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NCT Number: NCT02994706

A 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Heartlands Hospital

Birmingham, West Midlands, B9 5SS, United Kingdom

About this study

The principal question being answered by this research study is:

  • 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:

  • The effect of home monitoring on lung function in adults with cystic fibrosis (CF)
  • The effect of home monitoring on requirement for antibiotics in adults with CF
  • The effect of home monitoring on nutritional status in adults with CF
  • The effect of home monitoring on health related quality of life in adults with CF
  • Costeffectiveness analysis comparing the home monitoring period with the routine clinical care period
  • The patient experience of receiving home monitoring in adults with CF
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Clinical Care

Other

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

Primary outcomes

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

    Time frame: up to 12 months

Secondary outcomes

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

    Time frame: up to 12 months

  2. Change in FVC in the home monitoring group compared to the routine

    Time frame: up to 12 months

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

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

  6. Change in CFQ-R scores in the home monitoring group compared to the routine clinical care group

    Time frame: Up to 12 months

    The Cystic Fibrosis Questionnaire Revised version (CFQ-R) is a multiple choice and likert questionnaire split into two sections: Demographics and Quality of Life. Answers of 'Always' or similar are deemed a higher value than 'Never' or similar. The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. never) than those that are higher values (e.g. 'always)

  7. Health economic analysis measured by EQ-5D-5L

    Time frame: Up to 12 months

    The Euro Quality of Life (EQ5D) is a multiple choice questionnaire split onto sections including Mobility, Self-Care, Usual activities, Pain/Discomfort, and Anxiety/Depression. For each of these sections, it asks if a person always have issues, some issues or no issues (e.g. Mobility - I have no problems / I have some problems / I am confined to bed). The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. I have no issues) than those that are higher values (e.g. I am confined to bed). There is also a scale, ranging from 0 (worst imaginable health) to 100 (best imaginable health) with 99 intervals in between whereby the patient marks where they feel their current health lays.

  8. Health economic analysis measured by ICECAP-A

    Time frame: Up to 12 months

    The ICEpop CAPability measure for Adults (ICECAP-A) is a multiple choice questionnaire split onto sections including 'Feeling Settled and Secure, Love, Friendship and Support, Being Independent, Achievement and progress, and Enjoyment and pleasure. For each of these sections, it asks whether a person has no problem, some problems, many problems or total problem with a certain area (e.g. Being Independent - I can achieve in all aspects of my life / I can achieve in many aspects of my life / I can achieve in some aspects of my life / I am unable to be at all independent). The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. I can achieve in all aspects of my life) than those that are higher values (e.g. I am unable to be at all independent).

  9. 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

    Time frame: Up to 12 months

  10. Patient experience assessed by a semi-structured qualitative interview in the home monitoring group compared to the routine clinical care group

    Time frame: Up to 12 months

  11. Levels of relevant urine biomarkers in the home monitoring group associated with pulmonary exacerbations

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Heart of England NHS Trust

Other

Collaborators

  • National Institute for Health Research, United Kingdom
  • University of Birmingham

Registry information

Official study title

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

Acronym: HOME-CF

Important dates

Study start
2006
Primary completion
2018
Study completion
2018
First posted
Dec 16, 2016
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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