Cystic FibrosisSmartCareNCT02416375
Home Monitoring to Predict Exacerbation in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Papworth Hospital NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a number of parameters on a daily basis at home which might predict respiratory infections before they have symptoms and which might also predict treatment failures before this is obvious with conventional measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 147 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2015to Jan 2019
- Phase
- Observational
- 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
Study population: Adult Cystic Fibrosis patients who produce sputum daily and have not had a previous organ transplant, with a history of at least one pulmoanry exacerbation within the past 12 months.
Who may be able to join
- Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride.
- Age ≥ 18 years of age.
- A history of at least 1 acute pulmonary exacerbation in the past 12 months.
- Able to provide written informed consent.
- Willing and able to produce daily sputum samples.
- Willing and able to provide daily telemetric measure of several physiological parameters.
Who cannot join
- Patients unable to provide written informed consent
- Patients unable to produce daily sputum samples
- Less than 1 infective pulmonary exacerbation in 12 months
- Lung transplant recipients
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Papworth Hospital NHS Trust
Cambridge, Cambridgeshire, CB23 3RE
Papworth Hospital NHS Trust
Cambridge, CB23 3RE
About this study
Official title: A Standardized Multi-centre Analysis of Remote Monitoring in Cystic Fibrosis Adult Patients to Reduce Pulmonary Exacerbations
The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a number of parameters on a daily basis at home which might predict respiratory infections before they have symptoms and which might also predict treatment failures before this is obvious with conventional measures.
Read the detailed description
Participants will collect the following clinical information daily: pulse rate and oxygen saturations, wellness and cough scores, spirometry measurements, physical activity, temperature, weight and sleep quantity and quality. The patients will also collect daily sputum samples.
Data will be collected via Bluetooth-enabled devices and transmitted via a Smart-phone to a secure National Health Service approved web-based site to be analyzed.
The information obtained will allow the investigators to develop a software program that will identify signals that can predict the onset of a chest infection before symptoms develop.
The investigators will also measure specific substances in sputum to identify changes before, during and after chest infections. The investigators hope this additional information will enable them to more accurately predict the onset of chest infections in cystic fibrosis.
The results of this study will determine if it is possible to develop a simple sputum test for patients to use at home in combination with other home-based assessments of well-being to provide an early warning system of a chest infection before patients feel unwell.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Adult Cystic Fibrosis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home monitoring possible in adult Cystic Fibrosis patients
This will be measured by the number of patients recruited into the study and the patients compliance / adherence to the study protocol
Measured: 6 months
Secondary outcomes (2)
Whether daily monitoring can provide early warning of a new chest infection
Identification of predictive signals for early detection of an acute pulmonary exacerbations and treatment response in patients with cystic fibrosis
Measured: 6 months
Development of a web-based machine learning tool
Development of a web-based machine learning associated tool to predict acute pulmonary exacerbation and treatment response in patients with cystic fibrosis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2018
- Study completionJan 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Cystic Fibrosis Trust, King's College Hospital NHS Trust, Royal Brompton & Harefield, The Leeds Teaching Hospitals NHS Trust, University Hospital Southampton NHS Foundation Trust, Microsoft Research, Frimley Park Hospital NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust
- Responsible party
- Principal investigator, Judy Ryan, Papworth Hospital NHS Foundation Trust
- Investigators
- Andres Floto, Prof, Principal investigator, Papworth Hospital NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416375
- Sponsor's protocol ID
- PO1955
- Acronym
- SmartCare
- Status last verified
- Mar 2021
- First submitted
- 10 Feb 2015
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardized Multi-centre Analysis of Remote Monitoring in Cystic Fibrosis Adult Patients to Reduce Pulmonary Exacerbations
- ClinicalTrials.gov ID
- NCT02416375
- Acronym / sponsor ID
- SmartCare / PO1955
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Cystic Fibrosis Trust, King's College Hospital NHS Trust, Royal Brompton & Harefield, The Leeds Teaching Hospitals NHS Trust, University Hospital Southampton NHS Foundation Trust, Microsoft Research, Frimley Park Hospital NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 15 Apr 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.
The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a number of parameters on a daily basis at home which might predict respiratory infections before they have symptoms and which might also predict treatment failures before this is obvious with conventional measures.
Detailed description
Participants will collect the following clinical information daily: pulse rate and oxygen saturations, wellness and cough scores, spirometry measurements, physical activity, temperature, weight and sleep quantity and quality. The patients will also collect daily sputum samples.
Data will be collected via Bluetooth-enabled devices and transmitted via a Smart-phone to a secure National Health Service approved web-based site to be analyzed.
The information obtained will allow the investigators to develop a software program that will identify signals that can predict the onset of a chest infection before symptoms develop.
The investigators will also measure specific substances in sputum to identify changes before, during and after chest infections. The investigators hope this additional information will enable them to more accurately predict the onset of chest infections in cystic fibrosis.
The results of this study will determine if it is possible to develop a simple sputum test for patients to use at home in combination with other home-based assessments of well-being to provide an early warning system of a chest infection before patients feel unwell.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Adult Cystic Fibrosis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Cystic Fibrosis patients who produce sputum daily and have not had a previous organ transplant, with a history of at least one pulmoanry exacerbation within the past 12 months.
Key inclusion criteria (6 listed)
- Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride.
- Age ≥ 18 years of age.
- A history of at least 1 acute pulmonary exacerbation in the past 12 months.
- Able to provide written informed consent.
- Willing and able to produce daily sputum samples.
Key exclusion criteria (4 listed)
- Patients unable to provide written informed consent
- Patients unable to produce daily sputum samples
- Less than 1 infective pulmonary exacerbation in 12 months
- Lung transplant recipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Home monitoring possible in adult Cystic Fibrosis patients
Time frame: 6 months
This will be measured by the number of patients recruited into the study and the patients compliance / adherence to the study protocol
2 secondary outcomes
Whether daily monitoring can provide early warning of a new chest infection
Time frame: 6 months
Development of a web-based machine learning tool
Time frame: 6 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 16 Mar 2021.
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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.
Andres Floto, Prof principal investigator
Papworth Hospital NHS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Papworth Hospital NHS Foundation Trust at 2 sites 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 6 inclusion and 4 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Home monitoring possible in adult Cystic Fibrosis patients (time frame: 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 16 Mar 2021.