Predictors Of Cognitive Decline Using Digital Devices (NCT07051408) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Predictors Of Cognitive Decline Using Digital Devices
United Kingdom135 participantsStarted 2022-07-19
Plain-language summary
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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 0, 3, 6, 9, and 12 months
2
Mean proportion (%) of scheduled Mezurio data capture visits fully completed at each timepoint for individuals randomised to 14- and 28-day Mezurio schedules
. 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
Exclusion criteria
. 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