Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02994706
Study type Interventional
Source Heart of England NHS Trust
Contact
Status Completed
Phase N/A
Start date January 2006
Completion date September 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04696198 - Thoracic Mobility in Cystic Fibrosis Care N/A
Completed NCT00803205 - Study of Ataluren (PTC124™) in Cystic Fibrosis Phase 3
Terminated NCT02769637 - Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
Not yet recruiting NCT04451213 - Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis N/A
Recruiting NCT04039087 - Sildenafil Exercise: Role of PDE5 Inhibition Phase 2/Phase 3
Recruiting NCT04056702 - Impact of Triple Combination CFTR Therapy on Sinus Disease.
Completed NCT04038710 - Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
Completed NCT04058548 - Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation N/A
Active, not recruiting NCT03637504 - Feasibility of a Mobile Medication Plan Application in CF Patient Care N/A
Recruiting NCT03506061 - Trikafta in Cystic Fibrosis Patients Phase 2
Completed NCT03566550 - Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Not yet recruiting NCT04580368 - Testing Drug Efficacy in Cystic Fibrosis Through N-of-1 Trials N/A
Recruiting NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Recruiting NCT04010253 - Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis N/A
Completed NCT02449785 - Assessment of Cystic Fibrosis Lung Involvement With UTE Pulse Sequences N/A
Terminated NCT02170025 - Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients Phase 2
Recruiting NCT04602468 - Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER) Phase 4
Completed NCT04006873 - Gut Imaging for Function & Transit in Cystic Fibrosis Study 2 Phase 2
Completed NCT02465450 - Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis Phase 2
Recruiting NCT03335202 - Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis N/A