A Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)
A Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)
Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing
 recurrent chest infections and premature death due to lung failure. When patients develop
 chest infections their symptoms usually slowly worsen over the course of several days to
 weeks. Due to this gradual onset, patients often seek medical attention several days or weeks
 after symptoms start to worsen. The Investigators believe that if they were able to monitor
 patients more closely they could diagnose and treat chest infections earlier and consequently
 improve health outcomes.

 The HOMECF study aims to investigate whether home monitoring is beneficial for adults with
 CF. 100 subjects will be randomly allocated, 50 to receive home monitoring and 50 to receive
 routine clinical care for 12 months. Subjects receiving home monitoring will measure their
 lung function and symptoms twice weekly and this data will be transmitted to the medical team
 by means of a modified mobile phone.

 the Investigators hypothesize that home monitoring will allow them to diagnose chest
 infections at an earlier stage and reduce hospital inpatient days. They will also assess the
 subjects' experience of receiving home monitoring, the impact on body weight and lung
 function and and conduct a full health economic analysis to assess value for money. They will
 also ask subjects to collect a urine sample once weekly to allow us to measure urinary levels
 of inflammatory markers.

 Subjects will be recruited at the West Midlands Adult CF Centre in Birmingham. The research
 team are well placed to carry out the study because it is a large regional adult CF centre
 with an excellent record of conducting clinical research.
The principal question being answered by this research study is:

 1. Does home monitoring reduce the total number of inpatient hospital days in adults with
 cystic fibrosis (CF) compared to routine clinical care?

 The secondary objectives of this research study are to assess:

 1. The effect of home monitoring on lung function in adults with cystic fibrosis (CF)

 2. The effect of home monitoring on requirement for antibiotics in adults with CF

 3. The effect of home monitoring on nutritional status in adults with CF

 4. The effect of home monitoring on health related quality of life in adults with CF

 5. Costeffectiveness analysis comparing the home monitoring period with the routine
 clinical care period

 6. The patient experience of receiving home monitoring in adults with CF

 7. Whether urine levels of inflammatory markers correlate with symptoms and lung function
 in adults with CF

 The aim of this study is assess whether home monitoring is beneficial for adults with cystic
 fibrosis. Overall, 100 subjects will be recruited at the West Midlands Adult Centre and
 randomly allocated in a 1:1 ratio to receive home monitoring or routine clinical care for 12
 months.
Inclusion Criteria:

 -  confirmed diagnosis of CF

 -  age over 18 years

 -  the requirement for 1 or more admission to hospital to receive intravenous antibiotics
 over the preceding 24 months

 -  clinically stable at the time of recruitment

 -  Patients who give informed consent.

 Exclusion Criteria:

 -  patients who are currently participating in another clinical trial (excluding
 observational studies)

 -  pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract
 operation) in the previous 4 weeks (since these factors prevent measurement of
 spirometry)

 -  Sputum infection with Burkholderia cenocepacia or Mycobacterium abscessus

 -  Current diagnosis of active allergic bronchopulmonary aspergillosis (ABPA)

 -  Previous lung transplantation procedure.