Objective: To know the level of satisfaction on a CE Class IIa medical device for monitoring motor symptoms in Parkinson’s Disease (PD).

Background: Identifying and quantifying motor symptoms in Parkinson’s Disease is a challenging task as the patient is not able to provide accurate information to the neurologist in their visit to the doctor’s office. The use of wearable systems able to be used in home environments will increase the accuracy of information to physicians in order to evaluate more accurately the severity and distribution of motor complications.

Method: For the motor symptoms monitoring, it has been used the STAT-ON™ holter, composed of a waist-worn medical device class IIa and a specific belt. The sensor provides objective information from motor symptoms of the patients and it is necessary to know the opinion of the players involved in this new evaluation paradigm. A total of 4 surveys have been designed for neurologists, healthcare professionals (HCP) (nurses, physiotherapists, etc.), caregivers, and patients. The surveys are provided to neurologists in a meeting organized for MOMOPA-EC clinical trial (clinicaltrials.gov/ct2/show/NCT04176302) and provided to 6 different Parkinson’s Associations after explaining to health professionals, caregivers and patients the sensor characteristics, its functionality, firsts results achieved, and reports layouts.

Results: A total of 107 surveys are gathered, 17 neurologists, 19 health professionals, 30 caregivers, and 41 patients provide their opinion of STAT-ON. A total of 88% of neurologists think that the medical device can detect Advanced PD symptoms, the average score of the sensor is 7.9/10 and all neurologists find the information useful or very useful. The HCP sets a score of 8.6/10 and all of them see the sensor as a good or very good solution. A total of 80% of caregivers finds it a good or very good solution and no one dislikes the sensor, 76% think it is easy to use and no caregiver thinks the belt is difficult to wear and adjust. The patients rate the sensor with an 8.5/10 and 77.5% think it is very easy to use. The belt is rated with an 8.1/10.

Conclusion: The STAT-ON has achieved scores over 7/10 or 8/10 in level of satisfaction between the healthcare professionals, neurologists, caregivers, and patients, being considered as a tool to evaluate PD motor symptoms.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/satisfaction-survey-on-a-parkinsons-holter-a-medical-device-for-the-monitoring-of-motor-symptoms/