Remote Monitoring in Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Video and Activity Tracker

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob Simmering, MS, PHD, BA; Phone Number: 3196788037; Email: jacob-simmering@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Video and Activity Tracker

Other: Video and Activity Tracker; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity tracker wear rate	Percent of time activity tracker records a heart rate	14 Days
Accuracy of computer vision assessment of motor function	Average difference in UPDRS score between human and computer assessments	Baseline
Do step counts predict quality-of-life	Regression of PDQ-39 on demographics and activity tracker step counts	14 Days

Collaborators and Investigators

• Sponsor: Jacob E. Simmering
• Investigators: Principal Investigator: Jacob Simmering, MS, PHD, BA, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 202111199

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No