PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Great Lakes NeuroTechnologies Inc.
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Percent of subjects completing remote assessments
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.
Detailed Description
Currently, there is limited access to movement disorder specialist centers for a significant portion of the PD population. Treatment effectiveness is judged during office visits by improvement of patient motor symptoms and quality of life. Clinicians evaluate patients by having them perform specific motor tasks and rating the severity on a 0-4 scale. A major limitation is that a single evaluation in a clinical setting may not accurately reflect motor symptom fluctuations experienced over the course of a day, week, or month. Clinicians currently lack effective, affordable medical devices that can be easily delivered to a patient's home for monitoring symptoms on a more continuous basis as motor symptoms typically change throughout the day. Kinesia HomeView provides a repeatable, automated system clinicians can use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home. The investigators hypothesize use of the Kinesia HomeView system will improve outcomes and decrease costs especially for patient populations in areas not in close proximity to movement disorder specialists.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individuals with self-reported clinically-confirmed diagnosis of idiopathic Parkinson disease.
- •Be fluent in English
- •Willing and able to provide informed consent
Exclusion Criteria
- •Inability to carry out study activities
- •Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
- •Subjects who have dementia, exhibited by those with a score less than 22 on the Montreal Cognitive Assessment (MoCA)
- •Subjects with deep brain stimulation (DBS)
Outcomes
Primary Outcomes
Percent of subjects completing remote assessments
Time Frame: 7 Months
Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.
Secondary Outcomes
- PACIC responses(7 Months)
- Number and type of medication changes(7 Months)
- Number of videoconferences completed(7 Months)
- KHV Motor Scores(7 Months)
- Percent of remote assessments completed(7 Months)
- KHV measured fluctuations(7 Months)
- Number of patient/clinician communications(7 Months)
- Unified Parkinson's Disease Rating Scale (UPDRS)(7 Months)
- PDQ-39 responses(7 Months)
- PAM-13 responses(7 Months)
- Number of clinic visits(7 Months)