A multi-center, open label, longitudinal, observational, 12-week study of Flexilev treatment with the dosing device OraFID and accompanying digital app in Parkinson patients.
This research is looking at how people in the UK with Parkinson's disease use a medicine called Flexilev, specifically when taken with a special device called OraFID and a linked digital app. Over 12 weeks, participants will share their experiences through questionnaires about the device and app. The study will also gather information from the app itself, and participants will answer questions about their general health, mood, and Parkinson's symptoms. This helps researchers understand how helpful and easy the new way of taking medicine is, and how it might impact daily life for people with Parkinson's.
At a glance
What is this study about?
Imagine you have Parkinson's disease and your doctor prescribes a medicine called Flexilev. This study is all about a new way to take that medicine using a special device called OraFID and a digital app that works with it. The main idea is to see how well people can use this new system in their everyday lives and if it's easy and helpful.
Over 12 weeks, you would be sharing your experiences by answering questions about the device and the app. The researchers also want to understand if using this system helps with your Parkinson's symptoms, how your mood is, and your overall quality of life. All of this information helps them learn if this new way of taking Flexilev could be a good option for others with Parkinson's.
This is a 'post-market' study, which means Flexilev is already a licensed medicine. The study isn't testing if the medicine works, but rather how people use a new delivery method in their daily lives. By taking part, you'll be helping doctors and scientists understand how to make managing Parkinson's even better for patients in the future.
Key takeaways
- The study focuses on how people use a new medicine delivery system (OraFID + app) for Flexilev.
- It aims to understand real-world experiences and how the system impacts daily life for those with Parkinson's.
- Participation involves answering questionnaires about the device, app, and your health over 12 weeks.
- This research helps improve future Parkinson's care by understanding patient perspectives.
- It does not involve new medication or extra clinic visits beyond your usual care.
- You can withdraw from the study at any time without affecting your medical treatment.
Who may be eligible?
To join this study, you need to be at least 18 years old and have been diagnosed with Parkinson's disease. Both men and women can take part.
It's important that you are already using or about to start using the Flexilev medicine with the OraFID dosing device and its linked digital app as part of your regular treatment. This study is about understanding how people use this specific system in their real lives.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you at least 18 years old?
- Do you have Parkinson's disease?
- Are you currently using or about to start using Flexilev medicine with the OraFID device and its app?
- Are you able to complete questionnaires?
- Are you willing to participate for 12 weeks?
What does participation involve?
If you decide to take part, you'll be involved for about 12 weeks. During this time, you won't have extra clinic visits specifically for the study. Instead, you'll be asked to answer questionnaires about your experiences with the OraFID device and the digital app, and about your health and Parkinson's symptoms. These questionnaires will be completed by you and recorded in a system usually managed by your doctor. The study will also collect information directly from the app about how you're using it and your medicine. Your doctor will still be managing your regular Parkinson's care and prescribing your Flexilev medicine as usual.
Potential risks and benefits
Locations (1)
- —UnverifiedSweden
Common questions
What is the purpose of this study?
To understand how people with Parkinson's disease use the Flexilev medicine with the OraFID device and its app in their daily lives.
Do I have to take a new medicine?
No, this study is for people already using or starting Flexilev medicine with the OraFID device and app as part of their regular treatment.
How long will I be in the study?
The study lasts for 12 weeks.
Will I have extra doctor appointments?
No, your involvement is mainly through answering questionnaires, often at your regular check-ups, and data from the app.
What kind of questions will I be asked?
You'll answer questions about how you use the device and app, your health, mood, and how Parkinson's affects your daily life.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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