Parkinson's DiseasePDRemoteNCT02152319
Automated Telehealth Diagnostics for Remote Parkinson Monitoring
A study testing KHV reporting in people with Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 1 site in United States.
Trial summary
The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- KHV reporting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals with self-reported clinically-confirmed diagnosis of idiopathic Parkinson disease.
- Be fluent in English
- Willing and able to provide informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring
The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- KHV reporting, Standard care
- Keywords
- Parkinson's disease, Telemedicine, Telehealth, Kinesia, Tremor, Bradykinesia, Dyskinesia
- Medical subject headings
- Parkinson Disease, Tremor, Hypokinesia, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHV reportingDevice
Also called Kinesia HomeView
Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.
Standard careProcedure or surgery
Subjects will receive the same disease management as if they were not participating in this study.
| Study group | Role | What they receive |
|---|---|---|
| KHV reporting | Experimental | Clinicians will view the motor symptom severity reports and videoconference to titrate medications. Receives: Device: KHV reporting; Procedure: Standard care |
| 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. Receives: Procedure: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects completing remote assessments
Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.
Measured: 7 Months
Secondary outcomes (11)
Percent of remote assessments completed
Percent of remote home-based Kinesia-HomeView automated motor assessments successfully completed .
Measured: 7 Months
KHV Motor Scores
Tremor, bradykinesia, and dyskinesia scores given by the KHV system.
Measured: 7 Months
KHV measured fluctuations
Changes in KHV motor scores throughout each day.
Measured: 7 Months
PDQ-39 responses
PDQ-39 quality of life survey responses.
Measured: 7 Months
PACIC responses
The Patient Assessment of Care for Chronic Conditions (PACIC) is a questionnaire that measures specific actions or qualities of care
Measured: 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.
Measured: 7 Months
Number of clinic visits
Measured: 7 Months
Number of patient/clinician communications
Measured: 7 Months
Number and type of medication changes
Measured: 7 Months
Number of videoconferences completed
Measured: 7 Months
Unified Parkinson's Disease Rating Scale (UPDRS)
Measured: 7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Joseph P Giuffrida, Ph.D., Principal investigator, Great Lakes NeuroTechnologiesDustin A Heldman, Ph.D., Study director, Great Lakes NeuroTechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152319
- Sponsor's protocol ID
- R44MD004049
- Other IDs
- 5R44MD004049-05
- Acronym
- PDRemote
- Status last verified
- Apr 2016
- First submitted
- 27 May 2014
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring
- ClinicalTrials.gov ID
- NCT02152319
- Acronym / sponsor ID
- PDRemote / R44MD004049
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Telemedicine, Telehealth, Kinesia, Tremor, Bradykinesia, Dyskinesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- May 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHV reporting | Experimental | Device: KHV reporting, Procedure: Standard careClinicians will view the motor symptom severity reports and videoconference to titrate medications. |
| Standard care | Active comparator | Procedure: Standard careSubjects 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with self-reported clinically-confirmed diagnosis of idiopathic Parkinson disease.
- Be fluent in English
- Willing and able to provide informed consent
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KHV reportingAlso: Kinesia HomeViewClinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications. | Device | KHV reporting |
| Standard careSubjects will receive the same disease management as if they were not participating in this study. | Procedure or surgery | KHV reporting, Standard care |
Primary outcome
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.
11 secondary outcomes
Percent of remote assessments completed
Time frame: 7 Months
KHV Motor Scores
Time frame: 7 Months
KHV measured fluctuations
Time frame: 7 Months
PDQ-39 responses
Time frame: 7 Months
PACIC responses
Time frame: 7 Months
PAM-13 responses
Time frame: 7 Months
Number of clinic visits
Time frame: 7 Months
Number of patient/clinician communications
Time frame: 7 Months
Number and type of medication changes
Time frame: 7 Months
Number of videoconferences completed
Time frame: 7 Months
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 7 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph P Giuffrida, Ph.D. principal investigator
Great Lakes NeuroTechnologies
Dustin A Heldman, Ph.D. study director
Great Lakes NeuroTechnologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KHV reporting in people with Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of subjects completing remote assessments (time frame: 7 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.