ACtiF - RCT and parallel process evaluation (WP 3.2 and 3.3)
Research type
Research Study
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.
IRAS ID
218519
Contact name
Martin Wildman
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 3 months, 28 days
Research summary
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. 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 (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.
Summary of Results
People with cystic fibrosis need medication to stay well. They take some medication using a nebuliser. This is a machine that helps people to inhale medicine as a mist. Nebulisers are used to take medication that prevents health problems occurring. People do not always take all the doses of their nebuliser treatments and they often believe that they take more than they do. Our research aimed to develop a new intervention called ‘CFHealthHub’. This was a website and mobile application to show people with cystic fibrosis their actual medication use, and training for health-care professionals to help people to take more of their medication.
We used feedback from patients and staff in three cystic fibrosis centres to develop CFHealthHub. We tested it in a small study. We then improved the intervention before using it in a larger study. We focused on whether or not people with cystic fibrosis had fewer spells of being ill in hospital and whether or not they took more of their treatments.
A total of 19 cystic fibrosis centres took part in the main study. The study recruited 608 people with cystic fibrosis. They were in the study for 12 months. All participants received their usual treatment. Half were also given the CFHealthHub intervention. Numbers of nebuliser treatments taken by people with cystic fibrosis were automatically measured. People with cystic fibrosis completed questionnaires about their general health during the study. We interviewed 22 people with cystic fibrosis and 26 health-care professionals delivering the intervention about their views of CFHealthHub.
We found that CFHealthHub did not reduce spells of being ill in hospital. However, we found that those who used CFHealthHub took more of their nebuliser medication. People with cystic fibrosis felt that the new intervention was helpful and valued the relationship they had with health-care professionals delivering the intervention. We found that the intervention may be good value for money for the NHS. However, this depends on how long the intervention is effective for and whether or not increasing adherence also increases the numbers of prescriptions for medicines.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0035
Date of REC Opinion
2 Mar 2017
REC opinion
Further Information Favourable Opinion