Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05780866
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2023-03-10
Brief Title:
Remote Monitoring in Parkinsons Disease
Sponsor:
Jacob E Simmering
Organization:
University of Iowa
Study Overview
Official Title:
Remote Monitoring in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2024-01
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 goal of this observational study is to learn about the usefulness of physical activity measures and tremor detection using wearable devices and smartphone video to detect and evaluate disease burden in people with Parkinsons disease
Participants will wear an activity tracker at home and complete a short research visit where they will make a video using a smartphone of themselves performing a fine motor task They will wear the activity tracker for two weeks at home
Participants will wear an activity tracker at home and complete a short research visit where they will make a video using a smartphone of themselves performing a fine motor task They will wear the activity tracker for two weeks at home
Detailed Description:
For all groups there is no control group
At enrollment the participants will complete a baseline survey that records participant sex years since the diagnosis of Parkinsons disease current use of levodopa medication and whether levodopa was taken today
Next a research nurse from neurology will complete the Unified Parkinsons Disease Rating Scale UPDRS assessment As part of this assessment the researchers will make a video recording of Part 3 the motor assessment as a gold standard for comparison with the participant-recorded videos
Next the participant will complete the PDQ-39 Parkinsons disease questionnaire a 39 item questionnaire about the quality of life
After completing the PDQ-39 the researchers will provide the participant with a camera small tripod and a set of written directions about how to perform the UPDRS motor assessment The goal with this task is to simulate a home recording session to uncover any issues and create preliminary data for validation of the home recording compared to the gold standard collected by the study team The recordings will then be converted to x y z landmarks using MediaPipe running on UIowa hardware
After completing the video the participant will complete a short survey about ease of making the video recording
After completing the baseline assessments the research team will provide the participant with a Fitbit Inspire 3 activity tracker watch configure the tracker to sync with their phone and provide an overview of use
The participant will wear the activity tracker for 24 hours a day for the next 14 days except for if the device needs charging and when bathing
At 14 days the research team will send participants a link to complete a web-based exit survey about their experience with the activity tracker during the study
At enrollment the participants will complete a baseline survey that records participant sex years since the diagnosis of Parkinsons disease current use of levodopa medication and whether levodopa was taken today
Next a research nurse from neurology will complete the Unified Parkinsons Disease Rating Scale UPDRS assessment As part of this assessment the researchers will make a video recording of Part 3 the motor assessment as a gold standard for comparison with the participant-recorded videos
Next the participant will complete the PDQ-39 Parkinsons disease questionnaire a 39 item questionnaire about the quality of life
After completing the PDQ-39 the researchers will provide the participant with a camera small tripod and a set of written directions about how to perform the UPDRS motor assessment The goal with this task is to simulate a home recording session to uncover any issues and create preliminary data for validation of the home recording compared to the gold standard collected by the study team The recordings will then be converted to x y z landmarks using MediaPipe running on UIowa hardware
After completing the video the participant will complete a short survey about ease of making the video recording
After completing the baseline assessments the research team will provide the participant with a Fitbit Inspire 3 activity tracker watch configure the tracker to sync with their phone and provide an overview of use
The participant will wear the activity tracker for 24 hours a day for the next 14 days except for if the device needs charging and when bathing
At 14 days the research team will send participants a link to complete a web-based exit survey about their experience with the activity tracker during the study
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