Title: A Prospective Pilot Study of Home Monitoring in Adults with Cystic Fibrosis (HOME-CF)
Funder: Department of Health and Social Care

Abstract: Background: Cystic fibrosis (CF) is the most common inherited life-limiting condition in the Caucasian population, causing progressive lung damage due to recurrent chest infections. Currently, patients attend the CF clinic every 6-8 weeks to check their symptoms and lung function. However, patients have often had symptoms of a chest infection for several days or weeks before attending clinic. We suspect that if we were able to diagnose infections earlier by home monitoring, we could reduce the number of days that patients need to be admitted to hospital for intravenous antibiotics. We therefore propose a 12-month prospective randomised study of home monitoring in CF adults. Aims - In addition to informing the development of a definitive trial to assess the benefits of home monitoring in CF patients, this pilot study aims to assess: a. the effect of home monitoring on hospital inpatient days in CF adults b. the effect of home monitoring on the use of intravenous antibiotics, lung function and body weight in CF adults c. the cost-effectiveness of home monitoring d. subjects' expectations and experience of home monitoring. Questions addressed: 1. Is home monitoring effective in reducing the number of hospital inpatient days in adults with CF? 2. Does home monitoring reduce requirement for intravenous antibiotics, improve lung function and improve weight in CF adults? 3. Is home monitoring cost-effective from an NHS and patient perspective? 4. What are the expectations and experience of CF adults receiving home monitoring? Plan of Investigation: Eighty CF adults cared for at the West Midlands Adult CF Centre will be randomly allocated in a 1:1 ratio to receive either home monitoring or routine clinical care for a 12-month period. Patients randomised to home monitoring will be provided with a specially-configured mobile phone and digital spirometer, to monitor their own symptoms and lung function twice weekly. This encrypted data will be transmitted wirelessly and we will receive an email alert if subjects' symptoms or lung function fall below preset parameters. If we suspect that monitored participants are developing a chest infection we will arrange prompt treatment. Monitored subjects will also send a urine sample once weekly, with inflammatory markers being measured as an exploratory non-invasive measure of lung inflammation. For all recruited participants we will record a range of other parameters including overall antibiotic requirements and body weight at study visits. All subjects will also complete 3 questionnaires at 5 time points, to assess quality of life and health status. Subjects will take part in a semi-structured interview at the beginning and end of the 12-month period, to explore the experiential aspects of home monitoring and these interviews will be analysed by directed qualitative content analysis. The primary outcome measure is the number of hospital inpatient days. Secondary outcome measures include number of days of intravenous antibiotics, lung function, body weight and health-related quality of life during these phases. We will also perform a health economic analysis and analyse patient expectation and experience using the qualitative data. Potential benefits to patients and the NHS If home monitoring is demonstrated to be beneficial, it will be offered to a greater number of CF patients at our centre. We will publish our results and expect that any positive results will result in home monitoring becoming available for patients in other CF centres. This would potentially be beneficial to CF patients, by preventing complications of severe chest infections, but could also reduce NHS expenditure by avoiding prolonged and expensive hospital admissions. It also fulfills the NHS ethos of empowering patients wherever possible, facilitating home-based care by providing a closer link between patients and the CF centre.

Lay abstract: Adults with cystic fibrosis (CF) commonly require admission to hospital to receive intravenous antibiotics for chest infections. The HOME-CF study aims to determine whether home monitoring is beneficial in reducing the need for hospital admission in CF adults. Eighty CF adults will be randomly allocated, with 40 receiving home monitoring and 40 continuing with routine clinical care for a 12-month period. Participants allocated to receive monitoring will measure their own lung function using an electronic lung function monitor and record their symptoms twice weekly using a specially-configured mobile phone. Data will be automatically transmitted to the CF team via the mobile phone. We will use this data to diagnose chest infections and hypothesize that we will be able to reduce the number of hospital inpatients days by diagnosing chest infections at an early stage. Secondary outcome measures include antibiotic requirements, lung function and body weight. Subjects will complete 3 questionnaires (disease-specific and generic quality of life questionnaires) at 5 time points and also take part in 2 semi-structured qualitative interviews, to assess their expectations and experience of taking part in the trial. Participants receiving monitoring will send us a urine sample once weekly to determine the potential for urinary inflammatory markers as a non-invasive measure of lung inflammation. A health economic analysis will also be undertaken to assess whether home monitoring is cost effective. Patients will be recruited at the West Midlands Adult Cystic Fibrosis Centre at Birmingham Heartlands Hospital. The research team are well placed to carry out this research because we are a large regional adult CF centre with an excellent track record of clinical research.

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