Bruce, J. (Julie), Lall, Ranjit, Withers, Emma J., Finnegan, Susanne, Underwood, Martin, Hulme, Claire, Sheridan, Ray, Skelton, Dawn A., Martin, Finbarr and Lamb, S. E. (Sallie E.) (2016) 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). BMJ Open, 6 (1). pp. 1-8. e009362. doi:10.1136/bmjopen-2015-009362 ISSN 2044-6055.

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Abstract

Introduction: Falls are the leading cause of accidentrelated
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 and analysis: 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

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Breast -- Cancer -- Research, Cancer -- Risk factors
Journal or Publication Title:	BMJ Open
Publisher:	BMJ
ISSN:	2044-6055
Official Date:	18 January 2016
Dates:	Date Event 18 January 2016 Published 10 September 2015 Accepted 10 July 2015 Submitted
Volume:	6
Number:	1
Number of Pages:	8
Page Range:	pp. 1-8
Article Number:	e009362
DOI:	10.1136/bmjopen-2015-009362
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Date of first compliant deposit:	15 March 2016
Date of first compliant Open Access:	15 March 2016
Funder:	Breakthrough Breast Cancer, Sir John Fisher Foundation, Institute of Cancer Research: Royal Cancer Hospital, Great Britain. National Health Service (NHS), National Institute for Health Research (Great Britain) (NIHR)

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