Digitised Home Based Care for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Degree of compliance with wearable sensor
研究概览
简要总结
Parkinson's disease is the world's fastest-growing neurological condition. It is a progressive neurodegenerative disorder that causes a wide range of movement-related (motor) problems (slowness, stiffness, tremor, balance difficulties) and non-motor problems (disturbances of thinking, memory, perception, mood, bladder, bowels, blood pressure). Even before the pandemic, NHS services were struggling to meet the demand for care.
To address this need for support, the investigators have co-designed an innovative digital care pathway, Home Based Care (HBC), with people with Parkinson's (PwP) and care partners (CP) to deliver self-management support and clinical expertise to the patient's home. This pathway is supported by remote monitoring with a wrist-worn sensor and questionnaires.
In this study, the investigators will be digitising this pathway so that data from a variety of sources (including the sensor, questionnaires, and patients' health records) can be combined in one place to enable more personalised care and to provide advice to support self-management of symptoms by patients.
After the investigators have set up the digitised pathway, its implementation will be evaluated with a group of 120 people with Parkinson's and their care partners and associated healthcare providers through the Plymouth Parkinson's Service. The investigators will examine participants' adoption of and engagement with the patient-facing digital platform over the course of 3 months and gather their feedback about its usability and acceptability. A smaller group of the participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development.
The investigators anticipate that this system will result in improved quality of life and care and increased knowledge and confidence for self-managing symptoms. The results of the study will be used to improve the digitised Home Based Care pathway. People with Parkinson's and care partners involved in the project will help guide the sharing of these results with healthcare providers and the general public.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No blinding will be possible in the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over
- •Not resident in care home or nursing home
- •Have compatible smartphone/data access (access to a digital device is a necessary prerequisite of system use, and the formative usability study had success in recruiting participants with varying levels of experience with smartphones [18])
- •Be fluent in English
- •Normally under the care of the Parkinson's service in the participating organisation
- •Participant's healthcare provider in the participating organisation consented to participate in the study
- •Able and willing to provide informed consent
- •Able and willing to comply with intervention requirements
排除标准
- •Secondary cause of parkinsonism
- •Significant cognitive impairment or a diagnosis of Parkinson's disease dementia
- •Significant comorbidity, which in the opinion of the chief investigator would preclude safe participation in the study or protocol compliance
- •Previous involvement in development or testing of the NMS Assist system
- •A life expectancy of <6 months
- •Living in residential care facilities
- •Incapable of self-consent
- •In a dependent/unequal relationship with the research or care teams or any PPI representatives
结局指标
主要结局
Degree of compliance with wearable sensor
时间窗: 3 months
The wearable sensors are worn on the wrist and are known as the Parkinson's Kinetograph (PKG). The PKG assess objective motor measures including bradykinesia, dyskinesia and tremor. In accordance with the HBC pathway, patients are required to wear the PKG for 6 days and nights, after which the results are analyzed by their care team. From these results, therefore, it is clear to see where the patient has complied with wearing the PKG for the allotted time frame.
Proportion of digital questionnaires completed
时间窗: 3 months
In accordance with HBC pathway, patients are required to complete a set of questionnaires covering the same time period in which they are wearing the PKG, and are responsible for assessing subjective measures. This outcome will assess compliance by examining the patients' overall compliance with the digital monitoring questionnaires by calculating how many of the questionnaires they successfully complete over the study period.
Uptake
时间窗: 3 months
Rates of conversion to the digital platform
Engagement
时间窗: 3 months
Qualitative feedback about engagement from semi-structured interviews
次要结局
- Usability scores(3 months)
- Patient perceptions of usability(3 months)
- Patient perceptions of acceptability(3 months)
- Cost impact(3 months)
研究者
Edward Meinert, PhD
Associate Professor of eHealth
University of Plymouth