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)

摘要

Introduction: Falls are the leading cause of accidentrelated\udmortality in older adults. Injurious falls are\udassociated with functional decline, disability, healthcare\udutilisation and significant National Health Service\ud(NHS)-related costs. The evidence base for\udmultifactorial or exercise interventions reducing\udfractures in the general population is weak. This\udprotocol describes a large-scale UK trial investigating\udthe clinical and cost-effectiveness of alternative falls\udprevention interventions targeted at community\uddwelling older adults.\udMethods and analysis: A three-arm, pragmatic,\udcluster randomised controlled trial, conducted within\udprimary care in England, UK. Sixty-three general\udpractices will be randomised to deliver one of three\udfalls prevention interventions: (1) advice only; (2)\udadvice with exercise; or (3) advice with multifactorial\udfalls prevention (MFFP). We aim to recruit over 9000\udcommunity-dwelling adults aged 70 and above.\udPractices randomised to deliver advice will mail out\udadvice booklets. Practices randomised to deliver ‘active’\udinterventions, either exercise or MFFP, send all trial\udparticipants the advice booklet and a screening survey\udto identify participants with a history of falling or\udbalance problems. Onward referral to ‘active’\udintervention will be based on falls risk determined from\udbalance screen. The primary outcome is peripheral\udfracture; secondary outcomes include number with at\udleast one fracture, falls, mortality, quality of life and\udhealth service resource use at 18 months, captured\udusing self-report and routine healthcare activity data