A multi-centre RCT of a falls prevention programme (PDSAFE) for people with Parkinson's: study design and baseline characteristics of participants

Abstract

Purpose: This is a multi-centre, single-blinded, randomised controlled trial of the effectiveness and cost effectiveness of the PDSAFE intervention to prevent falls among PwP. The aim of this abstract is to present the design and the baseline population characteristics of 396 participants who have been randomised to date. Methods: Eligibility criteria are: confirmed diagnosis of Parkinson’s (P), living at home, having experienced at least one fall in the previous 12 months, can understand and follow instructions. PwP have been recruited from nine centres across England. Participants in the control group receive usual care and an information DVD. Participants in the experimental group receive usual care and PDSAFE, a multimodal physiotherapist delivered, individually tailored and progressive, home-based programme. It focuses on task orientated movement strategy training, functional lower limb strengthening and balance training over six months supported by printed material and visual feedback through tablets and DVDs. The primary outcome is risk of repeat falling between 0-6 months post randomisation and fall data have been collected through monthly self-completed diaries for three months prior and twelve months after randomisation. Results: Between October 2014 and August 2016, 541 eligible participants were recruited. Participants’ mean age = 72 (range 47 to 91); 58 % were male; mean time since Parkinson´s diagnosis = 8 (range 0 to 36) years; mean number of falls in previous 12 months = 21 (range 1 to 1195); mean MMSE score = 28. Twenty four percent lived alone; 70% with a spouse/partner; 6% with a friend/family. Mean baseline UPDRS score = 33 (range 2 to 92). Baseline Hoehn & Yahr scores: 1 = 12%, 2 = 33%, 3 = 41%, 4= 14%. To date, 394 (73%) have been randomised to either the intervention (n=199) or control group (n=197). In the intervention group, 127 participants have completed the PDSAFE intervention with at least 12 physiotherapy sessions; 38 are still undergoing treatment; 32 have withdrawn and two have died. 172 participants have been followed for 12 months. Randomisation will continue until November 2016 and treatment until May 2017. Conclusion(s): PDSAFE is the largest rehabilitation trial evaluating an intervention to reduce falls among PwP. Sufficient numbers of participants have been recruited to achieve the target 80% power assuming a difference of 63% to 50% reduction in repeat falling between the two groups. The main trial results will be available during September 2017