to progression to a definitive trial. 
The progression criteria for recruitment are the criteria used by the Northern Ireland Clinical 
Trials Unit (McConnell et al., 2016), and were confirmed by contacting Professor Mike Clark 
via e-mail. The inclusion of a qualitative component within progression criteria is 
recommended by O’Cathain et al., (2014) as qualitative research may be able to identify 
potential harms of an intervention that would not be captured within the quantitative results.  
 
Ethical Considerations 
As the chief investigator is an academic of Queen’s University Belfast, the University will 
sponsor this research and will be responsible for independent peer review of the study 
protocol. This research falls under Category B research in the University regulations for 
research involving human participants from within a healthcare trust (Queen’s University 
Belfast, 2013), therefore the application for ethical approval will be made to the Office of 
Research Ethics Committees Northern Ireland (ORECNI), through the Integrated Research 
Application System (IRAS). The local collaborator on site will be the consultant nephrologist 
Dr Robert Mullan.  
 
Informed Consent 
To ensure informed consent is obtained freely from participants they will initially be 
approached by the gatekeeper on site, who will provide them with a verbal summary of the 
project and the participant information sheet. This will ensure that participants feel free to 
decline to participate by removing the power dynamic that may be present in a direct 
approach from the researcher. The participant information sheet (Appendix 1, Appendix 3, 
Appendix 5) will contain information on the purpose and process of the research, how data 
will be collected, stored, and used, their ability to withdraw from the study at any time, the 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
19 
 
right to refuse to answer questions during the interviews, a guarantee of anonymity and how 
this will be maintained, the expectations of participants, including time commitments and any 
potential risks or difficulties that could arise during the research (Connolly, 2003). Contact 
details for the researcher will be provided should the participant have any questions. The 
patient will be given time to consider participation over 48 hours, before finally being 
approached by the researcher with a formal consent form.  
 
Confidentiality and Anonymity 
Participants will be allocated codes for the purpose of data collection for the feasibility 
randomised controlled trial. All data will be stored in accordance with the Data Protection 
Act (2018). All identifiable information will be confidential and stored in a locked filing 
cabinet in a locked room at Queen’s University Belfast School of Nursing and Midwifery. 
For the process evaluation pseudonyms will be allocated to participants during transcription 
(Allmark et al., 2009). Data will be stored for a minimum of 5 years and subsequently 
destroyed. The data recorded on all audio recording devices will be erased once it has been 
transcribed and stored on a secure, encrypted computer. As focus groups will be used for data 
collection during the process evaluation, the importance of confidentiality will be reiterated 
prior to the commencement of each group. During the process evaluation, participants will be 
provided with limitations of confidentiality and anonymity on information sheets prior to 
commencement of the study. Participants will be informed that if the interview or focus 
group provides evidence for serious concerns regarding child welfare, the safety of the 
participant or the safety of others, that a third party will have to be informed.  
 
Welfare of Participants  
The research involves participants who have an advanced illness. During the feasibility 
randomised controlled trial participants will be receiving an arts-based intervention whilst 
also receiving haemodialysis. Due to the importance of maintaining vascular access and not 
inhibiting the work of healthcare professionals, the intervention will be designed with input 
from healthcare professionals working in this clinical setting, as well as artists from Arts Care 
Northern Ireland who have experience adapting arts-based interventions to the clinical 
environment. The process evaluation will also occur in parallel to the implementation of the 
intervention, ensuring that any issues with the intervention are identified and can be 
addressed during the trial (Moore et al., 2014).  
 

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20 
 
As the questionnaires participants fill out explore subjects such as quality of life and mental 
health, and the interviews and focus groups may broach sensitive subjects relating to the 
experiences of living with ESKD or the experiences of working with patients who have an 
end-stage illness, there is a potential for participants to experience emotional distress. A 
distress protocol (Appendix 7, Appendix 8) will be in place to address these issues (Haigh 
and Witham, 2015) and participants will be provided with information regarding relevant 
supportive services available. Participants will be reminded they can stop the interview at any 
time, they are not obligated to answer questions they feel are too sensitive, or provide 
information they are not comfortable sharing. A renal counsellor will also be present on the 
advisory group and will provide guidance on maintaining the emotional wellbeing of 
participants. Two additional distress protocols have also been developed for the potential that 
a participant discloses suicidal thoughts (Appendix 9) or achieves a score on the Hospital 
Anxiety and Depression Scale that suggests the presence of a clinical mental health condition 
(Appendix 10).  
 
Welfare of the Researcher  
The supervisory team will be aware of the time and location of all focus groups and the 
researcher will follow the university’s lone working policy for interviews being conducted in 
participant’s homes. The researcher will provide the supervisory team with a sealed envelope 
containing the participants name and the address where the interview is taking place. The 
researcher will carry a mobile phone at all times to ensure they are contactable and their 
contact details will be provided to all members of the supervisory team. The team will be 
informed of the researcher’s method of transport and approximate time the interview/focus 
group will be completed. The researcher will contact the team via text on arrival and will call 
to confirm when the interview has been completed. If the team does not receive a phone call 
within an hour of the estimated completion time and are unable to contact the researcher, they 
will open the sealed envelope and contact the authorities with the information. The emotional 
wellbeing of the researcher will also be considered, due to the emotional impact of working 
with a patient group with an end-stage illness, and debriefing will be provided by the 
supervisory team if needed (Social Research Association, 2001) 
 
Dissemination of Results  
The protocol for the study, findings from the systematic review, feasibility randomised 
controlled trial, process evaluation and economic evaluation will be submitted for publication 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
21 
 
in high quality peer reviewed journals and presented at national and international conferences 
including the British Renal Symposium and the EDTNA/ERCA annual conference. Service 
users will also be involved in the dissemination of findings, and researchers will collaborate 
with the Northern Ireland Kidney Patient Association and Kidney Care UK. The economic 
evaluation data collection form will be listed on the MRC’s Database of Instruments for 
Resource Use Measurement (DIRUM). A social media plan will be created to incorporate 
platforms such as Twitter and Facebook to disseminate information, progress, events and 
findings from the study.  
 
 
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Lancaster, G. A., Dodd, S. and Williamson, P. R. (2004) ‘Design and analysis of pilot 
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Appendix 1: Participant information sheet Phase 2 
 
Developing an arts-based intervention for patients with end-stage kidney disease 
receiving haemodialysis 
Participant information sheet –Feasibility Trial 
 
We would like to invite you take part in a research study. Before you decide whether to take 
part it is important for you to understand what the research will involve and why it is being done. 
Please take time to read this information sheet carefully and discuss it with friends and family if you 
wish. You can choose to decide whether or not take part in this research, and if you decide not to 
take part it will not affect the care that you receive from your own healthcare team. Ask us if you 
have any questions or would like more information.  
 
 
 
 
 
Part 1: What is the study and why is it being carried out? 
What is the purpose of the study? 
Haemodialysis is a time-consuming treatment that requires people to spend a significant amount of 
time in hospital. Arts activities can be used in hospitals to help patients fill their time with something 
that is creative and enjoyable. The purpose of this study is to explore the best way of delivering 
artistic activities to patients who are receiving haemodialysis, whether these activities can improve 
mood and wellbeing, and how this can be measured in future studies.  
Why have I been asked to take part in this study? 
1. You are attending the Antrim Area Hospital’s Renal Unit and are currently receiving 
haemodialysis 
2. We would like to know whether art can be beneficial for patients receiving haemodialysis 
Do I have to take part? 
It is your decision whether to take part in this study or not. If you would like to take part you will be 
asked to keep this information sheet and sign a consent form. If you decide to take part you are able 
to withdraw at any time, and you do not need to provide a reason. Deciding to withdraw from the 
study will not impact on the standard of care you receive. 
Part 2: What does the study involve? 
CONTENTS 
Part 1: What is the study and why is it being carried out? 
Part 2: What does the study involve? 
Part 3: Important information  

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
34 
 
How will the research be carried out? 
The research is a ‘randomised controlled trial’. This means that when someone chooses to take part 
they are assigned at random to either take part in the artistic activity or not. This allows us to 
compare the people who take part in the activity to those who did not.  A small number of people 
will be asked to consider doing an interview about their experience of the study. 
What will happen if I decide to take part in the study? 
 
You will be asked to sign a consent form and will then be asked to complete three 
questionnaires (about your quality of life, symptoms, and mood).  
 
People will be assigned at random to take part in art, and will be offered a selection of 
artistic activities to choose from. You can choose whatever activity you feel you would enjoy 
the most. You will be asked to take part in this activity during your dialysis sessions over the 
course of three weeks. 
 
People assigned at random to not receive the intervention will attend the clinic as usual, and 
this will not affect the care that you receive from your own healthcare team. 
 
You will be asked to complete the three questionnaires at the start of the study, then three 
weeks, six weeks and three months after joining the study. This will happen during your 
regular visits to the hospital, so you will not need to make any extra trips to the hospital.  
 
You will also be asked to keep track of your hospital or GP visits during the study.  
 
We will ask to interview a small number of people about their experiences of the study. 
 
During the course of the study it is possible you may become unwell and be unable to 
complete the activity or the questionnaires. If this happens we would like to use the data 
you have already given us, with your consent.  
Will any other information be collected? 
We will ask you some questions about your occupation and education. We will also ask you about 
your medical history, diagnosis, medication and use of health services.  
How long will the research last? 
Most people will be in the study for three months. 
What are the possible disadvantages of taking part?  
We may ask you to take part in an artistic activity during haemodialysis sessions. We will try to make 
the activities easy, engaging and fun. It may seem strange or uncomfortable to take part in an arts 
activity in a clinical setting, and you may be worried it will affect your dialysis. The range of activities 
have been reviewed by an advisory group that includes patients, staff and artists who work in clinical 
settings, to ensure that they’re safe, appropriate for the dialysis unit and won’t impact your 
treatment. 
We will ask you to complete questionnaires over the 3 month period you are in the study. The 
questionnaires cover subjects that you may find intrusive or upsetting to talk about, including 
symptoms you’re experiencing, their impact on your life relationships and your mental health. You 
can choose not to answer any questions you do not feel comfortable answering and this will not 
affect your treatment or participation in the study. We will help you fill out these questionnaires and 
try and make this a quick and easy task, but if you feel you need additional emotional support we 
will be able to direct you to supportive services.    

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
35 
 
What are the possible benefits of taking part? 
We cannot promise that this study will help you, but many people find art enjoyable and find that it 
improves their mood and reduces anxiety. Taking part in artistic activities can also help distract 
people from unpleasant symptoms and medical treatments. Even if you are not allocated to the 
group who participates in are, people who take part in research also can feel a sense of satisfaction 
as they are helping improve the care of others.  
Due to the need to reduce the spread of infection in the clinical setting any arts supplies that are 
used will not be shared throughout the unit, because of this the art supplies will be your own and at 
the end of the study you will be able to keep these for your own use. If you have been randomly 
assigned to the comparison group and won’t be taking part in the arts activities during the study, we 
will provide you with a packet of identical arts supplies on completion of the study so you can take 
part in arts activities in your own time.   
Important information 
What will happen if I don't want to carry on with the study? 
Involvement in the study is completely voluntary and you can decide to stop at any point. You do not 
need to provide a reason for leaving the study. If you decide to leave we will ask if we can use the 
information that you have already provided, it is your choice whether to say yes or no.  
What if I become ill during the study and cannot speak for myself? 
We will ask for your permission at the start of the study to use the information that we have 
collected up until this point. If you become ill and cannot speak for yourself we will not collect any 
further information from you, and will only use the information in ways you had already agreed to. 
How will the researchers keep my information confidential? 
Any confidential written information will be stored in locked filing cabinets, in a locked office, at 
Queen’s University and will be destroyed after five years. All digital information will be stored on 
secure servers and will be password protected. Any identifiable information, including your name 
and address, will be removed. The results of this research will be published but will not include any 
information that will allow people to identify those who participated. If you have provided 
information that causes the researcher to be concerned about your wellbeing or the wellbeing of a 
child, we will discuss this with you and an appropriate third party may need to be informed. 
What will happen to the results of the research? 
 
The results of this study will be published in peer-reviewed journals, presented at research 
conferences and will form a final PhD thesis. If you are interested we can provide you with a 
summary of results once data analysis has finished, and you can contact the research team if you 
would like a copy of any publications. The hope is that these results will inform a larger study and 
influence policy and practice. 
Who funding and carrying out this research? 
This study is part of a PhD project funded by the Department for the Economy (DfE). It is being 
carried out by Claire Carswell, a registered mental health nurse at Queen’s University Belfast. Her 
supervision team includes Dr Helen Noble, Professor Joanne Reid and Dr Ian Walsh 
Who has reviewed the study? 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
36 
 
This research has been reviewed by an independent Research Ethics Committee that is responsible 
for protecting the rights and safety of research participants. This study has been given a favourable 
opinion by the Office of Research Ethics Committees for Northern Ireland. 
 
Who do I contact for further information? 
If you have any questions or would like further information please feel free to contact: 
Claire Carswell 
Telephone: 028 9097 5766 
Email: ccarswell02@qub.ac.uk 
Dr Helen Noble 
Telephone: 028 9097 2472 
Email: helen.noble@qub.ac.uk 
 
Professor Joanne Reid 
Telephone: 028 9097 2459 
Email: j.reid@qub.ac.uk 
 
Dr Ian Walsh 
Telephone: 028 9097 8983 
Email: i.walsh@qub.ac.uk 
 
Complaints procedure  
If you have any complaints about the research or a member of the research team you have the right 
to complain. If you don’t wish to discuss your complaint with a member of the research team or your 
own healthcare team, please contact:  
The Complaints Department 
Bush House 
Bush Road 
Antrim 
 BT41 2QB 
Tel: 0289442655 
E-mail: user.feedback@northerntrust.hscni.net 
 
 
 
 
 
School of Nursing and Midwifery 
Queen's University Belfast 
Medical Biology Centre 
97 Lisburn Road 
Belfast BT9 7BL 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
37 
 
Appendix 2: Participant consent form Phase 2 
 
 
Patient Consent form – Feasibility Trial 
Study Title: Developing an arts-based intervention in patients with end-stage kidney disease 
receiving haemodialysis 
Name of Researcher: Claire Carswell 
Please initial 
box 
1 
I confirm that I have read the information sheet dated 04.07.18, version 
0.4 for the above study. I have had the opportunity to consider the 
information, ask questions, and had my questions answered fully. 
 
 
 
 
2 
I understand that my participation is voluntary and that I am free to 
withdraw at any time, without giving any reason, without having my 
care affected.  
 
 
 
 
3 
I understand that the study is being conducted as part of a PhD project 
from Queen’s University Belfast and that my personal information will 
be held securely on the university premises and will be handled 
according to the Data Protection Act 2018 
 
 
 
 
4 
I understand that data collected as part of this may be looked at by 
authorized individuals from Queen’s University Belfast where it is 
relevant to my taking part in this research. I give permission for these 
individuals to have access to this information. 
 
 
5 
I agree to take part in the above study. 
 
 
 
 
 
Name of participant 
 
 
 
Date 
 
 
            Signature 
 
Researcher 
 
 
 
 
Date 
 
 
            Signature 
 
 
Anonymous ID code: 
 
 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
38 
 
Appendix 3: Participant information sheet – Patient Phase 3 
 
Developing an arts-based intervention for patients with end-stage kidney disease 
receiving haemodialysis 
Participant information sheet –Process Evaluation Interviews 
 
We would like to invite you take part in a research study. Before you decide whether to take 
part it is important for you to understand what the research will involve and why it is being done. 
Please take time to read this information sheet carefully and discuss it with friends and family if you 
wish. You can choose to decide whether or not take part in this research, and if you decide not to 
take part it will not affect the care that you receive from your own healthcare team. Ask us if you 
have any questions or would like more information.  
 
 
 
 
 
Part 1: What is the study and why is it being carried out? 
What is the purpose of the study? 
Haemodialysis is a time-consuming treatment that requires people to spend a significant amount of 
time in hospital. Arts activities can be used in hospitals to help patients fill their time with something 
that is creative and enjoyable. The purpose of this study is to explore the best way of delivering 
artistic activities to patients who are receiving haemodialysis and how best to carry out research in 
this area. 
Why have I been asked to take part in this study? 
1. You are attending the Antrim Area Hospital’s Renal Unit and are currently receiving 
haemodialysis 
2. You are taking part in the randomised controlled trial.  
Do I have to take part? 
It is your decision whether to take part in this study or not. If you would like to take part you will be 
asked to keep this information sheet and sign a consent form. If you decide to take part you are able 
to withdraw at any time, and you do not need to provide a reason. Deciding to withdraw from the 
study will not impact on the standard of care you receive. 
CONTENTS 
Part 1: What is the study and why is it being carried out? 
Part 2: What does the study involve? 
Part 3: Important information  

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
39 
 
Part 2: What does the study involve? 
How will the research be carried out? 
This part of the research is a ‘process evaluation’, this means we are gathering information on 
peoples experiences of the intervention and how it is being researched. 
What will happen if I decide to take part in the study? 
The researcher will arrange to meet with you to ask you some questions about your experiences 
relating to the intervention or the randomised controlled trial. For example, we are interested in 
why people decided to take part in the trial, what participants thought of the intervention and 
experiences of being part of a control group. Before the interview starts we will ask you to sign a 
consent form saying you are happy to take part in the process evaluation. To make sure the 
information is accurate we will record the interview. However you can ask us to stop recording at 
any time. The interview should not take any longer than 60 minutes. The interview can be carried 
out in your own home, at a place of your choosing or via telephone. 
 
What are the possible benefits of taking part? 
We cannot promise that this study will help you directly. However the results of this study will 
improve how the intervention is delivered and how future studies are carried out. Any relevant 
results will be presented to managers and staff so that service provision for patients with end-stage 
kidney disease receiving haemodialysis may be developed.  
Important information 
What will happen if I don't want to carry on with the study? 
Involvement in the study is completely voluntary and you can decide to stop at any point. You do not 
need to provide a reason for leaving the study. If you decide to withdraw we will not use any 
information that we have collected from you.   
What if I become distressed during the interview? 
The interview process has the potential to be distressing for you. Therefore if you would like to 
pause the interview the researcher will stop recording, and before starting again will ask you if you 
feel okay to continue. If the researcher feels you are too distressed they will discontinue the 
interview. If you feel you need further support after the interview the researcher will provide you 
with an information pack of support services you can access. 
 
How will the researchers keep my information confidential? 
Any confidential written information will be stored in locked filing cabinets, in a locked office, at 
Queen’s University and will be destroyed after five years. All digital information will be stored on 
secure servers and will be password protected. Any identifiable information, including your name 
and address, will be removed. The results of this research will be published but will not include any 
information that will allow people to identify those who participated. If you have provided 
information that causes the researcher to be concerned about your wellbeing or the wellbeing of a 
child, we will discuss this with you and an appropriate third party may need to be informed. 
What will happen to the results of the research? 
 
The results of this study will be published in peer-reviewed journals, presented at research 
conferences and will form a final PhD thesis. If you are interested we can provide you with a 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
40 
 
summary of results once data analysis has finished, and you can contact the research team if you 
would like a copy of any publications. The hope is that these results will inform a larger study and 
influence policy and practice. 
Who is funding and carrying out this research? 
This study is part of a PhD project funded by the Department for the Economy (DfE). It is being 
carried out by Claire Carswell, a registered mental health nurse at Queen’s University Belfast. Her 
supervision team includes Dr Helen Noble, Professor Joanne Reid and Dr Ian Walsh 
Who has reviewed the study? 
This research has been reviewed by an independent Research Ethics Committee that is responsible 
for protecting the rights and safety of research participants. This study has been given a favourable 
opinion by the Office of Research Ethics Committees for Northern Ireland. 
 
Who do I contact for further information? 
If you have any questions or would like further information please feel free to contact: 
Claire Carswell 
Telephone: 028 9097 5766 
Email: ccarswell02@qub.ac.uk 
Dr Helen Noble 
Telephone: 028 9097 2472 
Email: helen.noble@qub.ac.uk 
 
Professor Joanne Reid 
Telephone: 028 9097 2459 
Email: j.reid@qub.ac.uk 
 
Dr Ian Walsh 
Telephone: 028 9097 8983 
Email: i.walsh@qub.ac.uk 
 
Complaints procedure  
If you have any complaints about the research or a member of the research team you have the right 
to complain. If you don’t wish to discuss your complaint with a member of the research team or your 
own healthcare team, please contact:  
The Complaints Department 
Bush House 
Bush Road 
Antrim 
 BT41 2QB 
Tel: 0289442655 
E-mail: user.feedback@northerntrust.hscni.net 
School of Nursing and Midwifery 
Queen's University Belfast 
Medical Biology Centre 
97 Lisburn Road 
Belfast BT9 7BL 

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41 
 
Appendix 4: Participant consent form – Patient Phase 3 
 
Patient Consent form – Process evaluation - Interview 
Study Title: Developing an arts-based intervention in patients with end-stage kidney disease 
receiving haemodialysis 
Name of Researcher: Claire Carswell 
Please initial 
box 
1 
I confirm that I have read the information sheet dated 23.3.18, version 
0.3 for the above study. I have had the opportunity to consider the 
information, ask questions, and had my questions answered fully. 
 
 
 
 
2 
I understand that my participation is voluntary and that I am free to 
withdraw at any time, without giving any reason, without having my 
care affected.  
 
 
 
 
3 
I understand that the study is being conducted as part of a PhD project 
from Queen’s University Belfast and that my personal information will 
be held securely on the university premises and will be handled 
according to the Data Protection Act 2018 
 
 
 
 
4 
I understand that data collected as part of this study may be looked at 
by authorized individuals from Queen’s University Belfast where it is 
relevant to my taking part in this research. I give permission for these 
individuals to have access to this information.  
 
 
5 
I understand the interviews will be tape recorded and there is a 
possibility of direct quotation being used in publications. 
 
 
 
 
6 
I understand that what is discussed during the interviews is confidential 
with the exception that if I disclose information that indicates that I am 
at risk of harming myself or others, or in danger of being harmed by 
someone else, the researcher is legally obliged to pass on this 
information to the relevant authority 
 
7 
I agree to take part in the interview. 
 
 
 
 
 
 

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42 
 
 
Name of participant 
 
 
 
Date 
 
 
            Signature 
 
 
Researcher 
 
 
 
 
Date 
 
 
            Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Anonymous ID code: 
 
 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
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Appendix 5: Participant information sheet – Healthcare staff Phase 3 
 
Developing an arts-based intervention for patients with end-stage kidney disease 
receiving haemodialysis 
Participant information sheet – HCP Process Evaluation Focus Group 
We would like to invite you take part in a research study. Before you decide whether to take part it 
is important for you to understand what the research will involve and why it is being done. Please 
take time to read this information sheet carefully and discuss it with friends and family if you wish. 
You can choose to decide whether or not take part in this research, and if you decide not to take 
part it will not affect the care that you receive from your own healthcare team. Ask us if you have 
any questions or would like more information.  
 
 
 
 
 
Part 1: What is the study and why is it being carried out? 
What is the purpose of the study? 
Haemodialysis is a time-consuming treatment that requires people to spend a significant amount of 
time in hospital. Arts activities can be used in hospitals to help patients fill their time with something 
that is creative and enjoyable. The purpose of this study is to explore the best way of delivering arts 
activities to patients who are receiving haemodialysis, and how we can best measure the benefits of 
these activities. It is important to consider the setting where these activities are taking place and 
examine how they may affect the working environment for healthcare staff.  
Why have I been asked to take part in this study? 
You have been selected to take part as you are a healthcare professional working in the 
haemodialysis unit where we are carrying out research exploring the use of art within the clinical 
setting. 
Do I have to take part? 
It is your decision whether to take part in this study or not. If you decide to take part you are able to 
withdraw at any time, and you do not need to provide a reason.  
Part 2: What does the study involve? 
How will the research be carried out? 
CONTENTS 
Part 1: What is the study and why is it being carried out? 
Part 2: What does the study involve? 
Part 3: Important information  

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
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This research is a process evaluation, this means we are talking to people to gather information on 
their experiences of an intervention (the arts activities) and how it is being researched and 
evaluated. 
What will happen if I decide to take part in the study? 
If you decide to participate in this research you will take part in a focus group. This is a group 
interview facilitated by a researcher and that focuses on a specific subject. It will consist of four 
members of healthcare staff from the unit, who have been selected as they have worked on the unit 
during the implementation of the arts activities. The interview will focus on experiences of these 
activities and how they have affected the working environment. No questions will be directed at any 
individual but will be directed at the group as a collective. You can choose whether or not respond 
throughout the interview and are not required to respond to any questions you do not wish to 
answer. 
 The focus group will be organised at a place and time that is convenient for all participants. Before 
the focus group takes place we will ask you to fill in a consent form stating that you agree to take 
part. 
What are the possible benefits of taking part? 
We cannot promise that this study will help you directly; however the results of the study will inform 
future research and service development that will aim to improve care provided to patients with 
end-stage kidney disease receiving haemodialysis in a way that will also improve the working 
environment for healthcare staff.  
Important information 
What will happen if I don't want to carry on with the study? 
Involvement in the study is completely voluntary and you can decide to stop at any point. If you 
leave during the study we will not use the data that we have collected from you. You do not need to 
provide a reason for leaving the study.  
How will the researchers keep my information confidential? 
Any confidential audio or written information will be stored in locked filing cabinets, in a locked 
office, at Queen’s University and will be destroyed after five years. All digital information will be 
transferred and stored on secure servers at Queen’s University Belfast and will be password 
protected, therefore only the researchers (Claire Carswell, Dr Helen Noble, Dr Joanne Reid and Dr 
Ian Walsh) will have access to recordings of the interviews. Any identifiable information will be 
removed. If you have provided information that causes the researcher to be concerned about 
malpractice the researcher will be obliged to contact the line manager of the healthcare professional 
involved. 
What will happen to the results of the research? 
 
The results of this study will be published in peer-reviewed journals, presented at research 
conferences and will form a final PhD thesis. If you are interested we can provide you with a 
summary of results once data analysis has finished, and you can contact the research team if you 
would like a copy of any publications. The hope is that these results will inform a larger study and 
influence policy and practice. 

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45 
 
Who funding and carrying out this research? 
This study is part of a PhD project funded by the Department for the Economy (DfE). It is being 
carried out by Claire Carswell, a registered mental health nurse at Queen’s University Belfast. Her 
supervision team includes Dr Helen Noble, Professor Joanne Reid and Dr Ian Walsh 
Who has reviewed the study? 
This research has been reviewed by an independent Research Ethics Committee that is responsible 
for protecting the rights and safety of research participants. This study has been given a favourable 
opinion by the Office of Research Ethics Committees for Northern Ireland. 
 
Who do I contact for further information? 
If you have any questions or would like further information please feel free to contact: 
Claire Carswell 
Telephone: 028 9097 5766 
Email: ccarswell02@qub.ac.uk 
Dr Helen Noble 
Telephone: 028 9097 2472 
Email: helen.noble@qub.ac.uk 
 
Professor Joanne Reid 
Telephone: 028 9097 2459 
Email: j.reid@qub.ac.uk 
 
Dr Ian Walsh 
Telephone: 028 9097 8983 
Email: i.walsh@qub.ac.uk 
 
Complaints procedure  
If you have any complaints about the research or a member of the research team you have the right 
to complain. If you don’t wish to discuss your complaint with a member of the research team or your 
own healthcare team, please contact:  
The Complaints Department 
Bush House 
Bush Road 
Antrim 
 BT41 2QB 
Tel: 0289442655 
E-mail: user.feedback@northerntrust.hscni.net 
 
 
School of Nursing and Midwifery 
Queen's University Belfast 
Medical Biology Centre 
97 Lisburn Road 
Belfast BT9 7BL 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
46 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
47 
 
Appendix 6: Participant consent form – Healthcare staff Phase 3 
 
HCP Consent form – Process evaluation – Focus group 
Study Title: Developing an arts-based intervention in patients with end-stage kidney disease 
receiving haemodialysis 
Name of Researcher: Claire Carswell 
Please initial 
box 
1 
I confirm that I have read the information sheet dated 27.02.18 version 
0.2 for the above study. I have had the opportunity to consider the 
information, ask questions, and had my questions answered fully. 
 
 
 
 
2 
I understand that my participation is voluntary and that I am free to 
withdraw at any time without giving any reason.  
 
 
 
 
3 
I understand that the study is being conducted as part of a PhD project 
from Queen’s University Belfast and that any personal information will 
be held securely on the university premises and will be handled 
according to the Data Protection Act 2018 
 
 
 
 
4 
I understand that this study is confidential but there are limits to this 
confidentiality.  Revelations that are in clear breach of good medical 
practice may require confidentiality to be broken by the researchers. 
 
 
5 
I understand the focus group will be tape recorded and there is a 
possibility of direct quotation being used in publications. 
 
 
 
 
6 
I agree to take part in the focus group. 
 
 
 
 
 
 
Name of participant 
 
 
 
Date 
 
 
            Signature 
 
Researcher 
 
 
 
 
Date 
 
 
            Signature 
 
Anonymous ID code: 
 
 

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48 
 
Appendix 7: Distress Protocol Patients 
Distress Protocol - Patients 
Rationale 
Patients with end-stage kidney disease receiving haemodialysis are potentially vulnerable and 
experience lower health related quality of life compared to the general population, and are at a 
higher risk of developing mental health issues such as anxiety and depression. Discussions 
surrounding these issues may cause distress. Therefore it is important that researchers are sensitive 
to the person’s distress and acts to minimise any potential exacerbation, and help identify agencies 
or services that can provide support. 
Distress Protocol for Phase 2 and 3 
 
Distress 
•A participant indicates that they're experiencing high levels of emotional distress 
•A participant exhibits behaviour that suggests the questionnaire or interview is causing 
distress, such as crying, shaking, trembling, difficulty speaking 
Stage 1 
response 
•Stop  the discussion 
•Offer immediate support 
•Assess mental status. The researcher is a registered mental health nurse and will conduct a 
brief mental state examination, exploring the thoughts and feelings the person is 
experiencing in that moment. 
Review 
•The research will ask the participant if they feel able to carry on. 
•The research will recommenced completing the questionnaire or interview if they feel able. 
•If the participant feels unable to continue the researcher will move on to stage 2. 
Stage 2 
response 
•Discontinue data collection/interview 
•Offer the participant, with consent, for the researcher to approach a member of the clinical 
team for further advice or support. 
•Encourage the participant to contact their GP or mental health provider 
•Provide the participant with information relating to health psychology services and NIKPA 
Follow up 
•Follow up participant during next visit to the unit, with the patient's consent. 
•Encourage the participant to contact the researcher if they continue to experience increased 
distress. 
 

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Contact details for supportive services 
Health Psychology Services Northern Health and Social Care Trust 
The health psychology services provide a specialised renal counsellor. Please ask a 
member of your care team for a referral to this service 
Clinical Health Psychology Service Holywell 
Hospital Site, 60 Steeple Road, Antrim BT41 2RJ 
Tel: 028 9441 3127 
Email: psychology.bvh@northerntrust.hscni.net 
Northern Ireland Kidney Patient Association 
NIKPA, c/o Dialysis Unit,  
Belfast City Hospital, 
Lisburn Road,  
Belfast BT9 7AB  
email: info@nikpa.org 
HMRC Charities Ref. No: NI00338 
 Northern Ireland Charity number: NIC104608 
 
   
 
 
 
  
 
 
 
 
 
 
 

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Appendix 8: Distress Protocol Healthcare staff  
Distress Protocol – Healthcare Staff 
Rationale 
Patients with end-stage kidney disease experience difficult symptoms and have high rates of 
mortality. It is likely that during the course of this study healthcare staff working on the 
haemodialysis unit will experience the deterioration of the health of their patients, and potentially 
the death of patients. Discussions surrounding these issues may cause distress. Therefore it is 
important that researchers are sensitive to the person’s distress and acts to minimise any potential 
exacerbation, and help identify agencies or services that can provide support. 
Distress Protocol for Phase 3 
 
Distress 
•A participant indicates that they're experiencing high levels of emotional distress 
•A participant exhibits behaviour that suggests the questionnaire or interview is causing 
distress, such as crying, shaking, trembling or difficulty speaking 
Stage 1 
response 
•Stop focus group and offer immediate support 
•Assess mental status. The researcher is a registered mental health nurse and will conduct a 
brief mental state examination, exploring the thoughts and feelings the person is 
experiencing in that moment. 
Review 
•The researcher will ask the participant if they feel able to carry on. 
•The researcher will recommence the focus group if they feel able. 
•If the participant feels unable to continue the researcher will move on to stage 2. 
Stage 2 
response 
•Discontinue interview and the researcher will accompany the participant to a private area. 
•Encourage the participant to contact their GP or mental health provider. 
•Encourage the participant to speak to a member of their clinical team, eg. manager 
•Provide the participant with information relating to supportive services or occupational 
health 
Follow up 
•Follow up participant during next visit to the unit, with the participant's consent. 
•Encourage the participant to contact the researcher if they continue to experience increased 
distress. 
 

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Contact details for supportive services 
Occupational Health at Antrim Area Hospital 
Occupational Health 
Willow House 
45 Bush Road 
Antrim BT41 2RL 
Tel: 028 9442 4403 
Email: kevin.oconnor@northerntrust.hscni 
Royal College of Nursing Counselling Services 
To book a counselling session, call the RCN any time from 8.30am to 8.30pm, 365 days a 
year on 0345 772 6100. 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 9: Distress protocol – Suicide risk 
Distress Protocol – Suicide Risk 
Rationale 
Patients with end-stage kidney disease are at high risk for developing mental health issues such as depression. 
One consequence could be an increased risk of suicide. The researcher will be administering the Hospital 
Anxiety and Depression scale during the project, and while this scale is not diagnostic of mental health issues 
and does not ask information on suicide or thoughts of life not worth living, the questionnaire may prompt 
patients to spontaneously disclose thoughts of suicide. Therefore it is important that researchers respond 
appropriately to reduce risk of harm.  
Distress Protocol for suicide risk
 
Suicidal 
ideation 
•A participant indicates that they're experiencing thoughts of life not worth living or active 
suicidal ideation. 
Stage 1 
response 
•Stop the discussion 
•Offer immediate support 
•Assess immediate risk. The researcher is a registered mental health nurse and ASIST 
trained, and will conduct a brief risk assessment, identifiy protective factors, the presence 
or absence of an active plan and the ability to complete a suicide plan. This assessment will 
not consistute a formal mental health assessment as the researcher is not present within a 
clinical capacity so onward referral will be necessary.  
Stage 2 
response 
•If the participant is assessed not to be at immediate risk the researcher will inform the 
nurse in charge of the identified issues and the healthcare professional can determine the 
best course of action, including potential onward referral to the renal counsellor, GP or 
RAID. 
•If the participant is assessed as being at immediate risk, confidentiality will be breached 
and the nurse in charge will be informed. 
•The nurse in charge will be advised to contact the Rapid Assessment Interface and 
Discharge team, who can provide an emergency assessment and onward referral to a 
crisis response team.   
Follow up 
•Follow up participant during next visit to the unit, with the patient's consent. 
•Conduct another risk assessment and review current mental state. 
•As participants are not being excluded as a consequence of mental health issues, they will 
be asked if they wish to continue in the study. If the participant wishes to continue in the 
study risk will be reviewed at each follow-up session.  
 

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53 
 
 
The input from healthcare professionals to the distress protocol is an important consideration.  Even 
though the potential for a spontaneous disclosure of suicide or harm is low, a risk assessment will be 
taken by the researcher who is a trained Mental Health nurse.  The reason for the referral through 
the direct care team is procedural and reflects the standard process within the HSC.  The researcher 
as an experienced mental healthcare professional will be able to advise the care team but feels it 
would be inappropriate to operate outside of the standard practices on site.  The Sponsor has also 
requested that the researcher clearly separates their research and clinical roles. 
Contact details for supportive services 
Health Psychology Services Northern Health and Social Care Trust 
The health psychology services provide a specialised renal counsellor. Please ask a 
member of your care team for a referral to this service 
Clinical Health Psychology Service Holywell 
Hospital Site, 60 Steeple Road, Antrim BT41 2RJ 
Tel: 028 9441 3127 
Email: psychology.bvh@northerntrust.hscni.net 
 
Northern Ireland Kidney Patient Association 
NIKPA, c/o Dialysis Unit,  
Belfast City Hospital, 
Lisburn Road,  
Belfast BT9 7AB  
email: info@nikpa.org 
HMRC Charities Ref. No: NI00338 
 Northern Ireland Charity number: NIC104608 
 
   
Renal Patient Support Group  
The Renal Support Group meets on the second Monday every other month at All Saints Parish 
Centre in Ballymena from 11am – 12.30pm.  
 
Lifeline 
Telephone: 0808 808 8000 
Textphone: 18001 0808 808 8000 

PROTOCOL ; VERSION 1.3 ; DATE: 10.07.18 
54 
 
Appendix 10: Distress Protocol - HADS 
Distress Protocol – HADS 
Rationale 
Patients with end-stage kidney disease are at high risk for developing mental health issues such as depression 
and anxiety. The researcher will be administering the Hospital Anxiety and Depression scale during the project, 
and while this scale is not diagnostic of mental health issues it can be used as a screening tool to identify high 
risk of depression and anxiety. Therefore it is important that the researcher identifies patients who at an 
increased risk so they can be properly assessed.  
Distress Protocol for high risk of depression or anxiety 
 
HADS score  
•A participant scores 12 or above on the Hospital Anxiety and Depression Scale. 
This is the threshold identified for patients with ESKD that indicates that there is 
a risk that the person is experiencing clinical depression or anxiety.  
Response 
•Researcher will explain to the participant that the scale is not diagnostic but that 
their score indicates that they may benefit from a mental health assessment. 
Permission will be sought to speak to the nurse in charge about onward referral, 
this could include their GP for general mental health services or the renal 
counselling services for specialised health psychology services.  
•If there is an identified risk of suicide the Distress Protocol for suicide risk will be 
put into effect.  
•If there is no identified risk to the participant or anyone else confidentiality will not 
be breached without their permission. Participant will be provided with 
information on supportive services  
Follow up 
•Follow up participant during next visit to the unit, with the patient's consent. 
•If participant has declined referral this decision will be reviewed during the follow 
up data collection. 
•As participants are not being excluded as a consequence of mental health issues, 
they will be asked if they wish to continue in the study. If the participant wishes to 
continue in the study risk will be reviewed at each follow-up session.  
 

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55 
 
 
Contact details for supportive services 
Health Psychology Services Northern Health and Social Care Trust 
The health psychology services provide a specialised renal counsellor. Please ask a 
member of your care team for a referral to this service 
Clinical Health Psychology Service Holywell 
Hospital Site, 60 Steeple Road, Antrim BT41 2RJ 
Tel: 028 9441 3127 
Email: psychology.bvh@northerntrust.hscni.net 
 
Northern Ireland Kidney Patient Association 
NIKPA, c/o Dialysis Unit,  
Belfast City Hospital, 
Lisburn Road,  
Belfast BT9 7AB  
email: info@nikpa.org 
HMRC Charities Ref. No: NI00338 
 Northern Ireland Charity number: NIC104608 
 
   
Renal Patient Support Group  
 
The Renal Support Group meets on the second Monday every other month at All Saints Parish 
Centre in Ballymena from 11am – 12.30pm.