the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use
Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis.
Cystic Fibrosis (CF) affects 10000 people in the UK. The lungs of people with CF (PWCF) are prone to infections and require daily medication to stay healthy. Average adherence to medication has been shown to be only 36%. Poor adherence is associated with poor clinical outcomes including distressing unscheduled hospitalisations. We have designed an intervention that will feedback adherence data to PWCF using chipped nebulisers displaying real time treatment use on smartphones and the website (CFHealthhub). Feedback is a powerful support to habit formation and the interventionist will use CFHealthHub and a behaviour change manual to support PWCF in building successful
This work package follows on from a successful Pilot and Feasibility (WP 3.1) study that successfully met the recruitment target to deem the main RCT feasible. This was based on recruiting 64 PWCF over four months at two CF centres (across three NHS Trusts) between June and September 2016. For this main RCT we aim to recruit PWCF for seven months at up to 20 CF units. We intend to recruit 688 PWCF overall. A computer will decide whether people who consent to be in the study will receive usual care alone or also receive the intervention. Both groups have a short
period of two to four weeks when data is collected through their nebulisers and fed back to the website. It is only after that period that those allocated to the intervention are allowed to use the website and receive enhanced care from the interventionist. After that point, all participants are followed up for 12 months. Participants will complete a series of questionnaires at the outset and at 12 months.
Trial Reference Number
Add to watchlist
Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment
the name of the treatment or therapy being researched
complex intervention or usual care.
the number of participants who need to be recruited for the trial in the UK
Last edited date
18 September 2017
Sheffield Teaching Hospitals NHS Foundation Trust
CF sponsor type