Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment: protocol paper for the i-FOCIS randomised controlled trial

BACKGROUND: The rate of falls in community dwelling older people with cognitive impairment (CI) is twice that of a cognitively intact population, with almost two thirds of people with CI falling annually. Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people. However the potential benefit of these interventions in reducing falls in people with CI has not been established. This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI. We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers. A health economic analysis examining the cost and potential benefits of the program will also be undertaken. METHODS AND DESIGN: Three hundred and sixty people aged 65 years or older living in the community with CI will be recruited to participate in the trial. Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week. Participants will undergo an assessment at baseline with retests at 6 and 12 months. Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities. The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars. Secondary outcome measures will include the risk of falling, quality of life, measures of physical and cognitive function, fear of falling and planned and unplanned use of health services. Carers will be followed up to determine carer burden, coping strategies and quality of life. DISCUSSION: The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program. The results will have direct implications for the design and implementation of interventions for this high-risk group of older people. TRIAL REGISTRATION: The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry - ACTRN12614000603617