Wearable device and clinical outcome measures in real-life setting : an international survey.
Hello Families,
You are invited to participate in a research survey developed by Parent Project Muscular Dystrophy (PPMD) and Sysnav for patients living with a neuromuscular disease, their families, and caregivers. This is an international survey about your opinion, your expectations, and your concerns regarding the use of a wearable device in clinical trials as well as the clinical meaningfulness of potential outputs. The survey has been reviewed by The Myotubular Trust and several Steering Committees of patients registries contacted by the Treat-NMD Network.
- Here is the link dedicated to patients living with a neuromuscular disease:
https://www.surveymonkey.com/r/PatientsWebSite1
- Here is the link dedicated to families and caregivers of patients living with a neuromuscular disease:
https://www.surveymonkey.com/r/CarersWebSite1
- Why this survey?
Sysnav is a company developing a wearable device for clinical trials (called ActiMyo®) in collaboration with clinicians, patients’ associations, and other parties, with the goal of accurately measuring clinically meaningful variables to assess the efficacy of new drugs in neuromuscular diseases. ActiMyo® is composed of sensors worn on the wrist and/or on the ankle(s) aiming to capture movements of arm and/or leg. ActiMyo® has no GPS tracking function and could not detect where the patient is.
Digital clinical outcomes are still in their infancy. Your voice is central to ensure that the outcome qualified are relevant for the patients and match the needs from the community. In addition, regulatory agencies such as the FDA or EMA, rely on the input of patients and families to inform treatment approval decisions.
- How is this survey distributed ?
This survey will be distributed by patient and advocacy organizations from Europe, United Kingdom, and the United States.
- How are my information treated & analyzed ?
Data will be completely anonymous. Data will be collected, analyzed, and used by Sysnav. Data will be stored as long as required for regulatory purposes (and at least 15 years). Collected data will be shared with any regulatory authorities who may review applications for device or clinical outcome measures approbation.
- How do I participate ?
This research survey is online and will take 20-30 minutes. You will not be paid for completing the survey. It is your choice to complete the survey. You can stop the survey at any time. By answering the survey, you consent that your data could be used for development of new digital endpoints and regulatory qualification.