title: A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT).
abstract: BACKGROUND
  Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults.
  
  
  METHODS
  A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver 'active' interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to 'active' intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data.
  
  
  BACKGROUND
  The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the recommended SPIRIT Checklist. Amendments will be reported to relevant regulatory parties.
  
  
  BACKGROUND
  ISRCTN 71002650; Pre-results.
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.
authors.forename: Julie
authors.identifier: http://orcid.org/0000-0002-8462-7999
authors.initials: J
authors.lastname: Bruce
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.
authors.forename: Ranjit
authors.initials: R
authors.lastname: Lall
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.
authors.forename: Emma J
authors.initials: EJ
authors.lastname: Withers
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.
authors.forename: Susanne
authors.initials: S
authors.lastname: Finnegan
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Underwood
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Hulme
authors.affiliation: Royal Devon & Exeter Hospital, Exeter, UK.
authors.forename: Ray
authors.initials: R
authors.lastname: Sheridan
authors.affiliation: School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Dawn A
authors.initials: DA
authors.lastname: Skelton
authors.affiliation: Older Persons' Unit, Guys and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, UK.
authors.forename: Finbarr
authors.initials: F
authors.lastname: Martin
authors.affiliation: Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK Nuffield Department of Orthopaedics Rheumatology & Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Lamb
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D003376:Counseling; D004739:England; D015444:Exercise; D005081:Exercise Therapy; D050723:Fractures, Bone / Q000517:prevention & control*; D015577:Geriatric Assessment; D006801:Humans; D004856:Postural Balance; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires
keywords: Exercise; Falls prevention; Fracture; GERIATRIC MEDICINE; PRIMARY CARE