Title: PRevention Of Falls in COGnitively impaired older adults living in residential care (PROF-COG) A pilot multi-factorial intervention to prevent falls in older people living in care homes tailored towards risk factors related to cognitive impairment
Funder: Department of Health (England)

Abstract: Background Falls are a major public health problem affecting 50% of care home residents. Falls are costly to the individual in terms of their impact on confidence, independence and quality of life and the resultant injuries present huge costs for health and social services. Several interventions to prevent falls have been effective in cognitively intact community dwelling older people. However, the picture in care homes is less clear. There have been some effective interventions but others have actually increased falls. Meta-analysis of interventions to prevent falls in care homes found no overall significant effect. The reasons for the failure of some care home interventions to prevent falls may be because they are not targeted towards a risk profile that takes cognitive impairment into account. We have designed an intervention based on a theoretical framework explaining falls risk in cognitively impaired care home dwellers derived from a previous prospective falls risk study in this population. We will address these risk factors in the proposed study. Primary aims The primary aims will be to test the safety, feasibility, acceptability and clinical efficacy of this multi-factorial intervention with the future aim of testing this intervention in a definitive multi-centre trial powered to detect significant reductions in falls. Study design This pilot study will use a cluster randomised controlled trial design. We will recruit a purposive sample of 6 local care homes (to include 2 nursing and 2 EMI units) and invite all residents in the participating homes to take part in the study. Homes will be randomised into control and intervention groups stratified by size and presence of nursing/EMI unit. Baseline and follow up assessments Assessments will be undertaken at baseline and at 6 months in measures of balance, gait, strength, behaviour, anxiety, fear of falling, mood, cognition, falls, function, physical activity and quality of life. Adherence, drop outs, adverse events and level of engagement in the exercise programmes will also be measured. Other outcomes Recruitment rates, time taken to undertake assessments and the screening and intervention process will also be analysed. Care home and research staff and participants will be interviewed following the intervention. Intervention The 6-month intervention will be delivered based on an initial screening to determine risk factors amenable to intervention. Interventions will include; comprehensive geriatric assessment, balance training exercise and management of dementia related behaviours. There will be fortnightly multi-disciplinary team meetings for staff to critically review falls incidences. Usual care Participants in the control homes will receive usual care. Data analysis General linear models will be used to assess the effect of group allocation on continuously scored outcome measures and logistic regression models will be used to compare groups on dichotomous outcome measures. Adjustment will be made for cluster effects. Interviews and focus groups will be analysed using inductive thematic analysis. Potential benefits to the NHS The primary aim of this trial is to provide proof of concept and design a rigorous definitive trial to prevent falls in older care home dwellers. Should the future trial provide evidence to support this intervention, we expect to progress to long-term implementation to reduce falls and injuries resulting in better quality of life for residents and lower costs for treating falls and other health problems


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