Cystic FibrosisHOME-CFNCT02994706
A Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)
A study testing Home Monitoring and Clinical Care in people with Cystic Fibrosis, run by Heart of England NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Home Monitoring and Clinical Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2006to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Heartlands Hospital
Birmingham, West Midlands, B9 5SS
About this study
Official title: A Prospective Pilot 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Home Monitoring, Clinical Care
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home MonitoringProcedure or surgery
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 CareOther
Participants selected for this arm will continue to receive routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group
Measured: up to 12 months
Secondary outcomes (11)
Change in FEV1 in the home monitoring group compared to the routine clinical care group
Measured: up to 12 months
Change in FVC in the home monitoring group compared to the routine
Measured: up to 12 months
Days on oral and intravenous antibiotics in the home monitoring group compared to the routine clinical care group
Measured: Up to 12 months
Change in body weight in the home monitoring group compared to the routine clinical care group
Measured: Up to 12 months
Change in BMI in the home monitoring group compared to the routine clinical care group
Measured: Up to 12 months
Change in CFQ-R scores in the home monitoring group compared to the routine clinical care group
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)
Measured: Up to 12 months
Health economic analysis measured by EQ-5D-5L
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.
Measured: Up to 12 months
Health economic analysis measured by ICECAP-A
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).
Measured: Up to 12 months
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
Measured: Up to 12 months
Patient experience assessed by a semi-structured qualitative interview in the home monitoring group compared to the routine clinical care group
Measured: Up to 12 months
Levels of relevant urine biomarkers in the home monitoring group associated with pulmonary exacerbations
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJan 2006
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart of England NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Edward F Nash, MD, Principal investigator, Heart of England NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994706
- Sponsor's protocol ID
- 2012135RM
- Acronym
- HOME-CF
- Status last verified
- Feb 2019
- First submitted
- 16 Jul 2014
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35274585Choyce 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.
PubMed 28114922
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)
- ClinicalTrials.gov ID
- NCT02994706
- Acronym / sponsor ID
- HOME-CF / 2012135RM
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Heart of England NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Birmingham
- Study start
- Jan 2006 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home monitoring | Experimental | Procedure: Home MonitoringHome 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. |
| Clinical Care | Active comparator | Other: Clinical CareThroughout the study period, participants will attend outpatient clinic visits as usual and treatment with antibiotics as clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home MonitoringParticipants 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. | Procedure or surgery | Home monitoring |
| Clinical CareParticipants selected for this arm will continue to receive routine clinical care. | Other | Clinical Care |
Primary outcome
Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group
Time frame: up to 12 months
11 secondary outcomes
Change in FEV1 in the home monitoring group compared to the routine clinical care group
Time frame: up to 12 months
Change in FVC in the home monitoring group compared to the routine
Time frame: up to 12 months
Days on oral and intravenous antibiotics in the home monitoring group compared to the routine clinical care group
Time frame: Up to 12 months
Change in body weight in the home monitoring group compared to the routine clinical care group
Time frame: Up to 12 months
Change in BMI in the home monitoring group compared to the routine clinical care group
Time frame: Up to 12 months
Change in CFQ-R scores in the home monitoring group compared to the routine clinical care group
Time frame: Up to 12 months
Health economic analysis measured by EQ-5D-5L
Time frame: Up to 12 months
Health economic analysis measured by ICECAP-A
Time frame: Up to 12 months
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
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
Levels of relevant urine biomarkers in the home monitoring group associated with pulmonary exacerbations
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Derived from this study: PubMed 35274585Nash 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.
- Derived from this study: PubMed 28114922Choyce 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward F Nash, MD principal investigator
Heart of England NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Monitoring and Clinical Care in people with Cystic Fibrosis, run by Heart of England NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994706, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.