Experiencing Loss and Planning Ahead Study (ELPAS): Caring for a Relative or Friend With Dementia
Conditions: Grief
Sponsor: University College, London

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FULL PROTOCOL TITLE: 
EXPERIENCING LOSS AND PLANNING AHEAD STUDY: CARING FOR A RELATIVE OR FRIEND 
WITH DEMENTIA 
 
ACRONYM: ELPAS  
 
Chief Investigator: 
Dr Kirsten Moore, BA(Hons) PhD, Senior Research Fellow, Marie Curie Palliative Care 
Research Department, Division of Psychiatry, UCL 
 
 
Supported by: 
Alzheimer’s Society Senior Fellowship award 325 (AS-16-004) 
 
 
Sponsored by: 
University College London (UCL) 
 
 
Protocol version number and date: 
Version 1: 2 October 2017 
 
 
R&D / Sponsor Reference Number(s): 
17/0477 
 
NCT number: 
NCT03332979 
Study Registration Number: 
 
 

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PROTOCOL VERSIONS 
Version Stage 
Versions No 
Version Date 
Protocol updated & 
finalised by; 
Appendix 
No 
detail 
the 
reason(s) for the protocol 
update 
Current 
1 
2 October 2017 
Dr 
Kirsten 
Moore 
(Chief Investigator) 
NA 
 
DECLARATIONS 
The undersigned confirm that the following protocol has been agreed and accepted and that the 
investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the Research Governance Framework 2005 (as amended thereafter), the Trust Data & Information 
policy, Sponsor and other relevant SOPs and applicable Trust policies and legal frameworks. 
I (investigator) agree to ensure that the confidential information contained in this document will not 
be used for any other purposes other than the evaluation or conduct of the clinical investigation 
without the prior written consent of the Sponsor. 
I (investigator) also confirm that an honest accurate and transparent account of the study will be given; 
and that any deviations from the study as planned in this protocol will be explained and reported 
accordingly. 
 
Chief Investigator: 
Signature:.....................................................................   Date:  
Print Name(in full): Dr Kirsten Moore 
Position: Senior Research Fellow  
 
On behalf of the Study Sponsor: 
Signature:.....................................................................................        Date....../....../....... 
Print Name(in full):....................................................................... 
Position:....................................................................................... 
 
 
 
 

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STUDY SUMMARY 
Identifiers
IRAS Number 
232091 
REC Reference No
Sponsor Reference No
17/0477 
Other research reference 
number(s) (if applicable) 
 
Full (Scientific) title
Experiencing Loss and Planning Ahead Study (ELPAS): Caring for a 
relative or friend with dementia. 
Health 
condition(s) 
or 
problem(s) studied 
Pre-death grief experience by family and friend carers of people with 
dementia 
Study Type i.e. Cohort etc
Cross-sectional cohort study
Target sample size
150 
 
STUDY TIMELINES
Study Duration/length 
2.5 years 
Expected Start Date
2/10/2017
End of Study definition and 
anticipated date 
Completion of all interviews, follow-up, data analysis and initial 
publication draft: 31/3/2020 
Key Study milestones 
 
Budget and contract finalised: 15/12/2016 
Fellowship commenced: 1/4/2017 
Study submission for HRA approval:  
Approval to commence recruitment:  
First patient recruited:  
FUNDING & Other
Funding  
Alzheimer’s Society (Senior Fellowship)
Dr Claire De-May 

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Claire.De-May@alzheimers.org.uk  
Other support  
Administrative support provided by the Marie Curie Palliative Care 
Research Department, Division of Psychiatry, UCL 
Contact: Yana Kitova 
02076799713 
y.kitova@ucl.ac.uk 
STORAGE of SAMPLES 
(if applicable) 
Human tissue samples
Not applicable 
Data collected / Storage
Not applicable 
KEY STUDY CONTACTS 
Full contact details including phone, email and fax numbers
Chief Investigator  
Dr Kirsten Moore
Senior Research Associate 
Marie Curie Palliative Care Research Department 
Division of Psychiatry 
University College London  
6th Floor, Maple House 
149 Tottenham Court Road 
London W1T 7NF 
P: +44 (0)20 7679 9488 (ext 09488) 
kirsten.moore@ucl.ac.uk  
Fellowship supervisor
Dr Elizabeth Sampson
Marie Curie Palliative Care Research Department 
Division of Psychiatry 
University College London  
6th Floor, Maple House 
149 Tottenham Court Road 
London W1T 7NF 
P: +44 (0)20 7679 9730 
e.sampson@ucl.ac.uk  
Fellowship co-supervisor
Dr Claudia Cooper 
Division of Psychiatry 
University College London  
6th Floor, Maple House 
149 Tottenham Court Road 
London W1T 7NF 
P: +44 (0)20 7288 5717 
claudia.cooper@ucl.ac.uk  
 
 
 

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KEY ROLES AND RESPONSIBILITIES 
SPONSOR: The sponsor is responsible for ensuring before a study begins that arrangements are in 
place for the research team to access resources and support to deliver the research as proposed and 
allocate responsibilities for the management, monitoring and reporting of the research. The Sponsor 
also has to be satisfied there is agreement on appropriate arrangements to record, report and review 
significant developments as the research proceeds, and approve any modifications to the design.  
 
FUNDER: The funder is the entity that will provide the funds (financial support) for the conduction of 
the study. Funders are expected to provide assistance to any enquiry, audit or investigation related to 
the funded work.  
 
CHIEF INVESTIGATOR (CI): The person who takes overall responsibility for the design, conduct and 
reporting of a study. If the study involves researchers at more than once site, the CI takes on the 
primary responsibility whether or not he/she is an investigator at any particular site. 
 
The CI role is to complete and to ensure that all relevant regulatory approvals are in place before the 
study begins. Ensure arrangements are in place for good study conduct, robust monitoring and 
reporting, including prompt reporting of incidents, this includes putting in place adequate training for 
study staff to conduct the study as per the protocol and relevant standards. 
 
The Chief Investigator is responsible for submission of annual reports as required. The Chief 
Investigator will notify the RE of the end of the study, including the reasons for the premature 
termination. Within one year after the end of study, the Chief Investigator will submit a final report 
with the results, including any publications/abstracts to the REC.  
 
KEY WORDS 
Grief before death, family or friend carer, dementia, preparation for end of life 
LIST OF ABBREVIATIONS 
AE
Adverse Event 
AR
Adverse Reaction
Brief COPE 
Brief Coping Orientation to Problems Experienced scale
CI 
Chief Investigator
CRF
Case Report Form 
CRO
Contract Research Organisation
DMC
Data Monitoring Committee
DUREL
Duke University Religion Index (DUREL) 
GAfREC
Governance Arrangement for NHS Research Ethics 
HADS
Hospital Anxiety and Depression Scale

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HLQ
Health Literacy Questionnaire
IB
Investigator Brochure 
ICF
Informed Consent Form 
JDR
Join Dementia Research 
MCPCRD
Marie Curie Palliative Care Research Department
MMCGI-SF 
Marwit-Meuser Caregiver Grief Inventory Short Form 
PI
Principle Investigator
PIS
Participant Information Sheet
QA
Quality Assurance 
QC
Quality Control 
REC
Research Ethics committee 
SAR
Serious Adverse Reaction 
SAE
Serious Adverse Event 
SDV
Source Data Verification 
SOP 
Standard Operating Procedure
SSI
Site Specific Information 
TMF
Trial Master File 
 
 
 

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CONTENTS 
1 
INTRODUCTION ........................................................................................................................... 9 
2 
BACKGROUND AND RATIONALE ................................................................................................. 9 
3 
OBJECTIVES ............................................................................................................................... 11 
3.1 
Primary Objective .............................................................................................................. 11 
3.2 
Secondary Objectives ........................................................................................................ 11 
4 
STUDY DESIGN........................................................................................................................... 11 
4.1 
Quantitative interviews (n=150) ....................................................................................... 11 
4.2 
Qualitative semi-structured interviews (n=20) ................................................................. 12 
5 
ELIGIBILITY CRITERIA ................................................................................................................. 13 
5.1 
Inclusion Criteria ............................................................................................................... 13 
5.2 
Exclusion Criteria ............................................................................................................... 13 
6 
RECRUITMENT ........................................................................................................................... 13 
6.1 
Identifying potential participants ..................................................................................... 13 
6.1.1 
Join Dementia Research ................................................................................................ 13 
6.1.2 
NHS services .................................................................................................................. 14 
6.1.3 
Non-NHS services .......................................................................................................... 14 
6.1.4 
Monitoring recruitment ................................................................................................ 14 
6.2 
Obtaining consent ............................................................................................................. 15 
6.3 
Withdrawing from the study ............................................................................................. 15 
6.4 
What happens if a participant loses capacity after consenting? ...................................... 15 
7 
DATA ANALYSIS ......................................................................................................................... 16 
7.1 
Statistical Analysis ............................................................................................................. 16 
7.2 
Qualitative Analysis ........................................................................................................... 16 
8 
PATIENT AND PUBLIC INVOLVEMENT (PPI) .............................................................................. 17 
9 
FUNDING AND SUPPLY OF EQUIPMENT ................................................................................... 17 
10 
DATA HANDLING AND MANAGEMENT ..................................................................................... 17 
11 
PEER AND REGULATORY REVIEW .............................................................................................. 18 
12 
ASSESMENT AND MANAGEMENT OF RISK ............................................................................... 18 
12.1 
Assessment and management of risk to participants ....................................................... 18 
12.2 
Assessment and management of risk to research staff .................................................... 19 
13 
RECORDING AND REPORTING OF EVENTS AND INCIDENTS ..................................................... 19 
13.1 
Definitions of Adverse Events ........................................................................................... 19 
13.2 
Assessments of Adverse Events ........................................................................................ 20 
13.3 
Severity ............................................................................................................................. 20 
13.4 
Causality ............................................................................................................................ 20 

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13.5 
Expectedness .................................................................................................................... 21 
13.6 
Recording adverse events ................................................................................................. 21 
13.7 
Procedures for recording and reporting Serious Adverse Events ..................................... 21 
13.8 
Protocol deviations and notification of protocol violations ............................................. 23 
13.9 
Trust incidents and near misses ........................................................................................ 23 
14 
MONITORING AND AUDITING................................................................................................... 24 
15 
TRAINING .................................................................................................................................. 24 
16 
INTELLECTUAL PROPERTY ......................................................................................................... 25 
17 
INDEMNITY ARRANGEMENTS ................................................................................................... 25 
18 
ARCHIVING ................................................................................................................................ 25 
19 
PUBLICATION AND DISSEMINATION POLICY ............................................................................ 25 
20 
REFERENCES .............................................................................................................................. 25 
21 
LIST OF APPENDICES ................................................................................................................. 28 
 
 
 

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1 INTRODUCTION 
The course of dementia over many years, gradual losses and uncertain life expectancy can mean that 
family carers experience feelings and symptoms of grief before the death of the person for whom they 
are caring. UK guidelines recommending that carers are offered information about bereavement 
supports and dementia progression are rarely followed in practice.  
This study aims to examine the relationship between carers’ feelings of grief before the death of a 
person with dementia and how well they are prepared for that death. The study involves completing 
a questionnaire schedule with 150 carers of people with dementia (across all stages of dementia and 
for people with dementia living at home or in a care home). Twenty of these carers will be purposively 
selected to complete an additional semi-structured interview to further explore the research 
questions. The questionnaires will examine whether being prepared for end of life is linked to having 
lower levels of grief. Preparation will be measured by important factors shown in research including: 
knowledge of dementia progression; knowledge of the person with dementia’s end of life preferences; 
communication with healthcare professionals; family support; and having a Power of Attorney or 
advance directive in place. The study is one component of a larger senior fellowship being undertaken 
by the CI and will inform subsequent development of a resource for supporting carers to help prepare 
for end of life care and manage grief.  The study was informed by the Alzheimer’s Society Research 
Network who will also be involved throughout the study. It will increase understandings of how we 
can better support grieving carers and help them plan and prepare for end of life care. This is a critical 
area given that dementia is now the leading cause of death in the UK [1] and family and friend carers 
are relied on to meet an ever increasing proportion of the support and care needs for their relatives 
living with dementia in this time of austerity.  
2 BACKGROUND AND RATIONALE 
Grief is often felt before the death of a friend or relative with dementia. Grief before the death can be 
triggered by losses associated with dementia causing carers to experience sorrow, anger, yearning and 
acceptance that can wax and wane from diagnosis to the end of life [2]. It occurs due to the lengthy 
and uncertain disease trajectory; compromised communication between the person with dementia 
and family and friends; and changes in relationship quality and carer freedom.[2] Grief before the 
death can contribute to carer burden and depression.[2] Between 47-71% of family carers of people 
with dementia experience grief before the death and 20% experience complicated grief after the 
death.[3] Higher grief prior to death is associated with complicated grief after death [4], so emotional 
support during care rather than solely after the death may be beneficial.[5]  
Preparation for end of life has medical, psychosocial, spiritual and practical components, [6, 7] 
including having a family member or healthcare professional to help make decisions, knowing what to 
expect about the terminal condition and having finances in place.[8] Good communication with 
healthcare providers to discuss prognosis, treatments, cultural, spiritual and practical issues; and 
dealing with family conflict is critical.[6] Preparation for end of life is associated with a lower likelihood 
of complicated grief in bereavement [9-11] but has not been explored in the context of grief before 
the death (Figure 1). Preparation for end of life is influenced by socioeconomic factors associated with 
health literacy (Figure 1). Low health literacy is more common amongst those from more deprived 
backgrounds, ethnic minorities, older people and those with chronic health conditions.[12] In the UK 
a third of older adults have difficulty interpreting basic health information.[13] Despite the potential 
benefits of end of life discussions with carers, there are many barriers to such discussions.[14, 15] 
Carers struggle to formalise in writing future wishes on behalf of the person with dementia and 
professionals tend to be reluctant to initiate end of life discussions.[16] Family conflict can deter end 
of life decision making.[17] Factors reflecting preparation for end of life are potentially modifiable 
suggesting that improving preparation could reduce grief before the death. 

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Figure 1: Existing evidence linking preparation for end of life and grief (before and after the 
death) 
This will be the first UK study to assess the prevalence of grief before the death amongst a sample of 
carers for people with all stages of dementia and living either at home or in a care home. It will be one 
of few studies to explore whether modifiable factors showing preparation for end of life are associated 
with lower levels of grief before the death. The modifiable factors reflecting preparation for end of 
life include:  
• 
carers’ having a good knowledge of dementia progression,  
• 
high health literacy,  
• 
a lasting (enduring) Power of Attorney,  
• 
knowing the end of life wishes of the person with dementia and  
• 
being satisfied with support from their social network.  
Knowing which modifiable factors reflecting preparation for end of life are most closely associated 
with grief before the death will inform the development of a resource for carers. If this study is 
successful in developing the first evidence-based intervention for family carers to reduce grief before 
the death and improve preparation for end of life, it has the potential to reduce carer distress during 
the lifetime of the person with dementia, bringing benefits for the person with dementia as well as 
their carer. It will enable discussions to ensure care at the end of life is planned and in accordance 
with the person’s wishes; and may reduce the prevalence of complicated grief after the death of the 
person with dementia.  
The study builds on the previous research of the CI and the Marie Curie Palliative Care Research 
Department (MCPCRD), within UCL’s Division of Psychiatry where the study will take place. In 2013, 
the MCPCRD systematically reviewed the prevalence and predictors of grief before and after the death 
in carers of people with dementia.[3] Our analysis of primary care data found that carers of people 
with dementia used more psychotropic drugs prior to bereavement than other carers.[18] Mentor Dr 
Karen Harrison-Dening and supervisor Dr Liz Sampson reviewed evidence on advance care planning 
(ACP) in dementia and found considerable barriers to implementing ACP in practice. They found that 
carers’ capacity to make best interest decisions about end of life is influenced by religious beliefs, 
education, guilt and burden.[19] Their qualitative work identified that even in mild stages, people with 
dementia have difficulty envisaging themselves being more dependent on others.[14] The 3-year 
Compassion study, led by Dr Jones and Dr Sampson (National Institute for Health Research [NIHR] 
portfolio ref. CRN-PCRN 12621; 12623) [20], involved a small cohort study of people with advanced 
dementia and their family carers. We found that 26% of carers reported depression, 41% anxiety and 
grief before death was high. Carers were offered minimal emotional support before and after their 
relative’s death [21]. We developed the Compassion Intervention to promote integrated palliative 
Negative association in REACH study 
(dementia) and more broadly after death  
Complicated grief after the death 
•
White carers, carers with higher income and higher education  
•
Carers of nursing home residents report engagement in advance care planning (involving: the 
resident discussing ACP, appointing a proxy decision maker, having a living will; physician is aware 
of resident’s decisions regarding end of life care and has discussed DNR with carer)   
Preparation for end of life Question: to 
what extent are you prepared for the 
person’s death? 
Grief before the death 
Positive 
association 
?? 
Figure notes: Studies referenced 
are US. Only one study in 
dementia: Resources for 
Enhancing Alzheimer's Caregiver 
Health (REACH)  

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dementia care.[22, 23] This was tested in two care homes where the CI was employed as an 
Interdisciplinary Care Leader. Few carers were aware of common end of life symptoms.[24] The 
importance of studying grief and end of life support for carers of people with dementia was strongly 
endorsed by carers of the Alzheimer’s Society Research Network whom the CI consulted in a specially 
convened focus group. Network members expressed major concerns in the current provision of end 
of life preparation and information as well as grief support, reinforcing this as a neglected topic 
requiring more research and development. 
3 OBJECTIVES 
3.1 Primary Objective  
This study aims to examine the relationship between family and friend carers’ feelings of grief before 
the death of a person with dementia and how well carers are prepared for that death. 
The hypothesis that will be tested is that modifiable factors indicating preparation for end of life are 
associated with lower grief before the death in carers of people with dementia. 
3.2 Secondary Objectives  
• 
To examine the prevalence and severity of grief before the death in carers of people with 
dementia (Quantitative interviews) 
• 
To identify which modifiable factors reflecting preparation for end of life are most strongly 
related to grief before the death (Quantitative interviews) 
• 
To examine the extent to which carers feel prepared for the future and end-of-life care for 
their relative with dementia (Quantitative and qualitative interviews) 
• 
To explore whether carers recognize grief during caring and what supports they think would 
be helpful (Quantitative and qualitative interviews) 
• 
To identify unmet needs for information about end of life symptoms and emotional support 
for carers (Qualitative interviews) 
• 
To explore how carers experience and cope with changes in grief over time (Qualitative 
interviews) 
4 STUDY DESIGN 
This is a cross-sectional study using mixed methods. One hundred and fifty carers of people with a 
diagnosis of dementia will be recruited to take part in the study. They will take part in a quantitative 
interview with a range of questionnaires. A smaller purposive sample of 20 of these participants will 
be invited to take part in a qualitative interview as an additional component. The two components will 
enable exploration or the objectives listed in section 3.2 above. The content and procedures for each 
interview is described below. Participants will not be paid to participate in this study.  
4.1 Quantitative interviews (n=150) 
The study will aim to recruit 150 carers over a 15 month period starting in late 2017. The recruitment 
and consent process is described in detail in Section 6 and the power calculation in Section 7.  Carers 
will provide written, informed consent before completing a face-to-face interview in a location of their 
choice. Previous experience in research with carers indicates that the majority will wish to be 
interviewed in their own home or the home of the person with dementia. Researchers will undertake 
the interview in pairs to begin with but on their own after training is complete. They will adhere to the 
UCL lone worker policy. 
Researchers will ask questions and record answers on the Case Report Form (Appendix 1).  The CRF 
contains demographic questions about the carer and some basic information about the person with 
dementia (such as dementia severity, type of diagnosis and time since diagnosis).  

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The Marwit-Meuser Caregiver Grief Inventory Short Form (MMCGI-SF) [25] will be used to assess 
severity of grief before death. This scale contains three subscales: heartfelt sadness and longing, worry 
and felt isolation, and personal sacrifice burden; a cutoff of 70/90 is considered a high level of 
grief.[25] The Clinical Dementia Rating scale will assess dementia severity based on the carer’s report 
[26]. To test the primary hypothesis we will collect a number of measures to reflect the five modifiable 
factors that suggest preparation for end of life: 
1. Greater knowledge of how dementia progresses (Dementia Knowledge Assessment Scale [27]) 
2. Greater knowledge of the person with dementia’s end of life preferences (Discussed wishes 
regarding end of life with your relative? Have a good understanding of their wishes for end of 
life care?) 
3. Having a lasting Power of Attorney or other formal advance directives in place - a proxy 
indication of “preparedness” (binary variable; any form of directive in place/not in place) 
4. Higher satisfaction with communication with healthcare providers (Health Literacy 
Questionnaire [HLQ, excluding Social Support subscale] which examines how well carers 
understand health information and navigate the health system [28]) (See Appendix 2) 
5. Higher satisfaction with support for health from social network (HLQ-Social Support 
subscale.[28])  
A number of other measures have been included for other exploratory analysis and to control for 
possible confounders. These include: 
• 
Townsend Deprivation Index (identified through the participant’s postcode) 
• 
Hospital Anxiety and Depression Scale (HADS) [29] 
• 
Relationship Closeness Scale [30] completed to reflect current relationship as well as 
relationship prior to dementia [31]  
• 
Subscales (denial, self-blame, acceptance, active coping, humour, and substance abuse) from 
the Brief Coping Orientation to Problems Experienced scale (Brief COPE) [32] 
• 
Religiosity using the Duke University Religion Index (DUREL) [33] 
• 
Questions about the experience of taking part in the study (See justification and questions in 
Section ‘Assessment and Management of Risk’ in this protocol).  
After agreeing to a date for the interview carers will be sent the Health Literacy Questionnaire (HLQ) 
[28] and be encouraged to complete this before the face-to-face interview. The purpose of this is to 
reduce the time required to complete the face-to-face interview so that it is less burdensome for the 
carer. The questionnaire is suitable for this purpose as it contains neutral questions about 
communicating with healthcare professionals. 
4.2 Qualitative semi-structured interviews (n=20) 
A sub-sample of the 150 carers will be invited to participate in an additional set of semi-structured 
open-ended questions to enable more in-depth exploration of some of the secondary objectives as 
outlined in section 3.2 above. The interview will explore the dynamic and changing nature of grief over 
time, how carers identify with the concept of grief and whether they consider they are going through 
a grief experience. It will also examine what supports they have found helpful and what they perceive 
to be unmet information and support needs and possibly programs/resources that might address 
these needs. The interview guide (Appendix 3) provides a list of questions that will be used as a guide 
for a fluid conversation that will pick up on areas considered relevant by the participant. Qualitative 
interviews will be audio-recorded with permission from the participant on an encrypted digital 
recorder and then transcribed verbatim by the research team. 
Participants will be purposively selected to provide a mix of responses representing male and female 
participants, adult child and spouse participants, different ethnicity as well as carers of people at 

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different severity of dementia. Participants who agree to participate in the quantitative interviews will 
also be asked to participate in the qualitative interview after completing the quantitative interview. If 
the sample is not representing a mix of carers based on the above categories, we will reduce 
invitations to those who are not represented in the sample. We will aim to interview carers until 
saturation of data is reached. We envisage this will be between 15-20 carers. Once we have achieved 
saturation we will cease inviting carers to take part in this component of the study. Carers will have 
the choice of completing this interview on the same day or another day if they are feeling tired.  
5 ELIGIBILITY CRITERIA 
5.1 Inclusion Criteria 
Carers of people with dementia providing practical, social, emotional or supervisory support to a 
friend or family member. This will include carers of people with dementia living at home or in a care 
home. Carers will be 18 years of age or over and living in England. The person they care for will have 
received a formal diagnosis of any dementia related disease.  
5.2 Exclusion Criteria 
Carers who are not able to communicate in English or who do not have capacity to provide informed 
written consent.  
6 RECRUITMENT 
6.1 Identifying potential participants 
Participants will be identified and approached for consent from multiple sources as described below.  
6.1.1 
Join Dementia Research 
The study will recruit participants through the Join Dementia Research (JDR) website. The study is 
eligible to be included on the NIHR CRN portfolio as the funder (Alzheimer’s Society) is an NIHR non-
commercial partner. All studies on the NIHR CRN portfolio are eligible for inclusion on the JDR website 
to recruit participants. 
JDR is an on-line self-registration service that enables volunteers with memory problems or dementia, 
carers of those with memory problems or dementia and healthy volunteers to register their interest 
in taking part in research, giving their permission for researchers to contact them about relevant 
studies.  The purpose of JDR is to allow such volunteers to be identified by researchers as potentially 
eligible for their studies.  Researchers can then contact volunteers, in line with the volunteers 
preferred method of contact, to further discuss potential inclusion. 
JDR is funded by Department of Health working in partnership with the charities Alzheimer’s Society 
and Alzheimer’s Research UK and is Health Research Authority (HRA) endorsed.  The on-line service 
and all associated documentation, methods of contacting volunteers and handling their data, were 
reviewed by a specially convened HRA committee which included experts in research ethics, data 
protection and information governance.  Further information on JDR is available here: 
http://www.crn.nihr.ac.uk/dementia/about-dementia-research/join-dementia-research/  
The JDR will register the study and enter in the eligibility requirements including being a carer of 
someone with dementia and being over the age of 18 living within a specific distance of 3 postcodes 
(one each in London and North and South England; distances and postcodes can be extended during 
recruitment according to recruitment progress). Once full ethical approval is granted, the study will 
become live on the JDR website. When live, the research team members who have been registered to 
access the study (CI and research assistant) will receive a list of potentially eligible carers. Carers who 
express a specific interest in this study will be flagged on the system and will be a priority for contacting 

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by the research team with a requirement to contact them within five days of expressing interest. 
Potentially eligible carers will be contacted to see whether they would like to be involved in the study 
and if so, will be sent the PIS. After 3 days we will telephone them to ask if they have read the PIS and 
are happy to be involved. If they are, a time and date will be arranged for the quantitative interview.   
We will record the number of matched volunteers. We will also maintain a log of those we invite to 
participate but who do not agree to be involved. The log will include the carer’s gender, age category 
(18-39; 40-49, 50-59, 60-69, 70-79 and 80+) and relationship to person with dementia (spouse; adult 
child; other relative; other friend). This information will not identify the carer but will enable the 
research team to compare responders and non-responders and to calculate a response rate. 
6.1.2 
NHS services 
NHS services will assist with recruitment as and will include those providing memory assessment 
services/memory clinics, Community Mental Health Teams, Admiral Nurses (attached to NHS 
services), GP clinics and other dementia support programmes. Administrative staff or clinicians at NHS 
sites will identify carers potentially eligible for the study from databases they have routine access to. 
The research team will not have any access to the service’s databases. These databases will only be 
accessed by clinicians/administrators who have routine access to these databases through their usual 
employment. Recruiting services will mail by post or email an expression of interest letter (See 
Appendix 4) to carers. The letter provides brief information about what the study is examining and 
what participating in the study involves. GP clinics will display flyers promoting the study (Appendix 
5). Carers who are interested in learning more about the study can either telephone or email the 
research team directly using contact details in the letter, or will be able to return a reply slip with a 
pre-paid envelope with their name and phone number for the research team to call them back. If 
agreed by the NHS service, a staff member from the service will invite (face-to-face or by telephone) 
carers to participate. If the carer is interested the NHS staff member will ask them if they agree for 
their contact details to be forwarded to the researcher or if they would prefer to contact the 
researcher directly.   
NHS services will record a log of people who are sent the expression of interest letter. The log will 
record the same un-identifiable data as reported above in Section 6.1.1 (gender, age category and 
relationship). 
The following NHS services have agreed to support recruitment: 
• 
Barnet, Enfield & Haringey Mental Health NHS Trust  
• 
Camden and Islington NHS Foundation Trust 
The Dementia Research Review Board of the Sussex Partnership NHS Foundation Trust will review the 
research study at their next board meeting on the 12/10/2017 before they will confirm provisional 
support for the study. 
6.1.3 
Non-NHS services 
Other non-NHS services including care homes, Admiral nursing services that are not attached to NHS 
services and branches of the Alzheimer’s Society will also be invited to assist with recruitment. 
Recruitment through these services will be undertaken using the same approach as that used with 
NHS services. In addition, researchers may attend carer education/support groups to discuss the study 
and identify any interested carers or may promote the study via their newsletters. 
6.1.4 
Monitoring recruitment 
After 50 carers have been recruited to the study we will undertake summary statistics to assess the 
mix of carers in terms of dementia severity, gender, relationship and mix of deprivation.  

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6.2 Obtaining consent 
Telephone or email contact with the research team will enable carers to be screened for eligibility and 
to provide more details about the study and answer carers’ questions. The research team will maintain 
a log of calls for those who do not proceed to an interview. This log will not record any identifiable 
information but will record reasons why the person was not eligible or did not want to participate, 
along with the date of the call and where they had been informed about the study.  
If the carer is eligible and interested in being involved they will be sent a copy of the PIS (Appendix 6). 
After 3 days we will telephone them to ask if they have read the PIS and are still happy to be involved. 
If they are, a time and date will be arranged for the quantitative interview.  Interviews will be 
conducted in a location suitable for the carer – either in their own home, at a meeting room on the 
6th Floor, Maple House, 149 Tottenham Court Road, London W1T 7NF or another location of their 
choice (provided it is suitable for a private, quiet conversation).  Researchers will follow the UCL lone 
worker policy. Once a date has been agreed, carers will be sent a letter confirming the interview details 
(See Appendix 7) and asking they complete the enclosed Health Literacy Questionnaire (HLQ, 
Appendix 2).   They will be able to complete the HLQ before the interview if they wish to reduce the 
number of questionnaires that will need to be undertaken on the day of the interview.  
A sub-sample of carers (see selection criteria in Section 4.2) will be asked whether they would also like 
to take part in the additional qualitative semi-structured interview. We will endeavour to complete 
both the quantitative and qualitative interviews on the same day but will give carers the option of 
splitting it over two days if they want a break. The PIS indicates that only 20 carers will be invited for 
this additional component. Carers will be given this option at the end of the quantitative interview 
based on the purposive sampling strategy described in Section 4.2. They will either be able to continue 
on with the second interview or an alternative interview date will be arranged.  
On the day of the quantitative interview, the researcher will go through the details on the PIS and 
check that the carer understands all parts of the PIS. The carer will be given an opportunity to ask any 
questions and be reminded that they can withdraw participation at any time. If they are still happy to 
participate they will be asked to complete and sign two copies of the consent form (Appendix 8) before 
commencing the interview(s). The researcher undertaking the interview will also sign both copies of 
the consent form. One copy along with the PIS will be left with the participant and the researcher will 
take the other copy of the consent form. The consent form also includes a question to consent to the 
research team contacting them within the next 2 years to be asked whether they are interested in 
participating in any extensions of this study or related research studies. In particular, the final work 
stream of the study will involve developing a resource for carers. Carers recruited for the interviews 
will be invited to support developing or testing this resource. Participation in this final work stream 
will involve signing a separate consent form with a study amendment or new ethics approval process.  
6.3 Withdrawing from the study 
During the consent process it will be explained to participants that they are free to withdraw at any 
stage. As the initial interview is conducted on the same day as consent is provided, it is unlikely that 
participants will want to withdraw from the study on the same day. If they find the interview difficult 
or long, however, they may wish to cease the interview. Data collected to this point will be included 
in the analysis (if sufficient to warrant inclusion) as long as the participant agrees.  
6.4 What happens if a participant loses capacity after consenting? 
As consent will take place on the same day as the interview it is unlikely that they could lose capacity 
within the same day. If they agree to take part in the second interview on a date in the future we will 
briefly review the Participant Information Sheet before completing the second interview to check that 
they still understand what participating involves and still have capacity to take part. 

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7 DATA ANALYSIS 
7.1 Statistical Analysis 
The statistical analysis will be overseen by the project statistician (Victoria Vickerstaff). Multivariable 
regression analysis will be used to enable us to explore the impact of a range of modifiable factors 
reflecting preparation for end of life on the MMCGI-SF, our main outcome. This type of analysis also 
allows us to control for potential confounding variables. The analysis will use the MMCGI-SF as the 
dependent variable with five predictor variables: knowledge of how dementia progresses; knowledge 
of the person with dementia’s end of life preferences; having a lasting Power of Attorney or other 
formal advance directive in place; satisfaction with communication with healthcare providers; and 
satisfaction with support for health from your social network (detailed in Section 4.1).  
The latter two items are extracted from the Health Literacy Questionnaire [28]. Health literacy is likely 
to be related to deprivation, which we will measure using the Townsend Deprivation Index. We will 
first examine whether there is collinearity between the health literacy and deprivation variables. If 
they are not related we will add deprivation as a covariate. Other potential confounding variables will 
be included in the analysis:  
• 
Relationship type: being a spouse/partner, a child or another relationship (categorical 
variable; i.e. 2 covariates) 
• 
Gender (binary measure) 
• 
Care home status: living at home or in a care home (binary measure) 
• 
Religiosity (continuous measure) 
In total there are 10 potential covariates to be included in the model. A sample of 15 participants per 
covariate is preferable while ten may be sufficient.[34]. We will aim to recruit 150 participants for an 
adequately powered analysis.  
7.2 Qualitative Analysis 
We will aim to interview carers until saturation of data is reached. We envisage this will be between 
15-20 carers. Once we have achieved saturation we will cease inviting carers to take part in this 
component of the study. In qualitative studies robust data needs to be in-depth and a key method of 
assessing data quality is whether saturation is reached, where no new themes are being identified. A 
sample of 15-20 participants is likely to be adequate for data saturation and to provide a range of 
diverse views from carers representing a mix of gender, relationship and dementia severity (as 
described in Section 4.2).  
Qualitative interviews will be audio-recorded on an encrypted digital recorder and then transcribed 
verbatim by the research team. Transcripts will be entered into NVivo qualitative software package 
(QSR International) to support data coding.  This data will be thematically analysed [35, 36] by coding 
chunks of text and grouping these codes into themes and sub-themes that address the study 
objectives. Two researchers will independently code and analyse each interview independently and 
then compare codes and themes to ensure rigour in analysis. Discrepancies will be discussed until 
consensus on themes is reached. Interviews will be coded as collected to enable subsequent 
interviews to draw on and explore themes arising. While we aim to recruit carers from a mix of 
categories (gender, relationship type and dementia severity) we will not be able to make comparisons 
between groups because of the small numbers representing each group (eg there may be only one 
male son caring for someone with mild dementia). The themes identified will help to draw out 
individual experiences in relation to carer grief and access to supports to supplement and expand the 
quantitative data. 

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8 PATIENT AND PUBLIC INVOLVEMENT (PPI) 
This study is one component of a fellowship study focusing on grief amongst family and friends caring 
for someone with dementia and the relationship between preparation for end of life and grief before 
death in dementia care. The full study has been reviewed by the Alzheimer’s Society Research 
Network, which consists of people with dementia and family and friend carers. Seven Network 
members participated in a focus group to provide feedback on the study and expressed passionate 
views about the lack of information about dementia progression and end of life care and also the lack 
of service response to their grief throughout the trajectory of dementia. Written ratings were received 
from another 45 Network members in which two thirds rated the study between 1-4 on a priority 
rating from 1=highest priority to 10=lowest priority. Many provided positive feedback such as  
“One effect on carers of people with dementia has often been described as a living 
bereavement, if this project can help to improve the type and level of appropriate support 
to carers then it will be very welcome.” 
“Important. There is a general reluctance to look ahead after a diagnosis of dementia, and 
the progression of the disease is not always explained clearly to carers.” 
“From my personal experience as a carer of a relative with dementia I suffered a more 
intense level of grief coming to terms with the fact that the person I cared for was not the 
person I knew and loved. It was at this point that my relative died to me, their actual death 
was a relief to me that their suffering had ended. This loss referred to as 'grief before death' 
is very real indeed and from personal experience there was little to no support apart from 
family members, to help me cope with my relative who no longer was the person I knew and 
loved.”  
Carers are also involved as monitors of the study and involved in the project Steering Group and an 
Expert by Experience Group reviewing all aspects of the study, reviewing analyses and providing 
suggestions for dissemination. Refer to the ‘Monitoring and Auditing’ Section of this document for the 
research governance structure for this study which incorporates input from carers.   
9 FUNDING AND SUPPLY OF EQUIPMENT  
The study funding has been reviewed by the UCL/UCLH Research Office, and deemed sufficient to 
cover the requirements of the study. The research costs for the study have been supported by an 
Alzheimer’s Society Senior Research Fellowship, Grant Reference number 325 (AS-SF-16-004), 
Funding: £300,662 (1/4/2017-31/3/2020). The funding covers costs of a computer for the CI, a 
computer for the Research Assistant and an encrypted digital recorder for the study all located at UCL. 
Contracting costs for Dementia UK to support recruitment of carers and Admiral Nurses are also 
included in the budget. Admiral Nurses will be recruited for another element of this study which will 
have a separate protocol and ethics application. Mail out and postage costs incurred by services 
distributing expression of interest letters have been included in the grant budget.  
10 DATA HANDLING AND MANAGEMENT 
Questionnaires will be collected on a paper based Case Report Form (CRF) (See Appendix 1 [CRF] and 
Appendix 2 [HLQ]). The HLQ may be self-completed by the carer prior to the face-to-face interview 
and collected by the researcher at the time of the interview. The CRF will be completed at the 
interview by the researchers at a location selected by the participants (most likely in their own homes). 
The CRF and HLQ will be returned by the researcher to UCL and locked in a filing cabinet in the secure 
UCL offices.  

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The subsample of 20 carers taking part in the semi-structured interviews will be asked to provide 
consent for audio-recording the interview using an encrypted digital recorder. The encrypted recorder 
requires a 4 digit PIN to be entered to turn it on. Listening to any recordings also requires entering 
another password. If participants consent to be audio recorded the researcher will download the 
audio-recording to a secure University College London (UCL) computer as soon as feasible after 
completing the interview. Once downloaded it will be deleted from the digital recorder. If they do not 
consent to be audio-recorded, the researcher will take written notes from the interview. Audio-
recordings and written notes will be transcribed verbatim by the research team and saved on secure 
UCL computers.  
All paper documents (HLQ, CRF, and semi-structured interview notes) for the study will be stored in 
accordance with the Declaration of Helsinki. All the information will be kept strictly confidential and 
held in accordance with the principles of the Data Protection Act (1998). Each participant will be 
assigned a research number and all data will be stored without subject name or address or date of 
birth. Data will be held on a secure database on a password-protected computer in the Marie Curie 
Palliative Care Research Department, Division of Psychiatry, 6th Floor Maple House, 149 Tottenham 
Court Road, UCL. Access to data will be restricted to appropriate members of the research team.   
As per the research governance framework overseeing the study (See diagram in the ‘Monitoring and 
Auditing’ section), the Data monitoring and research ethics team will review and oversee all data 
collection and monitoring procedures.  
11 PEER AND REGULATORY REVIEW 
The study has been peer reviewed in accordance with the requirements outlined by UCL. The study 
was presented at workshops and seminars within UCL and received feedback from attendees. The CI 
received input into the design from Dr Louise Jones, previous head of the MCPCRD, the MCPCRD 
statistician and Professor Michael King, joint director of the Priment Clinical Trials Unit and joint lead 
on the UCL arm of the London Research Design Service. After this input the study was successfully 
awarded funding by the Alzheimer’s Society in an open competitive grant scheme. 
The Sponsor considers the procedure for obtaining funding from Alzheimer’s Society to be of sufficient 
rigour and independence to be considered an adequate peer review. 
12 ASSESMENT AND MANAGEMENT OF RISK 
12.1 Assessment and management of risk to participants 
The interview covers topics about future planning and plans for end of life care as well as loss and grief 
during caring for someone with dementia. These are sensitive topics that may arouse an emotional 
response from participants. We have developed a procedure to minimise and respond to any 
participant who becomes distressed. The procedure draws on the framework for ethical-decision 
making that has been developed in the UK for research with bereaved family and carers [37] and which 
are mostly applicable to this study. 
Prior to the interview, participants will be informed that the interview may be emotional and tiring 
and to think about and agree on avenues of post-interview support. Prior to the interview, participants 
will also be asked to make the interviewer aware if they want to pause the recording. This will also be 
offered to carers who appear upset or appear to be tiring during the interview. They will be offered a 
break, to postpone the interview or to withdraw their participation. At the end of the interview carers 
will receive information on local carer support agencies and if they are experiencing distress will be 
advised to contact their GP or Alzheimer's Society National Dementia Helpline. We will facilitate this 

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process if necessary. We have also included three questions from the above mentioned framework at 
the end of the CRF [37]: 
• 
Do you feel you could cope with the length of the interview? 
• 
Did you find talking in the interview helpful? 
• 
Did you feel the interview caused you distress? 
These questions will enable us to monitor the impact of the study. Sque et al [37] in their sample of 
bereaved carers (n=31) found that 90% could easily cope with the length of the interview, most found 
it very helpful (81%) or a little helpful (16%) and 58% found it a little distressing with only 3% reporting 
it caused a lot of distress.  We will revise the protocol if we are finding that this study is causing greater 
distress and burden and is unhelpful. We will call participants two days later to check whether thinking 
about the interview has raised any concerns or questions for them.  
In our extensive experience of undertaking interviews with carers of people with dementia and 
addressing topics such as grief, loss and end of life care, we find that interviews can provide a cathartic 
experience for carers, providing them an opportunity to talk about their thoughts and feelings to in 
impartial researcher who is disconnected to their personal social network. Death and end of life care 
are topics that tend to be avoided in society and yet impact all of us. Providing an avenue to talk about 
some of these issues can be welcomed by participants who have not had an opportunity to express 
these thoughts before. Family carers may be motivated to participate to educate others about their 
experiences of care to help improve services and to be able to talk about issues they haven’t previously 
had an opportunity to discuss. The benefits of learning about the process of grief and how we can 
improve supports to carers is an important area of research with the growing number of people living 
with dementia and as dementia is now the largest cause of death in the UK [1].  
12.2 Assessment and management of risk to research staff 
Research staff undertaking interviews within participants’ homes also face potential risks. Research 
staff will follow the following procedures to try to identify, minimise and manage risks following the 
UCL’s lone worker policy.  
13 RECORDING AND REPORTING OF EVENTS AND INCIDENTS 
13.1 Definitions of Adverse Events  
This is an observational study, there are no interventions, and we do not anticipate any adverse events 
associated with this project. We will however, use the standard definitions of adverse events as 
supplied by the UCL JRO. 
Term 
Definition 
Adverse Event (AE) 
Any untoward medical occurrence in a patient or study participant, 
which does not necessarily have a causal relationship with the 
procedure involved.  
Serious Adverse Event 
(SAE). 
Any adverse event that:
• 
results in death, 
• 
is life-threatening*, 
• 
requires hospitalisation or prolongation of existing 
hospitalisation**, 
• 
results in persistent or significant disability or incapacity, or 
• 
consists of a congenital anomaly or birth defect 

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*A life- threatening event, this refers to an event in which the participant was at risk of death at 
the time of the event; it does not refer to an event which hypothetically might have caused 
death if it were more severe. 
** Hospitalisation is defined as an in-patient admission, regardless of length of stay. 
Hospitalisation for pre-existing conditions, including elective procedures do not constitute an 
SAE. 
13.2 
Assessments of Adverse Events  
In the unlikely event that this occurs, each adverse event will be assessed for severity, causality, 
seriousness and expectedness as described below. 
13.3 Severity  
Category 
Definition 
Mild 
The adverse event does not interfere with the participant’s daily routine, and does 
not require further procedure; it causes slight discomfort 
Moderate 
The adverse event interferes with some aspects of the participant’s routine, or 
requires further  procedure, but is not damaging to health; it causes moderate 
discomfort 
Severe 
The adverse event results in alteration, discomfort or disability which is clearly 
damaging to health 
 
13.4 Causality 
The assessment of relationship of adverse events to the procedure is a clinical decision based on all 
available information at the time of the completion of the case report form.  As above we do not 
anticipate any adverse events will arise from this project. 
However, if necessary the following categories will be used after review by the CI to define the 
causality of the adverse event: 
Category 
Definition 
Definitely: 
There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. 
Probably: 
There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely 
Possibly 
There is some evidence to suggest a causal relationship (e.g. the event occurred 
within a reasonable time after administration of the study procedure). However, 
the influence of other factors may have contributed to the event (e.g. the 
participant’s clinical condition, other concomitant events). 
Unlikely 
There is little evidence to suggest there is a causal relationship (e.g. the event did 
not occur within a reasonable time after administration of the study procedure). 

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There is another reasonable explanation for the event (e.g. the participant’s 
clinical condition). 
Not related 
There is no evidence of any causal relationship. 
Not Assessable 
Unable to assess on information available. 
 
13.5 Expectedness 
Category 
Definition 
Expected 
An adverse event which is consistent with the information provided in the 
Participant Information Sheet or clearly defined in this protocol. 
Unexpected 
An adverse event which is not consistent with the information provided in the 
Participant Information Sheet or clearly defined in this protocol. 
 
13.6 Recording adverse events  
In the unlikely occurrence of an adverse events this will be will be recorded in the CRF.  
13.7 Procedures for recording and reporting Serious Adverse Events  
All serious adverse events will be reported to the CI and recorded in the CRF, and the sponsor’s AE log. 
All SAEs (except those specified in section 16.5 as not requiring reporting to the Sponsor) must be 
recorded on a serious adverse event (SAE) form. The CI will complete an SAE form and the form will 
be emailed to Research-incidents@ucl.ac.uk within 5 working days of becoming aware of the event. 
The CI will respond to any SAE queries raised by the sponsor as soon as possible. Where the event is 
unexpected and thought to be related to the procedure this must be reported by the Investigator to 
the Health Research Authority within 15 days. 
 

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Flow Chart for SAE reporting  
AE occurs 
Assign Severity Grade 
Was the event Serious? 
Was the event an Other 
Notifiable event?  
See section 13.8 for notifiable 
events which should also be 
reported as serious 
No 
No 
Yes 
Yes 
Yes
No 
Submit SAE form to Sponsor within 5 working days 
Record in CRF in accordance with the 
protocol  
 
Record in medical records
and CRF (if applicable) 
Is the event specified as an adverse event which does not require immediate reporting as an SAE?  
Record in CRF (and AE Log if required)  
Complete an SAE report form 

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13.8 Protocol deviations and notification of protocol violations 
A deviation is usually an unintended departure from the expected conduct of the study protocol/SOPs, 
which does not need to be reported to the sponsor.  The CI will monitor protocol deviations. 
A protocol violation is a breach which is likely to effect to a significant degree – 
(a) the safety or physical or mental integrity of the participants of the study; or 
(b) the scientific value of the study. 
The CI and sponsor will be notified immediately of any case where the above definition applies during 
the study conduct phase. 
13.9 Trust incidents and near misses 
An incident or near miss is any unintended or unexpected event that could have or did lead to harm, 
loss or damage that contains one or more of the following components: 
a) It is an accident or other incident which results in injury or ill health. 
b) It is contrary to specified or expected standard of patient care or service. 
c) It places patients, staff members, visitors, contractors or members of the public at 
unnecessary risk. 
d) It puts the Trust in an adverse position with potential loss of reputation. 
e) It puts Trust property or assets in an adverse position or at risk. 
Incidents and near misses must be reported to the Trust through DATIX as soon as the individual 
becomes aware of them. 
A reportable incident is any unintended or unexpected event that could have or did lead to harm, loss 
or damage that contains one or more of the following components: 
a) It is an accident or other incident which results in injury or ill health. 
b) It is contrary to specified or expected standard of patient care or service. 
c) It places patients, staff members, visitors, contractors or members of the public at 
unnecessary risk. 
d) It puts the Trust in an adverse position with potential loss of reputation. 
e) It puts Trust property or assets in an adverse position or at risk of loss or damage. 
 
 

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14 MONITORING AND AUDITING 
The CI will ensure there are adequate quality and number of monitoring activities conducted by the 
study team. This will include adherence to the protocol, procedures for consenting and ensure 
adequate data quality. The CI will inform the sponsor should she have concerns which have arisen 
from monitoring activities, and/or if there are problems with oversight/monitoring procedures. The 
study Governance Framework provides a clear framework for governance of the study including a data 
monitoring and research ethics group as shown in the governance structure below.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
15 TRAINING 
The CI will review and provide assurances of the training and experience of all staff working on this 
study.  Appropriate training records will be maintained in the study files. The CI will complete UCL core 
training requirements supervising staff as well as statistical courses on regression and statistics for 
health research (statistics will also be overseen by the study’s statistician Victoria Vickerstaff). Other 
compulsory training for researchers involved in the study will include Good Clinical Practice and SLMS 
Information Governance annual training.  
Interviews will be undertaken by the CI and the Research Assistant who will be employed. The CI has 
a psychology and social science background and extensive research experience in undertaking 
interviews with carers of people with dementia across all stages of dementia progression. The 
Research Assistant will be employed at a level 6B and will have research experience and a degree 
relevant to mental health and dementia care. The Research Assistant will be provided with training 
1. Supervisory Team: 
Dr Liz Sampson 
Dr Claudia Cooper 
3. Data monitoring and research ethics
Victoria Vickerstaff (statistician) 
Dr Liz Sampson 
2. Experts by Experience Advisory 
Group 
4. Steering Group 
Dr Kirsten Moore 
Representative from Supervisory team 
Representative from Experts by Experience Advisory Group 
Representative from Data monitoring and Research Ethics 
Mentors: Prof Michael King, Dr Marilyn Relf, Dr Karen Harrison-Dening, Associate Prof 
Briony Dow  
Representatives from Carers UK and Marie Curie 
Dr Nathan Davies 
Senior Research Fellow
Dr Kirsten Moore 
Funders 
Alzheimer’s Society 

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from the CI to conduct the interviews. The Research Assistant will observe the CI complete 1-2 
interviews. When they feel confident to complete the interview they will complete the interview 
under observation from the CI. It is envisaged that they will be observed for 2-3 interviews until they 
feel confident and the CI feels they have achieved the level of competency required for completing 
the interviews. This training process will also involve debriefing sessions and reflection on the topic 
and nature of the interviews. After the initial training period, the research assistant will also have 
regular debriefing sessions with the CI as well as any additional sessions if the research assistant feels 
they need it. They will ring or meet with the CI directly after any interviews they have found 
distressing. 
Additional clinical support to the CI and Research Assistant will be provided by the fellowship 
supervisor Dr Liz Sampson and co-supervisor Dr Claudia Cooper, both experienced, internationally 
renowned dementia and end of life care researchers and Old Age Psychiatrists.  
16 INTELLECTUAL PROPERTY 
We do not anticipate that this study will generate any intellectual property. 
17 INDEMNITY ARRANGEMENTS 
University College London holds insurance against claims from participants for harm caused by their 
participation in this clinical study. Participants may be able to claim compensation if they can prove 
that UCL has been negligent.  
18 ARCHIVING 
UCL and each participating site recognise that there is an obligation to archive study-related 
documents at the end of the study (as such end is defined within this protocol). The CI confirms that 
she will archive the study master file at UCL for the period stipulated in the protocol and in line with 
all relevant legal and statutory requirements.  
19 PUBLICATION AND DISSEMINATION POLICY 
We will disseminate findings via academic journals, conferences, to research participants and via social 
media and relevant websites (e.g. Alzheimer’s Society, National Council for Palliative Care, Marie 
Curie, Cruse Bereavement Care and carer support agencies). Admiral Nurses on the research team will 
help dissemination of the resource into their practice. The project’s steering group will provide further 
guidance on dissemination. A half day forum will be held at the end of the study to promote the study 
findings to members of the Steering Group, study participants and interested stakeholders. Study 
participants and recruiting agencies will also receive a lay summary of the key findings. A publication 
plan has been developed that defines authorship and an outline for planned publications arising from 
the fellowship.  
20 REFERENCES 
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assessment and advance care planning in severe dementia: an exploratory randomized 
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21 LIST OF APPENDICES 
1. 
Case report form – Quantitative interview 
2. 
Pre-interview questionnaire - Health Literacy Questionnaire 
3. 
Semi-Structured Interview guide 
4. 
Letter of invitation distributed by recruiting agencies with expression of interest form 
5. 
Flyer advertising for participants 
6. 
Participant information sheet 
7. 
Cover letter for posted Participant Information Sheet 
8. 
Consent form