Title: REducing and preventing COgnitive impairment iN older age groups (the RECON Programme)
Funder: Department of Health and Social Care

Abstract: 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 developing a similar intervention using the same processes, finishing in a trial of 10515 individuals aged 60-80 who do not have cognitive impairment, with the same primary outcome as WS1. Secondary outcomes will include progression to cognitive impairment at 5 years. Dissemination We propose using: high impact open access journals; professional publications; social media; stakeholder events; our PPI collaborators; and NICE. If cost-effective, we will rapidly disseminate the web-based intervention widely, at low cost to NHS patients, through appropriate partnerships or licensing arrangements. PPI The PPI experts will be integral team members in protocol development &ndash; both key charity stakeholders and also individuals. PPI collaborators will be members of the trial management team, have full collaborator status, will play a key role at all stages of the project and will play a leading role in interpretation of the results and dissemination. Management A Programme Manager will provide day-to-day coordination of the Programme. Each WS will be coordinated by WS leads, with regular team meetings, and whole Programme team meetings quarterly. The research will be hosted by Southern Health with the University of Southampton as sponsor; NHS ethics and research governance arrangements will apply; and the Programme will be overseen by a PSC, and also a DMEC as necessary. Benefits to patients and the NHS The Programme has the potential to improve cognitive functioning and activities of daily living among older age individuals in the UK.

Lay abstract: Background Dementia occurs in 6.5% of those aged over 65, and the number of sufferers will increase due to people living longer. Reduced functioning ( cognitive impairment ) is more common - including Mild Cognitive Impairment (MCI) and Age Associated Cognitive decline (AACD) (for definitions see below) - and approximately 5% progress to dementia annually. Intensive promotion of healthy behaviours (diet/physical activity) and cognitive exercises slow cognitive decline but use considerable staff resource. Aim. To develop and test efficient internet-supported healthy-behaviour/cognitive exercises to reduce cognitive decline among older age adults. Workstream 1 (WS1): participants with MCI or AACD. Past research will be reviewed to inform intervention development, and to identify particular types of support that might work. Internet applications will be developed that have already been developed for other conditions to promote healthy behaviours and cognitive exercises, but will be adapted for individuals over the age of 60. We will then carry out a study of around 180 patients taken from a variety of sources including general practices and also participants from existing large studies such as the Biobank study. This is to make sure the intervention is likely to work and be acceptable to patients and health professionals. Following this we will carry out a larger study of 10940 participants. In this study we will allocate patients to one of three groups by random numbers (so patients will have an equal chance of being in any one of the three groups): 1) Control. Patients will receive brief advice about diet, physical activity and keeping the mind active; 2) Web only: in addition to the brief advice, participants will have access to an Internet-based Healthy behaviour and Cognitive exercise Package; 3) As in 2 above but with support from a facilitator to use the Internet-based Healthy behaviour and Cognitive exercise Package (between 4 and 7 contacts for support in a year). We will follow up patients in all groups, initially over 1 year, to see if their cognitive functioning improves and to talk to them about what part of the intervention worked well for them and what could have worked better for them. If the intervention works at 1 year we will request release of funds for long term follow-up. WS2: participants with no cognitive impairment. This will proceed in parallel with WS1 developing a similar intervention using the same processes, finishing in a similar sized trial of 10515 participants. Dissemination : through journals; social media; stakeholder events; PPI collaborators; NICE. If cost-effective, we will rapidly disseminate at low cost to NHS patients. PPI Two named PPI individuals and the two major charities (Alzheimer s Research UK; Alzheimer s Society) are integral to protocol development, interpretation of the results and dissemination

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: NEUROLOGICAL