Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904288
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2023-05-08
Brief Title:
DTx Algorithms for Personalized Parkinsons Disease Treatment and Medication Plan Optimization
Sponsor:
Newel Health SRL
Organization:
Newel Health SRL
Study Overview
Official Title:
Development of Digital Therapeutics Algorithms for Personalized Parkinsons Disease Treatment and Medication Plan Optimization
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is aimed at developing Digital Therapeutics DTx algorithms for personalized PD treatment and medication plan optimization based on Real World Data RWD collected from patients via digital mobile app and wearable sensors
The study design is observationalnoninterventional prospective single-arm aimed at collecting data from wearable sensors for validation of symptom detection algorithms through 1 a supervised in-clinic motor assessment performed using validated clinical scales Visit 3 Visit 4 and 2 an unsupervised home-based 6-month Visit 3 to Visit 4 data collection from wearable devices passive monitoring for algorithm cross-validation using patient reported outcomes PROMs and remote clinical assessments The devices used in the study will be a commercial smartwatch Garmin Vivosmart 5 for inertial data collection and a digital application through which subjects will report PROMs via a digital symptom diary Screening visits Visit 1 and Visit 2 will be conducted prior to enrollment to verify eligibility criteria through clinical assessments the subjects symptom diary and by assessing adherence to the use of the study tools provided ie mobile application and smartwatch
The study design is observationalnoninterventional prospective single-arm aimed at collecting data from wearable sensors for validation of symptom detection algorithms through 1 a supervised in-clinic motor assessment performed using validated clinical scales Visit 3 Visit 4 and 2 an unsupervised home-based 6-month Visit 3 to Visit 4 data collection from wearable devices passive monitoring for algorithm cross-validation using patient reported outcomes PROMs and remote clinical assessments The devices used in the study will be a commercial smartwatch Garmin Vivosmart 5 for inertial data collection and a digital application through which subjects will report PROMs via a digital symptom diary Screening visits Visit 1 and Visit 2 will be conducted prior to enrollment to verify eligibility criteria through clinical assessments the subjects symptom diary and by assessing adherence to the use of the study tools provided ie mobile application and smartwatch
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None