FAQs for people taking part in the trial

This trial is designed to improve the way in which care and support is provided for people living with Parkinson’s and similar conditions. We have designed a new approach to caring for people with Parkinson’s but do not know yet whether this approach is better than how we currently care for people with Parkinson’s.

Everyone who participates, regardless of which group they are allocated, may find it helpful to undergo the assessments and better understand some of the symptoms they experience. The interviews that help you set goals for the future may help you focus on ways in which you can improve your experience of living with Parkinson’s. Some people feel better for having an opportunity to describe and write about their experience of their condition when they take part in a trial.

Whilst we anticipate that the new care (PRIME Parkinson Care) may be beneficial we don’t know for sure and that is why we need to perform the trial.

Taking part may not benefit you directly but it may benefit people with Parkinson’s in the future.

If you take part in the trial, you will be asked to:

• Complete questionnaires on 3 occasions over a 2-year period
• Attend the hospital a total of 2 times for the assessments. These may take place in your home or over the phone or video if appropriate.
• Take part in a discussion with a member of the study team about your ‘goals’ or things you would like to achieve.
  • A goal might be something that you currently find difficult to do and wish you could do more easily, or without getting frustrated. 
  • Or a goal might be something that you are currently not doing and would like to do more of.
• Receive telephone calls from the research team every 3 months for 2 years.

Everyone is asked to complete the questionnaires at home:

• At the start of the trial
• After 1 year
• After 2 years

These will be on a range of topics, including symptoms which people with Parkinson’s may experience and how any symptoms you experience affect your wellbeing and your quality of life.

Many of these questionnaires have been designed especially for use in research and are mainly tick-box or short answer questions. This will help us to ascertain whether the new model of care is effective. If you feel unsure about how to answer any questions on the questionnaires, or you feel uncomfortable answering any questions, you are welcome to leave these blank and/or to contact the research team for support.

We will send these questionnaires to you as a paper booklet for you to complete and post back to us (we will include a pre-paid envelope).

We can provide large print copies of the questionnaire if needed and can help facilitate completion of these – for example, if English is not your first language.

A friend or family member can help you to fill in the questionnaires so long as you provide the answers to the questions. If you do not have someone who can help you in this way, a member of the team can help you answer the questions when you come to hospital. 

Different people will need different amounts of time to complete the questionnaires.  We anticipate that the questionnaire will take between 1-3 hours to complete. However, you can take your time completing the questionnaires and do so over a few days.  It is important though to try and complete all the questionnaires in the booklet. If you complete the questionnaires before Visit 1, and decide at Visit 1 that you do not wish to take part or are ineligible to take part, the questionnaire booklet will not be kept.  

The research team will telephone you every 3 months to find out how you are progressing with your goals, whether you have had any falls and to answer any questions you have.

These telephone calls will last approximately 30-60 minutes and can be at a time convenient to you.

When you come to the hospital at the start of the trial and after 2 years, the team will:

• Answer any questions you may have and then ask you to sign a consent form if you agree to take part (first visit only)
• Ask you some further questions (for example, about symptoms you experience)
• Ask you about the things you would like to be able to do or achieve in your day-to-day life (your goals)
• Carry out some physical assessments (for example examining you for signs of parkinsonism and asking you to walk if you are able to do so). Some of these assessments may be video recorded which may include assessment of your movement and voice.
• Perform a bone density (DXA) scan at the first visit only to measure how strong your bones are.
  • This involves lying on the scanner bed in different positions while the scanner arm moves over you.
  • Each scan will take approximately 5 minutes.
  • This procedure uses X-rays, a form of ionising radiation, to measure the strength of your bones.
  • Ionising radiation may cause cancer many years or decades after the exposure. We are all at risk of developing cancer during our lifetime. 50% of the population is likely to develop one of the many forms of cancer at some stage during our lifetime. Taking part in this study will add only a very small chance of this happening to you as the amount of radiation involved is equivalent to that you naturally receive over the course of a week living in the UK. You can read more about this type of scan here: https://www.nhs.uk/conditions/dexa-scan/what-happens/

It may be possible to arrange for this visit to happen at home, or by phone call or video call, if appropriate. The research team will discuss this with you prior to arranging your initial visit (Visit 1). If the visits take place at your home, by phone or videocall, some of the tests may not be carried out (for instance, the bone density scan), or may be rescheduled for another time.

If your caregiver takes part, they will be asked to come to the hospital for the same two visits, at the start of the trial and after 2 years. They will be asked to complete questionnaires each time, and have some physical assessments carried out. They will not be asked about their goals, nor will they have a bone density scan. It may also be possible to arrange the visits for the caregiver to take place at home, by phone or by videocall if appropriate.

Yes, you can still take part in this trial even if you are currently taking part in another research study or trial.

The researchers in both trials would discuss with you the logistics and feasibility to taking part in more than one study/trial. 

It should not cost you any money to participate in this trial.

Your local team may be able to help organise transport to and from the hospital and will cover the cost of reasonable travel expenses including parking.

We will give you prepaid envelopes to return the questionnaires.

If any answer in the completed questionnaires raises a concern about your wellbeing, we would initially help you to access further care from a relevant professional.

If we felt that you were at significant risk, we may need to contact the relevant clinical or social care team on your behalf, but we would always seek to inform you that we were doing this.

If you wish to complain or have any concerns about the way you have been approached or treated during the course of this trial, you should contact: ruhtr.researchopu@nhs.net or telephone 01225 825797. You can also contact the Patient Advice and Liaison Service:

• Head of PALS, RUH Bath NHS Trust, Combe Park, Bath BA1 3NG
• 01225 825656
• ruh-tr.psct@nhs.net

If, for any reason, you are unable to visit the hospital for the assessment visits, we will seek to carry these out using other methods.

This might include researchers visiting you at your home or place of residence.

We may perform some of the assessments using video conferencing.

We would discuss with you what might best suit you and take into consideration any risks of travel and visiting the hospital.

Some of the team will need to know your name and contact details so that we can contact you to send you questionnaires. This information, which can identify you, is known as personal data.  

The team will record the information from the questionnaires that you complete and the information from your assessments and will combine it with the information from everyone else in the trial. This recorded information is called research data. 

Most of the team will not need to know your personal data such as your name.  In these cases, someone will remove your name from the research data and replace it with a code number.  This is called ‘pseudo-anonymised’ data. This means that your research data will be anonymous to the researchers, but the code can be used to find your name and other personal details if required, for example to contact you. 

If you agree to take part in the trial, we will also collect some data about you from hospital and GP records.

This data will include information about whether you have attended hospital for any reason.

If you have been admitted to a hospital other than the RUH Bath, we may also collect data from NHS Digital.

• This public body collects information from all hospitals on behalf of the Government. All this information is routinely collected by the NHS whenever someone has hospital treatment. NHS Digital will link your NHS number to data which will provide information about outcomes of people taking part in the trial. 
• To obtain this important information we will ask your permission to share your full name, gender, NHS number, postcode and date of birth with NHS Digital.
• This data will be sent and analysed by the University of Bristol research team working on the trial. 

The research data will be confidential.  

• We will store your pseudo-anonymised questionnaire data in password-protected files which will only be accessible from University of Bristol and RUH Bath computers.  
• Paper questionnaires and assessment outcomes will be stored securely at the RUH Bath and at the University of Bristol.  
• Any video recordings of you will be stored along with your other research data in line with the University of Bristol policy on storage of such data. Video recordings will only be used for assessment purposes and will be destroyed in line with other data that is collected as part of this trial.
• The team will use the data to understand the characteristics and needs of people with Parkinson’s and the people who support them. 
• We may use your stored pseudo-anonymised data for future medical and health-related studies.
• Your personal details (name, email address, postal address and telephone number) will be used only for this trial and will not be kept beyond the conclusion of the trial unless you have indicated that you wish to be contacted about future studies.
• The trial is being undertaken in full compliance with data protection legislation, specifically Article 6.1(e) of the General Data Protection Regulation, as it is covered by a public task, and Article 9.2(j) as it relates to scientific research. We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
• The University of Bristol will be the data controller for this trial.  You can find out more about how the University ensures information is handled appropriately here. 

Yes. We will follow ethical and legal practice and all information about you will be handled in confidence.

When you are enrolled you will be issued with a Participant Identification Code. This will protect confidentiality during routine collection of your data.

With your permission, your GP and Parkinson’s specialist will be informed of your participation in the trial.

RUH Bath will use your name, NHS number and contact details to contact you about the trial. They will make sure that relevant information about the trial is recorded for your care and oversee the quality of the trial.

Individuals from University of Bristol, monitoring and regulatory organisations may look at your medical and research records to check the accuracy of the research trial. RUH Bath will pass these details to University of Bristol along with the information collected from you and/or your medical records.

The only people in the University of Bristol who will have access to information that identifies you will be people who need to contact you to collect information about falls and goals or audit the data collection process.

We do not expect there to be any additional risks to you relating to the new type of Parkinson’s care itself.

Taking part in the trial will involve having some assessments with the team and also answering some questionnaires.  You may find some of the questionnaire items to be quite personal, for example questions about your recent thoughts and feelings. Some questions concern intimate topics such as sexual activity, bladder and bowel function. 

It is possible that filling in the questionnaires could raise an issue or concern for you. If this happens, you should discuss this with the specialist who looks after your Parkinson’s.  

If you agree to take part in a research trial, the pseudo-anonymised information about your health and care may be provided to researchers conducting improvement work or running other research studies in this organisation and in other organisations.

• These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. This may include the providers of the validated questionnaires (e.g. Insignia Health) used in the trial.
• Your information will only be used by organisations and researchers to conduct future research in accordance with the UK Policy Framework for Health and Social Care Research.
• This information will not identify you and will not be combined with other information in a way that could identify you.
• We may share your ethnicity (if provided) and pseudo-anonymised health data recorded as part of the trial.
• The information will only be used for health and care research and cannot be used to contact you or to affect your care.
• It will not be used to make decisions about future services available to you, such as insurance.

When the trial has ended, the results will be presented at scientific conferences and other relevant meetings and will be submitted for publication in medical journals.

When we share the results of key findings, we will upload a summary to the PRIME Parkinson website.  

If you have any concerns about how your personal data is being handled in the trial, you can contact the Data Protection Officer at the University of Bristol:

Email: data-protection@bristol.ac.uk or telephone: 0117 455 6325

If you have concerns, you have the right to complain to the Information Commissioner’s Office (ICO).  Further details can be found at www.ico.org.uk

The PRIME Parkinson RCT has been set up and sponsored by the University of Bristol in collaboration with the Royal United Hospital, Bath.

The research is being funded by the Gatsby Foundation. 

All research in the NHS is reviewed by an independent group of people, called a Research Ethics Committee, which is there to protect your safety, rights, wellbeing and dignity.

If you have any concerns or questions about anything to do with the PRIME Parkinson RCT or if there is anything in this participant information booklet that you do not understand, please telephone 0117 455 4083 (Monday to Friday: 9:00 – 17:00).

Thank you for helping us with this important trial.

Please ask one of the PRIME team for an expense claim form. Once complete, return the form to the PRIME team and we will arrange for the expenses to be repaid direct to your bank account. 

After you had agreed to take part in the trial and signed a consent form, you were enrolled in the study. Everyone who enrolled in the study was randomised - randomly allocated by a computer programme – to either the "usual care" arm or group, or the PRIME Parkinson care arm or group.

There was a 50:50 chance of being allocated to each type of care which means that both options were equally likely: half the people in the trial were allocated to usual care, and half were allocated PRIME Parkinson Care.  Neither you, your Parkinson’s team nor the researchers could decide which type of care you would receive.

The Usual Care group is the "control" group of trial. It is extremely important to have a control group in a randomised control trial like PRIME, because it allows us to show whether or not the ‘intervention’ of the study is successful.

We give huge thanks to everyone in the control group who has already spoken to our team members about how they are getting on with their goals. It's so important to the trial that we have a strong control group as without it we cannot demonstrate any differences in the PRIME active care group compared to usual NHS care.

In group A (usual care) you will receive exactly the same care as you would if you were not in the trial. The only difference will be that you will be asked to complete some questionnaires and speak to our researchers on a regular basis. The information collected on these questionnaires will help us to find out if the new model of care is effective.

‘Usual care’ is provided as normal through the NHS and other services. You will continue to be followed up in the usual way by your Parkinson’s consultant and nurse specialist. You will be given written information signposting you to ways of accessing help for your Parkinson’s disease via your usual team.

You will be asked to attend for an assessment on 2 occasions – once at the start of the study (Visit 1) and after 2 years (Visit 2). On both occasions you will be sent questionnaires to complete before you attend. You will also be sent a questionnaire to complete at home after 1 year (Mid-Point Assessment).   

Everyone who participates in the trial, regardless of which group they are allocated, may find it helpful to undergo the assessments and better understand some of the symptoms they experience.

The interviews that help you set goals for the future may help you focus on ways in which you can improve your experience of living with Parkinson’s.

Some people feel better for having an opportunity to describe and write about their experience of their condition when they take part in a trial.

Whilst we anticipate that the new care (PRIME Parkinson Care) may be beneficial we don’t know for sure and that is why we need to perform the trial.

Taking part may not benefit you directly but it may benefit people with Parkinson’s in the future.

If you wish to withdraw (stop taking part) from the trial completely you will be withdrawn, and we will not contact you again as part of this trial.

If you were to withdraw, we would ask you why you had made this decision, but you do not have to tell us.

Any information we have collected up until the point you withdraw will be used in our analysis of the trial results.

We would continue to collect data from your electronic records unless you ask us not to.

After you had agreed to take part in the trial and signed a consent form, you were enrolled in the study. Everyone who enrolled in the study was randomised - randomly allocated by a computer programme – to either the "usual care" arm or group, or the PRIME Parkinson care arm or group.

There was a 50:50 chance of being allocated to each type of care which means that both options were equally likely: half the people in the trial were allocated to usual care, and half were allocated PRIME Parkinson Care.  Neither you, your Parkinson’s team nor the researchers could decide which type of care you would receive.

People allocated to this group (also called the “active arm” will receive PRIME Parkinson Care.

• This provides people living with Parkinson’s, their caregivers, and their health-care professionals, with additional support to understand the condition and how best to manage symptoms.
• We will also ask people in this group to undergo assessments, complete questionnaires and receive telephone calls from the study team.
• The study team will help you set goals, personalise a care plan for you, and will telephone you to check on how you are progressing with reaching your goals.

You can contact the team from Monday to Friday, 09:00 – 17:00, on:

Telephone: 0117 455 4083 (outside working hours you can leave a voice message for the team)

or

email: prime-parkinson@bristol.ac.uk

If you are contacting us outside working hours, we will get back to you as soon as possible on our return.

If you are calling about a clinical issue or enquiry, the office team can pass your message onto the PRIME clinical team who will respond as soon as they are able. 

If you wish to withdraw (stop taking part) from the trial completely you will be withdrawn, and we will not contact you again as part of this trial. If you were to withdraw, we would ask you why you had made this decision, but you do not have to tell us.

Any information we have collected up until the point you withdraw will be used in our analysis of the trial results. We would continue to collect data from your electronic records unless you ask us not to.

If you are allocated to PRIME Parkinson Care but wish to stop receiving this care but not withdraw, it is important that you still receive the phone calls, return for your assessments and complete the questionnaires after 1 and 2 years.  We need to try to get results from everyone who took part to properly analyse the results of the trial. If you feel the burden of the trial is too much, you can withdraw, and we will not contact you again as part of this trial. Again, we would ask you why you had made this decision, but you are not obliged to tell us the reason.

Taking part in this trial would involve you attending 2 assessments and completing questionnaires.   

IF the person you support or care for is allocated to receive PRIME Parkinson Care you will be offered additional support.

You will be asked to complete questionnaires at home:

• At the start of the trial
• After 1 year
• After 2 years

The questionnaires will be on a range of topics, including symptoms which people with Parkinson’s may experience and how any symptoms you experience affect your wellbeing and your quality of life.

We are also interested in your own general health including your nutritional health, so there are some questions which ask about your food consumption.

Many of these questionnaires have been designed especially for use in research and are mainly tick-box or short answer questions. This will help us to ascertain whether the new model of care is effective.

The person for whom you provide care will be asked to complete questionnaires at the same three times, will be asked about their goals, and will be invited to have a bone density scan at their first visit only.

If the person you support or care for is allocated to receive PRIME Parkinson Care you will be offered additional support. This will help you care for your friend/relative who is living with Parkinson’s Disease.

The additional support you receive might be based around education, signposting to services, access to workshops delivered by the PRIME Team, or assistance with aspects of being a caregiver which you find most challenging.

If you wish to withdraw from the trial (stop taking part) completely you will be withdrawn, and we will not contact you again as part of this trial. If you were to withdraw, we would ask you why you had made this decision, but you are not obliged to tell us.

Any information we have collected up until the point you withdraw will be used in our analysis of the trial results. We would continue to collect data from your electronic records unless you ask us not to.

If the person you care for or support is allocated to PRIME Parkinson Care, but you wish to stop receiving the caregiver support, it is important, if possible, that you still complete the questionnaires after 1 and 2 years.  We need to try to get results from everyone who took part to properly analyse the results of the trial. If you feel the burden of the trial is too much, you can withdraw, and we will not contact you again as part of this trial. In this case, we would ask you why you had made this decision, but you are not obliged to tell us the reason.