Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: a randomized controlled trial

Abstract

Falls in older people are a major global public health concern due to their costly consequences. Few randomized controlled trials have been conducted in developing countries despite their substantial predicted population ageing in coming years. This article describes the design of a randomized trial to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls in Brazil. Methods/Design: This study is a multicenter parallel-group randomized trial among community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in São Paulo - Brazil and will be randomly allocated to a control group or an intervention group. The usual care control group will receive a leaflet with basic fall prevention information, a baseline fall risk factor assessment and will be referred to their clinician with a report of individual modifiable risk factors to be managed without any specific guidance. The intervention group will receive a 12-week Multifactorial Fall Prevention Program consisting of: an individualized medical management of the modifiable risk factor, a progressive on-site body balance exercise plus a home-based exercise program, an education of fallers recorded by falls diary and telephone calls over a 12 month period. Secondary outcomes measures will include risk of falling, fall-related self-efficacy score, measure of balance, mobility and strenath, health services use and difficulty with daily tasks. Data will be analyzed using the intention-to-treat principle. The incidence of falls in the intervention and control groups will be calculated and compared using negative binomial regression analysis. Discussion: This study is the first trial to be conducted in Brazil to evaluate the effectiveness of a program on falls reduction. The trial has been designed using a pragmatic approach to enhance its external validity. If this intervention is shown to reduce falls it will benefit older adults and help health care practitioners and policy makers to make better choices concerning fall prevention interventions. (AU)