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

NCT02994706 | Completed

• 1 other identifier: 2012135RM
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group

  up to 12 months

Secondary Outcomes (11)

• Change in FEV1 in the home monitoring group compared to the routine clinical care group

  up to 12 months

• Change in FVC in the home monitoring group compared to the routine

  up to 12 months

• Days on oral and intravenous antibiotics in the home monitoring group compared to the routine clinical care group

  Up to 12 months

• Change in body weight in the home monitoring group compared to the routine clinical care group

  Up to 12 months

• Change in BMI in the home monitoring group compared to the routine clinical care group

  Up to 12 months

Study Arms (2)

Home monitoring

EXPERIMENTAL

Home monitoring will involve participants recording their symptoms twice weekly on a modified mobile phone and recording their lung function twice weekly using a digital spirometer. This data will be automatically transmitted to the CF team and we will contact patients on the mobile phone if symptoms and/or lung function decline below a set threshold, suggesting the onset of a pulmonary exacerbation. We will contact patients within 24 hours of symptoms and/or lung function falling below this set threshold.

Procedure: Home Monitoring

Clinical Care

ACTIVE COMPARATOR

Throughout the study period, participants will attend outpatient clinic visits as usual and treatment with antibiotics as clinically indicated.

Other: Clinical Care

Interventions

Home Monitoring PROCEDURE

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.

Home monitoring

Clinical Care OTHER

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

Clinical Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart of England NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Birmingham: collaborator

Study Sites (1)

Birmingham Heartlands Hospital

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35274585 DERIVED

• 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.

  PMID: 28114922 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Edward F Nash, MD

  Heart of England NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: December 16, 2016
• Study Start: January 1, 2006
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)