Utilization of Target Ranges to Treat Patients With Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PD)- A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 41
- Locations
- 33
- Primary Endpoint
- Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Study Overview
Brief Summary
The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).
Detailed Description
This is a randomized controlled trial (RCT) to evaluate treating uncontrolled patients with Parkinson's Disease (PwP) to a target range as suggested by expert review papers. The study aims to evaluate clinical patient outcomes, quality of life measures and health care utilization of those patients specifically treated to a target range when using the PKG data in the clinical management of Parkinson's disease (PD) in routine clinical care (treatment group) compared to those managed with medical history and clinical evaluation alone (control group) performed by a neurologist experienced in PD management. Both groups will be recommended to undergo medication changes until they reach a "controlled state" that is determined by either the clinician using standard of care (SOC) (PKG- Group) or using PKG based targets and SOC assessments (PKG+ Group).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
Subjects will remain blinded to treatment group throughout the life of the trial. Investigator and research staff will be unblinded to the treatment group as they will or will not have access to the PKG results to be incorporated into their standard of care practice.
Eligibility Criteria
- Ages
- 46 Years to 83 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able and willing to sign a written informed consent for study participation
- •Presumed to have Levodopa responsive idiopathic Parkinson's Disease
- •Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)
- •Has not been previously managed with the PKG
Exclusion Criteria
- •Contraindication to increasing levodopa (e.g. orthostatic hypotension, hallucinations/psychosis or any other medical condition in the last year that would preclude increasing levodopa or other appropriate Parkinson's Disease medications)
- •MoCA score <23 at screening visit
- •Diagnosis of Essential Tremor
- •Wheelchair bound or bedridden
- •Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.)
- •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 unable to complete PKG watch wear instructions per Patient Instruction Manual)
Outcomes
Primary Outcomes
Change in Patient Outcomes Using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: From Baseline to the 4 month Follow-up Visit (approximately 3-9 months)
The change in total MDS-UPDRS score at 4 months from baseline defined as sections I, II, III and IV in Patients with Parkinson's. The endpoint will be compared between those who are treated with standard of care and access to the PKG (PKG+ Group) and those who are treated per standard of care alone (PKG- Group). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms).
Secondary Outcomes
- Change in PKG Percent Time Tremor (PTT)(From Baseline to the 4 month Follow-up Visit (approximately 3-9 months))
- PKG Patient Survey(Outcome measure evaluated at the 4-month Follow-up Visit)
- Change in Parkinson's Disease Questionnaire-39 Questions (PDQ-39)(From Baseline to the 4 month Follow-up Visit (approximately 3-9 months))
- Change in PKG Dyskinesia Score (DKS)(From Baseline to the 4 month Follow-up Visit (approximately 3-9 months))
- Change in PKG Fluctuation Score (FDS)(From Baseline to the 4 month Follow-up Visit (approximately 3-9 months))
- Change in MDS-UPDRS Sub Part III(From Baseline to the 4 month Follow-up Visit (approximately 3-9 months))
- Change in MDS-UPDRS Sub Part IV(From Baseline to the 4-month Follow-up Visit)
- Percentage of Responders for Total MDS-UPDRS(4 month Follow-up Visit)
- Change in MDS-UPDRS Sub Part I(From Baseline to the 4 month Follow-up Visit (approximately 3-9 months))
- Change in PKG Bradykinesia Score (BKS)(From Baseline to the 4 month Follow-up Visit (approximately 3-9 months))
- Change in MDS-UPDRS Total From Baseline(From Baseline to the 1, 2 and 3-Year Annual Visits)
- Change in Levodopa Equivalent Dose (LED)(From Baseline to the 4 month Follow-up Visit (approximately 3-9 months))
- Change in MDS-UPDRS Sub Part II(From Baseline to the 4 month Follow-up Visit (approximately 3-9 months))