Cystic FibrosisRIGHT-CFNCT02399241
Using Remote Telemonitoring to Detect Early Decline in Lung Function & Streamline Clinics in Adults With Cystic Fibrosis
A study testing Bluetooth enabled nebuliser device (I-neb) in people with Cystic Fibrosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Lung Health research study (Development of a predictive model) - To determine whether the I-neb breathing parameters (flow data) can act as a surrogate marker for lung function (Forced Expiratory Volume in 1 second FEV1) hence allow early detection of decline in lung function in cystic fibrosis patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Bluetooth enabled nebuliser device (I-neb)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to 1 Mar 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of cystic fibrosis via genetic testing
- Patients aged 16 and above
- Patients using inhaled mucolytics (to loosen secretions) or antibiotic treatments via the I-neb for all or part of their treatment
- Patients who have capacity to give informed consent
Who cannot join
- Patients with a lung transplant
- Patients on the active transplant list
- Patients who are pregnant (due to the variability of lung function during pregnancy)
- Patients in the palliative end stage of their life
- Patients using inhaled treatments with no objective adherence measure
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
About this study
Lung Health research study (Development of a predictive model) - To determine whether the I-neb breathing parameters (flow data) can act as a surrogate marker for lung function (Forced Expiratory Volume in 1 second FEV1) hence allow early detection of decline in lung function in cystic fibrosis patients.
Read the detailed description
- Initial phase of the study will involve retrospective data collection, to review 36 months of retrospectively collected clinic time data (i.e. total length of appointment, length of time seen by each discipline, waiting time). This data is routinely collected and displayed in run charts. It will be used to allow an understanding of the baseline variability in a standard un-streamed clinic and whether distinct patient sub-populations can be identified i.e. red (complicated and time consuming) and green (simple and rapidly processed) streams. These data may suggest a starting structure for clinic slot lengths and provide a baseline comparator for the subsequent bespoke clinic structures.
- In the prospective intervention phase, To recruit 50 participants to take part in the bespoke clinics using a home spirometer, weighing scales, and Bluetooth enabled I-neb providing breathing parameter and adherence data.
- Participants' baseline routinely collected demographics (age, gender, genotype) and clinical data (including comorbidities, number of intravenous antibiotic days and clinic attendances per year, and treatment regime) will be recorded.
- At baseline participants will be asked to complete the Patient Activation Measure questionnaire. This patient-reported measure is a powerful reliable tool which has been validated in the UK24. It involves 13 quick questions to identify a patient's knowledge, skills, and confidence in managing their own health and health care.
- Participants will be asked to measure lung function and weight one week prior to clinic. The I-neb adherence and flow data will be routinely captured and transferred.
- Prior to clinic when this data is collected participants will be asked the EQ-5D-5L as before, if they require a repeat prescription, and whether there are any issues they would like to focus on when they attend for their consultation.
- This data will then be reviewed to determine which stream patients would be predicted to need to require. i.e. adherence support, diagnostic, or stable brief review.
- Following review the standard clinic process will be analysed to see whether the streaming would have been appropriate and if it could have potentially saved time and resources.
- Conditions
- Cystic Fibrosis
- Being tested
- Bluetooth enabled nebuliser device (I-neb)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bluetooth enabled nebuliser device (I-neb)Device
| Study group | Role | What they receive |
|---|---|---|
| Remote telemonitoring of clinical data | Experimental | Bluetooth enabled nebuliser device (I-neb) providing breathing parameters and adherence data. Receives: Device: Bluetooth enabled nebuliser device (I-neb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second
The study will develop a predictive model and conduct a parallel service improvement project. It therefore does not have a specific primary outcome measure. The predictive model will be attempting to identify if there is a correlation between the I-neb breathing parameters (i.e. inhalation time, rest time) and lung function (Forced Expiratory Volume in 1 second FEV1). The clinic streaming will attempt to identify if the preclinic data (lung function, weight, adherence) can predict the clinic needs of a patient.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMay 2015
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachael Curley, MB ChB MRCP, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399241
- Sponsor's protocol ID
- STH18185
- Acronym
- RIGHT-CF
- Status last verified
- Jun 2017
- First submitted
- 17 Mar 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Remote Telemonitoring to Detect Early Decline in Lung Function & Streamline Clinics in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02399241
- Acronym / sponsor ID
- RIGHT-CF / STH18185
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 26 Mar 2015 (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.
Lung Health research study (Development of a predictive model) - To determine whether the I-neb breathing parameters (flow data) can act as a surrogate marker for lung function (Forced Expiratory Volume in 1 second FEV1) hence allow early detection of decline in lung function in cystic fibrosis patients.
Detailed description
- Initial phase of the study will involve retrospective data collection, to review 36 months of retrospectively collected clinic time data (i.e. total length of appointment, length of time seen by each discipline, waiting time). This data is routinely collected and displayed in run charts. It will be used to allow an understanding of the baseline variability in a standard un-streamed clinic and whether distinct patient sub-populations can be identified i.e. red (complicated and time consuming) and green (simple and rapidly processed) streams. These data may suggest a starting structure for clinic slot lengths and provide a baseline comparator for the subsequent bespoke clinic structures.
- In the prospective intervention phase, To recruit 50 participants to take part in the bespoke clinics using a home spirometer, weighing scales, and Bluetooth enabled I-neb providing breathing parameter and adherence data.
- Participants' baseline routinely collected demographics (age, gender, genotype) and clinical data (including comorbidities, number of intravenous antibiotic days and clinic attendances per year, and treatment regime) will be recorded.
- At baseline participants will be asked to complete the Patient Activation Measure questionnaire. This patient-reported measure is a powerful reliable tool which has been validated in the UK24. It involves 13 quick questions to identify a patient's knowledge, skills, and confidence in managing their own health and health care.
- Participants will be asked to measure lung function and weight one week prior to clinic. The I-neb adherence and flow data will be routinely captured and transferred.
- Prior to clinic when this data is collected participants will be asked the EQ-5D-5L as before, if they require a repeat prescription, and whether there are any issues they would like to focus on when they attend for their consultation.
- This data will then be reviewed to determine which stream patients would be predicted to need to require. i.e. adherence support, diagnostic, or stable brief review.
- Following review the standard clinic process will be analysed to see whether the streaming would have been appropriate and if it could have potentially saved time and resources.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote telemonitoring of clinical data | Experimental | Device: Bluetooth enabled nebuliser device (I-neb)Bluetooth enabled nebuliser device (I-neb) providing breathing parameters and adherence data. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a confirmed diagnosis of cystic fibrosis via genetic testing
- Patients aged 16 and above
- Patients using inhaled mucolytics (to loosen secretions) or antibiotic treatments via the I-neb for all or part of their treatment
- Patients who have capacity to give informed consent
Key exclusion criteria (5 listed)
- Patients with a lung transplant
- Patients on the active transplant list
- Patients who are pregnant (due to the variability of lung function during pregnancy)
- Patients in the palliative end stage of their life
- Patients using inhaled treatments with no objective adherence measure
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 |
|---|---|---|
| Bluetooth enabled nebuliser device (I-neb) | Device | Remote telemonitoring of clinical data |
Primary outcome
Forced Expiratory Volume in 1 second
Time frame: Baseline to 6 months
The study will develop a predictive model and conduct a parallel service improvement project. It therefore does not have a specific primary outcome measure. The predictive model will be attempting to identify if there is a correlation between the I-neb breathing parameters (i.e. inhalation time, rest time) and lung function (Forced Expiratory Volume in 1 second FEV1). The clinic streaming will attempt to identify if the preclinic data (lung function, weight, adherence) can predict the clinic needs of a patient.
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 22 Jun 2017.
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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.
Rachael Curley, MB ChB MRCP principal investigator
Sheffield Teaching Hospitals 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 Bluetooth enabled nebuliser device (I-neb) in people with Cystic Fibrosis, run by Sheffield Teaching Hospitals NHS Foundation 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 4 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 22 Jun 2017. 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?
Forced Expiratory Volume in 1 second (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2017.