ACtiF - Pilot and Feasibility study (WP 3.1)
Research type
Research Study
Full title
Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis. A feasibility study comprised of an external pilot randomised controlled trial and process evaluation \n
IRAS ID
199775
Contact name
Martin Wildman
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN13076797
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
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.\n\nWe 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.\nThere is currently insufficient information to plan a large scale study. This feasibility pilot is crucial to see whether we can recruit enough PWCF to the large study and also to understand how best to deliver the intervention informed by feedback from patients and clinicians .\nWe aim to recruit 64 PWCF over four months at two CF centres (across 3 NHS Trusts). A computer will decide whether people who consent to be in the study will receive usual care alone or also receive the intervention. Intervention and control groups will receive chipped nebulisers collecting adherence data but only those people allocated to the intervention will be invited to use the website and receive the complex intervention. All participants will be followed up for five months (+/-1 month) with some additional data collected through to April 2017 when the study ends. Participants will complete a series of questionnaires at the outset and at the last visit. A qualitative researcher will collect information in the form of audio recordings and interviews (which are optional) with study participants and health professionals to understand intervention acceptability. All feasibility data will inform the decision to procedures for the definitive trial.\n
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0356
Date of REC Opinion
11 Mar 2016
REC opinion
Favourable Opinion