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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
Jacob E. Simmering
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

50 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 10, 2023
    Last Updated
    March 10, 2023
    Sponsor
    Jacob E. Simmering
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    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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