Bringing Parkinson Care Back Home
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Falls
研究概览
简要总结
SUMMARY
Rationale: For persons with Parkinson's disease (PD), medical decisions are based almost exclusively on periodic in-clinic evaluations by a neurologist or a nurse. For a variety of reasons, such "snapshots" are unable to capture the actual impact of PD on the patient's functioning in their own home environment. Outpatient evaluations cannot detect rare and typically domestic events, such as falls. In addition, episodic visits are not well suited to detect changes in important lifestyle issues, such as gradual declines in physical activity.
Objective: To objectively, continuously and accurately collect detailed information on (changes in) physical activity and fall patterns among patients with PD in daily life.
Study design: Observational cohort study in 200 patients with PD, with a 12 month follow-up period.
Study population: Patients with PD (n=200), with an increased fall risk (i.e. at least one fall within the last six months).
Intervention (if applicable): This study does not include an intervention. After a baseline assessment on demographics and PD symptoms, patients will use a remote monitoring system at home (a pendant falls detector) combined with an smartphone application aimed at falls self-reporting, and an application to report medication intake for 12 months. A similar set up (i.e.Vital@Home) has been previously tested on feasibility (Dossiernummer: 2017-3382). Additionally, patients will report sleep patterns through paper-based diaries.
Main study parameters/endpoints: The main study parameters are physical activity and number of falls. They are remotely registered by the pendant falls detector.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, no invasive measurements will be performed. The participation is free of risks. Subjects could potentially benefit personally from participating in this study, as they can use the devices for free during the study and receive periodically feedback about physical activity and the occurrence of falls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must confirm that they have been diagnosed with Parkinson's Disease by a neurologist (self-reported)
- •Age 18 or older
- •At least 1 fall incident in the previous 6 months. A fall is defined as any unexpected event that caused the person to unintentionally land on any lower surface (object, floor, or ground), regardless of any sustained injury (self-reported)
- •Able and willing to provide written informed consent in accordance with Good Clinical Practice, and national and local regulation
- •Fluent in Dutch
排除标准
- •The patients receives advanced therapy for their Parkinson's disease (deep brain stimulation, duodopa pump, apomorphine pump);
- •The patients shows cognitive of psychiatric impairments that may hinder successful completion of the study protocol (as judged by the researcher running the recruitment).
结局指标
主要结局
Falls
时间窗: Continuously over 12 months
Number of alls measured with wearable sensors
Physical activity
时间窗: Continuously over 12 months
Minutes of physical activity performed during daily-life measured with wearable sensors
次要结局
- Physical activity(Twice - baseline and after 12 months)
- Falls(Twice - baseline and after 12 months)
- Patients demographics(Once - baseline)
- Disease status(Once - baseline)
- Functional lower extremity strength(Once - baseline)
- Disease severity(Part III - once at baseline. Part I, II and IV - twice baseline and after 12 months)
- Freezing of gait - II(Once - baseline)
- Walking capacity(Once - baseline)
- Balance - I(Once - baseline)
- Sleep quality(Twice - baseline and after 12 months)
- Sleep quality and quantity(Once for a full week)
- Fear of falling(Twice - baseline and after 12 months)
- Compliance(Continuously over 12 months)
- Medication(Continuously over 12 months)
- Balance - II(Once - baseline)
- Freezing of gait - I(Twice - baseline and after 12 months)
- Cognition(Once - baseline)