Title: The balanced mind: preventing falls in dementia
Funder: Department of Health (England)

Abstract: We propose 4 elements to the PDG Surveys of conventional and neuropsychological falls risk factors in people attending memory clinics and people seen by falls services Falls prevention intervention development Initial feasibility testing of delivery of the intervention Preparation of application for PGfAR. 1. Surveys of falls risk factors Many patients seen in regular falls services have mild dementia or mild cognitive impairment (often undiagnosed), and many patients attending memory clinics have fallen or are at risk of doing so. We will therefore study both groups. This work will investigate the prevalence of risk factors, and also determine the feasibility, tolerability and best location for the testing procedure in this population. This will demonstrate that both conventional and neuro-psychological impairments are present in our study populations, and can be measured. We will recruit two populations a) 50 people over 65 with newly diagnosed mild or early dementia or MCI (defined by performance on 2 pen-and-paper cognitive tests, >20 on the Mini-Mental State Examination, b) 50 people over 65 seen by falls services with similar levels of cognitive impairment and physical ability. Potential participants will be approached and invited by clinic staff, who may be supported by PPI volunteers. The St Francis Hospital memory clinic makes especial attempts to make people feel at ease, including an ‘Alzheimer café’ run in conjunction with the Alzheimer’s Society. Community Falls Service patients are seen at home. In both groups, those expressing initial interest will be approached and screened by a researcher or Mental Health Research Network research nurse, given a Participant Information Sheet, and invited to take part. Potential participants without mental capacity to consent to participate will be excluded (we anticipate that most will have capacity to give their own consent at this stage of the disease). Those participants agreeing to the initial invitation will be invited to return to a clinic, the day hospital or a dedicated research space in the hospital, where consent will be obtained by a researcher and demographic, cognitive and health variables will be collected, and gait assessment carried out. Carers will be recruited to act as informants. PPI consultation indicated a preference for research interviews to be undertaken at home. However, assessing gait speed in particular may be difficult in this setting. We will ask participants where they would have preferred to be assessed. This will inform the design of the randomised controlled trial that we will conduct in the subsequent PGfAR. Where clinic attendance proves impossible, we will offer home visits, and monitor completion rates of the tests. Measurement: To minimise burden, we will extract as much data as possible from clinical assessments if they have been performed at a recently. The researcher will record (using an informant to corroborate, if necessary) Background: demographic, medical history and health status, drugs. Established falls risk factors, including: previous falls history; extrapyramidal motor signs; physiological profile (vision, proprioception, sway, leg strength, reaction time); postural blood pressure. Neuro-psychological tests: We will perform a battery of different ‘pen and paper’ neuro-psychological tests, including, and subject to participant tolerance and fatigue, tests of: - visuospatial ability (Rey copy (Rey, 1959)) - executive abilities (Trail Making (Delis, 2001); BADS Key Search and Rule shift (Wilson1996)) - attention (TEA elevator counting and visual search (Robertson, 1994)) - working memory (digit span, non-verbal span (Wechsler, 2009)). We will assess gait, and measure dual task deficit in gait speed (whilst performing ‘serial 3s’ mental arithmetic). To minimise burden (a concern of the PPI reviewers) we will agree a core neuropsychological dataset and perform additional tests on overlapping samples of patients who are willing and able to do more to explore the utility of a broader range of tests. Researchers will be alert of the potential burden of assessment. We will include breaks in the assessment schedule, will split assessments if they become fatiguing or difficult, and complete them on a home visit if desired by the participant. Analyses will include Estimation of the prevalence of conventional, and neuro-psychological risk factors Descriptive statistics for the time required for neuro-psychological tests The proportion of neuro-psychological tests and gait parameters completed, and the proportion with floor or ceiling scores. Precision-based sample size calculations indicate that a sample of 50 can identify a feature with 50% prevalence +/- 14%; 30% +/- 13% and 5% +/- 6%. The combined sample size of 100 will give precision +/- 10%, 9% and 4% respectively. From these data we will select tests to incorporate into routine fall risk assessments 2. Intervention development In order to achieve patient benefit within 3-5 years of programme completion we will need to undertake a single centre RCT within the time frame of a PGfAR. This means that we need to commence intervention development before a PGfAR commences. We will build on our previous published falls prevention tools called the ‘Guides to Action’ for Falls Prevention (Robertson 2010, 2012) to include information on how to measure cognitive risk factors that may increase the chance of a fall, and also include targeted treatments that may reduce falls. Our two premises are that: a) addressing conventional falls risk factors is currently ineffective because people with dementia have difficulty in learning, and current approaches do not address their specific learning needs b) dementia-specific neuro-psychological factors are neglected, and that approaches to overcome them are not being used. The new Guide to Action for people with dementia (GtA-D) will include gait parameters and neuropsychological abnormalities that are dementia-specific. For example, it may include an assessment of gait asymmetry as this is seen in people with dementia, it can be measured and there is evidence that training can reduce the asymmetry. An example of a neuro-psychologically-informed approach to prevention might be the prior verbalisation of tasks. The GtA-D intervention manual will include assessments and information about delivery of treatments in an acceptable and suitable format, using strategies that take account of cognitive problems that limit the value of conventional training. This process has been used with success in our DRESS study (Walker, in press), which has developed a neuropsychological rehabilitation intervention for the treatment of stroke patients who are unable to dress themselves because of cognitive limitations. Our approach fits with the MRC Framework for the development and evaluation of complex interventions (MRC 2008). The PDG is about development and elements of feasibility, whilst the proposed PGfAR continues the development and feasibility elements and finishes with cost-effectiveness evaluation. The underpinning clinical model reflects our clinical and research backgrounds in rehabilitation. A commonly used definition of rehabilitation is: The process of trying to help people who have suffered some impairment to maximise psychological well being, functional ability and social integration (Wade, 1992) Its elements are mixed, including attention to diagnosis, body structure and function, activity limitation and social, psychological and contextual factors. We will use three sources of information to develop the intervention, and produce a draft manual: a systematic literature review to produce a list of falls risk factors and treatments associated with dementia. workshops with a group of falls and dementia clinical experts who will discuss the data on neuropsychological impairments found in the survey and the literature review data and will produce a list of clinically used interventions. We will use neuro-psychological therapy approaches and activity analysis (the basis of occupational therapy interventions) to develop logical interventions 3. Intervention feasibility and initial ‘proof of concept’: We will introduce the draft manual in the community falls service and formally and informally seek feedback from professional users, patients and carers. We will use routine before-and-after clinical measurements (such as the Berg Balance Scale (Berg 1987, Bogle-Thorbahn 1996, Stevenson 2001), gait speed and dual task deficit, and Timed Up and Go test) to give preliminary information on the effectiveness of the intervention. At this stage, this will be limited by the time frame, as the intervention will take a minimum of 3 months to deliver. We aim to recruit 5-10 participants who have had full baseline neuro-psychological assessment for this, on whom we will have considerable risk factor data. 4. Preparation of application for PGfAR. The core research team has already been assembled, although there will be some changes and additions from our previous application, including a new neuro-psychologist (due to retirement), and the addition of another statistician and a health economist. We aim to re-apply for a PGfAR as soon as is feasible within the time constraints of appointments and collecting and analysing sufficient data from the PDG to inform the application. PDG outputs will be: Information on the practicality and acceptability (including time taken) of the different conventional and neuro-psychological assessments to inform the intervention and the RCT Prevalence of different conventional and neuro-psychological risk factors in these populations to inform the intervention Selection of candidate neuropsychologcial tests to include in clinical practice A draft intervention manual Submitted PGfAR application A draft trial protocol


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