Remote Monitoring in Parkinson's Disease

NCT ID: NCT05780866

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Video and Activity Tracker

Group Type: OTHER

Video and Activity Tracker

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jacob E. Simmering

OTHER

Sponsor Role: lead

Responsible Party

Jacob E. Simmering

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jacob Simmering, MS, PHD, BA

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202111199

Identifier Type: -

Identifier Source: org_study_id