title: Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil).
abstract: BACKGROUND
  Falling in older age is a major public health concern due to its costly and disabling consequences. However very few randomised controlled trials (RCTs) have been conducted in developing countries, in which population ageing is expected to be particularly substantial in coming years. This article describes the design of an RCT to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls in community-dwelling older people.
  
  
  METHODS
  Multicentre parallel-group RCT involving 612 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 Sao Paulo, Brazil and will be randomly allocated to a control group or an intervention group. The usual care control group will undergo a fall risk factor assessment and be referred to their clinicians with the risk assessment report so that individual modifiable risk factors can be managed without any specific guidance. The intervention group will receive a 12-week Multifactorial Falls Prevention Program consisting of: an individualised medical management of modifiable risk factors, a group-based, supervised balance training exercise program plus an unsupervised home-based exercise program, an educational/behavioral intervention. Both groups will receive a leaflet containing general information about fall prevention strategies. Primary outcome measures will be the rate of falls and the proportion of fallers recorded by monthly falls diaries and telephone calls over a 12 month period. Secondary outcomes measures will include risk of falling, fall-related self-efficacy score, measures of balance, mobility and strength, fall-related health services use and independence with daily tasks. Data will be analysed 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.
  
  
  CONCLUSIONS
  This study is the first trial to be conducted in Brazil to evaluate the effectiveness of an intervention to prevent falls. If proven to reduce falls this study has the potential to benefit older adults and assist health care practitioners and policy makers to implement and promote effective falls prevention interventions.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT01698580).
authors.affiliation: Department of Internal Medicine, Geriatrics Division, Hospital das Clínicas, Faculty of Medicine, Universidade de São Paulo, São Paulo, Brazil. kelemcabral@hotmail.com
authors.forename: Kelem
authors.initials: K
authors.lastname: de Negreiros Cabral
authors.forename: Monica Rodrigues
authors.initials: MR
authors.lastname: Perracini
authors.forename: Aline Thomaz
authors.initials: AT
authors.lastname: Soares
authors.forename: Francine
authors.initials: F
authors.lastname: de Cristo Stein
authors.forename: Celisa Tiemi Nakagawa
authors.initials: CT
authors.lastname: Sera
authors.forename: Anne
authors.initials: A
authors.lastname: Tiedemann
authors.forename: Cathie
authors.initials: C
authors.lastname: Sherrington
authors.forename: Wilson Jacob
authors.initials: WJ
authors.lastname: Filho
authors.forename: Sérgio Márcio Pacheco
authors.initials: SM
authors.lastname: Paschoal
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D001938:Brazil / Q000453:epidemiology; D015984:Causality; D005081:Exercise Therapy / Q000379:methods* / Q000592:standards; D005260:Female; D006699:Home Care Services / Q000592:standards; D006801:Humans; D008297:Male; D008875:Middle Aged; D012111:Residence Characteristics; D016896:Treatment Outcome