ISRCTN71002650.

Trial name or title	The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT)
Methods	3‐arm cluster‐RCT and economic evaluation
Participants	N = 9821 Inclusion criteria: ≥ 70 years old, living in the community or in sheltered accommodation Exclusion criteria: terminally ill, residential and nursing homes
Interventions	3 arms: 1. Written advice 2. Written advice plus structured exercise 3. Written advice plus multifactorial fall prevention (MFFP) The total duration of follow‐up for all trial arms is 18 months (updated 13 August 2015: was previously 12 months) The total duration of treatment varies across trial arms as follows: 1. Advice: 30 minutes 2. Exercise: 12 weeks (2 x 1‐hour sessions a week) 3. MFFP: 8 weeks (depending on individual risk factors, but typically 6 x 30‐minute sessions over 8 weeks)
Outcomes	1. Number of people sustaining peripheral fractures 2. Time to first fracture 3. Rate of falls, quality of life, emotional and physical function, mortality 4. Resource use, out‐of‐pocket expenses
Starting date	September 2010
Contact information	Prof Sarah Lamb Warwick Clinical Trials Unit The University of Warwick Gibbet Hill Campus Coventry CV4 7AL United Kingdom +44 (0)24 7615 0404 Email: s.lamb@warwick.ac.uk
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