Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis (ACtiF - RCT and parallel process evaluation (WP 3.2 and 3.3))
- Therapeutic category
- Trial status
- closed Participating Centres
- Not Applicable
Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis. A randomised controlled trial and parallel process evaluation.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 treatment habits. This work package follows on from a successful Pilot and Feasibility 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
- Trial type
- Length of participation
- 12 months
- complex intervention or usual care.
- Recruitment target
- Last edited date
- CF sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- CF sponsor type
Who can take part?
- Top inclusion criteria
- Diagnosed with CF and within CF registry
- Aged 16 years and above
- Willing and able to taking inhaled mucolytics or antibiotics via a chipped nebuliser (e.g. eTrack or bi-Neb)
- Top exclusion criteria
- Post-lung transplant or People on the active lung transplant list
- Participants using dry powder devices to take antibiotics or mucolytics