Automated Telehealth Diagnostics for Remote Parkinson Monitoring

Parkinson's Disease Clinical Trial

— PDRemote  

Official title:

PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152319
• Other study ID #: R44MD004049
• Secondary ID: 5R44MD004049-05
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: April 26, 2016
• Start date: May 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• KHV reporting
Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.

Procedure:
• Standard care
Subjects will receive the same disease management as if they were not participating in this study.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.	National Institute on Minority Health and Health Disparities (NIMHD), University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects completing remote assessments	Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.	7 Months	No
Secondary	Percent of remote assessments completed	Percent of remote home-based Kinesia-HomeView automated motor assessments successfully completed .	7 Months	No
Secondary	KHV Motor Scores	Tremor, bradykinesia, and dyskinesia scores given by the KHV system.	7 Months	No
Secondary	KHV measured fluctuations	Changes in KHV motor scores throughout each day.	7 Months	No
Secondary	PDQ-39 responses	PDQ-39 quality of life survey responses.	7 Months	No
Secondary	PACIC responses	The Patient Assessment of Care for Chronic Conditions (PACIC) is a questionnaire that measures specific actions or qualities of care	7 Months	No
Secondary	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	No
Secondary	Number of clinic visits		7 Months	No
Secondary	Number of patient/clinician communications		7 Months	No
Secondary	Number and type of medication changes		7 Months	No
Secondary	Number of videoconferences completed		7 Months	No
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS)		7 Months	No