Clinical trial NCT02994706: A Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)
Official title: A Prospective Pilot Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Heart of England NHS Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of Birmingham
First posted: 2016-12-16
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group
timeFrame: up to 12 months
Secondary outcomes:
measure: Change in FEV1 in the home monitoring group compared to the routine clinical care group
timeFrame: up to 12 months
measure: Change in FVC in the home monitoring group compared to the routine
timeFrame: up to 12 months
measure: Days on oral and intravenous antibiotics in the home monitoring group compared to the routine clinical care group
timeFrame: Up to 12 months
measure: Change in body weight in the home monitoring group compared to the routine clinical care group
timeFrame: Up to 12 months
measure: Change in BMI in the home monitoring group compared to the routine clinical care group
timeFrame: Up to 12 months
measure: Change in CFQ-R scores in the home monitoring group compared to the routine clinical care group
timeFrame: Up to 12 months
measure: Health economic analysis measured by EQ-5D-5L
timeFrame: Up to 12 months
measure: Health economic analysis measured by ICECAP-A
timeFrame: Up to 12 months
measure: Costs associated with caring for each participant and the cost of conducting the study in the home monitoring group compared to the routine clinical care group
timeFrame: Up to 12 months
measure: Patient experience assessed by a semi-structured qualitative interview in the home monitoring group compared to the routine clinical care group
timeFrame: Up to 12 months
measure: Levels of relevant urine biomarkers in the home monitoring group associated with pulmonary exacerbations
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: West Midlands
Study officials:
affiliation: Heart of England NHS Foundation Trust
name: Edward F Nash, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nash EF, Choyce J, Carrolan V, Justice E, Shaw KL, Sitch A, Mistry H, Whitehouse JL. A prospective randomised controlled mixed-methods pilot study of home monitoring in adults with cystic fibrosis. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666211070133. doi: 10.1177/17534666211070133.
citation: Choyce J, Shaw KL, Sitch AJ, Mistry H, Whitehouse JL, Nash EF. A prospective pilot study of home monitoring in adults with cystic fibrosis (HOME-CF): protocol for a randomised controlled trial. BMC Pulm Med. 2017 Jan 23;17(1):22. doi: 10.1186/s12890-017-0366-x.