Remote Monitoring in Parkinson's Disease

Sponsor
Jacob E. Simmering (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05780866
Collaborator
(none)
25
1
24

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Video and Activity Tracker
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Remote Monitoring in Parkinson's Disease
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Activity tracker wear rate [14 Days]

    Percent of time activity tracker records a heart rate

  2. Accuracy of computer vision assessment of motor function [Baseline]

    Average difference in UPDRS score between human and computer assessments

  3. Do step counts predict quality-of-life [14 Days]

    Regression of PDQ-39 on demographics and activity tracker step counts

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jacob E. Simmering

Investigators

  • Principal Investigator: Jacob Simmering, MS, PHD, BA, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jacob E. Simmering, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT05780866
Other Study ID Numbers:
  • 202111199
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 23, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2023