Table 1 The REFORM trial

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