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

Global Kinetics

Status: Active, not recruiting

Conditions: Parkinson Disease

Treatments: Device: Personal KinetiGraph™ (PKG™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03741920

Study 002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 46 to 83 years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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231 participants in 2 patient groups

Personal KinetiGraph™ (PKG™) +

Experimental group

Description:

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.

Treatment:

Device: Personal KinetiGraph™ (PKG™)

Personal KinetiGraph™ (PKG™) -

Active Comparator group

Description:

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.

Treatment:

Device: Personal KinetiGraph™ (PKG™)