Improving Primary Care After Stroke (IPCAS): A Randomised Controlled Trial to Evaluate a New Model of Care for Stroke Survivors Living in the Community
Phase: NA
Conditions: Stroke
Sponsor: University of Cambridge

 
 
 
 
 
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Protocol 
 
Improving Primary Care After Stroke (IPCAS): A 
randomised controlled trial to evaluate a new model of care 
for stroke survivors living in the community 
 
 
Version 1.1   28th February 2018 
 
 
 

 
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Contents 
 
 
 
 
 
 
 
                            Page 
1. Trial Information…………………………………………………………………….. 
4 
1.1. Trial Investigators………………………………………………………… 
4 
1.2. Funding……………………………………………………………………… 4 
1.3. Reference Numbers………………………………………………………... 5 
1.4. Key Contacts & Trial Team……………………………………………….. 5 
2. Definitions…………………………………………………………………………….. 6 
3. Summary……………………………………………………………………………... 6 
4. Background and Rationale………………………………………………………….. 7 
5. Aims & Objectives……………………………………………………………………. 8 
6. Methods……………………………………………………………………………….. 8 
6.1. Design………………………………………………………………………. 8 
6.2. Trial Population…………………………………………………………….. 8 
6.2.1. Patient Inclusion Criteria………………………………………... 8 
6.2.2. Patient Exclusion Criteria……………………………………….. 8 
6.3. Recruitment………………………………………………………………… 8 
6.3.1. GP Practices……………………………………………………… 8 
6.3.2. Stroke Survivors…………………………………………………. 9 
6.4. Randomisation……………………………………………………………… 9 
7. Interventions…………………………………………………………………………. 9 
7.1. Intervention Arm…………………………………………………………… 9 
7.1.1. Structured Review of Patient Needs…………………………. 
10 
7.1.2. Self-management Programme (MLAS)……………………….. 10 
7.1.3. Direct Point of Contact…………………………………………. 11 
7.1.4. Optimised Communication……………………………………… 11 
7.1.5. Service Mapping……………………………………………….. 
11 
7.1.6. Training for General Practice Staff…………………………… 
11 
7.2. Control Arm………………………………………………………………… 12 
8. Outcomes……………………………………………………………………………. 12 
8.1. Primary Outcome………………………………………………………… 
12 
8.2. Secondary Outcomes……………………………………………………. 
12 
9. Data Collection……………………………………………………………………… 
12 
9.1. Baseline Data Collection………………………………………………… 
12 
9.2. Follow-up Data Collection………………………………………………. 
12 
10. Statistical Methods and Analysis……………………………………………….. 
13 
10.1. Sample Size……………………………………………………………. 
13 
10.2. Analysis of Primary Outcomes……………………………………….. 
13 
10.3. Economic Evaluation………………………………………………….. 
14 
11. Intervention Fidelity………………………………………………………………. 
15 
11.1. Structured Review of Patient Needs……………………………….. 
15 
11.2. Self-management Programme (MLAS)……………………………… 
15 
11.3. Direct Point of Contact………………………………………………… 
16 
11.4. Optimised Communication…………………………………………….. 
16 

 
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11.5. Service Mapping………………………………………………………. 
16 
12. Process evaluation……………………………………………………………….. 
16 
12.1. Patients ………………………………………………………………… 
17 
12.2. Health Care Professionals……………………………………………. 
17 
13. Flow Chart of Study………………………………………………………………. 
18 
14. Timescale………………………………………………………………………… 
19 
15. Trial Management……………………………………………………………… 
19 
15.1. Monitoring……………………………………………………………… 
19 
15.2. Data management…………………………………………………… 
19 
15.2.1. Data Transfer………………………………………………. 
19 
15.2.2. Data Storage………………………………………………. 
20 
15.2.3. Data Protection & Patient Confidentiality……………….. 
20 
16. Withdrawals……………………………………………………………………. 
20 
17. Serious Adverse Events (SAEs)…………………………………………….. 
21 
18. Ethical considerations………………………………………………………… 
21 
18.1. Participant Recruitment……………………………………………. 
21 
18.2. Inclusion & Exclusion Criteria……………………………………… 
21 
18.3. Utilisation of the Model…………………………………………….. 
22 
18.4. Questionnaires……………………………………………………… 
22 
18.5. Consent……………………………………………………………… 
22 
19. Patient and Public Involvement (PPI) ……………………………………… 
22 
20. Approvals……………………………………………………………………… 
23 
21. Dissemination……………………………………………………………………. 
23 
22. References………………………………………………………………………. 
23 
 
Appendix A. Checklist of post-stroke needs……………………………………… 
25 
 
Appendix B. Anticipated Patient Recruitment Flowchart …………………………… 27 
 
Appendix C. Gantt chart……………………………………………………………. 
28 
 
 

 
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1. Trial Information 
1.1. Trial Investigators 
 
Sponsor: NHS Cambridgeshire and Peterborough CCG & University of Cambridge 
 
Chief Investigator:  
 
Prof. Jonathan Mant, Professor of Primary Care Research 
Primary Care Unit,  
Strangeways Research Laboratory 
Public Health and Primary Care 
University of Cambridge 
Cambridge, CB1 8RN.  
Tel: 01223330325 
Email: jm677@medschl.cam.ac.uk  
 
Principal Investigators: 
 
Cambridge:  
 
Prof. Jonathan Mant, Professor of Primary Care Research 
Primary Care Unit 
Strangeways Research Laboratory  
Public Health and Primary Care 
University of Cambridge 
Cambridge, CB1 8RN.  
Tel: 01223330325 
Email: jm677@medschl.cam.ac.uk  
 
Leicester:  
 
Dr Marian Carey / Yvonne Doherty 
Structure Education Research Portfolio 
Leicester Diabetes Centre – Air Wing 
University Hospitals of Leicester NHS Trust 
Gwendolen Road 
Leicester 
LE5 4PW 
Tel: 0116 258 4104 
Email: marian.carey@uhl-tr.nhs.uk  /  Yvonne.Doherty@uhl-tr.nhs.uk 
 
1.2. Funding 
This study is funded by the National Institute for Health Research’s Programme Grant 
for Applied Research titled ‘Developing primary care services for stroke survivors’ 
reference PTC-RP-PG-0213-20001. The chief investigator for the study is Prof. 
Jonathan Mant. 
 

 
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1.3. Reference Numbers  
 
IRAS: 233891 
 
 
1.4. Key contacts & Trial Team 
 
Cambridge: Dr Ricky Mullis 
 
Primary Care Unit 
Department of Public Health & Primary Care 
Strangeways Research Laboratory 
Worts’ Causeway 
Cambridge CB 1 8RN 
Tel: 01223 746719 
Email: r.mullis@medschl.cam.ac.uk 
 
 
 
Lizzie Kreit 
Study Co-ordinator 
Primary Care Unit, Cambridge 
Gill Charman 
Research Nurse 
Primary Care Unit, Cambridge 
Ryc Aquino 
Research Associate 
Primary Care Unit, Cambridge 
Lisa Lim 
Clinical Research Associate 
Primary Care Unit, Cambridge 
Sally Schreder 
Senior Research Associate 
Leicester Diabetes Centre 
Jayna Mistry 
Research Administrator 
Leicester Diabetes Centre 
Sarah Dawson 
Statistician 
MRC Biostatistics Unit, 
Cambridge 
Sue Jowett 
Health Economist 
University of Birmingham 
Viv Shaw 
Sponsor representative, R&D 
Manager  
NHS Cambridgeshire and 
Peterborough CCG 
Carolyn Read 
Sponsor representative 
University of Cambridge 
 
Steering Committee Membership 
Alastair Hay 
Professor of Primary Care 
Independent Chair: Voting 
Richard Stevens 
Medical Statistician 
Independent member: 
Voting 
Anne Forster 
Professor of Stroke 
Rehabilitation 
Independent member: 
Voting 
Marney Williams 
Lay Representative 
Independent member: 
Voting 
 
 

 
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2. Definitions 
 
CCG  
Clinical Commissioning Group 
PID 
Patient Identifiable Data 
CI 
Chief Investigator 
PIS 
Participant Information Sheet 
CRF 
Case Report Form 
PN 
Practice Nurse 
CRN 
Clinical Research Network 
PPI 
Patient & Public Involvement 
DMC 
Data Monitoring Committee 
QALY Quality-Adjusted Life Year 
DMP 
Data Management Plan  
QoF 
Quality Outcomes 
Framework 
DOB 
Date Of Birth 
R&D 
Research & Development 
GP 
General Practitioner 
RCT 
Randomised Controlled Trial 
HADS 
Hospital Anxiety and 
Depression Scale 
REC 
Research Ethics Committee 
HLQ 
Health Literacy Questionnaire 
SAE 
Serious Adverse Event 
HRA 
Health Research Authority 
SAP 
Statistical Analysis Plan 
ICECAP-A 
ICEpop CAPability measure for 
Adults 
SDHS Secure Data Hosting Service 
IPCAS 
Improving Primary Care After 
Stroke 
SIS 
Stroke Impact Scale 
MLAS 
My Life After Stroke 
TIA 
Transient Ischaemic Attack 
NIHR 
National Institute for Health 
Research 
TSC 
Trial Steering Committee 
OTC 
Over The Counter 
VLAN Firewall-protected Virtual 
Network 
PI 
Principal Investigator 
 
 
3. Summary 
 
Background: No formal primary care based model of care exists to support stroke 
survivors living in the community. A large variation in the range, quality and access 
to health services offered to stroke survivors between and within local primary care 
trusts suggests that many of the stroke survivors’ needs are not being met 
systematically. Therefore, to address the longer term needs we have developed a 
multi-factorial primary care model that seeks to enable greater engagement with 
stroke care and community services, to link effectively to specialist services, and to 
improve the lives of stroke survivors. 
 
Aim: To evaluate the clinical and cost effectiveness of a novel model of primary 
care for stroke survivors living in the community. 
 
Method: The IPCAS Trial is a two-arm cluster randomised controlled trial with general 
practices as the unit of randomisation. People on the stroke registers of GP practices 
in the East of England and the East Midlands will be invited to take part. We will aim 
to recruit 920 people with a history of stroke registered with 46 general practices. 
 
Analysis: The primary endpoint for the trial will be two sub-scales (emotion and 
handicap) of the Stroke Impact Scale (SIS v3.0) as co-primary outcomes at 12 months 
(adjusted for baseline). 
 
 

 
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4. Background and Rationale  
Survival after stroke is improving1,2 which means the longer-term care of people with 
stroke is going to play an increasingly important part of population based stroke care. 
Surveys demonstrate that the longer term needs of people with stroke and their 
carers are not being adequately addressed and that the majority of stroke survivors 
are dissatisfied with care after discharge from hospital.3,4 Two of the themes that run 
through these surveys are information needs (54% of respondents to the national 
Stroke Association survey reported wanting more information about stroke) and 
feelings of abandonment (42% of respondents to a Stroke Association survey 
reported feeling abandoned after leaving hospital).3 Other important themes include 
the emotional and social impact of stroke in addition to the many physical and 
cognitive sequelae of stroke including memory and concentration problems and 
fatigue.5   
 
The longer term problems faced by people with stroke and their carers have been 
highlighted in recent national reports such as the National Audit Office report 
‘Progress in Improving Stroke Care’ (2010)4 and the Department of Health 
Cardiovascular Disease Outcomes Strategy (2013).6 Approximately a third of stroke 
survivors are left with moderate to severe levels of disability at 6-months7. However, 
evidence for how best to support long-term stroke survivors is sparse8 especially 
beyond the first year after stroke9. Recent trials of greater specialist input for specific 
tasks such as speech and language therapy and occupational therapy have not 
demonstrated patient benefit2,8. 
 
Primary care could play an important role in the care of people with stroke, supporting 
access to community services, facilitating transfer back to specialist services when 
new problems emerge, education about stroke and provision of information, and 
continuing to manage those aspects of care that are traditionally managed in primary 
care (for example, risk factor management and psychological issues). However, the 
feeling of ‘abandonment’ of people with stroke after hospital discharge suggests this 
role is not always being fulfilled. Despite the recommended annual and structured 
health and social care review at six months and 1 year after the stroke10, in reality 
the majority of survivors do not have a structured review of needs beyond the first 
six weeks after discharge11. 
 
At present no formal primary care based model of care exists to support stroke 
survivors living in the community. There is a large variation in the range, quality and 
access to health services offered to stroke survivors between and within local 
primary care trusts12. To address the longer term needs we have developed a multi-
factorial primary care model that seeks to enable greater engagement with stroke 
care and community services, to link effectively to specialist services, and to improve 
the lives of stroke survivors. 
 
 
 
 
 
 

 
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5. Aims and Objectives 
5.1. Aim 
 
To evaluate the clinical and cost effectiveness of a novel model of primary care for 
stroke survivors living in the community. 
5.2. Objectives 
 
 To assess the clinical effectiveness of the new model of primary care for stroke 
survivors compared with standard care. The primary endpoint for the trial will be 
two sub-scales (emotion and handicap) of the Stroke Impact Scale (SIS v3.0)13 as 
co-primary outcomes at 12 months (adjusted for baseline). 
 To assess the long-term cost effectiveness of the new model of primary care for 
stroke survivors compared with standard care. 
 
 
6. Methods 
6.1. Design 
 
The IPCAS Trial is a two-arm cluster randomised controlled trial with general 
practices as the unit of randomisation. 
6.2. Trial Population  
 
People with a history of stroke on the registers of GP practices in the East of England 
and the East Midlands will be invited to take part. We will aim to recruit approximately 
920 people registered with 46 general practices. We will aim to evaluate the primary 
care model in contrasting catchment areas to reflect the different demographic 
characteristics of the general population. 
 
6.2.1. Inclusion Criteria 
 
 On practice register with a history of stroke 
 Able to provide written informed consent (with or without the help of a carer) 
 Age 18 years or older 
 
6.2.2. Exclusion Criteria 
  
 Patients on the palliative care register 
 Living in a nursing home 
 
6.3. Recruitment 
  
6.3.1. GP Practices 
 
Practices from the East of England and the East Midlands will be recruited in 
collaboration with the local Clinical Research Networks (CRNs), who will identify 
interested practices representing a range of urban/rural and different socio-economic 
status. We will target Practices with a stroke register comprising a minimum of 100 

 
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patients, to ensure that we reach our cluster target of 16 – 24 participants (see 
appendix B). 
 
6.3.2. Stroke Survivors 
 
Prior to randomisation at practice level (see below) electronic searches of the clinical 
computer system will generate a list of people on the register with a history of stroke 
who meet the inclusion criteria for the study. 
 
Potentially eligible participants will be sent an invitation to take part in the study. The 
invitation pack will contain an invite cover letter, the Patient Information Sheet (PIS), 
a consent form, a questionnaire containing the primary outcome, and instructions to 
return the consent form and questionnaire to the researchers in a pre-paid envelope 
(provided). If no response is received within 2 weeks from the initial mail-out, the 
Practice will send a reminder. If no response is received after a further 4 weeks, no 
further attempts at contact will be made. 
 
6.4. Randomisation 
 
Once all invitation letters and reminders have been sent out to patients in a practice, 
the GP practice will be randomised to intervention or control (ratio of 1:1). 
Randomisation will be performed using a stratified, random permuted block design. 
The stratification factor will be GP practice size, split into two levels: ≤10,500 and 
>10,500 patients. 
   
Randomisation will be performed centrally by the study team who will then inform 
each practice about their allocation.  
 
 
7. Interventions 
7.1. Intervention Arm 
 
The new model of care incorporates a multi-factorial package of service aimed at 
providing a review of patient needs, facilitated self-management of longer-term stroke 
care needs for survivors and their carers, optimised communication between patients 
and health and social care services, enhanced communication pathways between the 
different care services, and increased awareness of and access to national and local 
community and charity provided services. 
 
Specifically, the intervention will comprise the following components: 
 
1. Structured review of patient needs; 
2. A self-management programme (Managing Life After stroke, MLAS) for stroke 
survivors and their carers; 
3. A direct point of contact for stroke survivors and carers at the GP surgery; 
4. Enhanced Communication Pathways between General Practice staff and 
specialist services; 
5. Service mapping for stroke related needs; 
6. Training for General Practice staff. 
 
 

 
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7.1.1. Structured Review of Patient Needs 
 
A structured review will be performed by a Practice nurse or other appropriately 
trained member of the Practice team as part of the regular annual review 
recommended by current guidelines10. As part of the review, a 15-item checklist of 
post-stroke needs (see appendix A) will be sent by the Practice to the stroke survivor 
in advance. The survivor will be asked to tick all needs which apply to them, and to 
bring this with them to the appointment. At the review, the patient will be asked which 
of the ticked items is the most important and they would like to discuss most. 
Dependent upon time availability at the review, Practice staff will discuss and address 
up to three key needs identified by the survivor. A blank checklist will also be available 
in the Practice if needed. 
 
The review will last approximately 20-30 minutes, and include a routine physical 
check-up based on QoF recommendations (e.g. blood pressure, record of 
immunisation, and medication review) followed by the discussion of up to three post-
stroke needs as identified by the stroke survivor. The expected outcome of the review 
is an action plan agreed with the stroke survivor on how to address each of the needs 
identified in the review. A record of the checklist and the agreed action plan (e.g. 
referrals, agreed actions to be undertaken by the patient) will be kept in the patient 
records. 
 
The patient will be provided with an information leaflet about the MLAS programme, 
with instructions on how to get further information from the MLAS team and how to 
access the programme. 
 
7.1.2. Self-management Programme (MLAS)  
 
“My Life After Stroke” (MLAS) is a self-management programme for stroke survivors 
and their carers (where appropriate) consisting of an initial individual preparatory 
session, 4 weekly group-based sessions, and a final individual session 4 weeks after 
the last group session. Group sessions cover topics under the categories of stroke 
prevention, information, social needs and psychological issues. All sessions will be 
held at a suitable, accessible, local community facility. 
 
Individual appointments will last approximately 30-45 minutes. The introductory 
appointment aims to explore the stroke survivor’s needs to support their active 
engagement in the group sessions and introduce them to key components of the 
programme. The final follow-up appointment will aim to address any remaining 
signposting that is needed, discuss goals, achievements and plans following the 
programme.   
 
Group sessions will consist of stroke survivors and their carers (where relevant).  
Sessions will last approximately 2½ hours (including breaks). Participants will be 
given a handbook containing educational content and further information based on 
the session topics. Sessions will cover a variety of topics and include risk factors for 
stroke and prevention, psychological well-being, problem solving and goal setting. 
 
The programme will be run by two trained facilitators who may be health care 
professionals or lay people i.e. from the voluntary sector (e.g. Stroke Association 
workers) with an interest/experience of stroke. Facilitators will be trained before 
delivery of the programmes and supported by the research team. 

 
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7.1.3. Direct Point of Contact  
 
A direct point of contact will be provided for stroke survivors and their carers at the 
GP surgery. We operationalise the direct point of contact as: (1) signposting to further 
specialist or community services, and (2) providing advice for stroke specific issues, 
brief support over the phone, arranging follow-up appointments and, if appropriate, 
case management. A single or several Practice nurses or other appropriately trained 
members of the Practice team (depending on Practice and staff’s preference) will 
assume the role. Stroke survivors and carers will be able to call the Practice and 
indicate that they would like to talk to someone about their stroke (or if they are a 
carer, the stroke of their family member/friend). If unavailable at the time, a 
designated member of the care team will call them back. We will provide the Practice 
with a comprehensive resource of local services based on our service mapping work 
(described below). The staff member conducting the review will explain to the patient 
how to make contact with the Practice with a stroke related issue at the end of the 
enhanced annual review.  
 
7.1.4. Enhanced Communication Pathways 
 
We will arrange an initial meeting between primary care staff from several practices 
and specialist staff (hospital and community) to agree how to facilitate 
primary/secondary care communication going forward. Practice staff will be 
encouraged to attend additional training/ meetings organised by the specialist 
services, and given direct contact details for informal communication. Video 
recordings of local specialist(s) describing their service, the type of patients normally 
referred to the service, and ways of contacting the service will be made available to 
all general practice staff. 
 
7.1.5. Service Mapping  
 
To address the information need regarding local services for stroke related problems, 
we will catalogue stroke (and other relevant) services in participating localities, 
including information on how to access them. This information and training on how 
best to use it will be provided to the relevant Practice staff. Set-up of the resource in 
the best format will be in collaboration with the designated IT or administrative staff 
at the Practice. 
 
7.1.6. Training for General Practice Staff 
 
Training for Practice staff involved in structured stroke reviews will include an 
overview of stroke and stroke related long-term needs, followed by discussion of 
vignettes based on items from the stroke review checklist. Practice staff will suggest 
and discuss with the research team the most suitable course of action in each 
situation. 
 
The list of key health and social services available in the local area will be provided, 
and Practice staff will be familiarised with the service mapping resource that will be 
made available to them at the Practice. The outcomes of the structured review will be 
recorded on a template in the patient records. 
 
 
We will discuss with the practice how best to embed the direct point of contact role 
within the current Practice operations. 

 
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7.2. Control Arm 
 
The control arm will consist of usual care administered by the practice. 
8. Outcomes 
8.1. Primary Outcome 
 
The primary endpoint for the trial will be two sub-scales (emotion and handicap) of the 
Stroke Impact Scale (SIS v3.0)13 as co-primary outcomes at 12 months (adjusted for 
baseline) after entry into the trial. 
 
8.2. Secondary Outcomes 
 
To be collected at baseline, 6 and 12 months comprise: 
 
 SIS Short Form13 
 EuroQol EQ-5D-5L14 
 ICEpop CAPability measure for Adults (ICECAP-A)15 
 * Southampton Stroke Self-management questionnaire (SSSQ)16 
 * Health Literacy Questionnaire (HLQ)17 
 
* Only collected at 12 months follow-up. 
9. Data Collection 
9.1. Baseline Data Collection  
 
The primary outcome data will be collected via postal questionnaire at the time of 
invite to the study prior to Practice randomisation. Secondary outcome data (SIS 
Short Form, EuroQol EQ-5D-5L, and ICEpop CAPability measure for Adults 
(ICECAP-A)) will also be collected by postal questionnaire after randomisation. Non-
responders to the secondary outcome questionnaire will be followed-up by telephone. 
Where a patient has difficulty completing a questionnaire because of physical or 
communication difficulties, they will be encouraged to seek the help of a carer. 
 
Demographic data including age, ethnicity, gender, time since stroke, partial post 
code, and co-morbidity and medication use (prescription & ‘Over the Counter’, OTC) 
will also be collected at baseline. 
 
9.2. Follow-up Data Collection 
 
Follow-up via postal questionnaire will take place at six months after entry into the 
trial. These will include all of the baseline instruments. Non-responders will be 
followed up by telephone.  
 
Follow-up at twelve months will comprise a combination of postal and telephone 
administered questionnaires including all of the baseline instruments plus the 
Southampton Stroke Self-management questionnaire (SSSQ) and the Health 
Literacy Questionnaire (HLQ). Non-responders to the postal questionnaires will be 

 
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followed up by telephone. Again, where a patient has difficulty completing a 
questionnaire because of physical or communication difficulties, they will be 
encouraged to seek the help of a carer. 
 
A review of general practice notes will also be conducted. Data extracted will include 
number and nature of primary care visits, secondary care inpatient and outpatient 
visits, investigations, medications and use of social services. 
10. Statistical Methods and Analysis 
10.1. Sample size 
With 23 clusters per arm and an average of 20 patients per cluster, assuming an intra-
class correlation of 0.03, a typical coefficient of variation of the cluster size of 0.6518, 
and 2.5% significance (adjusted to 2.5% because of the use of two co-primary 
outcomes), we would be able to detect an effect size of 0.33 with at least 90% power 
on the co-primary outcomes (emotion and handicap sub-scales of the Stroke Impact 
Scale (SIS v3.013)). The sample size calculation has been inflated to allow for a rate 
of 20% loss to follow-up for patients within clusters. Loss to follow-up of entire clusters 
is not anticipated. 
The conservative estimate of 20 patients per practice is drawn from our own pilot data 
(unpublished) and our experiences of running previous trials in this population19,20,21. 
A typical practice with a list size of between 7,000 to 10,000 will have approximately 
100 - 150 patients on the stroke register4. We anticipate that the electronic search 
applying the exclusion criteria will eliminate around 40% of these (based on our pilot 
study) leaving 60 – 90 eligible patients per practice, of which about 30% will agree to 
take part (18 – 27 per practice). This will yield between 16 – 24 participants per 
practice. For further information see Anticipated Patient Recruitment Flowchart in 
Appendix B. 
 
10.2. Analysis of Primary Outcome 
 
We will use intention to treat (ITT) methods for the analysis of the primary end-points. 
A mixed effects model will be used to model each of the co-primary outcomes with a 
cluster random effect and fixed effects for the intervention and covariates that might 
potentially confound the relationship. Distributional assumptions will be assessed 
graphically by residual q-q plots and residual by fitted value plots. To handle the co-
primary outcomes, 97.5% confidence intervals will be reported for the two primary 
treatment effects which are equivalent to having the Bonferonni correction on the 
planned 5% significance level for a single endpoint. 
 
The missing data will be analysed under the assumptions of missing completely at 
random and missing at random. Multiple imputation will be used to impute missing 
outcome data and the various potential predictors of missingness will be included in 
the imputation model. Additionally, a sensitivity analysis may be used to investigate 
non-ignorable missingness mechanisms and their influence on the results.  
 
The full details of the statistical analysis will be specified in the statistical analysis 
plan (SAP). 
 
 

 
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10.3. Economic evaluation 
 
The long-term cost-effectiveness (cost-utility) of the new system of care (intervention 
package) compared with usual care will be determined in a within-trial economic 
evaluation. 
 
Data will be collected on resource use implications of the intervention (including 
training), primary care visits, secondary care inpatient and outpatient visits, 
investigations, medications and use of social services, via electronic primary care 
records and patient questionnaires. Data on patient and carer-incurred costs will also 
be collected to allow analysis from a broader societal perspective. Data collection will 
be undertaken within the trial to determine the time taken to deliver the structured 
review, and any additional resources required. Attendance at the individual and group 
MLAS sessions will also be recorded for every participant, and each session will be 
costed, taking into account staff time, any consumables and use of the venue. 
Standard unit costs will be applied to health care resource use including NHS 
reference costs, the BNF for medications and Unit Costs for Health and Social Care 
(PSSRU). 
 
The main outcomes of interest from the trial are quality of life (measured using EQ 5D-
5L14 at baseline and six and twelve months after attendance at review) and capability 
(using the ICECAP-A questionnaire15). Both measures will be scored using the 
appropriate values sets. 
 
Initially, a cost-consequence analysis will be performed, to present a disaggregated 
analysis of all mean resource use and costs related to the intervention and usual care, 
health care, social care, patient/carer costs and EQ-5D-5L and ICECAP-A scores at 
all time points. Quality-adjusted life years (QALYs) will be calculated by the area-
under-the-curve method using responses at all time points, and adjusted for baseline 
covariates including EQ-5D-5L score. Multiple imputation will be undertaken where 
there is missing cost and outcome data. An incremental cost-utility analysis will then 
be undertaken to determine the cost per QALY gained of the intervention compared 
with usual care. Base-case analyses will be conducted from an NHS/Personal Social 
Services perspective, with a sensitivity analysis from a societal perspective, taking into 
account broader costs and outcomes. 
 
To explore uncertainties in the analyses, deterministic sensitivity analysis is proposed 
to test the robustness of the results when varying key assumptions (for example, 
length of time required to deliver the intervention). Probabilistic sensitivity analysis will 
be undertaken to incorporate the uncertainty around parameter values and quantify 
the overall decision uncertainty, with results presented as cost-effectiveness planes 
and cost-effectiveness acceptability curves. 
 
 
 
 
 
 
 
 

 
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11. Intervention fidelity 
 
There will be both quantitative and qualitative assessment of the extent to which the 
intervention is implemented as planned. Our general approach to fidelity assurance is 
to use both real time practice data and real time informal feedback from the practice 
staff from regular telephone conversations, with visits where appropriate. These 
regular contacts will enable us to devise shared solutions to any fidelity issues. 
 
11.1. Structured Review of Patient Needs 
 
We will capture data relating to completion of the review checklist, development of 
action plans, and resolution of problems. A random sample (up to 10%) of the reviews 
will be audio-taped and assessed for fidelity. We will also ascertain whether the 
checklist continues to be used at the end of follow up (i.e. at twelve months). 
 
We will regularly review the process and clinical data, and feedback to practice staff 
either in person or by telephone. We will ask practice staff whether they have 
encountered problems implementing the review service, and discuss the reasons for 
this (e.g. operational issues, staff capacity). Where implementation and intervention 
fidelity are a concern, we will ask the practice staff to reflect upon the specific actions 
or processes, and through negotiation develop a joint action plan to address these 
issues. This “real-time” feedback to practice staff will ensure that the model of care is 
delivered consistently in accordance with the implementation plan across the duration 
of the practice involvement. 
 
11.2. Self-management Programme (MLAS) 
 
We aim to assess both facilitator fidelity (do the facilitators deliver the intervention as 
trained?) and participant receipt (does the participant understand the information and 
acquire the skills?). This will be achieved using tools adapted from previous 
educational programmes for long term conditions developed by the team at Leicester 
Diabetes Centre. Direct observation of delivery of a sample (up to 10%) of the sessions 
will be carried out by observers trained in the use of a structured observation tool and 
an observation sheet. The observers will code the degree of participant/facilitator 
interaction and measure delivery of content, facilitator behaviour and facilitation skills. 
Participant receipt measures will include specific determinants of self-management 
(e.g. participant engagement in writing their own action plan; cognitive strategies and 
behavioural skills used). A case report form (CRF) capturing delivery of the modular 
programme and facilitators’ behaviours will be completed on a sample of MLAS 
sessions. The CRF will combine an ‘adherence measure’ to capture delivery (mode of 
delivery, dose, duration, content), use of resources (materials/activities) and a 
structured observation tool to assess facilitator delivery of Behaviour Change 
Techniques. Methods may incorporate remote observation (e.g. through video) if this 
is judged to be appropriate and feasible.  
 
Feedback on the observed sessions will be provided to the facilitators on an on-going 
basis, and will be followed-up with further observation and top-up training if 
appropriate. We will provide a detailed description of any modifications/adaptations to 
the intervention as the study progresses. 
 
 

 
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11.3. Direct Point of Contact  
 
The extent of use of this system will be captured during the regular feedback sessions 
with practice staff. We will capture from the medical records the proportion and total 
number of practice contacts that participants have with the named contact(s) and ask 
participants during post-review interviews whether they are aware of the direct contact 
system. 
 
If necessary we will amend our information and training of practice staff to ensure that 
all participants are better informed. 
 
11.4. Optimised Communication  
 
We will audiotape the initial meeting that takes place and analyse the nature of the 
interactions, and the extent to which the meeting follows the study plan. The practice 
staff will log any contacts that they have with the specialist services, recording the 
contact as formal or informal communication, whether the advice received was helpful, 
and any actions taken as a result of the contact (e.g. referral, diagnostic tests or 
change of management/medication). Staff will also log instances when they had tried, 
but been unable to contact specialist services for advice in a timely manner.  
 
We will analyse the logs on a regular basis, and where problems with contact occur 
we will confirm contact details and mechanism for getting in contact. 
 
11.5. Service Mapping  
 
This will be monitored through the regular feedback sessions with practice staff. We 
will look at how often the data is referred to, is it easy to access, whether the service 
being recommended was appropriate for the patient, and whether the service data is 
comprehensive i.e. does it contain all relevant sources or are there significant 
omissions. 
 
If necessary, we will amend the format to allow easier access and searching of the 
data. Where significant omissions are found we will update our search to include new 
services. 
12. Process evaluation 
 
In both intervention and control practices, we will capture process data from the GP 
records to count the number of consultations, sub-divided into those related to stroke 
and those unrelated to stroke, and whether the consultation was with GP or practice 
nurse; prescriptions; and the number of referrals to secondary care. We will collect 
data on the background/speciality of the nurses performing reviews and of the 
facilitators conducting the MLAS courses, and how the direct point of contact was 
operationalised within each practice. Patient questionnaire at follow up will assess 
contact with other local services. To enable comparison of process between 
intervention and control practices, a sample of up to 10% of annual reviews in the 
control practices will be audiotaped. We will carry out semi-structured interviews with 
participants to explore experience of stroke care over the period of the study. We will 
also carry out semi-structured interviews with primary care professionals to explore 
attitudes to and experience of communication with specialists and confidence with 

 
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using referral pathways; reflections on the annual review; awareness of local services; 
strengths and weaknesses of current stroke services in the community.  
 
12.1. Patients 
 
At the end of their study follow-up 25 participants (15 intervention; 10 control) will be 
recruited to take part in a semi-structured interview. Participants will be purposively 
selected to allow for a range of baseline characteristics and what aspects of the 
primary care model they had accessed. When participants are invited to take part 
they will be offered further information about the structure and content of the interview 
and given the chance to ask questions. Once the researchers have confirmed that a 
participant is still happy to be interviewed they will arrange for a member of the study 
team to visit them in their own home or at an alternative venue if they prefer. 
Participants will be consented by a member of the study team at the start of each 
interview.    
 
12.2. Health Care Professionals 
 
Up to 15 primary care professionals (10 intervention; 5 control) will be recruited to take 
part in a semi-structured interview at the end of study follow-up. Staff with be 
purposively selected to provide a range of trial roles and practice characteristics. The 
interview invitation with include information about the structure and content of the 
interview as well as data storage and confidentiality. Participants will be consented by 
a member of the study team at the start of each interview.  
 
 
 

 
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13. Flow Chart of Study 
 
 
 
 
Individual 
Patient Consent
Cluster 
Randomisation 
(Practice level)
Model Practices
Baseline 
measures
IPCAS review + 
MLAS
6 months 
follow-up
12 months 
follow-up
Control 
Practices
Baseline 
measures
Usual care
6 months 
follow-up
12 months 
follow-up

 
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14. Timescale 
See Gantt chart (appendix C) 
 
15. Trial Management 
 
Trial Sponsor: The Sponsor is responsible for initiation, management and financing 
of the trial. Sponsorship activities will be performed by NHS Cambridgeshire and 
Peterborough CCG and the University of Cambridge as detailed in the co-sponsorship 
agreement and sponsor letter. The nominated lead sponsor is the University of 
Cambridge. 
 
Chief Investigator (CI): The CI (Professor Jonathan Mant) is the overall lead for the 
design, conduct, co-ordination and management of the trial. The CI has overall 
responsibility for the scientific quality and delivery of the trial.  
 
Principal Investigator (PI): The IPCAS trial will be managed from the University of 
Cambridge. The Cambridge PI (Professor Jonathan Mant) will be responsible for the 
day to day leadership of the trial, ensuring the trial is delivered in line with this protocol.  
 
Clinical Research Network (CRN): The study team will work with local CRNs in the 
East of England and the East Midlands to identify and recruit GP practices. 
 
15.1 Monitoring  
 
Oversight of the trial will fall to an independent committee fulfilling the combined roles 
of Trial Steering Committee (TSC) and Data Monitoring Committee (DMC). They will 
provide overall supervision of the conduct of the trial on behalf of the trial sponsor(s) 
in accordance with NIHR recommendations22,23. The committee will consider relevant 
factors in interim decision-making, such as recruitment rate and completion schedule, 
baseline comparability across treatment arms, data completeness and follow-up, 
safety profile and ethical issues. 
 
Initially, the TSC/DMC will meet after the first 100 participants are recruited, then 6-
monthly. This frequency may increase or decrease according to need. 
 
15.2. Data Management 
 
The full details of the data management will be specified in the data management plan 
(DMP). 
 
15.2.1. Data Transfer 
 
Data completed by participants, such as consent forms and questionnaires, will be 
returned to the study team via post. All relevant data collected at practice sites will be 
sent to the study team by trained and delegated practice staff via a secure transfer 
server (“https”). The study team may also make use of NHS.NET accounts as an 
alternative method of information sharing with practices, for example during the 
process of reporting and assessing Serious Adverse Events.  
 

 
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Data sharing between the study team members based at Cambridge and Leicester 
will occur through joint access to a Secure Data Hosting Service (see below) and a 
secure transfer server. Only appropriately trained and delegated members of the study 
team will have access to patient identifiable data.  
 
15.2.2. Data Storage 
 
Paper data (questionnaires, consent forms, reply slips and CRFs) will be stored in 
locked filing cabinets within a security card-protected building at the University of 
Cambridge, with access restricted to the study team. 
 
Electronic data (including audio-recordings) will be stored on an ISO-27001 data 
security accredited Secure Data Hosting Service (SDHS) protected by a dual 
authentication (password-secured and personal security code secured) located on a 
firewall-protected virtual network (VLAN). Access to electronic study data is restricted 
to the study team by dual authentication and group permissions. Once stored centrally 
and checked, the data on audio and video recorders will be erased.  
 
Personal identifiable data (participant contact details) will be archived for up to 3 years 
after completion of the trial and then destroyed. All anonymised data will be stored 
permanently and made available to bona fide researchers on a suitable repository only 
upon receipt of a valid data request and appropriate regulatory approval.  
 
15.2.3. Data Protection & Patient Confidentiality 
 
All investigators and trial site staff involved in this trial will comply with the requirements 
of the Data Protection Act 1998 with regards to the collection, storage, processing and 
disclosure of personal information. 
 
The trial staff will ensure that the participants’ anonymity is maintained. The 
participants will be identified by initials, DOB and a participant ID number on the CRF 
and Trial Management System Database. Consent forms will contain participant 
names. All documents will be stored securely and only accessible by trial staff and 
authorised personnel. 
16. Withdrawals 
The main ground for withdrawal from the trial is participant request. Participants may 
request this at any time. It is anticipated that the research team will seek to understand 
the participant’s barriers to further trial participation and to address these where 
possible. In this instance, the researcher should ascertain whether the participant is 
still willing to undergo follow up, and if possible document the reason for withdrawal. 
Participants also may be withdrawn if the study sponsor or regulatory authorities 
terminate the study prior to its planned end date. 
 

 
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17. Serious Adverse Events (SAEs) 
It is not anticipated that the intervention sessions will result in any serious adverse 
events. However, each PI will report all SAEs not listed below to the CI within 24 hours 
of first notification. The Chief Investigator is responsible for ensuring the assessment 
of all SAEs for expectedness and relatedness is completed and the onward notification 
of all non-exempt SAEs to the Sponsor immediately but not more than 24 hours after 
first notification.  
 
 Cardiovascular (CV) death e.g. fatal myocardial infarction [MI] / 
cerebrovascular accident [CVA] / congestive heart failure [CHF] / arrhythmia, 
cardiac arrest, death following CV intervention 
 Non-fatal stroke/TIA 
 Non-fatal MI 
 Acute coronary syndrome 
 CHF requiring hospitalisation  
 Unstable angina requiring hospitalisation 
 Any hospitalisation due to cardiovascular events 
 Hospitalisation for any elective/pre-planned surgical procedure for pre-existing 
condition prior to trial enrolment 
 Atrial fibrillation/Atrial flutter 
 Ventricular fibrillation/tachycardia requiring intervention 
 Deep Vein Thrombosis (DVT) 
 Pulmonary embolism  
 Percutaneous Coronary Intervention (PCI) – (including non-serious events) 
 Accelerated or malignant hypertension/hypertensive urgency 
 
The sponsor will keep detailed records of all SAEs reported to them by the trial team. 
 
 
18. Ethical Considerations 
18.1. Participant Recruitment 
 
Patients will be initially contacted by the Practice and their identity only disclosed to 
the researchers once they return the consent form and primary outcome questionnaire 
to the study team. We assume that ability to complete the questionnaire and respond 
to the invitation letter implies capacity, whether provided with or without the help of a 
carer/guardian. 
 
18.2. Inclusion & Exclusion Criteria 
 
We designed inclusion criteria with the aim of broadest reach to maximise inclusivity. 
For example, we included survivors regardless of the severity of their stroke. However, 
due to the nature of research and the service offered, we recognise that certain groups 
of patients will most likely be excluded. For example, patients in living in nursing care 
homes may not be able to benefit from the components offered (e.g. referrals to other 
services). We therefore chose to exclude these groups. 
 
 

 
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18.3. Utilisation of the Model 
 
The structured review will confer minimal additional burden to participants as it will be 
performed as part of the annual review. Patients may bring an informal caregiver to 
the review. 
 
The MLAS service and direct point of contact is offered as an additional, opt-in service 
component which patients may use at their discretion. 
 
18.4. Questionnaires 
 
All the questionnaires are finding out complementary information of importance to 
evaluating the impact of the model. A full set of questionnaires should take no longer 
than 10 - 30 minutes to fill in during baseline and 45 minutes at follow-up. Patients are 
clearly informed in the Participant Information Sheet (PIS) about the flexibility of filling 
in the questionnaires in multiple sittings.  
 
Information disclosed in the questionnaires will be kept confidential, anonymised and 
stored separately from patient identifiable data (PID; see data storage and 
confidentiality). The questionnaires (SIS, EQ-5D-5L, ICECAP-A, SSSQ, HLQ) do not 
include sensitive screening information and have been either used in large stroke trials 
or observational studies which included stroke patients. 
 
18.5. Consent  
 
The patient information sheet explains that their General Practice is taking part in a 
research study evaluating different models of care for stroke. It is entirely up to the 
patient to decide whether or not they wish to take part in the study. We are seeking 
consent to send them some questionnaires, possibly contact them by phone, and 
review their medical records. Patients will be sent a consent form by post (with an 
opportunity to contact the research team if they have any questions about the study). 
 
19. Patient and Public Involvement (PPI) 
Patient representatives were involved in the initial conception of the programme prior 
to funding submission. This included a patient representative attending the initial 
writing group plenary and two public workshops with stroke survivors and their carers.  
Stroke patients and their carers were involved throughout the subsequent qualitative 
development work through interviews (n=36) and focus groups (n=19). Likewise, 
healthcare professionals including primary care representatives were engaged in 9 
focus groups. This qualitative work was used to understand the current experience of 
primary care for stroke survivors and their carers and inform model components such 
as the structured review, checklist of stroke needs, and direct point of contact. In 
addition, we have consulted several local stroke support groups (Bedford, Bradford, 
Cambridge and London) during the development of the model. A multidisciplinary team 
of clinicians involved in stroke care, including a patient representative, has been 
regularly consulted on the model throughout the developmental stages.  
Continued PPI will be achieved through the Trial Steering Committee which includes 
a patient representative. Some PPI members have also expressed an interest in 

 
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becoming facilitators for the “My Life After Stroke” course which we will seek to 
achieve. 
20. Approvals 
Favourable ethical opinion for the research will be sought via Health Research 
Authority (HRA) prior to the recruitment of participants commencing at any NHS site.  
 
Any subsequent amendments to study documentation, along with safety, annual 
progress and final study reports will be submitted to R&D and REC for information 
and/or approval, as required. 
21. Dissemination 
Dissemination will be via peer-reviewed journals and presentation at relevant 
conferences and local stroke groups. Participants will also receive a summary copy of 
the results, if they so wish. 
22. References 
 
1. 
Gulliford MC, Charlton J, Rudd A, et al. Declining 1-year case-fatality of stroke and 
increasing coverage of vascular risk management: population-based cohort study. Journal of 
Neurology, Neurosurgery & Psychiatry 2010;81(4):416-22. 
 
2. 
Lee S, Shafe ACE, Cowie MR. UK stroke incidence, mortality and cardiovascular risk 
management 1999–2008: time-trend analysis from the General Practice Research Database. 
BMJ Open 2011;1(2). 
 
3. 
McKevitt C, Fudge N, Redfern J, et al. Self-reported long-term needs after stroke. 
Stroke 2011;42(5):1398-403. 
 
4. 
National Audit Office. Progress in improving stroke care. Department of Health, 2010. 
 
5. 
Murray J, Young J, Forster A. Review of longer-term problems after a disabling stroke. 
Rev Clin Gerontol 2007;17(04):277-92. 
 
6. 
Department of Health. Cardiovascular Disease Outcomes Strategy. Improving 
outcomes for people with or at risk of cardiovascular disease, 2013. 
 
7. 
Royal College of Physicians CEaEUobotISWP. Sentinel stroke national audit 
programme (SSNAP): clinical audit April - June 2014. Sentinel Stroke National Audit 
Programme (SSNAP); 2014. 
 
8. 
Logan P, Leighton M, Walker M, Armstrong S, Gladman JR, Sach T, et al. A multi-
centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for 
people after stroke: study protocol for a randomised controlled trial. Trials. 2012; 13(1): 86.  
 
9. 
Aziz Noor A, Leonardi-Bee J, Phillips Margaret F, Gladman J, Legg Lynn A, Walker M. 
Therapy-based rehabilitation services for patients living at home more than one year after 
stroke. Cochrane Database Syst Rev. 2008;(2): [CD005952 p.].  
 

 
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10. 
Intercollegiate Stroke Working Party. National clinical guideline for stroke. London 
Royal College of Physicians. 2016. 
 
11. 
Department of Health. National Stroke Strategy. London. Report Number: 
284536, 2007. 
 
12. 
Care Quality Commission. Supporting life after stroke: a review of services for people 
who have had a stroke and their carers. London. 2011. 
 
13. 
Jenkinson, C., Fitzpatrick, R., Crocker, H. and Peters, M. (2013) The Stroke Impact 
Scale. Validation in a UK setting and development of a SIS short form and SIS index. Stroke 
44 pp 2532-2535 
 
14. 
van Reenen M, Janssen B. EQ-5D-5L user guide: basic information on how to use the 
EQ-5D-5L instrument. Version 2.1. Rotterdam; 2015. 
 
15. 
Al-Janabi H, N Flynn T, Coast J. Development of a self-report measure of capability 
wellbeing for adults: the ICECAP-A. Quality of Life Research. 2012;21(1):167-76. 
 
16. 
Boger, E., Hankins, M., Demain, S., and Latter, S. (2015) Development and 
psychometric evaluation of a new patient-reprted outcome measure for stroke self-
management: The Southampton Stroke Self-Management Questionnaire (SSSMQ). Health 
and Quality of Life Outcomes; 13; 165 
 
17. 
Osborne RH, Batterham R, Elsworth GR, Hawkins M, Buchbinder R. The grounded 
theory, psychometric development and initial validation of the Health Literacy Questionnaire 
(HLQ). BMC Public Health. 2013;13:658.  
 
18. 
Campbell, M.J. and Walters, S.J. 2014. How to Design, Analyse and Report Cluster 
Randomised Trials in Medicine and Health Related Research. John Wiley & Sons. New York.  
 
19. 
Fletcher K, Mant J, McManus RJ, Campbell S, Betts J, Taylor C, Virdee S, Jowett S, 
Martin U, Greenfield S, Ford G, Freemantle N, Hobbs FDR. Protocol for Past BP: a 
randomised controlled trial of different blood pressure targets for people with a history of stroke 
of transient ischaemic attack (TIA) in primary care. BMC Cardiovascular Disorders 2010, 10:37 
 
20. 
McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S et al. Telemonitoring 
and self-management in the control of hypertension (TASMINH2): a randomised controlled 
trial. Lancet 2010; 375:163-72 
 
21. 
O’Brien C, Bray EP, Stirling Bryan S, Greenfield SM, Haque MS, Hobbs FDR, Jones 
MI, Jowett S, Kaambwa B, Little P, Mant J, et al. Targets and self-management for the control 
of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised 
controlled 
trial. 
BMC 
Cardiovascular 
Disorders 
2013, 
13:21 
http://www.biomedcentral.com/1471-2261/13/21 
 
22. 
NIHR Good Clinical Practice (GCP) Reference Guide (Version 3.1 August 2016) 
https://www.nihr.ac.uk/our-faculty/documents/GCP%20Reference%20Guide.pdf 
 
23. 
NIHR: A Guide to Efficient Trial Management; Trial-Managers’-Network-Guide Fourth 
Edition: January 2014  ISBN 9780854329748 
 
 
 
 
 

 
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Appendix A 
 
Stroke Review Checklist 
 
This is a list of problems some people have after a stroke. This is to help you 
think about problems you may be having.  
 
Under each heading there are some examples. This list does not cover 
everything. If you have a problem that is not listed here please write it under 
number 15.  
 
Please tick ( ) all the areas you have difficulty with.  
 
Please bring this completed checklist to your stroke review.  
 
 
1. Secondary Prevention 
 
 
I need advice on changes to lifestyle or medications for 
preventing another stroke. 
 
2. Activities of Daily Living (ADL) 
 
 
 I have difficulty dressing, washing and/or bathing. 
 I have difficulty preparing hot drinks and/or meals. 
 I have difficulty getting outside. 
 
3. Mobility 
 
 
 I am finding it difficult to walk.   
 I am finding it difficult to move safely around the house. 
 
4. Pain 
 
 
 I experience physical/muscular pain.  
 I have headaches. 
 
5. Stiffness 
 
 
I find that my arms, hands, and/or legs are stiff. 
 
6. Incontinence 
 
 
I am having a problem controlling my bladder or bowels. 
 
 
 
 
 
 
Tick here 

 
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7. Communication 
 
 
 I am finding it difficult to understand / communicate with 
others.  
 I have problems with speech, word finding or talking to 
others. 
 I lack confidence when talking to others either in person 
or over the phone. 
 
8. Mood 
 
 
 I feel anxious or depressed.   
 I feel that my personality since stroke has changed. 
 
9. Cognition 
 
 
I find it difficult to think, concentrate, or remember things. 
 
10. Relationships with Family 
 
 
My personal relationships with my family have become difficult 
or stressed. 
 
11. Fatigue 
 
 
 I feel tired most of the time or I get easily tired. 
 I find it difficult to concentrate and do things. 
 
12. Intimate relationships 
 
 
Since my stroke I have problems with sex. 
 
13. Work 
 
 
I am having problems at work or I would like support and 
advice on returning to work. 
 
14. Social activities 
 
 
I find it difficult to take part in hobbies or leisure activities. 
 
 
15. Have you noticed anything else that you are concerned about? 
 
 
 
 
 
Tick here 

 
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Appendix B 
 
 
 

 
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Appendix C