Clinical trial NCT03741920: Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status
Official title: Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Personal KinetiGraph (PKG) Movement Recording System
Lead sponsor: Global Kinetics Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-15
Enrollment: 231
Sex: ALL
Minimum age (years): 46
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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:

1. 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).
2. 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Evaluation of treatment changes with or without the use of PKG data
timeFrame: 90 day
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: San Diego
country: United States
facility: University of California
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institute
state: Maryland
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Houston
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: University of Kansas Medical Center
name: Rajesh Pahwa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maetzler W, Klucken J, Horne M. A clinical view on the development of technology-based tools in managing Parkinson's disease. Mov Disord. 2016 Sep;31(9):1263-71. doi: 10.1002/mds.26673. Epub 2016 Jun 7.
citation: Pahwa R, Isaacson SH, Torres-Russotto D, Nahab FB, Lynch PM, Kotschet KE. Role of the Personal KinetiGraph in the routine clinical assessment of Parkinson's disease: recommendations from an expert panel. Expert Rev Neurother. 2018 Aug;18(8):669-680. doi: 10.1080/14737175.2018.1503948. Epub 2018 Jul 26.