(Form to be on headed paper)
Participant Information Sheet (PIS)
Study Title: Can paper based reading exercises improve reading speed and accuracy in people who have lost one side of their visual field (homonymous hemianopia) following stroke?
Lead Researcher: Roisin Buckels
Invitation to participate in the above study:
We would like to invite you to take part in a research study. Before you decide we would like you to understand why the research is being done and what it will involve for you. Please take time to read the following carefully and discuss it with others if you wish.
The complete description can be read to you over the phone if you prefer.
We suggest setting aside XX minutes for the complete description.
Part 1 of the PIS tells you the purpose of this study and what will happen to you if you take part.
Part 2 gives you more detailed information about the conduct of the study.
Please ask us if there is anything that is not clear. Take time to decide whether or not you wish to take part.
If you are interested in participating in the study please contact the lead researcher to arrange a convenient time for your first appointment.
Roisin Buckels : tel
What is the purpose of the study?
The purpose of this study is to investigate whether reading can be improved using simple exercises for people with a homonymous hemianopic type of visual field loss which has followed a stroke.
It is very important to emphasise that these exercises cannot restore the part of your vision that has been lost because of the stroke. The exercises are purely aimed at improving reading ability using the vision you have remaining.
If you have found that your reading has been relatively unaffected by your lost visual field you may decide not to enrol in the study.
What is a homonymous hemianopia?
A homonymous hemianopia (HH) is when someone loses the ability to see to one side of them, either left or right. It can be “complete”, meaning that all of the visual field to that side has been lost, or “incomplete”, where some of the vision to the affected side has been spared.
Figure 1
Figure 1 shows the world view of someone with a complete left sided homonymous hemianopia.
Why have I been invited?
This is a joint research project between the Moorfields Eye service at St George’s Hospital and the community rehabilitation services at St John’s centre. We have been screening referrals into the eye clinic and an occupational therapist in the community service has screened their database to find people who have a HH following stroke and may benefit from these exercises.
There will be a maximum of 24 participants in the study and spaces will be allocated on a first come first serve basis.
Do I have to take part?
It is completely up to you to decide whether you would like to take part in the study. We have sent you this information pack to describe the study but should you wish be involved you will need to contact us using the telephone number provided on the front sheet and at the end of this pack.
If you do take part you will be asked to sign a consent form when you arrive for your first appointment in the hospital clinic. You are still free to leave the study at any time during the data collection period of the study and do not need to give a reason.
Not being involved in or leaving the study will not affect any other care you receive from the hospital or community rehabilitation centre in any way.
In some people, ability to talk or understand written and spoken language may be affected after stroke or as a result of other general health issues. If this is the case you will not be able to participate in this particular research project.
What will happen to me if I take part?
Everyone entering the study will be given a month course of exercises and two appointments in the outpatient Moorfields clinic at St George’s Hospital.
At the first appointment the orthoptist who is leading the research will assess your visual field, your reading ability and ask you a number of questions to understand how you feel your reading has been affected by the vision loss. The exercises will then be demonstrated to you. This appointment will last up to one hour.
These exercises are not currently offered to patients who attend the Moorfields Eye clinic. This study is the first of its kind and which we are doing to see what effect the exercises have on reading & how participants feel about the exercises. Based on the results of this study, we will then decide whether these exercises should be offered to future patients.
At the second appointment the orthoptist will repeat the assessments of your visual field and reading ability. You will then we asked a number of questions to understand whether you think your reading has improved. This appointment will also last up to an hour.
It is important to note that the orthoptist will not be able to tell you whether your reading has clinically improved at this point as analysis won’t happen until everyone has completed the study.
What do I have to do?
As part of the study, you will be expected to read two pages of text with a line guide for one month. A line guide is a cut section of coloured plastic – see Figure 2 – will is designed to isolate a section of text on a page and make it easier to either; find the next word in right sided vision loss or find the start of the line again in left sided vision loss.
Figure 2
You will be given a printed section of a book to use when performing the exercises at home to make sure the exercises are standardised for everyone.
You must then attend the second appointment in St George’s Hospital so we can assess your reading and ask your opinions of the exercises.
Visual field loss can have significant recovery within the first three months after stroke. We will therefore arrange the first appointment after this period so we provide exercises to people with residual field loss.
Other than this, there are no other lifestyle, medical or dietary requirements to be involved in the study.
If you are involved in any other research studies or have done these exercises before please inform the orthoptist when you call to express your interest in the study.
What are the alternatives for treatment?
Currently, no treatments are prescribed at St George’s Hospital for the reading issues associated with visual field loss following stroke. This is an area which still needs a large amount of research and while alternative treatments are available, none are recommended by NHS/orthoptic guidelines as they have not been proven to work.
What are the possible disadvantages and risks of taking part?
There are no risks associated with the study other than inconvenience in attending the hospital and performing the exercises daily.
What are the side-effects of any treatment received when taking part?
Some participants may find the exercises tiring if they find reading particularly difficult and may experience headaches and other signs of fatigue. Severe fatigue and headaches are very unlikely but should the participant feel unable to continue they should contact the orthoptist to withdraw from the study.
There are no risks to unborn children or pregnant mothers.
What are the possible benefits of taking part?
Your ability to read and ease of reading may improve.
What if there is a problem?
If you experience any problems with the exercises please contact the orthoptist for advice on the telephone number provided between 9am-6pm.
In the case of complaints or concerns, direction and contact details will be provided in section 2.
Expenses and payments
Unfortunately, we are not able to cover expenses of your travel during this study. We will try and give you appointment times which fit around your daily routine to reduce any inconveniences to you.
Will my taking part in the study be kept confidential?
Yes, we will follow ethical and legal practice and all information about you will be handled in confidence. The details are included in Part 2.
This completes Part 1.
If, having read Part 1, you are interested in participating in the study please read the additional study information in Part 2 before making a decision.
Part 2
What if relevant new information becomes available?
We will review the research regularly during the study and it is possible than new information about the reading exercises may be published during that time. If this happens we will contact you directly to discuss the new findings, any differences between the research projects and whether you would like to continue in the study. If you do decide to continue you may be asked to sign an agreement outlining our discussion.
As stated previously, leaving the study will not affect any care you receive from the hospital or community rehabilitation centre in any way.
If the study is stopped for any other reason, we will discuss this with you.
What will happen if I don’t want to carry on with this study?
As previously stated, leaving the study will not affect any care you receive from the hospital or community rehabilitation centre in any way and you do not need to provide reasons for your withdrawal.
If you do withdraw, with your permission we would like to use the data provided by you up to that point but you retain the right to decide if the data collected at your visits can be used in the study. If you decide that you would prefer for your data not to be used we will destroy all your identifiable papers (survey results, visual field results, consent papers etc)
What if there is a problem?
Complaints:
If you have questions or concerns during the study please feel free to contact the orthoptist & researcher who will do their best to address the issue.
Name
Number: Mon – Fri 9am to 6pm
If you have any complaints about the way you have been dealt with or any effects of the exercises which you would rather not discuss with the orthoptist a contact number for the Primary Investigator who oversees the project has been provided at the end of the pack. All conversations will be treated confidentially.
Name:
Number:
The normal National Health Servicecomplaints mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Joint Research and Enterprise Office at St George’s.
Harm:
St Georges, University of London has agreed that if you are harmed as a result of your participation in the study, you will be compensated, provided that, on the balance of probabilities, an injury was caused as a direct result of the intervention or procedures you received during the course of the study. These special compensation arrangements apply where an injury is caused to you that would not have occurred if you were not in the trial. We would not be bound to pay compensation where: -The injury resulted from a drug or procedure outside the trial protocol and/or -The protocol was not followed. These arrangements do not affect your right to pursue a claim through legal action.
Will my taking part in the study be kept confidential?
Any information collected from you in paper format (survey results, consent forms etc) will be kept in a locked locker (to which only the researcher has the key) within a locked clinical room at the hospital. The papers will not be removed from the hospital site during the process.
When the data leaves the site it will do so in an anonymised way in which participants are identified by a code number.
When the study has ended any personal data will be given to the hospital research and development teams to be kept securely for 10 years, after which they will be securely destroyed.
Your data will not be used in any future studies.
Your GP does not need to be notified that you are participating in the study.
§ who will have access to view identifiable data (authorised persons such as researchers, sponsors, regulatory authorities and R&D audit (for monitoring of the quality of the research) etc (not normally RECs in the UK);
§ Participants have the right to check the accuracy of data held about them and correct any errors. Participants should be informed of any transfer of their identifiable data to countries having a lower standard of data protection than the UK.
§ The following or similar words could be used:
Data collected during the study may be sent to associated researchers to countries where the laws don‘t protect your privacy to the same extent as the law in the UK but the Sponsor will take all reasonable steps to protect your privacy.
What will happen to the results of the research study?
This research is being undertaken as part of a Masters degree in Clinical Research. The results of the study will be written up in a dissertation and following that we intend to publish the results in a scientific journal. The results from the study will be disseminated to colleagues working in stroke both individually and at scientific conferences. All results will be anonymised.