Automated Telehealth Diagnostics for Remote Parkinson Monitoring (PDRemote)

PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring

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

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: KHV reporting; Procedure: Standard care

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KHV reporting; Clinicians will view the motor symptom severity reports and videoconference to titrate medications.	Device: KHV reporting; Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.; Other Names: Kinesia HomeView; Procedure: Standard care; Subjects will receive the same disease management as if they were not participating in this study.
Active Comparator: 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.	Procedure: Standard care; Subjects will receive the same disease management as if they were not participating in this study.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Great Lakes NeuroTechnologies Inc.
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); University of Rochester
• Investigators: Principal Investigator: Joseph P Giuffrida, Ph.D., Great Lakes NeuroTechnologies; Study Director: Dustin A Heldman, Ph.D., Great Lakes NeuroTechnologies

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Telemedicine; Telehealth; Parkinson's disease; Tremor; Dyskinesia; Bradykinesia; Kinesia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: R44MD004049 (U.S. NIH Grant/Contract); 5R44MD004049-05 (U.S. NIH Grant/Contract)