Participant Information Sheet1.4(Caregiver Survey)

Study Title:Neuro LTC: Assessing Baseline Factors and Critical Events that Influence Care Requirements in Long Term Neurological Conditions

Researcher: Dr Christopher Kipps

ERGO number:23026

Please read this information carefully before deciding whether to take part in this research. If you are happy to participate you will be asked to confirm your consent on the first page of the survey.

What is the research about?

This research studyaims to identify the factors that influence the level of care required by persons living with a specific neurological condition. It will identify thefactors that predict levels of care (baseline factors). It will alsoidentify the events that lead to an increase in care either at home or with an admission to hospital (critical events).

The study is organised by Dr Christopher Kipps, Consultant Neurologist at University Hospital Southampton NHS Foundation Trust. It is sponsored by the University of Southampton. It is being supported by the National Institute for Health Research (NIHR), Collaborations for Leadership in Applied Health Research and Care (CLAHRC), Ageing and Dementia: Improving Routine Clinical Care theme.

Why have I been chosen?

You have been asked to participate in this research study because you provide care or assistance to someone who has one of the following neurological conditions we are interested in learning more about: epilepsy, Huntington's disease, motor neurone disease, multiple sclerosis, or Parkinson's disease. We would like to see whether you would be willing to take part in a survey. The survey is about factors that influence the level of care that the person you care for needs due to their neurological condition. This would involve you completing an online or paper-based version of a questionnaire. It will ask you about the things that you think increase or decrease the level of care that the person you care for needs.

Do I have to take part?

Your participation in this research study is entirely voluntary. It is up to you to decide whether or not you would like to participate. The care or treatment you or the person you care for receives now or at any time in the future will not be affected by your decision. If you do agree to take part in the research study we will ask you to sign an informed consent form to demonstrate your agreement. If you decide to take part you are still free to withdraw at any time.

What will happen to me if I take part?

If you agree to take part in this research study we would like you complete a survey questionnaire. We estimate that it would take you under 30 minutes to complete. It can be completed on a computer with internet access, on paper or over the telephone. There will only be one survey to complete and no further participation from you is required at this time. However, there will be future opportunities to participate again in the study if you would like to, for example in focus groups. At the end of the survey we will ask you if you would like take part in future activities in the research project.

Are there any benefits in my taking part?

We cannot guarantee any direct advantages to your participation in this research study. However, sometimes people do find it useful to talk about and share their experiences. What you tell us will help us to better understand the factors that influence care levels for people living with certain neurological conditions. This may help us to develop new ways of assessing and monitoring important aspects related to neurological conditions. It may also help us to better organise care and service provision in the future.

Are there any risks involved?

We do not anticipate any risks or disadvantages in your taking part.This study has been reviewed by an independent ethics committee to protect your safety, rights, well-being and dignity. This study has been given a favourable opinion by the University of Southampton Faculty of Medicine Ethics Committee.

If any topic in the survey does cause you distress and would like to speak to somebody, we can arrange for a member of the clinical team to contact you to provide support. We also provide details of Southampton Counselling run by the YMCA Fairthorne Group who offer a self-referral counselling service (see contact details below).

Will my participation be confidential?

All information that is collected about you during the course of the research study will be kept strictly confidential. It will be stored in accordance with the Data Protection Act and the University of Southampton policies. All data collected from you will be link anonymised using a code or pseudonym instead of your name. Only researchers working on the study will have access to the original names and their linked codes and pseudonyms. All data will be stored on a password protected computer in a locked office at an NHS site.

What happens if I change my mind?

Your participation in the research study is voluntary. You are free to withdraw at any point without giving any reason. If you do decide to withdraw we would like to maintain any data we have already collected up to your withdrawal. If you do decide to withdraw, this will not affect the present or future treatment or care of you or the person you care for.

What happens if something goes wrong?

If you have a concern about any aspect of this research study, you should ask to speak to the researchers involved who will do their best to deal with your concerns (see contact details below). If they are unable to resolve your concern you can contact Patient Support Services, Southampton General Hospital, tel:02381206325 or email . In the unlikely event that you should you wish to complain formally you should contact the University of Southampton Research Governance Office, tel. 023 8059 5058,

Where can I get more information?

Research Officer
Dr Sarah Fearn
Tel: 07393762105 or 023 8120 8301
Email: / Chief Investigator
Dr Christopher Kipps
Wessex Neurological Centre
Mailpoint 101 Level A
Southampton General Hospital
Tremona RoadSouthampton
SO16 6YD
Tel:023 8120 5434
Email: / Admin contact
Ms Lesley MacKinnon, Research co-ordinator
Tel: 023 8120 6132 Thursday-Friday
Email:
Southampton Counselling Service Fairthorne Group
Email:
Phone:02380639966

Last updated:08/11/2016Version number1.4