If you have Parkinson’s and live in the community and would like to get involved in this study there are a couple of ways of doing so. You could either take part as 1., a participant in one of the stages of the study described below or 2., as a member of the Patient and Public Involvement group (PPI).
1., Taking part as a study participant:
The creation of the Live well with Parkinson's new resource will take several stages. It is firstly important to find out about the experiences, needs and goals of people with Parkinson’s. This will be done by asking those with Parkinson’s about their experiences of what helps them manage their Parkinson’s at home. It will also be done by looking at the existing research. This information will then be used to develop the content of a self-management resource, and a training programme for health professionals. These will then be tested in a feasibility trial and then a Randomised Controlled Trial (RCT) to see how effective they are in making a positive difference in the health and lives of those with Parkinson’s.
Who can take part?
Anyone who has been diagnosed with Parkinson’s’ who is living at home in the community. We are also interested to meet with partners and those who help and support those with Parkinson’s.
What is involved?
The different stages to the study require different activities and level of involvement for participants. The different stages are described below:
- Development of content for the new resource: Up to around 40 people will take part in this stage of the study. Those taking part will meet with a member of the research team on one occasion to answer some questions about their experiences of having Parkinson’s. This will help provide essential information about what should be included in the new resource and how this should best be presented.
- Co-design of the new resource: Those taking part in this stage of the study will help with the design and content of the new resource by using and commenting on it, so that modifications can be made if felt to be necessary. Taking part will involve meeting with members of the research team and other people with Parkinson’s, their partners/carers and healthcare professionals. Meetings will take place on several occasions (around three in total), with six week gaps.
- Feasibility of the toolkit: Those taking part in this stage of the study will use the newly developed resource, which will make it possible for us to evaluate its effectiveness. Taking part will involve meeting with the research team on two separate occasions to complete some assessments and some questionnaires. This is as well as using the new resource, supported by a facilitator. Some participants will also be invited to meet with a member of the research team on one occasion to answer some questions about how they found completing the questionnaires and using the new resource.
- Randomised Controlled Trial: Taking part in this stage of the study will involve meeting with the research team on three separate occasions throughout a year (at the beginning, after six months and finally after 12 months from the start of the study). Half the people taking part will be allocated by chance to a group where they will be given access to the Live well with Parkinson's resource as well as their usual care. The other half will be allocated to a group that continues to receive their usual care as normal, but will not be able to access the new resource. This means the benefits of the new resource can be measured. Up to around 350 people will be involved in this stage of the study.
- Process Evaluation: The final stage of the study will help with the evaluation of the effectiveness of the Live well with Parkinson's resource. Taking part in this stage of the study will involve meeting with the research team on one occasion for an interview asking some questions about how it was using the new resource. We are interested in understanding how it might help, any improvements that could made and how it could be best used in the NHS more widely.
If I take part, will my information be kept confidential?
Any information collected during the study will be kept confidential. Assessment and test results will be stored on secure, confidential, computer network systems. None of the participants involved in the study will be identified in any report or publication. Parts of the transcripts from the interviews may be published, but in a form whereby the person making the comments cannot be identified.
How do the changes in data protection law affect the information I give you?
Under the new General Data Protection Regulation (GDPR) the Royal Free London NHS Trust, as the sponsor for this study based in the United Kingdom, will act as the data controller for this study. This means the Royal Free London NHS Trust are responsible for looking after your information and using it properly. As a NHS organisation we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
What if I no longer want to take part?
You are free to withdraw at any time. Your decision to take part or not will not affect the care you are receiving.
2., Becoming a member of the Patient and Public Involvement group (PPI)
We would like to hear from you if you would be interested in joining our Patient and Public Involvement (PPI) group. This would involve advising on the content and progress of the study, for example commenting on the content of study documents and design of the new resource. Meetings with others who have Parkinson’s and use NHS services would take place a couple of times a year, and more often during the time when the toolkit is being designed.
Health Care Professionals:
If you are a member of a multidisciplinary team looking after people with Parkinson’s and frailer older people we would like to invite you to consider taking part in our study. Taking part would be to help with the design and content of the new resource, and training for health care professionals. This would involve meeting with members of the research team and other health care professionals in focus groups or for a semi-structured interview. Doing this will help provide essential information about what should be included in the new resource and how this should best be presented; and the training for health care professionals using the resource to support those with Parkinson's.
Who to contact for further information
If you are interested in finding out more please contact the study team:
- Name: Megan Armstrong - Trial Manager or Joy Read - Study Co-ordinator
- Email: email@example.com