PDRemote Phase II: Automated Telehealth Diagnostics for Remote Parkinson Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Percent of subjects completing remote assessments
研究概览
简要总结
The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.
详细描述
Currently, there is limited access to movement disorder specialist centers for a significant portion of the PD population. Treatment effectiveness is judged during office visits by improvement of patient motor symptoms and quality of life. Clinicians evaluate patients by having them perform specific motor tasks and rating the severity on a 0-4 scale. A major limitation is that a single evaluation in a clinical setting may not accurately reflect motor symptom fluctuations experienced over the course of a day, week, or month. Clinicians currently lack effective, affordable medical devices that can be easily delivered to a patient's home for monitoring symptoms on a more continuous basis as motor symptoms typically change throughout the day. Kinesia HomeView provides a repeatable, automated system clinicians can use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home. The investigators hypothesize use of the Kinesia HomeView system will improve outcomes and decrease costs especially for patient populations in areas not in close proximity to movement disorder specialists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with self-reported clinically-confirmed diagnosis of idiopathic Parkinson disease.
- •Be fluent in English
- •Willing and able to provide informed consent
排除标准
- •Inability to carry out study activities
- •Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
- •Subjects who have dementia, exhibited by those with a score less than 22 on the Montreal Cognitive Assessment (MoCA)
- •Subjects with deep brain stimulation (DBS)
结局指标
主要结局
Percent of subjects completing remote assessments
时间窗: 7 Months
Percent of subjects who successfully completed the requested home-based Kinesia HomeView (KHV) automated motor assessments.
次要结局
- PACIC responses(7 Months)
- Number and type of medication changes(7 Months)
- Number of videoconferences completed(7 Months)
- KHV Motor Scores(7 Months)
- Percent of remote assessments completed(7 Months)
- KHV measured fluctuations(7 Months)
- Number of patient/clinician communications(7 Months)
- Unified Parkinson's Disease Rating Scale (UPDRS)(7 Months)
- PDQ-39 responses(7 Months)
- PAM-13 responses(7 Months)
- Number of clinic visits(7 Months)
