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 range40 Years
SexALL
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.
✓. 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
✓
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 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