Information for Patients

Information for Patients

What is the purpose of the study?

The study is looking at how best to encourage people who have had a hip or knee replacement to do more physical activity. 

All patients that have a hip or knee replacement will receive rehabilitation (physiotherapy) after the operation as per standard care and practice in the NHS. Half the study patients will also receive a new treatment designed to help increase physical activity.

Unfortunately, after a hip or knee replacement quite a few people do not do as much physical activity as should be possible after a hip or knee replacement. Researchers want to investigate if adding in something called a behaviour change treatment (which is a group discussion, and then 3 private telephone calls) PLUS the standard NHS rehabilitation programmes could improve the amount of physical activity patients do after a hip or knee replacement. 

Who is taking part?

We are hoping to recruit 260-300 men and women from across the UK who are having either a hip or knee replacement. 

You could been invited because you are about to undergo a hip or knee replacement and potentially may benefit from being more physically active

What will happen to me if I take part?

If you decide to take part then, during your pre-operative assessment appointment at the hospital, you will be asked to sign a consent form and will be asked to complete some questionnaires on your health and wellbeing. This should take about 30 minutes. Your answers to the questionnaires will not affect whether you enter into the study or not.

A few weeks after that, when you come in to have your new hip or knee replacement, we will check that you are still happy and safe to take part in this study and check that your operation went as planned. If you remain eligible, you will be entered into the study.

A researcher will enter your details into a computer and a computer program will make a decision about which group you will be in whilst in the study. Two-thirds of patients involved will be allocated to the new treatment group, one-third will be allocated to the ‘usual care alone’ group. This allocation is made by chance.. This is important because it ensures that the treatments are tested fairly and no one can guess the group the computer puts you into.

The computer will allocate you to either usual rehabilitation (physiotherapy) or usual rehabilitation (physiotherapy) PLUS the behaviour change treatment (group discussion and phone calls).

Either before you leave the hospital or shortly afterwards, you will be provided with your group appointments to either of the groups you are allocated to.

You will then attend rehabilitation sessions (physiotherapy) over 6 weeks – this will generally start at the latest within 4 weeks of your operation, and will be provided by your local physiotherapy team. Each rehabilitation session (physiotherapy) will last no longer than 30 minutes. As part of normal care, you will also be given home exercises to continue to strength your legs between the exercise sessions.

If you have been allocated to the group discussion – in addition to your rehabilitation sessions (physiotherapy), and home exercises, you will be asked to attend a group discussion meeting before each physiotherapy group over the 6 weeks.  Each group discussion will last for no longer than 30 minutes. In these discussion, we will talk to you about things which may stop you being more physically active when you want to be. We will also help you to find out ways to overcome these difficulties, to support you to be more physically active in your everyday lives. Then once your rehabilitation sessions finish, your physiotherapist will telephone you 2, 4 and 6 weeks afterwards to see how you are getting on.

What will happen after I have finished my treatment?

Six-months after your operation, we will send you (either by post or by email) questionnaires similar to the ones we asked you complete before your operation.

This will be used to see the difference your rehabilitation sessions (physiotherapy) have made. We will ask you to complete and return them in a pre-paid envelope.

We will then send the same questionnaires 6 months later (12 months from your operation) to complete and return in the post. Each questionnaire pack will take about 30 minutes to complete. Once the questionnaires have been completed and returned at 12 months that is the end of the study for you. If you forget to complete and return these, we will telephone you up to two times for a reminder.

You will not have to make any extra visits to your doctor or the hospital over and above those needed for your normal care.

Members of the PEP-TALK team based in Oxford may attend some of your rehabilitation sessions (physiotherapy) or the group discussion – this is only to ensure that the sessions are being ran correctly.

Further information

If you would like further information about joining the PEP-TALK Trial, you can access the generic PEP-TALK Participant Information Leaflet here.