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Completed

NCT Number: NCT02152319

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

KHV reporting

Device

Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.

Other names: Kinesia HomeView

Standard care

Procedure

Subjects will receive the same disease management as if they were not participating in this study.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Great Lakes NeuroTechnologies Inc.

Industry

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • University of Rochester

Registry information

Official study title

PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring

Acronym: PDRemote

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2014
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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