Adapted Cognitive Stimulation Therapy (CST) for Pre-frail Stroke Survivors: A Non-randomised, Acceptability and Feasibility Pilot Study
Phase: NA
Conditions: Stroke, Frailty, Carers
Sponsor: University of East Anglia

PROTOCOL 
 
FULL/LONG TITLE OF THE STUDY 
Adapted Cognitive Stimulation Therapy (CST) for Pre-frail Stroke Survivors: A Non-
Randomised, Acceptability and Feasibility Pilot Study 
  
SHORT STUDY TITLE / ACRONYM 
Pilot of Cognitive Stimulation Therapy for Pre-frail Stroke Survivors 
 
PROTOCOL VERSION NUMBER AND DATE 
0.4 - 27/03/2024 
 
RESEARCH REFERENCE NUMBERS 
 
IRAS Number: 335493 
  
Aims 
This study aims to establish whether an adapted version of Cognitive Simulation 
Therapy (CST) is an acceptable treatment for stroke survivors meeting criteria for pre-frailty (an 
intermediate stage of frailty where some, but not all, signs of frailty are present) and their 
informal carers. This will inform further research on the application and efficacy of an adapted 
CST intervention within stroke rehabilitation.  This is of relevance to the field of clinical 
psychology as it would constitute the first stage of development of a psychosocial intervention 
for use in rehabilitation pathways for frail and pre-frail stroke survivors and potentially suggest a 
role for clinical psychology within frailty treatment. 
Background and Introduction 
Stroke 
There are around 100,000 strokes every year in the UK and, in 2021, approximately 1.3 
million people were living with stroke (Stroke Association, n.d.) There are several adverse 

outcomes and additional difficulties which are common after a stroke, such as depression, 
anxiety, dementia and possibly death (Craig et al., 2020; Ivan et al., 2004; Knapp et al., 2020; 
Medeiros et al., 2020). 
Compared with other long-term conditions, stroke causes a greater range of disability 
(Adamson et al., 2004). Survivors often rely on informal carers in their day-to-day lives (Han & 
Hayley, 1999), with an Australian survey finding that 65% of stroke survivors need assistance 
with activities of daily living, with most spending over 40 hours per week supporting the survivor 
(Deloitte Access Economics, 2020). In the UK, the value of care by informal carers is estimated 
at £15.8 billion, almost double the £8.6 billion in NHS and care home and professional carer 
costs (Patel et al., 2020). Caring can give informal carers a sense of responsibility and value 
(Gok Metin et al., 2019). However, caring can also cause potential risk for strain, leading to 
financial, physical and psychosocial burdens, something more pronounced in caring for those 
who are frail due to associated morbidity (Garlo et al., 2010). 
Frailty is another significant issue for the health, well-being and recovery of stroke 
survivors. Approximately 21% of stroke patients meet the criteria for frailty and another 48% 
meet the criteria for pre-frailty - roughly double the rates of those without stroke (Palmer et al., 
2019). Research indicates that those who develop frailty post-stroke have an increased risk of 
adverse outcomes (Burton et al., 2022; Evans et al., 2020, 2022) and that the severity of their 
frailty increases over time (Lee et al., 2014; Trevisan et al., 2017).  
Frailty 
Frailty is a state of vulnerability characterised by a multi-system decline in physiological 
reserves needed to maintain homeostasis following a stressor e.g., cold weather or bronchitis 
(Morley et al., 2013; Fried et al., 2001; Campbell & Buchner, 1997). The definition of frailty was 
first operationalised by Fried et al. (2001) as the presence of at least three out of the following 

five clinical indicators: unintentional weight loss, exhaustion, weakness, slow walking speed and 
low level of physical activity.  They also defined an 'intermediate frailty status', now referred to 
as 'pre-frailty’, as the occurrence of one or two of the five criteria. An alternative perspective on 
frailty was proposed by Mitnitski et al. (2001) suggesting that frailty refers to the number of 
health deficits an individual has accumulated.  
Individuals assessed as 'pre-frail' have an increased risk of becoming frail in the 
following few years and those assessed as frail are 3-5 times more likely to die than those who 
are not frail or pre-frail (Gill et al., 2006). Frailty and pre-frailty are independently associated with 
many adverse outcomes, including psychosocial outcomes such as dementia, loneliness, 
cognitive decline, depression and lower quality of life (Chu et al., 2021; Hoogendijk et al., 2016; 
Soysal et al., 2017). However, Gill et al. (2006) identified that frailty is potentially reversible at 
the pre-frail stage, making pre-frailty an important target for intervention.   
Multicomponent interventions are recommended as a first-line therapy for the 
management of frailty (Dent et al., 2019); these typically consist of weight-based training, 
provision of caloric supplements, and other physical interventions. Cognitive training 
interventions have also been found to reduce frailty scores, including as standalone 
interventions (Ng et al., 2015).  Short-term memory, orientation, attention and concentration, 
speed of information processing, visuospatial processing, linguistic ability, and areas of 
executive function are targeted in cognitive interventions for frailty. These domains are targeted 
through a variety of games, including “spot the difference” tasks, maze activities, sorting 
activities, colouring tasks, memory games, matrix reasoning tasks, and in one study, virtual 
reality orientation tasks (Murukesu et al., 2020; Dent et al., 2019; Kwan et al., 2021). Cognitive 
interventions thus show the potential to prevent progression to frailty and associated adverse 
outcomes of frailty for individuals and informal carers, indicating a potential role for clinical 
psychology and psychologically informed interventions in the field of frailty management. Given 

the prevalence of post-stroke frailty, there is a clear need for interventions to prevent or reverse 
frailty and reduce the risk of associated adverse outcomes; the above research indicates that 
multi-component interventions might be the way forward.  
The FIESTO Project  
Dr Nicholas Evans, Honorary Consultant in Stroke Medicine at Addenbrooke’s Hospital 
and Senior Clinical Lecturer at the University of Cambridge, is leading the ‘Frailty and Its Effects 
on Stroke Treatments and Outcomes’ (FIESTO) project. This is hoped to lead to a feasibility 
randomised controlled trial (RCT) of a multicomponent intervention consisting of physical, 
cognitive and nutritional components for pre-frail stroke survivors. Initial work is required to 
develop each component, or ‘strand’, of the overall multicomponent intervention.  
The development of a cognitive training intervention as part of this project will inform 
wider stroke rehabilitation research on psychological interventions for stroke survivors and their 
carers, identified as a research priority by the James Lind Alliance (2021) and the National 
Institute of Health and Care Excellence (NICE; 2013).   This research also has the potential to 
be a valuable contribution to the growing understanding of interventions for frailty and identifying 
a role for clinical psychology within frailty management.  
Cognitive Stimulation Therapy 
Currently, there is limited consistency across multi-component interventions for pre-frail 
individuals regarding the mode of delivery, content, and duration of the cognitive training 
component (e.g. Apóstolo et al., 2019; Chen et al., 2020; Murukesu et al., 2020; Ng et al., 
2015). However, some formats of the cognitive training used in these interventions share 
similarities with Cognitive Stimulation Therapy (CST; Spector et al., 2003) a NICE-
recommended intervention with clearly defined principles for individuals with mild to moderate 
dementia (NICE, 2018).  CST for dementia has been researched globally and found to improve 

cognition, quality of life, well-being, activities of daily living, and mood (Aguirre et al., 2013; 
Lobbia et al., 2019). It does so in an environment promoting fun, learning, and the strengthening 
of abilities and social relationships among group members and facilitators, while maintaining 
cognitive skills - such as memory and orientation - in the context of dementia (Spector et al., 
2006; Hall et al., 2013).   
Aguirre et al. (2014) hypothesise informal carers may also benefit from CST due to an 
improvement in cognitive skills in those for whom they provide care. There is a small but 
promising qualitative literature supporting the benefits of CST for informal carers (Lauritzen et 
al., 2022, Rai et al., 2021), particularly when informal carers are involved in the delivery (Bailey 
et al., 2017., Leung et al., 2017; Orrell et al., 2017; Rai et al., 2021). Individuals with dementia 
attending CST interventions with informal carers were found to become more able to 
communicate socially and interact with others, leading to more positive relationships with 
informal carers (Bailey et al., 2017; Orrell et al., 2017).  
Studies analysing the indirect benefit of CST for carers who did not attend CST reported 
greater equality in communication between the group member and carer due to improved verbal 
skills from the group member (Lauritzen et al., 2022; Spector et al., 2011). In these instances, 
the carer perceived the group as a possible source of happiness leading to carer enrichment 
and a sense of mutual growth in their relationship (Lauritzen et al., 2022). Positive interactions 
and bonding during the group generated and modelled feelings of positivity at home (Murray et 
al., 2016). A multicomponent intervention consisting of CST, exercise, and psychoeducation 
was beneficial for carers, reported the groups were meaningful for them (Skov et al., 2022). 
Psychoeducation about CST and the clinical contexts in which it is used may increase the 
acceptability for family carers, due to being reassured CST is a meaningful activity.  
There is promising qualitative research supporting the benefits of CST for carers both 
when they were involved with the CST intervention in some form and when they were not 

(Lauritzen et al., 2022; Skov et al., 2022; Orrell et al., 2017). Little research has analysed 
quantitative data for caregiver well-being regardless of whether they attend the group. However, 
in the two studies that do, the results were inconsistent (Aguirre et al., 2014; Rai et al., 2021) 
suggesting a need for further research in this area. 
CST might, therefore, provide a good basis for the cognitive training strand of a 
multicomponent frailty intervention, including within stroke. CST has not yet been trialled in 
individuals with a primary diagnosis of stroke, but 25%-30% of ischemic stroke survivors go on 
to develop delayed vascular cognitive impairment or vascular dementia (Kalaria et al., 2016) 
and therefore may receive CST at a later stage.  Two connected doctoral thesis projects are 
being proposed to test whether CST is a feasible and acceptable intervention for pre-frail stroke 
survivors. Although the majority of the recruitment will be conducted jointly, one project (led by 
Sophie Livsey) will invite stroke survivors to provide feedback about their experience and 
opinions of the intervention via an online acceptability questionnaire and a focus group and the 
other (led by Max Bramley) will invite their informal carers to provide their views on acceptability 
via separate focus groups. The data will also be analysed separately.   
 
Research questions 
The stroke survivor arm of this study will address the primary research question: ‘Is an 
adapted Cognitive Stimulation Therapy intervention acceptable to pre-frail stroke survivors?’. 
Similarly, the informal carer arm will address the primary research question: ‘Is an adapted 
Cognitive Stimulation Therapy intervention acceptable to the informal carers of pre-frail stroke 
survivors?’.  These questions are important because, if the intervention were deemed 
unacceptable by either group then further adaptations, or a new intervention, will be required for 
use in the later feasibility trial of the full multicomponent intervention. Acceptability will be 

operationalised in this study according to the Theoretical Framework of Acceptability (TFA) 
developed by Sekhon et al. (2017) which consists of seven constructs of acceptability (Appendix 
A). 
Secondary research questions are: ‘’How can the intervention be improved?’, this 
question will help inform the development of the cognitive stimulation intervention adopted in the 
feasibility RCT; and “Is the intervention feasible to use in further research?”, in particular, we are 
interested to find out if it is feasible to recruit and retain the required numbers to run the group 
intervention to inform the protocol of future research hoping to utilise this intervention.   
Patient and Public Involvement 
Patient and Public Involvement (PPI) was sought from a pre-frail stroke survivor and her 
IC (husband). Their input has been sought to determine the acceptability of recruitment 
materials (participant information sheets [PIS] and joint leaflet), as such we have adapted the 
PIS and joint leaflet to include careful consideration when explaining frailty, to be more friendly 
and gentle to lay-persons and reduce the use of the term, in an effort to move away from the 
negative connotations that the PPI members felt the term holds. We continue to discuss how to 
best adapt CST materials to be acceptable to stroke survivors, this has included a suggestion of 
music being played in the background to the group song to compensate for difficulties common 
in projecting one's voice after stroke.  
Adaptation of CST Materials 
CST was developed by Spector et al. (2003) as a group intervention to help improve the 
cognition and quality of life in those with a diagnosis of dementia and was based on the 
theoretical concepts of reality orientation and cognitive stimulation. The intervention consists of 
14 45-minute long sessions, recommended to be delivered twice per week for seven weeks. 
Each session is focused on a theme (e.g. food, sounds, faces and scenes) and contains 

activities and discussion points designed to stimulate the use of memory and other cognitive 
skills (Spector et al., 2001). The CST manual (Spector et al., 2020) provides the theme for each 
session and suggests a choice of two activities relating to this theme.  
Eight sessions of CST will be adapted for use in this pilot study. Adaptations have been, 
and will continue to be, made based on discussions with the PPI advisors and input from 
research team member, Dr Huw Green (Principal Clinical Psychologist in Stroke at 
Addenbrooke’s Hospital). Adaptations will consider the types of activities that are included within 
the sessions and the ‘take home sheets’ and how the original principles of CST can be 
maintained as much as possible whilst still allowing for changes that will make the intervention 
more suited for stroke patients, based on the existing evidence for psychological and cognitive 
interventions for stroke.  
The ‘take home sheets’, will be sheets that are given out after each session for the 
stroke survivor to take home and will include some psychoeducation information along with 
some optional, additional activities that can be completed at home with the informal carer. This 
is not something suggested in the original CST manual but is instead informed by the later 
developed Individual Cognitive Simulation Therapy, or iCST. In iCST the intervention sessions 
are completed in the home setting and led by a carer and have been found to improve the 
quality of the caregiving relationship between a person with dementia and their carer (Orrell et 
al., 2017).  
Consent has been gained from the developers of CST to adapt the materials for use in 
this novel context.  
For the remainder of this protocol, the adapted CST intervention that is to be used in this 
research will be referred to as stroke-adapted cognitive stimulation therapy or sCST. A draft, 
example session plan for sCST can be found in Appendix B. 

 Method 
Design  
This study will gather rich data on the acceptability of sCST for pre-frail stroke survivors 
to ascertain the suitability of the intervention for incorporation in the FIESTO feasibility RCT. As 
the study will examine the acceptability of the intervention prior to clinical trial, there will be no 
randomisation or control group, it is categorised as a non-randomised pilot study: a study in 
which “all or part of the intervention to be evaluated and other processes to be undertaken in a 
future trial are carried out without randomisation of participants”  (Eldridge et al., 2016, p. 15).  
This research will adopt a mixed methods design. Qualitative data will be collected via 
focus groups to gain a rich understanding of the acceptability of the intervention and how it 
could be changed and improved to best suit the needs and abilities of pre-frail stroke survivors 
from the perspective of both stroke survivors themselves and their informal carers.  Descriptive 
quantitative data will also be collected from stroke survivors (not the informal carers) using the 
Theoretical Framework of Acceptability Questionnaire (Sekhon et al., 2022) to quantify 
acceptability, helping to highlight areas of strength or weakness in intervention acceptability. 
Data relating to recruitment success and group retention rates will also be collected and 
descriptively reported in order to determine the feasibility of recruiting participants to research 
using this intervention.  
The philosophical stance, or paradigm, taken in this piece of research is that of 
pragmatism, where reality is socially constructed and, as such, it is unlikely that reality can ever 
be wholly understood. However, knowledge can be generated by understanding what practically 
works best (or doesn’t work) within the specific context (Kaushik & Walsh, 2019). Due to its 
balanced position and practical approach, pragmatism is well suited to feasibility research 
(Johnson & Onwuegbuzie, 2004).  

Participants 
Participants for this study will be ten dyads of adult pre-frail stroke survivors and their 
informal carers.  The aim will be to recruit ten participants. The CST manual (Spector et al., 
2020) suggested that a suitable group size for the intervention is between five and eight, 
however recruiting ten will allow for the possibility of group drop-out. This number is also 
thought to provide enough data to make meaningful conclusions about the acceptability of the 
intervention whilst also being a manageable number for a group intervention with two co-
facilitators, thereby meeting the criteria suggested by Thabane et al. (2010).  A sample size of 
10 dyads is also supported by existing guidelines for qualitative analysis (Braun & Clarke, 
2013). It is suggested that ten participants, divided into two focus groups of equal numbers, in 
line with previous research (Braun & Clarke, 2013; Guest et al., 2017) would be acceptable for 
this analysis.  
 It is planned to begin to recruit dyads when the stroke survivors are under the care of 
Addenbrooke’s Hospital stroke services (Acute Stroke Unit and Lewin Rehabilitation Unit), 
participants will either be due to be discharged home or have recently been discharged home. 
Potential participant dyads will be identified by Addenbrooke’s stroke services clinicians, who 
will have been fully briefed via a letter about the study and the below inclusion and exclusion 
criteria. Clinicians will bring the identified patients to the attention of Dr Nicholas Evans or Dr 
Huw Green, who work within the stroke services as an Honorary Consultant in Stroke Medicine 
and Principal Clinical Psychologist in Stroke, respectively. As Dr Evans and Dr Green are 
members of the clinical team, they will access the stroke survivors’ medical records to confirm 
eligibility for the research before asking the identifying clinician to provide a poster about the 
research and seek consent from the patient to be contacted about research by completing a 
‘consent to contact’ form which will be uploaded onto the patients’ records and uploaded to a 
secure online folder (password-protected and located on the UEA OneDrive for Business). The 

research poster will also give potential participants the option to register their interest in the 
research via an online Microsoft Forms form or to email the lead researchers directly, meaning a 
completed ‘consent to contact’ form would not be required.  
If a dyad registers their interest in the research (using at least one of the above-
mentioned methods), a member of the research team (Sophie Livsey, Max Bramley, Dr 
Nicholas Evans or Dr Huw Green) will contact the dyad by their preferred means (on the unit, or 
by phone or email) to discuss the research study and provide the participant information sheets. 
After a minimum of 24 hours, a member of the research team will visit them (either at home or 
on the unit, depending on circumstance), answer any questions they may have about the study 
and, if they agree to take part, complete the informed consent process. 
 
Stroke Survivor Specific Inclusion and Exclusion Criteria  
Stroke survivor participants will meet clinical criteria for pre-frailty and emerging frailty 
according to the Clinical Frailty Scale (CFS, Appendix C; Rockwood et al., 2005) where pre-
frailty equates to a score of 3-4, but to include emerging frailty, CFS scores will fall between 3-5 
(Flaatten et al., 2017; Muessig et al., 2018). CFS ratings are collected routinely in the 
Addenbrooke’s Hospital stroke services and clinicians will identify potential participants based 
on these. There may also be potential to corroborate the CFS ratings by calculating a Frailty 
Index (FI), using information from patients' medical records. FI gives a score between 0 and 1 
and is calculated based on the presence of diagnostic variables from a given list and pre-frailty 
is thought to lie between 0.08 and 0.24 (Song et al., 2010).  
Participants must also demonstrate impairment in at least one domain of the Oxford 
Cognitive Screen (OCS; Demeyere et al., 2015) which is also conducted routinely by clinicians 
Commented [MR1]: changes made to CFS as 
discussed 27/03/2024 

working in Addenbrookes’ Hospital stroke services. Again, these scores will be reviewed by 
clinicians to help them determine potential eligibility. 
Participants will be within 6 months post-stroke. This is the criteria likely to be used in 
the later feasibility trial of the full multicomponent intervention. Due to reports of worsening frailty 
post-stroke, it’s important to recruit participants early, before they transition from pre-frail to frail 
when it might become harder to reverse frailty (Gill et al., 2006). Additionally, six months is the 
window in which it is thought most recovery can happen, although this idea has been critiqued 
(Teasell et al., 2012). 
Participants will be required to have an informal carer (a family member or friend who is 
not paid for the care they provide) to support the stroke survivor with participation and take part 
in the informal carer arm of the research. Please refer to the below informal carer inclusion and 
exclusion criteria.  
In order to be eligible, the potential participants must be due to be discharged home 
before the commencement of the pilot intervention. They cannot be discharged to a care home 
or other facility.  This follows previous research into multi-component interventions for frailty, 
where the participants are community-dwelling (e.g.  Ng et al., 2015) 
Those with an additional diagnosis of dementia will not be eligible to participate as 
dementia was the original target population for CST and may confound the study findings. 
Inclusion and Exclusion Criteria for Both Stroke Survivor and Informal Carer 
Participants must be over 18 years of age. Although there is a correlation between frailty 
and age, we do not want to exclude those who may be younger and also experiencing pre-frailty 
as their experience may be different and valuable to capture. In terms of informal carers, we do 
not feel it would be ethical to involve young carers in this study due to the commitment involved.  

Individuals with significant cognitive or language difficulties (assessed via clinical 
judgement as likely to impact their ability to actively participate in the focus group) and those 
assessed as lacking the capacity to consent to participation will be excluded. These scores will 
not be used to determine eligibility. 
Participants need to be able to access and use Microsoft Teams on a computer or tablet 
(with support) to attend the focus group. Therefore, those unable to do so will not be eligible to 
take part. 
Measures and Data Collection 
Qualitative Data 
Qualitative data will be collected via semi-structured focus groups. Focus groups draw on the 
interaction of participants to generate data often rich with language participants use in life 
outside of research as discussion occurs between participants, merely facilitated by the 
researcher (Kitzinger, 1994; Wilkinson, 1998). Four focus groups will be held; two of these 
groups will involve five informal carers each and two will involve five stroke survivors each. This 
group size fits the recommended size for groups where there may be more information for each 
participant to share (Krueger, 1988, as cited in Wong, 2008).  
Focus groups will be held via Microsoft Teams and will be recorded using the in-built 
record function so that they can be later transcribed ready for analysis. The groups will take 
place in the weeks soon after the last session of the intervention and will each last between one 
and two hours  
The topic guides used for the informal carer and stroke survivor focus groups will each 
be based on the Theoretical Framework of Acceptability (TFA; Sekhon et al., 2017) and data will 
be analysed through framework analysis (FA) so that data can be mapped onto this pre-existing 
theoretical framework. The use of the TFA to inform a topic guide and to structure FA has been 

shown an effective way of collecting and analysing qualitative data on pilot interventions for pre-
frailty (Western et al., 2023). A draft version of the topic guide for stroke survivor participants 
can be found in Appendix D. Development of the topic guides is ongoing, as discussions with 
PPI volunteers continue.  
Quantitative Data  
Stroke survivor’s perspectives of the acceptability of the intervention will also be 
assessed using a questionnaire measure adapted from the ‘generic TFA questionnaire’ (Sekhon 
et al., 2022; Appendix E), which was produced by the team who developed the TFA itself 
(Sekhon et al., 2017). From this, descriptive data (mean ratings for each acceptability construct) 
can be collected.  This scale has been used in several other studies investigating the 
acceptability of a new intervention, including with populations of pre-frail older adult memory 
clinic patients (Western et al., 2023). This questionnaire will be conducted via a pseudonymised 
online form, using Microsoft Forms, and distributed by email after the last session of the sCST 
intervention is completed and will need to be completed prior to the focus group discussions. 
Participants may be prompted by a further email to complete the form if response numbers are 
lower than expected in the lead-up to the focus groups.  
Where possible, researchers will also keep an anonymous record of the number of 
participants identified as being eligible for the research so that a recruitment success 
percentage can be calculated. A percentage will also be calculated for stroke survivor 
participant retention rates; in other words, how many participants remain in the intervention for 
the full eight sessions. This will help to assess the feasibility of recruiting participants to take 
part in this research that uses this sCST intervention.   
Procedure  

Participants for this study will be identified and recruited by clinicians within 
Addenbrooke’s stroke unit, as described in the Participants section, above. Once informed 
consent has been obtained, all participants will be asked to fill in a demographics form asking a 
range of questions relating to personal information (e.g. date of birth, ethnicity, education level) 
which will be reported in the write-up of the study to contextualise the participant sample, and 
contact information (email address, telephone number, address).  After informed consent is 
obtained, a letter will be sent to the GP of the stroke survivor participant to let them know of their 
involvement in the research and their participation in a pilot intervention. The GP details will be 
collected from the stroke survivor’s medical records along with their Clinical Frailty Scale and 
Oxford Cognitive Screening scores.  
The sCST intervention will run as a weekly group at a location, yet to be specifically 
confirmed, on the Cambridge Biomedical Campus for four weeks. Each week, two of eight 45-
minute sCST sessions will be delivered, separated by a 15-30 minute comfort break. After each 
weekly session, informal carers will be provided with an information sheet about the sessions 
provided, their suggested benefits, and optional activities to complete with the stroke survivor at 
home.  
After the final session, stroke survivor participants will be emailed a link to the 
acceptability measure, via Microsoft Forms, and provided with a date by which this needs to be 
completed. At the same time, both members of each dyad will be emailed a link to join a focus 
group. The focus group will take place via Microsoft Teams. This will last up to two hours, with a 
comfort break if required. Stroke survivor participants will be randomly allocated to one of the 
two focus groups, and the same will apply for the informal carer participants.  
Following the focus groups, the participant dyads will be sent a follow-up pack that will 
include a debriefing letter, including contact details if they wish to discuss their involvement in 

the study or any concerns they may have. This pack will also provide a token of gratitude for 
both the stroke survivor and the carer; this will be a shopping voucher with a value of £10, each. 
The total time of involvement will be approximately 11-11.5 hours, not including the time 
required for travel to and from Addenbrooke’s Hospital. If dyads are required to park their car 
whilst the stroke survivor attends the four weekly sCST intervention sessions, they will be able 
to claim the discounted parking rate of £4.80 per day, which they can then request to have 
reimbursed by the researchers. 
If a stroke survivor participant reports that they no longer wish to attend the sCST 
intervention, they will be given the option to drop out of the intervention but remain a participant 
in the study so that they can attend a focus group and provide their feedback or withdraw from 
the study altogether. In either case, the informal carer is able to remain in the study and attend 
the focus group if they are still keen to do so.   
If the carer withdraws from the study, the stroke survivor can remain a participant, 
providing the carer is still able to support the stroke survivor to attend the interventions sessions 
and access the focus group. If they are not able to do this, then both members of the dyad will 
be withdrawn.  
These are not necessarily the only options available when one member of the dyad 
wished to withdraw, there may be other case-specific factors to take into consideration. 
In all cases, withdrawal from the study will not be possible after the focus groups have 
taken place.  
It is predicted that the last participant contact will take place on 19th July 2024, however 
this is subject to chang; if there are unexpected delays then the last contact may take place up 
to a few weeks after this date. If participants have opted to receive a summary of the results, 
their contact information will be stored until this has been actioned, no later than one year later. 
Commented [SL2]: Assessment - Further information 
required. 
Please include a definition of the end of study in the 
protocol 

Ethical Issues 
This study will require full NHS ethical approval, due to recruitment and other research 
activities taking place in an NHS setting. Approval will also be sought from the University of East 
Anglia Research Sponsor team and the Research and Development department of Cambridge 
University Hospitals NHS Trust (CUHT) due to recruitment and other research activities taking 
place on the Addenbrooke’s Hospital site. Approval for the lead researchers to work on CUHT 
premises and to recruit from the service will be sought by completing the NHS proforma to 
obtain a letter of access as stipulated by CUHT Research Governance. 
Authors of the original CST programme have consented to the use and adaptation of the 
materials and permission has been sought from Hawker Publications to reproduce any materials 
as part of the final write-up, however, we are yet to receive a response. This will be followed up 
if necessary.  
The NHS HRA guidelines have informed the participant information sheets and consent 
form. 
Ethical issues around informed consent, confidentiality, distress/harm, burden, 
debriefing, reimbursement, coercion, research bias and debriefing have been considered. 
Informed Consent 
Participants will be provided with a PIS and will be required to provide informed consent 
before study enrolment. Stroke services staff will be asked to identify individuals with the 
capacity to consent to participate in research, though capacity will also be assessed before 
completion of the consent form. Consent will be sought in person (either on the unit or at home) 
to facilitate discussion which is thought to be crucial to the decision process (Health Research 
Authority, 2019).  If there are any doubts about capacity, the informed consent process will stop, 
and the individual will be informed sensitively that they do not meet the eligibility criteria for the 

study.  Capacity to consent will be monitored during all contact with participants, and any 
concerns that arise will be discussed with the clinical team.  
As part of the informed consent process, participants will be informed of their right to 
withdraw participation from the study. Withdrawal must be done prior to the focus group. 
Participants can only be recruited in dyads, if one potential participant from the dyad does not 
wish to enrol then the other member will not be eligible, this will be explained sensitively by the 
research team, explaining the rationale and aims of the study. 
Anonymity and Confidentiality 
Participants will be required to sign to confirm they understand and agree to the 
confidentiality arrangements as part of the consent form.  
All data will be stored securely on a password-protected computer on One Drive for 
Business, a secure central repository linked to the University of East Anglia (UEA) in line with 
the UEA Data Management Policy (2022). Data will be deleted when the project is submitted. 
Participants will be informed how their data will be stored before consenting to the study in 
accordance with The Data Protection Act (2018).  
Sensitive participant data will be anonymized, via the use of participant ID codes, and 
identifiable participant data will be stored on a separate secure file to ensure these two sets of 
information are kept separate and unconnected. Participant-identifying data will be redacted 
from transcripts of the focus groups, and names replaced with participant identification codes, 
However, participants will be required to share some personal information (e.g. their first 
names) with other participants to aid effective communication and rapport within the intervention 
sessions and the focus group. The intervention sessions may also require the sharing of other 
personal information, such as biographical anecdotes, although participants will have a choice 
in what they do or do not choose to share.  

Efforts will be made to ensure as much confidentiality as possible (e.g., by not using 
participant’s surnames within groups and reiterating the importance of confidentiality at the 
beginning of each group session).  
As per existing NHS confidentiality policy, confidentiality can be broken if it is felt the 
individual is likely to come to immediate significant harm or cause significant harm based on 
disclosures to researchers. In this case, it will be important that concerns are raised with the 
relevant parties; in the case of psychological distress or concerning physical health 
presentations, the stroke services team will be informed and follow-up appointments with 
members of the clinical team can be arranged if needed.  Participants will be made aware of this 
via the PIS and asked to consent to information being shared with their clinical team if/when 
necessary.  
Harm, Burden and Benefits  
Researchers will be sensitive to participant distress during focus groups and between 
sCST intervention group sessions. Distress is relevant to intervention feasibility and 
acceptability, however, the right to withdraw is preserved.  
It is possible that taking part in this research may cause distress, harm or burden to 
participants. Anticipated risks, such as the burden of time commitment, fatigue, or clashes with 
fellow participants, will be outlined in the PIS. Risk assessments of the intervention delivery 
space will take place and Dr Evans will be present during sessions, as a member of 
Addenbrooke’s Hospital staff and as a medic, should any participants require medical 
assistance during the group. Stroke survivor participants will also have the opportunity to 
receive ad-hoc follow-up appointments with clinicians within the stroke services if this is deemed 
necessary throughout the period of participation in this research.  

If stroke survivor participants wish to withdraw from the group for any reason, there 
remains the opportunity to remain enrolled in the study in order to attend the focus group to 
provide feedback, however, this will not be a requirement, as participants must have the right to 
withdraw without question. 
All participants will be encouraged to speak up should they experience any harm or 
distress as a result of the study, at which point effort will be made to resolve or reduce issues 
(e.g., difficult group dynamics may benefit from alternative seating arrangements). Options 
around full withdrawal from the study or withdrawal from the intervention phase alone will be 
discussed with them. 
 No deception will be used in the current study, but attention will be given to managing 
expectations around the intervention and its effect on frailty. Although participants may 
experience some benefits from participating in this study (such as improvements to their 
psychological well-being or day-to-day functioning), benefits are not guaranteed. This has been 
clearly stated in the information sheets. 
Reimbursement and Coercion 
If participants withdraw from the study, there remains the opportunity to attend the focus 
group to provide feedback, however, this will not be a requirement, as participants must have 
the right to withdraw without question.  
Study participation will require participants to donate approximately 10-11 hours of their 
time, not including travel time. There will be a financial cost of travelling to and from 
Addenbrooke’s for the four, weekly intervention visits but participants will be able to park at 
Addenbrooke’s Hospital at the discounted rate of £4.80 per day which can be reimbursed. 
Participants will be given a token of appreciation after their participation is complete via a £10 
shopping voucher.  

Debrief and Communicating Results  
A debriefing letter will be sent to participating dyads, thanking them for their involvement 
in this study and reiterating the invitation to contact the researchers about any questions or 
concerns that may arise after participation is complete, or if they wish to withdraw their data 
from the study. This letter will also include information about how the results of the study may be 
communicated to them. 
Analysis 
The focus group will be transcribed, supported by the transcription function within 
Microsoft Teams and reviewed by the researcher for accuracy, making amendments where 
required.  
Qualitative focus group data will be analysed using framework Analysis (FA) (Ritchie & 
Spencer, 1994), with the Theoretical Framework of Acceptability (TFA) (Sekhon et al., 2017) as 
the framework guiding analysis. FA seeks to understand an event through five stages of 
analysis (Green & Thorogood, 2018) and is an increasingly popular approach in medical and 
health research (Gale et al., 2013). It is described as a systematic way to analyse data in a way 
that makes it clear how the findings of the research were obtained. This is useful to implement 
recommendations based on findings to guide further studies (Kiernan & Hill, 2018). This method 
of analysis will help to identify which theoretical constructs of acceptability are strong for this 
intervention and which could benefit from further attention and improvement, therefore guiding 
further development of the intervention.  
FA will be applied as described by Green and Thorogood (2018) but using the TFA 
deductively. Audio data will be transcribed and read until the researcher is familiarised with the 
broad themes of the data. A coding key will be established using the TFA. The key will be 
applied to the data systematically, described as indexing. Indexed data will be charted, by 

tabularising and rearranging according to thematic content in summary form. The final stage will 
involve mapping and interpretation to explore the relationships between the concepts 
connecting the TFA with the charted data; an example of this is found in Western et al.’s (2023) 
study on an intervention for pre-frail individuals. Some ‘open coding’ will also be carried out to 
ensure no important data are missed from the analysis (Gale et al., 2013).  
In terms of quantitative data obtained from the stroke survivor participants, the degree of 
acceptability will be calculated by calculating the mean ratings for responses to each of the 
seven TFA constructs on the acceptability questionnaire measure, the mean rating for the 
general acceptability item (item 10), and the total mean rating of all items. For two of the seven 
constructs, Sekhon et al., (2022) suggest a choice of two questions, whereas all other 
constructs have only one question. For these two constructs, it has been decided that both of 
the suggested questions would be included in the acceptability questionnaire used in this study, 
as it was felt that the questions were different enough from one another that they would both be 
helpful to ask. For example, the generic TFA questionnaire suggests either ‘How fair is 
[Intervention] for [people/ participants/ recipients] with [condition]?’ or ‘There are moral or ethical 
consequences [behaviour i.e. to engage with] [intervention]’ as questions to measure the 
construct of ethicality.  
To improve the sensitivity to context (Yardley, 2000) the researchers will keep reflective 
diaries of the data analysis process to ensure that consideration is taken of their role in the 
research and the analysis and to increase awareness of how this, as well as their existing 
knowledge, experiences and assumptions, may influence the analysis.  
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Appendix A  
Theoretical Framework of Acceptability 
Theoretical 
Framework of 
acceptability  ( TFA)  
Definition  
Ethicality  
The extent to which the intervention has good fit with an individual’s 
value system  
 
Affective 
 Attitude  
Anticipated Affective Attitude:  How an individual feels about the 
intervention, prior to taking part  
 
Experienced Affective Attitude: How an individual feels about the 
intervention, after taking part 
Burden  
Anticipated burden: The perceived amount of effort that is required to 
participate in the intervention 
 
Experienced burden: the amount of effort that was required to 
participate in the intervention 
Opportunity 
 Costs  
Anticipated opportunity cost : The extent to which benefits, profits, or 
values must be given up to engage in the intervention  
 
Experienced opportunity cost:  the benefits, profits or values that were 
given up to engage in the intervention 
Perceived  
effectiveness  
Anticipated effectiveness: the extent to which the intervention is 
perceived to be likely to achieve its purpose 
 
Experienced effectiveness: the extent to which the intervention is 
perceived to have achieved its intended purpose 
Self-efficacy  
The participant's confidence that they can perform the behaviour(s) 
required to participate in the intervention 
Intervention 
Coherence 
The extent to which the participant understands the intervention and 
how it works 
 
Note. From “Acceptability of healthcare interventions: An overview of reviews and development 
of a theoretical framework” [Supplementary File 6] by M, Sekhon, M. Cartwright and J. J. 
Francis. Sekhon, 2017, BMC Health Services Research, 17(1):88, 
(https://doi.org/10.1186/s12913-017-2031-8). CC BY 4.0 
(http://creativecommons.org/licenses/by/4.0/) 

Appendix B 
Example draft session plan for sCST 
 
Topic - Current Affairs 
• 
Introduction 
o Welcome all to the group by name, name labels.  
o Group rules – confidentiality and respect. Sometimes we might slip up and make 
mistakes but that’s ok, it is important to discuss that privately.  
o Come up with group name 
o Come up with group song – YouTube backing track 
o Orientation – what is the date? Errorless learning? On this day discussion 
o One key headline/news event discussion 
• 
Main activity  
o What possession do you treasure the most? 
o Boomers, Gen x, Millenials, Gen z 
o Fashion 
o Where would you to visit? 
o Social media? Case study use of twitter for good?  
• 
Closing 
o Psycho-ed about summaries as a memory strategy/ rehearsal of information 
o Bullet points – what have you learned during the session or what surprised you? 
• 
Take-home activity 
o Practise the summarising technique, find a news story you find interesting or 
enjoyable, discuss it with your carer and practise together summarising key 
points 
 
 
 

Appendix C 
Clinical Frailty Scale 
 
Note. From “A global clinical measure of fitness and frailty in elderly people”  by K. Rockwood,  
X. Song, C. MacKnight, H. Bergman, D. B. Hogan, I. McDowell, A. Mitnitski, 2005, CMAJ, 
173(5), p. 490 (https://doi.org/10.1503/cmaj.050051) Copyright 2005 by CMA Media Inc. or its 
licensors 
 
 
 
 

Appendix D 
Example Focus Group Topic Guide (Draft) 
Please note, this is a draft topic guide for the stroke survivor participants. Development of topic 
guides is ongoing, with input from PPI volunteers. 
 
Research goals of the focus group: 
 
• 
How would pre-frail stroke survivors feel about adapted CST as an intervention? 
• 
What do pre-frail stroke survivors think about the amount of effort that 
would be required to participate in an adapted CST intervention?  
• 
What, if any, ethical consequences did pre-frail stroke survivors feel there 
might be to engaging in an adapted CST intervention? 
• 
What did pre-frail stroke survivors see as the potential costs of 
engaging in an adapted CST intervention? 
• 
How effective do pre-frail stroke survivors think an adapted CST 
intervention could be? 
• 
How confident do pre-frail stroke survivors feel about engaging in an 
adapted CST intervention? 
• 
How well do pre-frail survivors understand the adapted CST 
intervention and how it works? 
 
Introduction – approximately 10 minutes: 
• 
Welcome, introduction of the focus group 
 
• 
Instructions regarding the focus group: “I am interested in how you felt about the 
sample sessions of adapted CST that you tried and how you would feel about 
the idea of attending a full programme of perhaps 14 weekly sessions” 
 
• 
Ground rules: “I will ask a number of questions, and I would like to hear from as 
many of you as possible for each question. It would be helpful for me if only one 
person speaks at a time so please wait until one person is finished before the 

next person speaks. If you are able to use the ‘hands up’ button, it would be 
helpful if you can press this when you have something to say and I will then 
invite you to speak. Please be respectful of one another, every opinion is valid 
and helpful. Please be honest because your comments will help us to know what 
works well and what we might need to change in order to make it better. We will 
take a break half way through so you can go to the loo or get a drink, but if you 
need to step out at any point before or after this break please go ahead – just 
turn off you camera and microphone and turn them on again when you come 
back” 
 
Main questions – approximately 90 minutes: 
• 
“To start us off, could you please each tell me one word that you feel 
summarises what you thought of the eight sample sessions you had?” 
• 
“Thank you, let’s talk a bit more about how you felt about the sessions you tried” 
 
o What did you like about the sessions? 
o What did you not like? 
o What did you find difficult about the sessions or the process of attending 
the sessions? 
o Did you find the activities enjoyable? 
o What did you think was the purpose of the activities? And do you think 
that the activities helped you in any way? 
o Did you gain anything from coming to these sessions? 
o Were there any negatives to coming to these sessions? 
o Did the sessions feel relevant to the difficulties you experience after your 
stroke?  
o Thinking back to before the sessions, how did you feel about attending 
the first one?  
 
~Comfort break – 10 minutes~ 
 
• 
Now I would like to ask you a few questions about how you would feel about 

attending a full course of sessions like these, perhaps 14 sessions once a 
week? 
o Do you think there would be any benefits to attending a full course of this 
intervention? If so what do you think the benefits could be? 
o (if not mentioned – do you think this intervention would have any effect 
on your ability to complete your usual day-to-day tasks/your mood/your 
memory and thinking skills?) 
o Do you think a full course of this intervention would help you to achieve 
your goals? 
o What would be the barriers or challenges involved in attending a full 
course of this intervention? 
 
• 
Finally, I want to ask you about any changes or improvements that might be 
needed 
o Is there anything you would change about the general format of the 
sessions? (e.g. length, frequency, session structure) 
o Is there anything you would change to the content/themes of the 
sessions? 
o Is there anything missing that you feel would be helpful? 
o Is there anything you would change about the types of activities included 
in the sessions? 
 
Conclusion – approximately 10 minutes: 
• 
Sum up what has been discussed, mention the positive aspects, compliment and thank 
the participants 
o “Is there anything important to you we haven't mentioned?” 
o “If you want to follow any issues you have talked about, you can contact 
myself or my supervisor via email” 
o “We will shortly send you a debrief letter which will explain your options 
about withdrawing from the study, raising concerns, and how you can be 
updated on the results of the study. You will also receive a £10 shopping 
voucher.”  
 
 

Appendix E 
Generic TFA-Q 
TFA construct  
Generic TFA questionnaire items 
Notes   
Affective 
attitude  
 
How an 
individual feels 
about the 
intervention  
 
 
 
 
 
 
 
 
 
Did you like or dislike  [intervention]? 
Strongly 
dislike 
Dislike 
No 
opinion 
Like 
Strongl
y like 
1 
2 
3 
4 
5 
 
OR  
 
How comfortable did you feel  [behaviour i.e. to engage 
with] [intervention]? 
Very 
uncomfort
able 
Uncomfort
able 
No 
opinio
n 
Comfor
table 
Very 
comf
ortabl
e  
1 
2 
3 
4 
5 
 
Depending on the context 
of the intervention and 
behaviours associated 
with the intervention one 
of the two items should be 
used.  
 
In some contexts, ‘like or 
dislike’ will not be 
appropriate, thus 
‘comfortable’ may be more 
appropriate.  
 
 
 
Burden 
 
The amount of 
effort required 
to participate 
in the 
intervention  
 
How much effort did it take [behaviour i.e. to engage with] 
[intervention]? 
No effort 
at all 
A little 
effort 
No 
opinion 
A lot of 
effort   
Huge 
effort  
1 
2 
3 
4 
5 
 
 
Ethicality  
 
The extent to 
which the 
intervention 
has good fit 
with an 
individual’s 
value system  
 
 
 
 
 
How fair is [Intervention] for [people/ participants/ 
recipients] with [condition]?  
Very 
unfair  
Unfair 
No 
opinion 
Fair 
Very 
fair  
1 
2 
3 
4 
5 
 
OR 
There are moral or ethical consequences [behaviour i.e. to 
engage with] [intervention] 
Strongly 
disagree  
Disagre
e 
No 
opinion 
Agree 
Strongl
y agree  
1 
2 
3 
4 
5 
 
Depending on the context 
of the intervention and 
behaviours associated 
with the intervention  one 
of the two items should be 
used.  
 
 
 
 
 
 
 
Perceived 
effectiveness 
 
The extent to 
which the 
intervention is 
The [intervention] has improved [behaviour/ condition/ 
clinical outcome]: 
Strongly 
disagree  
Disagre
e 
No 
opinion 
Agree 
Strongl
y agree  
1 
2 
3 
4 
5 
 
This item should relate to 
the primary outcome 
variable in the main 
trial/study, thus the item 
will be intervention 

perceived to 
have achieved 
its objective   
specific. E.g. quality of life, 
walking ability 
 
Intervention 
coherence  
 
The extent to 
which the 
participant 
understands 
how the 
intervention 
works  
 
 
It is clear to me how [intervention] will help [manage/ 
improve] my [behaviour/ condition/clinical outcome]   
Strongly 
disagree  
Disagre
e 
No 
opinion 
Agree 
Strongl
y agree  
1 
2 
3 
4 
5 
*Please tell us more about your views 
 
*In some studies, 
researchers may want to 
include an option for 
participants to provide 
more information for this 
item. 
  
This will depend on the 
resources of the study for 
analysing qualitative data 
and whether having more 
information will be 
relevant.  
Self -efficacy  
A participant’s 
confidence 
that they can 
perform 
behaviour(s) 
required to 
participate in 
the 
intervention  
 
How confident did you feel about [behaviour i.e. engaging 
with] [intervention]? 
Very 
unconfid
ent  
Unconfi
dent 
No 
opinion 
Confide
nt 
Very 
confide
nt  
1 
2 
3 
4 
5 
 
 
Opportunity 
costs 
The benefits, 
profits or 
values that 
would have to 
be given up to 
engage with 
the 
intervention  
 
[Behaviour i.e. engaging in] [intervention] interfered with 
my other priorities 
Strongly 
disagree  
Disagre
e 
No 
opinion 
Agree 
Strongl
y agree  
1 
2 
3 
4 
5 
 
 
General 
acceptability  
 
How acceptable was the [intervention] to you?  
Complet
ely 
unaccept
able 
Unacce
ptable 
No 
opinion 
Accepta
ble 
Complet
ely 
accepta
ble 
1 
2 
3 
4 
5 
 
 
The general acceptability 
item has been included as 
in some instances, an 
overall acceptability item 
may be useful and to allow 
for researchers to explore 
which of  the 7 TFA 
constructs influences/ 
drives participants’ general 
acceptability judgment.  
 
 

 
 Note. From “Development of a theory-informed questionnaire to assess the acceptability of 
healthcare interventions”  by M, Sekhon, M. Cartwright and J. J. Francis. Sekhon, 2017, BMC 
Health Services Research, 22(279), supplementary file 7(https://doi.org/10.1186/s12913-022-
07577-3). CC BY 4.0 http://creativecommons.org/licenses/by/4.0/)