Predictors Of Cognitive Decline In Attenders Of Essex Memory Clinic From Digital Devices Using Classical Statistical Methods, Machine Learning And Disease Progression Modelling
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint
研究概览
简要总结
The overall aim of this study is to find out if people with cognitive difficulties will wear and use different types of digital technology, and if they will allow data from that technology and their clinical profile to be collected. Participants will be patients in Essex Memory clinic and their partners/carers. The digital technology used will include a smartwatch, a sleep headband and two smartphone applications, which have been selected as part of the Early Detection of Neurodegenerative Disease (EDoN) initiative. The investigators will also investigate how the digital data can be analyzed together with routinely captured clinical data using machine learning models, a complex type of statistical analysis.
The aim of the wider EDoN initiative is to combine digital and clinical data to develop machine learning models which can predict individuals' risk of developing dementia decades before the onset of symptoms.
详细描述
Study Design & Methods of Data Collection: This study is designed as an observational, pilot and feasibility study. Recruitment will be over 18 months with clinical data collected at baseline and up to 5 years follow up, and digital data collected at baseline, 3, 6, 9 and 12 months.
Setting: Essex Memory Clinics within the Essex Partnership University NHS Foundation Trust which serves older adults living in greater London and Essex areas.
Participants: The investigators aim to recruit a minimum of 100 participants, comprising of a 3:1 ratio of patients to controls respectively (refer to section 6 for eligibility criteria). Participants will include patients of the memory clinic with cognitive complaints, mild cognitive impairment or dementia, and their partners/carers/family members/friends as controls. As this is a feasibility study, this sample is not based on a power calculation, but findings will inform future work in this area. Sampling will follow a convenience strategy, appropriate for a feasibility study.
Methods: Overall feasibility of implementing digital tools within a clinical population will be evaluated through a combination of direct usage data from the devices and apps and via questionnaires. Digital tools (Fitbit, Dreem headband, Mezurio app, Longevity app) will be provided to participants at a baseline visit at the participant's home.
The broad, but not exclusive, areas of interest will include:
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who present to the Essex Memory Clinic and their relatives or carers
- •Capacity to provide written informed consent
- •Sufficient proficiency in English to understand study documents and use the digital devices
- •Own a compatible smartphone (Android 7.0 or higher / iOS 12.2 or higher). If participants own a smartphone which is not a compatible device (i.e. prior to Android 7.0 or iOS 12.2), a new handset will be provided to them, as long as they are willing to use this as their primary phone.
- •Ability to use a smartphone and EDoN digital devices, either alone, or with appropriate support (carer, partner, family member, etc). Support would involve reminding participants to complete study tasks and to charge / wear devices.
- •Able to connect to the internet using their smartphone at home. Note: In order to use the Dreem headband, participants will additionally require a home WiFi connection. However, participants without a WiFi connection will still be able to join the study and will not be asked to use the Dreem headband.
- •For people with a diagnosis of dementia, a carer, partner or family member willing to support their participation in the study by reminding patients to complete study tasks and to charge/wear their devices
- •For patients who do not have a record of neurocognitive and physical assessments outlined in section 4.5.3, they must be willing to undergo these additional assessments
- •For the blood donation sub study only: consented to participate in the main CODEC II study.
- •For the qualitative sub study only: able to use a phone or video-conferencing platform to participate in the interviews
- •Aged 40+ years
排除标准
- •Patients with active major psychiatric disorder which requires regular reviews by secondary care, for example schizophrenia, schizoaffective disorder or bipolar affective disorder
- •Patients under end-of-life care
- •Previous sensitivity or allergic skin reaction to latex, rubber or plastics
- •Do not have a personal smartphone with internet access
- •Participating in a clinical trial of an investigational medicinal product
- •Not meeting all inclusion criteria
结局指标
主要结局
Mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint
时间窗: 0, 3, 6, 9, and 12 months
The investigators will assess the feasibility of capturing digital data from digital technologies that have been selected as part of the EDoN initiative. This will be achieved by assessing the mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint. In addition, a subset of participants who consented to the main study will be invited to participate in a qualitative sub-study to explore the perspectives of people with cognitive impairment and their partners, carers or family members on the use of digital devices included in the EDoN toolkit.
Mean proportion (%) of scheduled Mezurio data capture visits fully completed at each timepoint for individuals randomised to 14- and 28-day Mezurio schedules
时间窗: 0, 3, 6, 9, and 12 months
One of the digital technologies being evaluated/utilised in the study is a cognitive testing application called 'Mezurio' created by Dr Chris Hinds at the University of Oxford. Participants will be asked to install Mezurio on their smartphone at baseline and complete a range of short tasks over a period of either 14 or 28 consecutive days during the 12 month study period. Participants on the 14 day schedule will repeat the assessments at 3 month intervals; participants on the 28 day schedule will repeat the assessments at 6 month intervals. Participants will be allocated to each assessment period randomly. The investigators will assess the mean proportion (%) of scheduled Mezurio data capture visits fully completed at each timepoint for individuals randomised to 14- and 28-day Mezurio schedules.
Mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint
时间窗: 0, 3, 6, 9, and 12 months
The investigators will assess the feasibility of capturing digital data from digital technologies that have been selected as part of the EDoN initiative. This will be achieved by assessing the mean proportion (%) of scheduled digital data capture visits fully completed for each digital technology (Fitbit Charge 4/5, Dreem 2/3 headband, Mezurio smartphone app, and Longevity smartphone app) at each timepoint. In addition, a subset of participants who consented to the main study will be invited to participate in a qualitative sub-study to explore the perspectives of people with cognitive impairment and their partners, carers or family members on the use of digital devices included in the EDoN toolkit.
Mean proportion (%) of scheduled Mezurio data capture visits fully completed at each timepoint for individuals randomised to 14- and 28-day Mezurio schedules
时间窗: 0, 3, 6, 9, and 12 months
One of the digital technologies being evaluated/utilised in the study is a cognitive testing application called 'Mezurio' created by Dr Chris Hinds at the University of Oxford. Participants will be asked to install Mezurio on their smartphone at baseline and complete a range of short tasks over a period of either 14 or 28 consecutive days during the 12 month study period. Participants on the 14 day schedule will repeat the assessments at 3 month intervals; participants on the 28 day schedule will repeat the assessments at 6 month intervals. Participants will be allocated to each assessment period randomly. The investigators will assess the mean proportion (%) of scheduled Mezurio data capture visits fully completed at each timepoint for individuals randomised to 14- and 28-day Mezurio schedules.
次要结局
- Incident subjective cognitive decline (SCD), mild cognitive impairment (MCI), or dementia(12 months)
- Incident subjective cognitive decline (SCD), mild cognitive impairment (MCI), or dementia(12 months)