Evaluation of the Personal KinetiGraph™ (PKG™) to Improve Insight Into Parkinson's Disease Status (APPRISE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 231
- 试验地点
- 24
- 主要终点
- Evaluation of treatment changes with or without the use of PKG data
研究概览
简要总结
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.
详细描述
This is a prospective, multicenter, randomized controlled trial. The study consists of 3 phases as follows:
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Randomization phase: subjects undergo screening, baseline, interim and 90-day follow-up visits
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PKG+ Group (standard of care clinical evaluation plus use of PKG data)
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PKG- Group (standard of care clinical evaluation without use of PKG data - the MDS is blinded to PKG data)
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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.
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The clinical investigator, study site staff, and subject will not be blinded to the randomization assignment during the randomization phase of the study
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 46 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Evaluation of treatment changes with or without the use of PKG data
时间窗: 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).
次要结局
未报告次要终点