Home-based, tailored intervention for reducing falls after stroke (FAST): Protocol for a randomized trial
Catherine M. Dean, Lindy Clemson, Louise Ada, Katharine Scrivener, Natasha A. Lannin, Stefanie Mikolaizak, Sally Day, Anne Cusick, Benjamin Gardner, Gillian Z. Heller, Stephen Isbel, Taryn Jones, Virginia Mumford, Elisabeth Preston
Abstract
RATIONALE: People with stroke experience falls at more than twice the rate of the general older population resulting in high fall-related injuries. However, there are currently no effective interventions that prevent falls after stroke. AIMS: To determine the effect and cost-benefit of an innovative, home-based, tailored intervention to reduce falls after stroke. SAMPLE SIZE ESTIMATE: A total of 370 participants will be recruited in order to be able to detect a clinically important between-group difference of a 30% lower rate of falls with 80% power at a two-tailed significance level of 0.05. METHODS AND DESIGN: rial (FAST) is a multistate, Phase III randomized trial with concealed allocation, blinded assessment, and intention-to-treat analysis. Ambulatory stroke survivors within five years of stroke who have been discharged from formal rehabilitation to the community and who have no significant language impairment will be randomly allocated to receive habit-forming exercise, home safety, and community mobility training or usual care. STUDY OUTCOMES: The primary outcome is the rate of falls over the previous 12 months. Secondary outcomes are the risk of falling (proportion of fallers), community participation, self-efficacy, balance, mobility, physical activity, depression, and health-related quality of life. Health care utilization will be collected retrospectively at baseline and prospectively to 6 and 12 months. DISCUSSION: ANZCTR 12619001114134.