Extracorporeal photopheresis in the treatment of chronic lung allograft dysfunction: long-term follow-up study
Chronic lung allograft dysfunction
The study is a follow on from the E-CLAD study. https://www.isrctn.com/ISRCTN10615985 E-CLAD UK Long-term is an observational study. Participants will be required to complete two different quality of life questionnaires at up to three different time points over a two-year period. The timepoints will depend on whether participants completed the 24-week visit in the E-CLAD UK trial. The questionnaires will be the same as those used in the original trial and should take no more than ten minutes to complete. The first timepoint will coincide with the scheduled week-24 visit for the E-CLAD UK trial. Should participants reach this study visit in the original trial then they will be completed as part of the E-CLAD UK trial and will not be repeated for this study. Questionnaires will then be repeated at 52 weeks and 104 weeks after the start of participants involvement in the E-CLAD UK trial. Questionnaires will be set up to allow participants to complete remotely on a mobile phone, tablet, computer or laptop. Consent will be obtained to allow the collection of additional information from participant's medical records. This will be information on their condition, any further treatments received and their usage of the NHS. This information will be collected by the research team at the participant's local hospital. This information will be collected at the 52- and 104-week timepoint. Participants will also be invited to be interviewed as part of a qualitative sub-study. Up to 20 participants will take part in an interview about their long-term views on their medical treatment during the trial and subsequent post-trial care. Interviews will be conducted remotely and expected to last about an hour.
1. Consented and subsequently randomised to the E-CLAD UK clinical trial 2. Capacity to provide written informed consent to E-CLAD UK Long-term 3. Completed participation in the E-CLAD UK clinical trial
1. Any participants that are consented to the E-CLAD UK clinical trial but during final eligibility checks are found to not meet eligibility requirements and are therefore not subsequently randomised to the E-CLAD UK clinical trial would not be eligible for E-CLAD UK Long-term 2. Lacking capacity to provide written informed consent to E-CLAD UK Long-term