Stage 3 – Comparing the intervention to usual care

We will take the lessons learned from the feasibility study and set up a much larger study called a randomised controlled trial (RCT). We aim to recruit around 500 people who have had delirium during a hospital stay along with a close family member or friend. We will increase the number of hospitals we recruit in to 12 NHS hospitals.

We will use a computer programme to put participants into one of two groups at random using a process called randomisation:

1) The rehabilitation programme group (intervention)
2) The usual care group (the comparator)

By putting people into groups at random, we will create balanced groups that are not affected by ‘bias’ that could skew the results of the trial.

Participants will be followed up at 3- and 6-months, the same as in the feasibility study.

We will look to see if there is an improvement in participants’ activities of daily living (their ability to do daily tasks) after 6 months. Other things we’ll look at include health-related quality of life, cognition, depression, safety and value for money. We will also look at the wellbeing and quality of life of the close family member or friend of the person with delirium.