APPRISE: Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status

Sponsor

Global Kinetics Corporation (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03741920

Collaborator

(none)

231

Enrollment

Locations

Arms

90.5

Anticipated Duration (Months)

19.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to understand the utility of Personal KinetiGraph movement recording system data in the clinical management of Parkinson's disease (PD) in routine clinical care at a movement disorders clinic. Specifically:

Measure medication use and clinical management plan changes in a large, multicenter cohort among participants undergoing a clinical assessment with an MDS in which the MDS reviews the participant's PKG during the clinical assessment in half of the enrolled participants (PKG + Group) and in half of the enrolled participants the MDS completes the clinical assessment without the PKG (PKG- Group).
Determine the association between frequency of medication changes, the PKG information, and other clinical assessments among participants with and without a PKG report of their PD motor status available to the clinician at the time of evaluation.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: Personal KinetiGraph™ (PKG™)	N/A

Detailed Description

This is a prospective, multicenter, randomized controlled trial. The study consists of 3 phases as follows:

Randomization phase: subjects undergo screening, baseline, interim and 90-day follow-up visits
PKG+ Group (standard of care clinical evaluation plus use of PKG data)
PKG- Group (standard of care clinical evaluation without use of PKG data - the MDS is blinded to PKG data)
Randomization ratio will be 1:1 with assignments generated in advance of the start of the trial by the unblinded statistician who will provide a list containing group assignments that will be available in an Electronic Database (EDC) for site use.
The clinical investigator, study site staff, and subject will not be blinded to the randomization assignment during the randomization phase of the study
Open-label phase: at the end of the 90-day randomization phase visit for PKG- Group subjects, the MDS will report on the PKG and review it with the subject, the subject will complete follow-ups with the MDS using the PKG information during the clinical assessment following the same process as the PKG+ Group during the randomization phase
Extended open-label follow-up phase: annual follow-ups for all subjects at 1, 2, and 3 years during which the MDS will use the PKG information during clinical assessments for all subjects.

Study Design

Study Type:

Interventional

Actual Enrollment :

231 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)

Actual Study Start Date :

May 17, 2017

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personal KinetiGraph™ (PKG™) + For subjects in the PKG+ Group, the study MDS will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment. PKG results will be recorded in the PKG Reporting case report form (CRF). The study MDS will complete the MDS-Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures along with the PKG information.	Device: Personal KinetiGraph™ (PKG™) The Personal KinetiGraph™ (PKG™) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by Global Kinetics (GKC). The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following: A wrist-worn data logger designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.
Active Comparator: Personal KinetiGraph™ (PKG™) - For subjects in the PKG- Group (control group), the study Movement Disorder Specialist (MDS) will complete the MDS - Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures. The study Movement Disorder Specialist will be blinded to the PKG information until the second part of the 90-day follow-up visit.	Device: Personal KinetiGraph™ (PKG™) The Personal KinetiGraph™ (PKG™) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by Global Kinetics (GKC). The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following: A wrist-worn data logger designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.

Arm

Intervention/Treatment

Experimental: Personal KinetiGraph™ (PKG™) +

For subjects in the PKG+ Group, the study MDS will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment. PKG results will be recorded in the PKG Reporting case report form (CRF). The study MDS will complete the MDS-Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures along with the PKG information.

Device: Personal KinetiGraph™ (PKG™)

The Personal KinetiGraph™ (PKG™) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by Global Kinetics (GKC). The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following: A wrist-worn data logger designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. An application to configure the data logger and transfer the acquired data at the end of a recording. A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.

Active Comparator: Personal KinetiGraph™ (PKG™) -

For subjects in the PKG- Group (control group), the study Movement Disorder Specialist (MDS) will complete the MDS - Clinician Assessment CRF to denote patient-reported symptoms, treatable findings, and clinical management planning based on his/her routine clinical assessment procedures. The study Movement Disorder Specialist will be blinded to the PKG information until the second part of the 90-day follow-up visit.

Device: Personal KinetiGraph™ (PKG™)

Outcome Measures

Primary Outcome Measures

Evaluation of treatment changes with or without the use of PKG data [90 day]
The proportion of patients in which the clinical management plan was changed in patients followed in the PKG- Group (clinician standard of care) compared to the PKG+ Group (clinician standard of care with the use of PKG data).

Eligibility Criteria

Criteria

Ages Eligible for Study:

46 Years to 83 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Able and willing to sign a written informed consent for study participation
Age 46 - 83 years at the time of consent (per PKG Indications for Use, see Technical Instructions Manual)
Responsive to dopaminergic medications

Exclusion Criteria:

Contraindication to increasing dopaminergic therapy, such as current or treated freezing gait, symptomatic postural hypotension, or bothersome hallucinations
Wheelchair bound or bedridden
Utilizing or planning advanced PD therapies (DBS, infusion, etc.)
History of delirium in the past year
In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints (e.g., subject able to complete PKG wear instructions per Patient Instruction Manual, or ability to comply with required study procedures and visit schedule)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sutter Health	Sacramento	California	United States	95816
2	University of California	San Diego	California	United States	92037
3	Parkinson's Disease and Movement Disorders Center	Boca Raton	Florida	United States	33486
4	University of Florida	Gainesville	Florida	United States	32604
5	University of Miami	Miami	Florida	United States	33136
6	University of South Florida	Tampa	Florida	United States	33613
7	University of Kansas Medical Center	Kansas City	Kansas	United States	66103
8	Johns Hopkins Medical Institute	Baltimore	Maryland	United States	21287
9	Michigan State University	East Lansing	Michigan	United States	49824
10	Northwell Health	Great Neck	New York	United States	11021
11	New York University	New York	New York	United States	10017
12	University of Texas	Houston	Texas	United States	77030

Sponsors and Collaborators

Global Kinetics Corporation

Investigators

Principal Investigator: Rajesh Pahwa, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

Responsible Party:

Global Kinetics Corporation

ClinicalTrials.gov Identifier:

NCT03741920

Other Study ID Numbers:

Study 002

First Posted:

Nov 15, 2018

Last Update Posted:

Mar 4, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Global Kinetics Corporation

Personal KinetiGraph (PKG) Movement Recording System

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Mar 4, 2020