Remote Monitoring in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video and Activity Tracker
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria Diagnosis of PD Current patient at UIHC Movement Disorders clinic Owns a smartphone that is compatible with a activity tracker. Exclusion Criteria Non-English speaking Bedridden or uses a wheelchair the majority of the time Prisoner status Inability to provide own informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Video and Activity Tracker
Arm Description
Outcomes
Primary Outcome Measures
Activity tracker wear rate
Percent of time activity tracker records a heart rate
Accuracy of computer vision assessment of motor function
Average difference in UPDRS score between human and computer assessments
Do step counts predict quality-of-life
Regression of PDQ-39 on demographics and activity tracker step counts
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05780866
Brief Title
Remote Monitoring in Parkinson's Disease
Official Title
Remote Monitoring in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacob E. Simmering
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 Parkinson's 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.
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 Parkinson's disease, current use of levodopa medication, and whether levodopa was taken today.
Next, a research nurse from neurology will complete the Unified Parkinson's 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 (Parkinson's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video and Activity Tracker
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Video and Activity Tracker
Intervention Description
At enrollment, the participants will complete a baseline survey, PDQ-39 (Parkinson's disease questionnaire), and the Unified Parkinson's Disease Rating Scale (UPDRS) assessment. The researchers will provide the participant with a camera, small tripod, and a set of written directions about how to record the UPDRS motor self-assessment video.
After completing the baseline assessments, the research team will provide the participant with a Fitbit Inspire 3 activity tracker watch. 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.
Primary Outcome Measure Information:
Title
Activity tracker wear rate
Description
Percent of time activity tracker records a heart rate
Time Frame
14 Days
Title
Accuracy of computer vision assessment of motor function
Description
Average difference in UPDRS score between human and computer assessments
Time Frame
Baseline
Title
Do step counts predict quality-of-life
Description
Regression of PDQ-39 on demographics and activity tracker step counts
Time Frame
14 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Diagnosis of PD
Current patient at UIHC Movement Disorders clinic
Owns a smartphone that is compatible with a activity tracker.
Exclusion Criteria
Non-English speaking
Bedridden or uses a wheelchair the majority of the time
Prisoner status
Inability to provide own informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Simmering, MS, PHD, BA
Phone
3196788037
Email
jacob-simmering@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Simmering, MS, PHD, BA
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Remote Monitoring in Parkinson's Disease
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