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Automated Telehealth Diagnostics for Remote Parkinson Monitoring (PDRemote)

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ClinicalTrials.gov Identifier: NCT02152319
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : April 28, 2016
Sponsor:
Collaborators:
University of Rochester
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: KHV reporting Procedure: Standard care Not Applicable

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  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring
Study Start Date : May 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Percent of subjects completing remote assessments [ Time Frame: 7 Months ]
    Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.


Secondary Outcome Measures :
  1. Percent of remote assessments completed [ Time Frame: 7 Months ]
    Percent of remote home-based Kinesia-HomeView automated motor assessments successfully completed .

  2. KHV Motor Scores [ Time Frame: 7 Months ]
    Tremor, bradykinesia, and dyskinesia scores given by the KHV system.

  3. KHV measured fluctuations [ Time Frame: 7 Months ]
    Changes in KHV motor scores throughout each day.

  4. PDQ-39 responses [ Time Frame: 7 Months ]
    PDQ-39 quality of life survey responses.

  5. PACIC responses [ Time Frame: 7 Months ]
    The Patient Assessment of Care for Chronic Conditions (PACIC) is a questionnaire that measures specific actions or qualities of care

  6. PAM-13 responses [ Time Frame: 7 Months ]
    The Patient Activation Measure (PAM) assessment gauges the knowledge, skills and confidence essential to managing one's own health and healthcare.

  7. Number of clinic visits [ Time Frame: 7 Months ]
  8. Number of patient/clinician communications [ Time Frame: 7 Months ]
  9. Number and type of medication changes [ Time Frame: 7 Months ]
  10. Number of videoconferences completed [ Time Frame: 7 Months ]
  11. Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 7 Months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152319


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
University of Rochester
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Joseph P Giuffrida, Ph.D. Great Lakes NeuroTechnologies
Study Director: Dustin A Heldman, Ph.D. Great Lakes NeuroTechnologies

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT02152319     History of Changes
Other Study ID Numbers: R44MD004049 ( U.S. NIH Grant/Contract )
5R44MD004049-05 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by Great Lakes NeuroTechnologies Inc.:
Parkinson's disease
Telemedicine
Telehealth
Kinesia
Tremor
Bradykinesia
Dyskinesia

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases