REducing and preventing COgnitive impairment iN older age groups (the RECON Programme)

Background and Rationale. Dementia occurs in approximately 6.5% of those aged over 65, and although the prevalence has fallen slightly in 20 years the absolute number of sufferers is likely to increase due to people living longer. For those with no dementia, there is a range of cognitive impairment including Mild Cognitive Impairment (MCI) where the incidence ranges from 51 to 76.8 per 1,000 person-years, and commonly leads to dementia, with annual conversion rates of between 5 and 10%, and so called Age Associated Cognitive decline (AACD; up to 20% of the population) with similar conversion rates to dementia as MCI, but with no formalised treatment or diagnostic pathway. There is mounting evidence that healthy behaviour change (particularly physical activity) and cognitive exercises improve cognitive functioning and activities of daily living, and a recent trial from other settings has demonstrated the potential effectiveness of combining healthy behaviour and cognitive interventions (the FINGER trial). However, behavioural interventions are complex and resource intensive if delivered by purely face-to-face methods. In contrast, the internet is now used extensively and successfully by older people for self-management. Although many individuals may benefit from a free standing intervention, the additional impact of behavioural facilitation may be important in helping initiate and maintain behaviour change - and the effectiveness and cost-effectiveness of a more intensive intervention may vary with the risk of developing dementia. Aim. To develop and evaluate internet-supported interventions for healthy behaviours and cognitive exercises among older age adults, both for those with cognitive impairment and those without cognitive impairment. Objectives. Among older age individuals both with and without cognitive impairment: 1) To estimate the effectiveness and cost-effectiveness in maintaining cognitive functioning of a complex internet supported behavioural intervention to promote healthy behaviours (diet and physical activity) and perform cognitive exercises. 2) To estimate the effectiveness and cost-effectiveness in maintaining cognitive functioning of a complex internet supported behavioural intervention to promote healthy behaviours and perform cognitive exercises when supported as necessary by a trained behavioural facilitator. Research plan Workstream 1 (WS1): participants with MCI or AACD. Study 1.1 will update and review literature to inform theoretical modelling for the intervention. Study 1.2 will identify key components of the intervention using an intervention mapping process and develop the intervention iteratively with participants. Study 1.3 is a feasibility trial of the interventions among 180 participants. Qualitative work will continue during the feasibility trial and final modifications to the interventions and package of outcome measures will be made as necessary following the feasibility trial. Study 1.4 will be a randomised controlled trial of two interventions compared to a control group among 10940 individuals aged 60-80 who have cognitive impairment identified by an internet based assessment. 1) Control. Brief advice with written materials (control group); 2) Web only. As in 1) but with encouragement to use an internet based Healthy behaviours and Cognitive Exercise Package 3) Web with flexible central facilitator support. As in 2) but with additional structured guidance and support in use of the self-help intervention provided flexibly by a behavioural facilitator as necessary. Primary outcome: cognitive functioning at 1 year (verbal reasoning) Secondary outcomes: other measures of cognitive impairment; activities of daily living; enablement; quality of life; cognitive functioning and progression to dementia at 5 years Study 1.5 will estimate cost-effectiveness of the interventions trialled in 1.4. WS2: participants with no cognitive impairment. This will proceed in parallel with WS1 developi