Change in MND
Research type
Research Study
Full title
Cognitive, behavioural and lifestyle change in Motor Neurone Disease
IRAS ID
229656
Contact name
Eneida Mioshi
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Summary of research
Motor neurone disease (MND) is a progressive neurodegenerative disease that affects movement. Recent research has demonstrated that in up to 50% of individuals behaviour and/or thinking ability might also be affected, with up to 15% of patients developing associated dementia.
However, it is important to understand how these changes develop throughout the disease and their impact on everyday life, wellbeing and everyday functioning (such as mood, motivation, sleep, discomfort) of the person living with MND, as well as their family members.
The aim of this study is to investigate how different elements of everyday life, wellbeing and functioning associate with thinking abilities and behaviour in people with MND and their family members. Approximately 36 people with MND and 36 of their family carers (spouse/relative/close friends) will be recruited to take part in the study per year. This will amount to a total of 180 people with MND and 180 of their family carers (spouse/relative/close friends) over 5 years.
This study will include repeated visits and interviews both for the people with MND and their family carers. Each of these visits will last about 1 hour and a half, taking place every 3 months, totalling approximately 4 visits. At these visits we will assess thinking abilities (e.g. memory, language, attention), behaviour, wellbeing and everyday functioning of the people living with MND, as well as the lifestyle and wellbeing of the family carers.
Researchers will visit participants and their families at home, but they will also be provided an option to come to the University of East Anglia or a local NHS facility for participation. Eligible participants should have a diagnosis of MND and a family carer who is willing to participate in the study.Summary of Results
This study was carried out by a research team based at the University of East Anglia (UEA), Norwich. We created an acronym to facilitate communication and identification of the study, CHANGE-MND. We will refer to the study with this acronym from here onwards.CHANGE-MND was the parent study to the Norwich-based arm of ‘Clinical impact of apathy in motor neurone disease (CIAMND)’. CIAMND was a study led by Dr Ratko Radakovic and Prof Sharon Abrahams, in Scotland (October 2017 to September 2020). CHANGE-MND was sponsored by the UEA (UEA: University of East Anglia | Norwich, UK - UEA).
Participants were recruited from many clinical teams. The research team based at UEA had a very strong partnership with the clinical team at the Norfolk and Norwich University Hospitals NHS Foundation Trust which was key for recruitment purposes. We also had great support from James Paget University Hospitals NHS Foundation Trust, The Queen Elizabeth Hospital King’s Lynn NHS Trust and the Norfolk Community Health and Care NHS Trust. Recruitment via another approved related study run by the same research team, TRACC study (REC 16/LO/1366) was also pursued.
As CHANGE-MND study involved home visits to participants for data collection, and more than one visit to collect the information on the research protocol, we had to focus on residents living around Norfolk, Suffolk, Cambridgeshire, and Peterborough. Therefore, the great majority of our research participants involved in CHANGE-MND were residents from the East of England region.
The main purpose of CHANGE-MND was to investigate how cognitive and behavioural symptoms in people living with MND impacted on their everyday life and their family carers’. By identifying and understanding the trajectory of non-motor symptoms in people living with MND and how their quality of life and those of their families is affected as a consequence of cognitive and behavioural symptoms, we may be able to inform and develop ways to address non-motor symptoms for healthcare professionals (such as new interventions) and for families (such as delivering information and suggesting coping strategies).
A novel focus of our study was to investigate the impact of MND on families. By this we meant involving not only the person who had the diagnosis of MND, but also their primary informal carer, who was usually a spouse or child. We will refer to them as a ‘dyad’. To better understand the impact of MND on families, we intended to visit dyads at 4 different time points, if possible: baseline, and after 3 months, 6 months and 9 months. In these visits we completed various questionnaires about health and wellbeing of both the person with MND and their primary carer. All families were visited at their own homes. Due to limited resources and recruitment challenges, the study protocol suffered a few amendments.
Each visit involved a short assessment pack to be completed by the research team with person living with MND and a short person living with MND/study partner interview to be completed with the family carer, with a combined maximum length of an hour and a half, to avoid fatigue. Additionally, a package of self-completed questionnaires for each participant (person living with MND and family carer) was left with them for their completion. A free-postage envelope was also given to the participants so they could mail back the questionnaires to the research team.
The pandemic negatively affected our study, like most research studies across the world. In our case, it negatively impacted the intended recruitment. Participants could not be visited at home, as MND patients were advised to shield. Due to the nature of the assessments, these could not be adapted to be completed online or over the phone. We also had very limited resources.
RESEARCH STUDY AIMS
1. Explore cognitive and behavioural symptoms relations with disease progression, everyday life, quality of life and caregiver burden in MND and MND-FTD
2. Determine the acceptability and applicability of quality of life and caregiver burden as outcome measures for future interventions
RESULTS
A total of 65 eligible participants were recruited: 33 participants with a diagnosis of MND, and 32 study partners. From these participants, there were 32 pairs (person living with MND and their informal carer) and one person living with MND who participated without a study partner.
Thirty-two dyads completed baseline; after 3 months, 20 dyads; after 6 months, 15 dyads, and after 9 months, 12 dyads.People with MND were, on average, 68 years old and 70% were male. Family carers were on average 64 years old, and 78% were female; 85% had a spousal/partner relationship with the person with MND and were residing in the same house.
Forty-seven percent of people living with MND presented with behavioural changes, from which 6 had changes in the disinhibition domain, 8 in the apathy domain and 4 presented with stereotypical behaviour. This percentage is in line with other national and international studies in the field.
To understand if behavioural changes in the person with MND were having any impact on the carer, we split the participants in two groups: one group included carers who were looking after someone with MND and behavioural changes, and another group where carers were looking after someone with MND without behavioural changes.
We then run statistical tests to make comparisons that could help us understand the clinical impact of behavioural changes in the health of the carers. We compared the two groups of carers in terms of reported burden, depression and anxiety. Results suggested that levels of reported carer burden, depression and quality of life, were not different between carers of people living with MND who presented with or without behavioural changes. However, carers who were looking after someone with behavioural changes seem to report greater anxiety.
In relation to acceptability of quality of life and caregiver burden as outcome measures for future interventions, we can report that carers did not seem to find any problems in completing those measures. Completion rates were high.
In relation to applicability, we are less certain as to whether these measures would be the most appropriate as outcome measures in future interventions because even though the two carer groups were dealing with very different levels of behavioural changes in the person with MND, carer burden and carer quality of life were perhaps not sensitive enough to detect these. We had not anticipated that carer anxiety would have been the factor distinguishing the carer health state, and we conclude that studies involving behavioural symptoms as a target may benefit from including measures of carer anxiety.REC name
London - Queen Square Research Ethics Committee
REC reference
17/LO/1820
Date of REC Opinion
27 Nov 2017
REC opinion
Further Information Favourable Opinion