Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R44MD004049-05 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Rochester | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHV reporting | Experimental | Clinicians will view the motor symptom severity reports and videoconference to titrate medications. |
|
| Standard care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHV reporting | Device | Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joseph P Giuffrida, Ph.D. | Great Lakes NeuroTechnologies | Principal Investigator |
| Dustin A Heldman, Ph.D. | Great Lakes NeuroTechnologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D014202 | Tremor |
| D018476 | Hypokinesia |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard care | Procedure | Subjects will receive the same disease management as if they were not participating in this study. |
|
| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |