The Impact of a Digital System on the Monitoring and Self-management of Non-motor Symptoms in People With Parkinson's
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
Parkinson's can cause a wide range of non-motor symptoms (NMS), including pain and problems with mental health, memory and sleep. These affect the quality of life of people with Parkinson's (PwP) and their care partners (CP). If these issues are not recognised and managed quickly, they can result in escalating problems. Many PwP are unsure of the extent and variety of the NMS and how simple adjustments at home could improve them. We have developed a digital system to help PwP monitor their non-motor symptoms and develop skills to self-manage them.
Such a tool needs to be simple to use, safe and effective. We will ask 30 PwP and CPs to use the digital tool for 6 months, and we will monitor how they use the tool. PwP and CPs will be asked if they feel more knowledgeable and confident to manage their own symptoms whilst being better able to discuss a problem with their healthcare professional.
A smaller group of participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development.
It is thought that the use of this system will result in improved quality of life and increased knowledge and confidence for managing symptoms while safely reducing the time spent by healthcare professionals on manageable non-motor symptoms.
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
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
- •Individuals will be eligible if they meet the following inclusion criteria:
- •Age 18 years or over
- •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)
- •Be fluent in English
- •Able and willing to provide informed consent
- •Able and willing to comply with intervention requirements
- •For clinically diagnosed people with Parkinson's (PwP) (ICD-10-CM G20):
- •Not resident in a care home or nursing home
- •Interested in monitoring and managing their NMS
- •- Be caring for a clinically diagnosed PwP (ICD-10-CM G20) who is participating in the study
排除标准
- •Participants will be ineligible for the study if they meet any of the following exclusion criteria:
- •Previous involvement in the development or testing of the digital system
- •In a dependent/unequal relationship with the research or care teams or any PPI representatives
- •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
- •A life expectancy of <6 months
- •Living in residential care facilities
结局指标
主要结局
Feasibility of the intervention
时间窗: Assessed throughout the 6-month study duration
The primary outcome will be assessed using a composite of variables: recruitment, retention, system uptime, adherence/engagement, technical issues, and a review of the health and well-being outcomes (secondary outcomes). Adherence/engagement will be measured using system use data (trend of use over time). This will be supplemented with semi-structured interviews and a user engagement questionnaire to gain a better understanding of users' experience engaging with the intervention and the recommended behaviours. Technical issues will be identified through system use data (including logs of complaints made by participants during the intervention delivery period) as well as asking participants about any technical issues encountered during the semistructured interviews. Product complaints will be collected through feedback recorded via the platform, collected at study assessment points or manually provided via email throughout the study duration.
次要结局
- Presence of non-motor symptoms(Measured monthly for 6 months)
- Patient (and care partner) activation(Assessed monthly for 6 months)
- Frequency and severity of non-motor symptoms(Measured at baseline, 3, and 6 months)
- Acceptability(3 and 6 months)
- Costs will be conducted, in conjunction with an adaptation of Client Service Receipt Inventory (CSRI)(Throughout 6 months)
- Long-form self-assessment of functioning and well-being related to Parkinson's disease(Measured at baseline, 3, and 6 months)
- Short-form self-assessment of functioning and well-being related to Parkinson's disease(Measured monthly for 6 months)
- Carer well-being and quality of life(Measured monthly for 6 months)
- Health status(Measured at baseline, 3, and 6 months)
- Adverse events(Throughout the 6-month study period)
- Healthcare contacts(Throughout the 6-month study period)
- Quantitative usability(3 and 6 months)
研究者
Edward Meinert
Professor of Digital Health and Clinical Artificial Intelligence
Newcastle University