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Home Monitoring to Predict Exacerbation in Cystic Fibrosis (SmartCare)

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ClinicalTrials.gov Identifier: NCT02416375
Recruitment Status : Unknown
Verified February 2016 by Judy Ryan, Papworth Hospital.
Recruitment status was:  Recruiting
First Posted : April 15, 2015
Last Update Posted : February 17, 2016
Sponsor:
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 NHS Foundation Trust
Information provided by (Responsible Party):
Judy Ryan, Papworth Hospital

Brief 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.

Condition or disease
Cystic Fibrosis

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Standardized Multi-centre Analysis of Remote Monitoring in Cystic Fibrosis Adult Patients to Reduce Pulmonary Exacerbations
Study Start Date : May 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort
Observation
Adult Cystic Fibrosis patients



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Whether daily monitoring can provide early warning of a new chest infection [ Time Frame: 6 months ]
    Identification of predictive signals for early detection of an acute pulmonary exacerbations and treatment response in patients with cystic fibrosis

  2. Development of a web-based machine learning tool [ Time Frame: 6 months ]
    Development of a web-based machine learning associated tool to predict acute pulmonary exacerbation and treatment response in patients with cystic fibrosis.


Biospecimen Retention:   Samples Without DNA
Daily sputum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride.
  2. Age ≥ 18 years of age.
  3. A history of at least 1 acute pulmonary exacerbation in the past 12 months.
  4. Able to provide written informed consent.
  5. Willing and able to produce daily sputum samples.
  6. Willing and able to provide daily telemetric measure of several physiological parameters.

Exclusion Criteria:

  1. Patients unable to provide written informed consent
  2. Patients unable to produce daily sputum samples
  3. Less than 1 infective pulmonary exacerbation in 12 months
  4. Lung transplant recipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416375


Contacts
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Contact: Andres Floto, Prof 01480364673 andres.floto@papworth.nhs.uk
Contact: EmEm-Fong Ukor, Dr 01480364116 ememfong.ukor@nhs.net

Locations
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United Kingdom
Papworth Hospital NHS Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Judy Ryan, BSc    01480364116    judy.ryan@papworth.nhs.uk   
Contact: Emem Fong Ukor, Phd    01480364116    ememfong.ukor@nhs.net   
Papworth Hospital NHS Trust Recruiting
Cambridge, United Kingdom, CB23 3RE
Contact: Judy Ryan, BSc, RGN    014800364116    judy.ryan@papworth.nhs.uk   
Principal Investigator: Andres Floto, MA, MRCP         
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
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 NHS Foundation Trust
Investigators
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Principal Investigator: Andres Floto, Prof Papworth Hospital NHS

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Responsible Party: Judy Ryan, Research & Database Manager, Papworth Hospital
ClinicalTrials.gov Identifier: NCT02416375     History of Changes
Other Study ID Numbers: PO1955
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases