The Live well with Parkinson's randomised controlled trial is now open to recruitment.
We have already developed and user tested the toolkit with people with Parkinson's. We are now looking to formally test the effectiveness of the toolkit to make a positive difference in the health and lives of those with Parkinson's, such as quality of life and symptom management.
What is Involved?
After finding out more information and consenting to taking part in the study there will be a few things involved:
All participants will complete assessments at 3 time points throughout the year (at the beginning, after 6 months and after 12 months of starting the study).
Half of the participants taking part will be allocated to the group receiving the Live well with Parkinson's toolkit, as well as their usual care. The other half will continue to receive their usual care as normal, with no access to the new resource. This enables the outcomes of people from both groups to be compared and the results to be trusted. It is imporant for people to be in both groups to answer the research question and decide if the toolkit can be adopted by the NHS and replace the current standard care.
When participants have completed the assessments after 12 months we may ask them to be involved in an interview with a member of the research team to understand how they found using the new toolkit. This feedback will help the research team to make improvements to the toolkit and how it will be implemented intp the NHS more widely.
Previous Participants Reasons for Taking Part
"I should do all I can to help [the hospital teams] because, they help me when I [see them]." "It is a principle of his, to give back."
"If you're going to make the best of it, it seems to me you need to manage it as well as you can."
"I suppose what I hoped to get out of it was to see if it plugged the gap... and it [did], so I'm absolutely delighted."
"I try and help research where I can, because it's good for you, it's good for us, it's good for everybody."
"I think its good to support research...because the more we do the better things can get for the people in the future."
Frequently Asked Questions
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 xomputer 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.
For more information, you can download a copy of the participant information sheet and leaflet here.
If you would like to speak to a member of the study team to find out more then please contact us here: firstname.lastname@example.org