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Table 1 The REFORM trial

From: Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention

Objectives:To determine the clinical and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community dwelling older people at risk of falling, relative to usual care.
Design:A pragmatic, multicentre RCT with an economic evaluation and qualitative study. 1010 participants aged ≥ 65 years were randomised (intervention, n = 493; usual care, n = 517) via a secure, remote randomisation service.
Interventions:All participants received a falls prevention leaflet and routine care from their podiatrist and GP. The intervention also included: footwear advice; footwear provision (if required); foot orthoses; and foot and ankle strengthening exercises.
Control:Participants in the control group continued to receive usual care from their podiatrist and GP, which m ay have included prescription of an orthosis and footwear advice. They also received the same falls prevention leaflet sent to the intervention participants.
Primary outcome:The primary outcome was the incidence rate of falls per participant in the 12 months after randomisation.
Trial status:Completed (ISRCTN68240461)
Funder:NIHR Health Technology Assessment
  1. GP general practitioner, NIHR National Institute for Health Research RCT randomised controlled trial