Home-Based Monitoring in Parkinson's Disease
Remote Monitoring Using Commercially Available Activity Trackers and Computer Vision Provides a Holistic, Low-cost Assessment of Parkinson's Disease Symptoms
1 other identifier
observational
120
1 country
1
Brief Summary
The goal of this observational study is to learn about the usefulness of automated analysis of speech, physical activity measures tracked using wearable devices at home, and tremor detection measured using computer-vision analysis of smartphone video to detect impairments related to Parkinson's disease and improve prediction of one-year progression. Participants will attend a short research visit at the University of Iowa. During this visit, they will make a video recording using a smartphone of them performing a fine motor task and audio recordings of pre-written text. They will be provided with an activity tracker and asked to wear it at home for four weeks. After four weeks, a video visit will be conducted and the speech and video tasks will be repeated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedStudy Start
First participant enrolled
April 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
April 10, 2025
April 1, 2025
1.7 years
August 21, 2024
April 7, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Number of Patients with a Diagnosis of Parkinson's Disease
Among Group 1 (those newly referred to the clinic for possible Parkinson's disease), a primary outcome will be whether the diagnosis made by the provider in the clinic was Parkinson's disease versus any other diagnosis. This is not an outcome for Group 2 (those with a recent diagnosis of Parkinson's disease) as everyone in that group will have that diagnosis.
Baseline
Change in Fine Motor Function
Motor function will be evaluated using the UPDRS rating system.
Baseline, One Year
Change in Total Cognition Composite Function
Total Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Baseline, One Year
Change in Total Crystallized Cognition Function
Crystallized Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Baseline, One Year
Change in Total Fluid Cognition Function
Fluid Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Baseline, One Year
Change in Montreal Cognitive Assessment Scores
The Montreal Cognitive Assessment (MoCA) has a range of 0-30. Higher scores are associated with better cognitive function. Scores of 26 or higher are considered cognitively normal. Scores less than 26 are suggestive of cognitive impairment, with dementia scores being below 20 but without a universally-accepted cutoff.
Baseline, One Year
Secondary Outcomes (2)
Change in Short Form Survey 20 (SF-20) Health Quality of Life
Baseline, One Year
Change in Parkinson's Disease Questionnaire 39 (PDQ-39) Quality of Life
Baseline, One Year
Study Arms (2)
Recently Referred for Possible Parkinson's Disease
Patients referred to the University of Iowa Hospitals and Clinics (UIHC) Movement Disorders Clinic for possible Parkinson's disease.
Recently Diagnosed with Parkinson's Disease
Patients of the UIHC Movement Disorders Clinic with a recent (less than 6 months) diagnosis of Parkinson's disease.
Eligibility Criteria
Participants will be drawn from the patients seen at the UIHC Movement Disorders Clinic.
You may qualify if:
- \. Newly referred to UIHC Movement Disorders Clinic
You may not qualify if:
- Prior diagnosis of Parkinson's disease
- Confined to wheelchair or bed
- Non-English speaking
- Prisoner status
- Inability to provide own informed consent
- Phone unable to support the Fitbit app
- Group 2: People with a recent diagnosis of Parkinson's disease
- Patient of UIHC Movement Disorders Clinic
- Diagnosed with Parkinson's disease
- First diagnosed \> 6 months ago
- Confined to wheelchair or bed
- Non-English speaking
- Prisoner status
- Inability to provide own informed consent
- Phone unable to support the Fitbit app
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Simmering, PhD
University of Iowa
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 27, 2024
Study Start
April 7, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Data will be released to the broader research community when the paper dependent on those results is posted as a pre-print, published, or when the award period ends, whichever happens first.
- Access Criteria
- To access the data, researchers will use the standard processes at the NACDA to obtain access to the data. The data generated in this study will be suitable for public access as it will be deidentified. NACDA provides a brief data use agreement prohibiting redistribution, identifying participants, and requires citing the data resource. Access is granted through an NACDA account, which may be created through a Google, OrcID, or Facebook account.
De-identified data will be deposited in the National Archive of Computerized Data on Aging (NACDA). Analytical code and documentation of study procedures will be shared both via the NACDA record and via GitHub repositories.