A Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)

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.

Conditions

• Cystic Fibrosis

Interventions

PROCEDURE

Home Monitoring

Participants selected to receive home monitoring, in addition to routine CF care, will be given a digital lung function monitor (spirometer) and a modified mobile phone.

OTHER

Clinical Care

Participants selected for this arm will continue to receive routine clinical care.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• University of Birmingham

  collaborator OTHER

• Heart of England NHS Trust

  lead OTHER

Principal Investigators

• Edward F Nash, MD · Heart of England NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2018-09-30

Completion

2018-09-30

Countries

• United Kingdom

Study Locations