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/<=65-years) and baseline modified Barthel Index score (>14/<=14).?

Intervention: Usual care plus AF program.? The AF program will be delivered a maximum of three times – once at baseline, once at 6 months post baseline and once if the participant has either had a fall or has moved residence.? Control:? Usual care alone? Primary outcome: Annual falls rate?

Secondary outcomes: Number of falls in each 3-month period; rate and severity of injurious falls, fear of falling, activities of daily living, psychological stress, quality of life, resource use.?

Sample size: 464 participants (232 per arm) will allow detection of a 33% reduction from 2.5 to 1.675 falls/year with 90% power at the 5% significance level (2-sided) assuming 10% loss of evaluable primary outcome data.?

Data collection:?Baseline data, participant recorded number and severity of falls on a monthly basis either paper based or electronically.? Questionnaires collecting the secondary outcomes every 3 months.?? SWAT:? Whether a video in 4 languages and English, improves trial recruitment and retention.

Analysis: Evaluation of the primary outcome will be performed on an intention to treat basis without imputation of missing data and using a negative binomial model including minimisation factors.? Secondary outcomes will be analysed using appropriate regression models which include the minimisation factors and the baseline value of that variable where available.??

Timelines 48 months - 9 m set up, 19 m recruitment, 12 m follow up, 2 m data cleaning, 6 m analysis, write up and dissemination.? Dissemination to patients, the public, researchers, and policy makers including NHS England