Automated Telehealth Diagnostics for Remote Parkinson Monitoring

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Procedure: Standard care; Device: KHV reporting

• Registration Number: NCT02152319
• Lead Sponsor: Great Lakes NeuroTechnologies Inc.

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-06-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	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.
KHV reporting	Standard care	Clinicians will view the motor symptom severity reports and videoconference to titrate medications.
KHV reporting	KHV reporting	Clinicians will view the motor symptom severity reports and videoconference to titrate medications.

Primary Outcome Measures

Name	Time	Method
Percent of subjects completing remote assessments	7 Months	Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States