Q-Index: A Proof of Concept Investigation Towards Monitoring the Health-related Quality of Life of Parkinson's Disease Patients Using Wearable and Portable Devices.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Koios Care
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Primary objective
研究概览
简要总结
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease at different stages of progression.
详细描述
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease at different stages of progression.
The study takes place in hospitals in Belgium. The study populations are as follows: up to 100 patients between stages H&Y 1.5 and 3 (population A), up to 15 patients with early-stage Parkinson's disease H&Y 1 (population B), and up to 15 healthy controls (population C). The duration of the study is approximately 9 months, between September 2023 and November 2024, and will include a baseline clinical assessment (month 0), the first follow-up (month 4) and the second follow-up (month 8).
The main objective is to build an algorithm capable of remotely assessing the health-related quality of life (HrQoL) of patients belonging to population A. This objective will be achieved by formulating and estimating the quality of life index (Q-index) based on continuously and passively recorded data from commercially available wearable devices (an Android smartwatch and a smartphone). The secondary objective is to determine whether the Q index is sufficiently sensitive to monitor the quality of life of people who are in the early stages of the disease (population B). A group of healthy control subjects (population C) will be used to identify the range of Q index values corresponding to healthy and PD populations.
To achieve this objective, we will compare the information extracted from connected devices (micro-indicators) with the responses of participants to questionnaires and clinical tests aimed at evaluating PROMs (patient-related outcome measures). The list of data collected is included in the following table.
To calculate the Q index, we plan to use a combination of several micro-indicators, each acting as a surrogate for the subject's ability to effectively perform certain activities of daily living; communication, sleep, eating, sociability and physical independence. An example of a micro-indicator is Plate-to-Mouth1 (PtM), which measures the individual's eating behavior by estimating the time required to transfer a quantity of food ready to be consumed, from the plate to the mouth.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between the ages of 30 and 75
- •Agree to download and install the Koios Care application to their personal Android smartphone.
- •People diagnosed with idiopathic PD based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson's Disease.
- •o PD patients that are under the effects of a Deep Brain Stimulation (DBS) device or a levodopa pump (duodopa or lecigimon). Given that all other conditions are also met.
- •Score between one-and-a-half (1.5) and three (3) at the H&Y rating scale in the "ON" state (population A)
- •Score of one (1) at the H&Y rating scale in the "ON" state (population B)
排除标准
- •The candidate cannot speak or comprehend the French/Dutch (depending on the clinical site s/he belongs to) language at a sufficient level.
- •The reluctance of the candidate or her/his inability to provide written consent (e.g., due to mental health problems or severe physical disabilities).
- •The candidate is not an Android smartphone owner and user for at least six (6) months.
- •The candidate's Android smartphone is not compatible with the Koios Care application.
- •The candidate suffers from dementia as judged by the investigator. For this we will use MMSE score with a cut-off value ≥
- •The candidate has exhibited uncontrolled/extreme measures of depression as judged by the expert investigator, e.g., self-harm, suicide attempts or patient admitted to the hospital for a similar reason.
- •-- If the participant develops such behavior or s/he is admitted to the hospital for the above reasons during the study, then the candidate is immediately removed from the study.
- •Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.
研究组 & 干预措施
Population A
Parkinson's disease patients between H&Y stages 1.5 and 3
Population B
Early Parkinson's disease patients of H&Y stage 1
Population C
Healthy controls
结局指标
主要结局
Primary objective
时间窗: Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.
Primarily, this longitudinal study targets patients with Parkinson's Disease between the stages of one-and-a-half (1.5) and three (3) in the Hoehn \& Yahr scale (in the context of this study; population A). By considering the aforementioned population, the primary objective is to build an algorithm towards the remote assessment of the individuals' Health-related QoL (HrQoL). This is to be achieved by formulating and estimating the Quality-of-Life index (Q-index) based on continuously and passively recorded data from commercially available wearable and portable technology (i.e., an Android smartwatch and an Android smartphone).
次要结局
- Secondary objective(Clinical assessments are collected in the clinic at month 0, month 4 and month 8 of the study. Moreover, two self-assessment questionnaires are collected remotely (a) once per month, and (b) once per week.)