University of Warwick

Big TOE Trial

Big Toe OstEoarthritis trial.

The Big TOE Trial is testing whether carbon fibre show inserts can reduce pain caused by osteoarthritis in the big toe joint.

Early childhood is when children begin learning to manage their emotions and behaviour, but some find this more challenging than others. The Healthy Start, Happy Start study evaluated a short, relationship-based programme where health visitors used video feedback to help parents better understand and respond to their child’s behaviour. The trial involved 300 families and found that children whose parents received the programme showed lower levels of behavioural problems, with benefits still visible years later.

Morph solution

Morph worked with the BigTOE Trial team to develop a digital Participant Information Tool and animation to support recruitment and help potential participants understand the study.

Participant Information Tool (PIT) – a structured digital information tool that explains the study step by step. The tool introduces the condition, the purpose of the research and explains what taking part involves, allowing participants to explore the information at their own pace.
Explainer Animation – a short animation introducing big toe osteoarthritis and explaining how the BigTOE Trial is testing carbon fibre shoe inserts. The animation provides a simple overview of the research and helps people quickly understand the study and what participation involves.

The PIT and animation were produced in English and Welsh switchable by the user.

Morph are great to work with. They really understand clinical trials and make an excellent end product"

Associate Professor Mike Backhouse, University of Warwick

Big TOE Trial Animation

Osteoarthritis in the joint where the big toe joins the rest of the foot can hurt and cause the joint to become stiff and swollen. This is often worse when walking and can make it difficult to do your usual activities.

The BigToe trial is trying to find out whether special inserts that go inside your shoes can help people with painful big toe osteoarthritis.

Shoe inserts are commonly used to treat big toe osteoarthritis and can be made from different materials. We want to find out if using certain materials help people living with painful big toe osteoarthritis.

If you decide to take part you will be put in one of two groups. One group will use one type of shoe insert and the other group will use the other type. These shoe inserts look similar but are made with different materials.

To keep the trial fair neither you nor your healthcare provider can choose which group you will be in. There is an equal chance of receiving either shoe insert.

You will be given your own individual information about looking after your osteoarthritis including what types of shoes might help.

The trial has been designed to be as simple as possible. This means you won't need to come back for another appointment.

We will send you a short questionnaire five times over the next year asking you about your pain levels and general health.

If you'd like more information, please get in touch with the BigToe team who will be happy to help.