Automated Telehealth Diagnostics for Remote Parkinson Monitoring (PDRemote)

Great Lakes NeuroTechnologies

Status: Completed

Conditions: Parkinson's Disease

Treatments: Procedure: Standard care; Device: KHV reporting

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02152319

5R44MD004049-05 (U.S. NIH Grant/Contract)

R44MD004049

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

KHV reporting

Experimental group

Description:

Clinicians will view the motor symptom severity reports and videoconference to titrate medications.

Treatment:

Device: KHV reporting

Procedure: Standard care

Standard care

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard care