Clinical trial NCT02152319: Automated Telehealth Diagnostics for Remote Parkinson Monitoring
Official title: PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Telemedicine
Telehealth
Kinesia
Tremor
Bradykinesia
Dyskinesia
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Rochester
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2014-06-02
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Percent of subjects completing remote assessments
timeFrame: 7 Months
Secondary outcomes:
measure: Percent of remote assessments completed
timeFrame: 7 Months
measure: KHV Motor Scores
timeFrame: 7 Months
measure: KHV measured fluctuations
timeFrame: 7 Months
measure: PDQ-39 responses
timeFrame: 7 Months
measure: PACIC responses
timeFrame: 7 Months
measure: PAM-13 responses
timeFrame: 7 Months
measure: Number of clinic visits
timeFrame: 7 Months
measure: Number of patient/clinician communications
timeFrame: 7 Months
measure: Number and type of medication changes
timeFrame: 7 Months
measure: Number of videoconferences completed
timeFrame: 7 Months
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 7 Months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Great Lakes NeuroTechnologies
name: Joseph P Giuffrida, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Great Lakes NeuroTechnologies
name: Dustin A Heldman, Ph.D.
role: STUDY_DIRECTOR
References: