Automated Telehealth Diagnostics for Remote Parkinson Monitoring

Study Overview
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Brief Summary
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The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.

Detailed Description
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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.

Official Title
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PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: KHV reporting
* Procedure: Standard care


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHV reporting<br>Clinicians will view the motor symptom severity reports and videoconference to titrate medications. | Device: KHV reporting<br>* Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.<br>* Other names: Kinesia HomeView;Procedure: Standard care<br>* Subjects will receive the same disease management as if they were not participating in this study.<br>|
| Active Comparator: Standard care<br>Subjects in this group will still use KHV at home to minimize any placebo effects that could be attributed to using the system; however, clinicians will view the motor symptom severity reports and videoconference to titrate medications solely for the experimental subjects. | Procedure: Standard care<br>* Subjects will receive the same disease management as if they were not participating in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects completing remote assessments | Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments. | 7 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of remote assessments completed | Percent of remote home-based Kinesia-HomeView automated motor assessments successfully completed . | 7 Months | 
| KHV Motor Scores | Tremor, bradykinesia, and dyskinesia scores given by the KHV system. | 7 Months | 
| KHV measured fluctuations | Changes in KHV motor scores throughout each day. | 7 Months | 
| PDQ-39 responses | PDQ-39 quality of life survey responses. | 7 Months | 
| PACIC responses | The Patient Assessment of Care for Chronic Conditions (PACIC) is a questionnaire that measures specific actions or qualities of care | 7 Months | 
| PAM-13 responses | The Patient Activation Measure (PAM) assessment gauges the knowledge, skills and confidence essential to managing one's own health and healthcare. | 7 Months | 
| Number of clinic visits |  | 7 Months | 
| Number of patient/clinician communications |  | 7 Months | 
| Number and type of medication changes |  | 7 Months | 
| Number of videoconferences completed |  | 7 Months | 
| Unified Parkinson's Disease Rating Scale (UPDRS) |  | 7 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Telemedicine, Telehealth, Kinesia, Tremor, Bradykinesia, Dyskinesia