A development study and randomised feasibility trial of a tailored intervention to improve activity and reduce falls in older adults with mild cognitive impairment and mild dementia

Abstract

BackgroundPeople with dementia progressively lose abilities and are prone to falling. Exercise- and activity-based interventions hold the prospect of increasing abilities, reducing falls, and slowing decline in cognition. Current falls prevention approaches are poorly suited to people with dementia, however, and are of uncertain effectiveness. We used multiple sources, and a co-production approach, to develop a new intervention, which we will evaluate in a feasibility randomised controlled trial (RCT), with embedded adherence, process and economic analyses.MethodsWe will recruit people with mild cognitive impairment or mild dementia from memory assessment clinics, and a family member or carer. We will randomise participants between a therapy programme with high intensity supervision over 12 months, a therapy programme with moderate intensity supervision over 3 months, and brief falls assessment and advice as a control intervention. The therapy programmes will be delivered at home by mental health specialist therapists and therapy assistants. We will measure activities of daily living, falls and a battery of intermediate and distal health status outcomes, including activity, balance, cognition, mood and quality of life. The main aim is to test recruitment and retention, intervention delivery, data collection and other trial processes in advance of a planned definitive RCT. We will also study motivation and adherence, and conduct a process evaluation to help understand why results occurred using mixed methods, including a qualitative interview study and scales measuring psychological, motivation and communication variables. We will undertake an economic study, including modelling of future impact and cost to end-of-life, and a social return on investment analysis.DiscussionIn this study, we aim to better understand the practicalities of both intervention and research delivery, and to generate substantial new knowledge on motivation, adherence and the approach to economic analysis. This will enable us to refine a novel intervention to promote activity and safety after a diagnosis of dementia, which will be evaluated in a definitive randomised controlled trial.Trial registrationClinicalTrials.gov: NCT02874300; ISRCTN 10550694.

A scoping review of behaviour change theories in adults without dementia to adapt and develop the ‘PHYT in dementia’, a model promoting physical activity in people with dementia

“…To ensure that the synthesised constructs had validity and relevance in a population with dementia, we utilised data from our feasibility study of the PrAISED 2 [28]. Twenty participants with dementia and their carers who had taken part in the PrAISED feasibility study were qualitatively interviewed, to investigate which aspects had promoted or hindered engagement in the intervention.…”

Developing an Intervention for Fall-Related Injuries in Dementia (DIFRID): an integrated, mixed-methods approach

“…While we are aware of a current study examining enhanced recovery of confused patients following hip fracture [6], this focuses on a single type of injury. Other current studies are focusing on falls interventions for people with dementia, but are not targeted at those who have already had an injurious fall [87,88]. The DIFRID intervention therefore targets a neglected group, and could potentially clarify whether the preventive component is effective in patients who have already fallen.…”

An intervention to improve outcomes of falls in dementia: the DIFRID mixed-methods feasibility study

“…This study comprehensively addressed the requirements of the MRC guidance on process evaluations. 169 However, a limitation is that we only had a small number of participants and carers. Nevertheless, the ways that we can optimise the intervention will be useful in further evaluations of this intervention.…”