FEMUR III is definitive randomised controlled trial and economic evaluation of a community-based Rehabilitation package following hip fracture. Hip fracture is a common, major health problem in old age, especially for people with other health problems or who are frail. Some patients who suffer this type of fracture need surgery to repair it. They take a long time to recover, and others may not recover fully.
Once patients are discharged, the routine care they receive can vary depending on local NHS policy. Some may not find it as easy to live independently afterwards.
We have designed an enhanced rehabilitation package for patients who are recovering from this surgery, which is delivered in addition to standard NHS care. FEMuR III will compare the enhanced package with standard NHS care to see if it can improve recovery for patients.
The enhanced rehabilitation package is made specifically for each patient and we think this should improve recovery. We think this package should work better if it includes physiotherapy (to help patients recover movement), occupational therapy (to help patients with activities associated with daily living) and also provides tools to help build confidence and mood.
The enhanced rehabilitation package we have designed involves additional rehabilitation at follow up visits. You will be given a workbook and a goal-setting diary to complete during the first few months of recovery. We will follow your progress in the 12 months after surgery and collect information from you during that time so we can see how you are. The information we collect will help us to see whether there is a difference between those people who have standard NHS treatment and those who receive standard NHS treatment and the enhanced rehabilitation package
We are inviting you to take part in this study because you are a patient at one of the hospitals taking part and have recently had surgery to repair a hip fracture.
A member of the clinical team can talk to you in more detail about this study and you will be able to ask any questions that you have. If you have had all of your questions answered and are happy to take part then you will be asked to sign a consent form to confirm you want to take part. You will be given a copy of your consent form and this information sheet to keep.
This study is comparing standard NHS care with the enhanced rehabilitation package. Both of these will be tailored to individual patients so it is difficult for us to describe exactly what your rehabilitation will look like. However, the main differences between the two are that if you are receiving the enhanced rehabilitation package you will also:
If you do decide to take part and have given your consent, we will ask you to complete some questionnaires and do a grip-strength test so we can get some information about how you are feeling both mentally and physically. This will allow us to see how you are recovering over time.
We will arrange an appointment with you around 4 months after you have started the study to see how you are getting on. This visit may take place at your home or in a community Hospital depending on what is best with you. At the visit, we will ask you to complete the same questionnaires and do some basic physical tests so we can see how you are recovering. At around 12 months after you started the study we will arrange one more visit to complete the questionnaires and physical tests again so we can track your progress.
We may also telephone you soon after the 4-month visit to ask some questions about how you are finding being involved in the study. This will give you a chance to give some feedback on your experiences and your views on the care you are receiving. Not all patients will receive a phone call, we aim to call 60 patients who have agreed to take part. We will offer you a £30 shopping voucher for your time and inconvenience in taking part in the telephone interview.
No, taking part is voluntary. It is up to you to decide whether or not you want to take part. If you choose to take part you can also choose to stop at any time without giving a reason. The standard of care you receive now or in the future will be the same whether you take part or not.
If at any point you decide to stop taking part in the study you will receive the treatment and follow up usually offered in your area. The standard of care you receive will remain the same if you decide to stop taking part. If you do decide to stop taking part we will ask you if you would like to either:
We will use any study information collected up until the time you stop taking part.
If you are taking part in FEMUR III we advise you to speak to your doctor research team at the hospital where you joined the trial.
If you have any questions about FEMUR III please contact firstname.lastname@example.org
The University of Liverpool is the sponsor for this study based in the United Kingdom/ country; they have delegated the day-to-day running of the study to the Clinical Trials Research Centre, which is part of the University of Liverpool.
Our Data Protection Officer is Victoria Heath and you can contact them at LegalServices@liverpool.ac.uk
As a University we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
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Data obtained at: April 27, 2017 20:05
Data obtained at: April 27, 2017 20:05