The Therapy ‘Pill’: Achieving Treatment Dose Within a Rehabilitation Trial

Abstract

Background: Developing high quality clinical trials within rehabilitation research is achievable and should be pursued wherever possible. One of the greatest challenges rehabilitation trialists face is defining experimental and control interventions and ensuring that the intervention dose is delivered as planned. Aim: We describe procedures employed within a pilot randomised controlled trial of a rehabilitation intervention to monitor therapy dose. Method: The trial setting was two acute stroke units in large teaching hospitals in Melbourne, Australia. The design was a randomised controlled trial of very early mobilisation (commenced within 24 hours of stroke onset) plus standard care (VEM) versus standard care alone. Assessors were blinded to group and analysis was intention to treat. All therapy data (both intervention and control) were acquired using personal digital assistants. Monitoring of therapy dose and feedback to trial staff was given 6 months into the trial by a researcher independent of the trial team. Results: Before feedback, therapists were barely meeting intervention protocol minimum targets. Following feedback, compliance with trial protocol was achieved. Conclusion: Monitoring of the therapy dose within a clinical trial is important to achieve trial quality. This article shows how monitoring including feedback leads to improved delivery of the therapy ‘pill’.