Remote Monitoring in Parkinson's Disease

NCT05780866 | Completed

• 1 other identifier: 202111199
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Video and Activity Tracker

OTHER

Other: Video and Activity Tracker

Interventions

Video and Activity Tracker 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.

Video and Activity Tracker

Eligibility Criteria

• Age: 50 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PD
• Current patient at UIHC Movement Disorders clinic
• Owns a smartphone that is compatible with a activity tracker.

You may not qualify if:

• Non-English speaking
• Bedridden or uses a wheelchair the majority of the time
• Prisoner status
• Inability to provide own informed consent

Sponsors & Collaborators

• Jacob E. Simmering: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Videotape Recording; Fitness Trackers

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Jacob Simmering, MS, PHD, BA

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: August 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

US (1)