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Automated Telehealth Diagnostics for Remote Parkinson Monitoring (PDRemote)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KHV reporting
Standard care
Sponsored by
Great Lakes NeuroTechnologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Parkinson's disease, Telemedicine, Telehealth, Kinesia, Tremor, Bradykinesia, Dyskinesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KHV reporting

Standard care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent of remote assessments completed
Percent of remote home-based Kinesia-HomeView automated motor assessments successfully completed .
KHV Motor Scores
Tremor, bradykinesia, and dyskinesia scores given by the KHV system.
KHV measured fluctuations
Changes in KHV motor scores throughout each day.
PDQ-39 responses
PDQ-39 quality of life survey responses.
PACIC responses
The Patient Assessment of Care for Chronic Conditions (PACIC) is a questionnaire that measures specific actions or qualities of care
PAM-13 responses
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
Number of patient/clinician communications
Number and type of medication changes
Number of videoconferences completed
Unified Parkinson's Disease Rating Scale (UPDRS)

Full Information

First Posted
May 27, 2014
Last Updated
April 26, 2016
Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
University of Rochester, National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02152319
Brief Title
Automated Telehealth Diagnostics for Remote Parkinson Monitoring
Acronym
PDRemote
Official Title
PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
University of Rochester, National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Telemedicine, Telehealth, Kinesia, Tremor, Bradykinesia, Dyskinesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHV reporting
Arm Type
Experimental
Arm Description
Clinicians will view the motor symptom severity reports and videoconference to titrate medications.
Arm Title
Standard care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
KHV reporting
Other Intervention Name(s)
Kinesia HomeView
Intervention Description
Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.
Intervention Type
Procedure
Intervention Name(s)
Standard care
Intervention Description
Subjects will receive the same disease management as if they were not participating in this study.
Primary Outcome Measure Information:
Title
Percent of subjects completing remote assessments
Description
Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.
Time Frame
7 Months
Secondary Outcome Measure Information:
Title
Percent of remote assessments completed
Description
Percent of remote home-based Kinesia-HomeView automated motor assessments successfully completed .
Time Frame
7 Months
Title
KHV Motor Scores
Description
Tremor, bradykinesia, and dyskinesia scores given by the KHV system.
Time Frame
7 Months
Title
KHV measured fluctuations
Description
Changes in KHV motor scores throughout each day.
Time Frame
7 Months
Title
PDQ-39 responses
Description
PDQ-39 quality of life survey responses.
Time Frame
7 Months
Title
PACIC responses
Description
The Patient Assessment of Care for Chronic Conditions (PACIC) is a questionnaire that measures specific actions or qualities of care
Time Frame
7 Months
Title
PAM-13 responses
Description
The Patient Activation Measure (PAM) assessment gauges the knowledge, skills and confidence essential to managing one's own health and healthcare.
Time Frame
7 Months
Title
Number of clinic visits
Time Frame
7 Months
Title
Number of patient/clinician communications
Time Frame
7 Months
Title
Number and type of medication changes
Time Frame
7 Months
Title
Number of videoconferences completed
Time Frame
7 Months
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame
7 Months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P Giuffrida, Ph.D.
Organizational Affiliation
Great Lakes NeuroTechnologies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dustin A Heldman, Ph.D.
Organizational Affiliation
Great Lakes NeuroTechnologies
Official's Role
Study Director
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Automated Telehealth Diagnostics for Remote Parkinson Monitoring

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