Title: Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis (ACtiF)
Funder: Department of Health and Social Care

Abstract: Patient and Public Involvement (PPI) The programme has been developed in collaboration with a PPI panel of people with Cystic Fibrosis (PWCF). This panel will work with the research team. One member is a co-applicant, and two members will be part of the management and steering groups. Aims The overall aim is to develop and evaluate a behaviour change intervention (BCI) which our PPI panel would like to call a &ldquo;toolkit&rdquo; to support adherence to medication in adults with Cystic Fibrosis. The objectives are (i) to develop a web-portal cfhealthhub to display adherence data to PWCF and clinicians, (ii) develop a toolkit that uses feedback of measured adherence data linked to personalised evidence based strategies to increase adherence, and (iii) test the cost effectiveness of the toolkit. Background and rationale Medicines are the biggest cost in the NHS after staff, costing &pound;13-14 billion each year. Yet NICE reports that 30-50% of medicines are not taken as intended. &pound;30 million was spent on high cost inhaled drugs for the 10,000 PWCF in the UK in 2012 yet studies in adults with CF suggest the median adherence to these drugs is only 36%. PWCF who collect less than 50% of their medicines have higher healthcare costs than PWCF who collect more than 80% due to increased use of emergency care. Systematic reviews suggest that adherence interventions have been relatively ineffective because they have tended to be one size fits all single component interventions. We will embed adherence measurement in routine care and develop a toolkit to support adherence that diagnoses individuals' barriers and produces a personalised intervention to support adherence. The lessons learned from this work will be transferable to the challenges of supporting adherence in long term conditions in the NHS as a whole. Research plan The programme will consist of three Work Packages. WP1 Build the IT infrastructure to capture adherence data from nebulisers. Develop a web-portal cfhealthhub to display adherence data to PWCF and clinicians. Co-produce the web-portal interface with patients and clinicians to facilitate maximum utility. WP2 Develop a toolkit based on psychological theory that can support PWCF to adhere to treatment. This will use feedback of measured adherence data from WP1, and personalised interventions to increase adherence. Manualise the BCI for use by physiotherapists and PWCF. WP3 Evaluate the toolkit from WP2. (i) Explore the feasibility and acceptability of the toolkit by undertaking observation and qualitative interviews with the physiotherapist and PWCF using the toolkit within a pilot trial in one CF unit. Test recruitment and data collection procedures in a pilot trial. (ii) Test the efficacy of the toolkit in an RCT of 560 patients in 10 CF Units. (iii) Undertake a process evaluation including observation and qualitative interviews with staff and PWCF to understand how the toolkit is implemented in practice. (iv) Model cost effectiveness. Dissemination & projected outputs The programme has been developed with the CF Trust a patient and clinician advocacy organisation which will disseminate the work to the CF community through its website and conference programme. In the future there is the potential for the development of adherence as a NHS indicator embedded in CF Registry reports and linked to quality improvement initiatives will facilitate the dissemination of adherence support within the CF community. The adherence toolkit manual will provide transferable learning to other long term conditions. Relevant expertise & experience of the research team The team links multi-disciplinary expertise including clinical understanding of CF, skills to roll out IT systems across the NHS, health services research including health economics, RCT design and process evaluation, and behaviour change expertise to understand how to build the habits of adherence. Input from a committed PPI panel will enable co-production at all levels. Management & Governance, including Programme Management and ethical implications The programme will be led by a CF clinical researcher and health services researcher using a programme steering group and programme management group. The trial will be co-ordinated by a Clinical Trials Research Unit. Full ethical submissions will be made for all aspects of the study. Justification of costs This long term large scale funding will create and maintain a world class multidisciplinary partnership of PWCF, clinicians, psychologists and health services researchers to enable the development and evaluation of a complex intervention to transform self-management for PWCF and produce transferable knowledge with potential to improve adherence across the NHS.

Lay abstract: Cystic Fibrosis (CF) is an inherited disease affecting 10000 people in the UK with a median age at death in 2012 of 28 years. The lungs of people with CF (PWCF) are prone to infections and daily physiotherapy and inhaled medications are needed to stay healthy. Around &pound;30 million is spent annually on inhaled therapy but median adherence has been shown to be only 36%. Data suggest that adherence is better in younger children (71% in under 12s, falling to 50% in teenagers) but of the 10 000 UK PWCF almost 6000 are now adults. PWCF who collect What we will do: Help adult PWCF to see how much treatment they carry out. Dose counting nebulisers will be provided and we will display data in a website called cfhealthub.org.uk. We will work with PWCF to make information easy to understand. Learn how to help PWCF build successful treatment habits. We will develop a toolkit to help PWCF and physiotherapists work together to form habits of adherence to treatment. Rigorously test the intervention. We will carry out a pilot study in one CF unit and then test the intervention in 10 units with an accompanying health economics evaluation to make sure that the intervention works and is good value. Establish cfhealthhub as a resource for the CF community by working to ensure that cfhealthhub is sustainable . Ethical issues. We will train staff to work with PWCF in a way that is non-judgmental. Personal data will be protected and PWCF will be free not to take part. Study team. The team provides expertise to make the study a success combining PWCF, CF clinicians, behaviour change specialists, IT specialists and health services researchers. Study benefits. We hope that PWCF who can see their adherence rates and use the toolkit we develop will adhere more to their treatment and have less health damaging exacerbations which send them to hospital for emergency treatment. Enhancing the quality of life of people with long term conditions is a priority of NHS England and an important dimension of this is to ensure that people feel supported to manage their condition in partnership with professionals. Medicines are the biggest cost in the NHS after staff and we will learn how to use them more effectively. The study will have widespread applicability to many other people with long term conditions managed within the wider NHS.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CONGENITAL DISORDERS