A randomised controlled trial to evaluate the clinical and cost effectiveness of the Action Falls rehabilitation programme compared to usual care alone to reduce falls in stroke survivors.

Question:?Does Action Falls (AF) reduce the number of falls in stroke survivors in the first year after discharge from hospital, when compared to usual care??

Background: Stroke survivors fall frequently (73% fall each year). There are no evidence-based interventions addressing this problem.? A multifactorial rehabilitation intervention (AF), which has been shown to be both effective and cost effective in reducing falls in care home residents, has been adapted for stroke survivors' use in their own home.? This trial will assess whether it can reduce falls in stroke survivors.???

Primary objective: To determine whether the addition of AF to usual care is better than usual care alone in reducing the number of falls in stroke survivors in the first year after discharge from hospital.?

Secondary objectives:??

1. Investigate the effect of AF on fear of falling, psychological distress, quality of life and activities of daily living.?

2. Establish the health economic implications of AF

3. Explore how AF has reduced falls, for which stroke survivors, in what circumstances, and why, using a process evaluation with realist approach?

Methods: Pragmatic, parallel group multicentre randomised controlled trial (RCT) with an internal pilot phase, nested health economic, process evaluation and Study Within A Trial (SWAT).This trial will be reproduced in an Australian stroke population allowing results to be combined. ?

Setting: 10 UK NHS stroke units; intervention at home provided by a ‘Falls Lead’ from the stroke unit or appropriate community service.?

Participants: People aged over 18 years admitted to hospital following a stroke who have been discharged home.?

Randomisation: 1:1 individual randomisation minimised by stroke unit, residence (living alone/with others), age (>65/14/