INFORMATION SHEET
(for People with Motor Neurone Disease)
Study title: Clinical Impact of Apathy in Motor Neurone Disease (CIA-MND)
REC Reference: 17/SS/0094
Name of Researchers: Dr Ratko Radakovic and Prof Sharon Abrahams
You are being invited to take part in a research study. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read through the following information with care and discuss it with others if you wish. Ask us if there is anything that is not clear or would like to be provided with more information. Take time to decide whether or not you wish to take part in the research study.
What is the purpose of the study?
Motor Neurone Disease (MND) is an illness characterised by deteriorating motor neurones but a common behavioural symptom associated with MND is a lack of motivation otherwise known as apathy. Only some people with MND display apathy and evidence has suggested that there may be different types of apathy that could be associated with different problems in everyday life such as understanding emotions, managing different tasks and thinking of new things to do. Apathy has been shown to change over time and could influence behaviour, lifestyle, quality of life, wellbeingand coping of both the person living with MND and their families. The aim of this study is to explore how apathy as a symptom changes over time and relates to lifestyle,quality of life, wellbeing,coping and other behaviour in people living with MND and their families.
Why have I beeninvited?
We are aiming to recruit 60 people living with MND and 60 of their carers/relatives/friends from across Scotland and England who may or may not have difficulties with motivation. You have been contacted as you have either given permission to be contacted about different types of research associated with the Scottish Motor Neurone Research Audit Research and Trials (SMART) Register of the Clinical Audit Research Evaluation-MND (CARE-MND)platform or associated with other similar research studies, or have expressed interest in receiving information about this study when talking to someone in your care team.
Do I have to take part?
No, it is your choice whether to take part or not. If you decide to take part, you will be given this information sheet to keep and read for as much time as you need. If you agree to take part in the study, you will be visited by a member of the research team and asked to sign a consent form. Please keep in mind that your participation in this study is voluntary so you may withdraw from the study at any time without explanation. This decision for you to withdraw or not take part will not affect the standard of care you receive, now or in the future.
What will happen if I take part?
The research study will consist of private interviews where you will be asked to answer questions about your feelings, motivation, physical abilities and your lifestyle. In addition to this you will be asked to complete a mixture of short and simple verbal and written tasks to test your thinking skills and memory.
There will be a total of 4 visits over 12 months, occurring every three months, where you will be asked to take part in these interviews. Each of these visits will take approximately 1 hour to completeand can take place in your home whenever is most convenient for you.
As part of the study, we would separately like to ask a carer/relative/friend who knows you well to complete some questionnaires and a semi-structured interview about their observations of your behaviour and motivation. These questionnaires and semi-structured interviews for carers/relatives/friends are designed to get as many perspectives as possible on changes in behaviour and motivation that may, or may not occur in people living with MND.We will also separately ask the carers/relatives/friends about their lifestyle, wellbeing and coping mechanisms, as well as the carers/relatives/friend’s own experience of MND. Any responses given to us by your carer/relative/friendwill remain confidential and we will not reveal them to you.
The interviews will take place at a time and place of your convenience. We will reimburse you for your time at £10 per session.
What do I have to do?
You will not have to come off medication or undergo any invasive procedure whatsoever. The interview will be short questionnaires about your mood, motivation, physical abilities and lifestyle andsimple verbal or written tasks. If you are unable to write we will assist you in filling out the questionnaires. If you are unable to speak we may skip certain tests that rely on spoken answers.
Will my General Practitioner/specialist be informed?
If you agree to join the study, your General Practitioner/Neurologist will be sent a letter and informed that you have agreed to take part in this study. We will ask you for permission to inform your General Practitioner.
It is possible that incidental findings arise from your participation in this study. We will ask your permission to share any relevant, incidental findings with your General Practitioner/Neurologist that might be relevant to your treatment.
What are the possible disadvantages and risks of taking part?
We do not anticipate any health risks from taking part in this study. If you feel distressed at all by the interview please do not hesitate to contact Professor Sharon Abrahams 0131 650 3339 (co-project leader).
What are the possible benefits of taking part?
There are no direct known benefits. The information obtained during the interview may be used to enhance your care. For example if there are symptoms of cognitive or behavioural change clinical advice may be given to your health care team. We will ask for your permission to do this. This study will help increase awareness and understanding of motivation in motor neurone disease and the lifestyle changes associated with it, for both the family and the patients.
What if something goes wrong?
Whilst we do not anticipate any adverse effects from taking part in this study, if you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone’s negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms willbe available to you. Before participating you should consider if this will affect any insurance you have and seek advice if necessary.
Will my taking part in this study be kept confidential?
All information which is collected about you during the course of the research will be kept strictly confidential. Only people from the research team and the specialist neurology or MND-clinical team at your hospital may have access to your medical records and notes. Any information about you which leaves the hospital will have your name and address removed so that you cannot be identified from it. You will be allocated an anonymous ID code during testing which will be used in place of your name in our testing materials, computers or on any future publications.
In the unlikely event that you lose the ability to give informed consent during the study, the information we have already collected about you will be retained and used in the research but no further information will be collected. As stated earlier, all personal information will be kept strictly confidential.
In exceptional circumstances, disclosure without consent, or against your expressed wish may be necessary in situations in which failure to disclose appropriate information would expose you, or someone else, to a risk of serious harm (including physical or sexual abuse) or death.
What will happen to the results of the research study?
The results of the research will be published in appropriate peer-reviewed scientific journals for distribution to other healthcare professionals. Talks and presentations may be made at meetings and conferences. In all cases, your name and personal details will not be identifiable or disclosed.
We will only share your anonymous results between the research team and ethically approved collaborators. We will ask your permission to share your anonymized data for other collaborating researchers to use in similar ethically approved studies, including collaborations that may be based outside the EU.
If you and your carer/relative/friend would like a summary of the findings of the study this will be made available on the MND Scotland website or other appropriate outlets (e.g. Euan Macdonald Centre for MND research website).
Who is organising the research?
The study is being organised by Dr Ratko Radakovic, University of East Anglia, Norwich, UK and Professor Sharon Abrahams, University of Edinburgh, Edinburgh, UK.
The study is funded by MND Scotland.
Who has reviewed the study?
This study has been reviewed and received favourable ethical opinion by the South East Scotland REC 02 Ethics Committee. The study has also been given NHS management approval.
Contact
If you have any further questions about the study please contact Dr Ratko Radakovic on: 01603 591 441 or email:
If you would like to discuss this study with someone independent of the study team please contact:
Scotland:
Dr Thomas Bak, University of Edinburgh, 7 George Square, Edinburgh, EH8 9JZ. 0131 650 3441
Or
England:
Dr Helen Copsey, University of East Anglia, Norwich Research Park, Norwich, Norfolk, NR4 7UY, 0160364 7221
If you wish to make a complaint about the study please contact NHS Lothian:
Patient Experience Team,
NHS Lothian
Tel: 0131 536 3370
Email:
Or
PALS (Patient Advice and Liaison Service),
Email:
Phone: 01603 421191 or BT Freephone: 0800 279 7257 (calls from mobiles may be charged)
Office open 9am to 5pm Monday to Friday. Outside these hours, please leave an answerphone message.
Thank you for reading this information sheet. You will be given a copy to keep. If you have understood the contents of this sheet and wish to take part, please complete the consent sheet on the next page. If you have any questions please feel free to ask them now.
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CIAMND Information Sheet Version 2, 10 August 2017