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))

Details

Therapeutic category
Behavioral
Trial status
closed Participating Centres
Phase
Not Applicable

Full title

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
89701
Trial type
Non-medication
Length of participation
12 months
Intervention
complex intervention or usual care.
Recruitment target
556
Last edited date
18/09/2019
CF sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
CF sponsor type
Academic

Who can take part?

Age
16+
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

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