Cystic Fibrosis Clinical Trial
Official title:
A Prospective Pilot 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.
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