A randomised crossover trial to assess the acceptability and feasibility of electronic and paper based data collection of a patient reported outcome measure questionnaire for use in a clinical trial.
The aim of this study is to examine the acceptability and feasibility of an electronic and paper based case report form (questionnaire) developed for use in a future clinical trial (ACL SNNAP) of the management of patients following ACL injury.
We are carrying out this study because we want to ensure that the way we administer the questionnaire (electronic or paper) in this trial will be acceptable to patients with ACL injury. We feel that the thoughts and views of patients who have experienced an ACL injury are a vital part of this evaluation.
The study is a multi-centre randomised within subjects crossover trial in which all participants will complete both paper and Web-based version of the same questionnaire. 130 patients will be recruited from approximately 15 NHS physiotherapy and orthopaedic outpatient departments from across the UK. The hospital sites involved are those that have indicated an interest in participating in the ACL SNNAP trial.
Patients either attending a clinical follow up outpatient appointment or physiotherapy sessions for the management of anterior cruciate ligament deficiency/ACL reconstruction will be invited to participate.
How can patients take part?
- Patients can consent to participate in this study by completing the contact details form following the link below (alternatively they can contact the Oxford office, details below, and a paper verion of the form can be sent to the patient).
- On receipt of this form the patient will then be asked to complete the questionnaire in two different formats (with a short time period in between), one will be e-mailed and the other sent in the post with a free post envelope to return the completed questionnaire.
- This will be coordinated by the central study office in Oxford.
In addition, the patient will be asked to complete a short evaluation form to provide some feedback on the questionnaires.
Further information can be found in the Participant Information Sheet (link). To participate in the study, please click on this link below to complete the Contact Details Form:
- Patient is willing and able to give informed consent for participation in the study
- Aged 18 years or above
- Patient is attending physiotherapy for ACL deficiency management or following ACL reconstruction (at least 6 weeks after surgery)
- Patient has access to the internet/emails