TailorEd iNtervention for brain HeAlth aNd Cognitive Enrichment
Study Code / Acronym
ENHANCEAward Number
NIHR203670Programme
Programme Grants for Applied ResearchStatus / Stage
CompletedDates
1 January 2023 -31 December 2028
Duration (calculated)
05 years 11 monthsFunder(s)
NIHRFunding Amount
£2,939,023.00Funder/Grant study page
NIHRContracted Centre
Camden and Islington NHS Foundation TrustPrincipal Investigator
Dr Sergi Costafreda GonzalezPI Contact
s.costafreda@ucl.ac.ukPI ORCID
0000-0001-6914-086XPrincipal Investigator
Professor Gill LivingstonPI ORCID
0000-0001-6741-5516WHO Catergories
Development of novel therapiesEconomic Impact of Dementia
Tools and methodologies for interventions
Disease Type
Dementia (Unspecified)CPEC Review Info
| Reference ID | 212 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Study Code / Acronym | ENHANCE |
|---|---|
| Award Number | NIHR203670 |
| Status / Stage | Completed |
| Start Date | 20230101 |
| End Date | 20281231 |
| Duration (calculated) | 05 years 11 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | Camden and Islington NHS Foundation Trust |
| Funding Amount | £2,939,023.00 |
Abstract
ENHANCE” blended eHealth multidomain intervention effective and cost-effective in enhancing cognition for people aged ≥60 and ≤80 years without dementia, when compared with care as usual (CAU)? Background Our research established that 40% of dementia cases are potentially preventable by addressing modifiable risk factors. These risks cluster in socio-economically deprived individuals and specific cultural/ethnic groups. Prevention should target these individuals for effectiveness and equity. Previous multicomponent interventions neither addressed many of these risks nor recruited such individuals, and were limited by poor engagement. However, SUPERBRAIN, a South Korean intervention achieved high engagement using games and coaching. We will gamify interventions, intervene to include all important risk factors, and target those who can benefit the most from it. Aims To develop ENHANCE, a blended eHealth multidomain app, delivered with individual coaching, and including personalised dementia risk profile and evidence-informed interventions to facilitate behavioural change and assess: Effectiveness in enhancing cognition Cost-effectiveness Implementation Objectives To co-produce ENHANCE, To test and refine prototype-ENHANCE in a pilot RCT, To test ENHANCE versus CAU in a full RCT, To assess ENHANCE implementation into routine care Methods Work package (WP) 1: Intervention co-production and user testing Our interdisciplinary expert team includes PPI representatives, doctors, psychologists, policy leads, trialists, implementation, behaviour change and human-computer interaction experts. We will co-produce, iteratively test and refine a 24-week blended eHealth intervention to address dementia risks (ENHANCE-prototype), engaging hard-to-reach populations. WP2: Pilot RCT and intervention refinement Design: RCT with 2:1 randomisation to ENHANCE-prototype vs CAU. Setting: Primary care recruitment of 60 people aged ≥60 and ≤80 years, purposefully sampled from underserved postcodes Tablets and internet packages provided for those without them. Inclusion criteria: No dementia; ≥3/10 dementia risks (uncontrolled hypertension, uncontrolled diabetes, obesity, current smoking, drinking >21U/week, Recruitment, acceptability of randomisation, intervention adherence, attrition Primary and secondary outcomes completion: cognition (80% follow-up), use of app, blood pressure, BMI, HbA1c, Dementia Risk Score, mood, use of hearing aid, social contact, quality of life and resource use Process evaluation: think-aloud interview and focus groups considering active elements, acceptability, barriers and facilitators. WP3: Full RCT with internal pilot Design: Two-arm pragmatic RCT recruiting 588 people, 1:1 randomisation stratified by site, masked outcome assessment, and process evaluation. Setting, population, intervention, comparison: As WP2 with refinements made following WP2 Primary research question: Does ENHANCE versus CAU improve cognition at 1 year? Primary Outcome: Cognition (RBANS). Secondary outcomes: refined using WP2 WP4: Implementation – cross-cutting theme Implementation is embedded throughout, from co-production to process evaluation, as well as in-depth analysis from participants recruited post-trial. Timeline Month(M)1-18: WP1 M18-30: WP2 M30-72: WP3 M1-72: WP4 Impact Successfully enhancing cognition, delaying or preventing dementia would substantially benefit individuals, families, NHS, social-care, and the economy. Dissemination We will launch a website and social media accounts, produce newsletters, and disseminate and implement with PPI, national charities, media and policy-makers. We will publish peer-reviewed articles, presenting findings at scientific and public meetings.
Aims
To develop ENHANCE, a blended eHealth multidomain app, delivered with individual coaching, and including personalised dementia risk profile and evidence-informed interventions to facilitate behavioural change and assess: Effectiveness in enhancing cognition Cost-effectiveness Implementation Objectives To co-produce ENHANCE, To test and refine prototype-ENHANCE in a pilot RCT, To test ENHANCE versus CAU in a full RCT, To assess ENHANCE implementation into routine care