Digital Intervention for Dementia Risk: DIDER Study
Research type
Research Study
Full title
Assessing the feasibility, accessibility, usability of a multi-domain digital lifestyle coach and a virtual clinic to drive behaviour change in middle-aged adults.
IRAS ID
314417
Contact name
Ivan Koychev
Contact email
Sponsor organisation
Five Lives SAS
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
Summary of Research
SharpTx's mission is to build an engaging app allowing individuals to measure, monitor and reduce their dementia risk through targeted lifestyle interventions. We have built a product containing a dementia risk assessment (Class I Medical Device) and are also conducting clinical studies in collaboration with the University of
Oxford to improve its predictive accuracy for future versions of the product.
This project will develop and demonstrate the feasibility, acceptability, usability and
preliminary effectiveness of two additional app modules, a 'digital coach' that
includes logging and monitoring lifestyle with additional educational content and engaging activities, as well as a 'virtual clinic' that provides highly abbreviated sessions with a qualified
clinical psychologist. The clinician will help the user to understand their results and plan and
motivate lifestyle related behaviour change. This project evaluates the commercial and
clinical opportunities of various lifestyle coach + virtual clinic combinations assessing the most optimal frequencies and durations and thus informing the nature of the developing product and providing evidence supporting further investment culminating in a future full-scale clinical validation study.
The main research aims are:
-To assess the feasibility, usability and acceptability of the digital coach and virtual clinic.
-To assess the effect of the Five Lives lifestyle coach and virtual clinic experience on mood, anxiety and memory concerns
-To assess behavioural change in relation to healthy lifestyle habits, motivation and wellbeing in response to the digital coach and virtual clinic.
-To determine the effectiveness of the virtual clinic and the most effective duration and frequency of the clinic sessions for positive lifestyle change.
-To test whether taking part in the coach and virtual clinic intervention leads to a decline in future risk of dementia as assessed by the Five Lives risk assessment in the form of a Brain Health Score.
-To assess the engagement level with the digital coach and virtual clinic and participant’s willingness to pay.Summary of Results
An estimated ∼40% of dementia cases are due to modifiable risk factors which can be targeted in lifestyle interventions. Effective interventions employ face-to-face delivery, making them resource-intensive and burdensome. Digital interventions offer scalability, accessibility and cost-effectiveness. Engagement and efficacy of digital interventions are unknown, as is whether the ‘human component’ of these interventions must be retained.
The Five Lives app is a digital health solution that combines a CE-marked dementia risk assessment with a digital coaching programme (DC) to facilitate behaviour changes which could lead to eventual reduced dementia risk. Three groups were compared: DC-only, DC and access to brief 1-to-1 virtual clinician services(DC+VC) and no intervention (control). The study spanned 12 weeks and participants(n = 154) were aged 50-69 with normal cognition. A lifestyle score was conducted at baseline and exit, which scores participants on behaviour relating to sleep, physical activity, diet, stress & mood and mental stimulation. Engagement was measured as the total number of app activities (brain games, articles, quizzes and lifestyle log)completed during the intervention period. Participant engagement was high (mean participant activities = 35/week).There was a significantly greater change in lifestyle score between intervention group(DC-only and DC+VC pooled) and control (F(1,81) = 3.10, p = 0.049), and a trend for significance for a greater change in DC-only versus control (F(1,24) = 3.96, p = 0.058).The change in lifestyle score between DC-only and DC+VC was not significant, nor was the difference in app engagement. Total engagement was not predictive of lifestyle score change.
Participant engagement indicates the intervention is feasible in older adults. Results suggest the Five Lives app is a promising tool to facilitate behaviour change to potentially reduce dementia risk, and the VC does not provide significant additional benefits. This study provides initial data to warrant further development of DC interventions to reduce dementia risk. Future analyses should investigate which participants respond best to the intervention, barriers to change, and how engagement interplays with sustained dementia-targeted lifestyle change.REC name
West of Scotland REC 4
REC reference
22/WS/0129
Date of REC Opinion
9 Sep 2022
REC opinion
Favourable Opinion