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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

Tracking Information
First Submitted Date February 10, 2015
First Posted Date April 15, 2015
Last Update Posted Date February 17, 2016
Study Start Date May 2015
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2015)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02416375 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 9, 2015)
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Home Monitoring to Predict Exacerbation in Cystic Fibrosis
Official Title A Standardized Multi-centre Analysis of Remote Monitoring in Cystic Fibrosis Adult Patients to Reduce Pulmonary Exacerbations
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Daily sputum samples
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.
Condition Cystic Fibrosis
Intervention Not Provided
Study Groups/Cohorts Observation
Adult Cystic Fibrosis patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 9, 2015)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02416375
Other Study ID Numbers PO1955
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Judy Ryan, Papworth Hospital
Study Sponsor Papworth Hospital NHS Foundation Trust
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
Investigators
Principal Investigator: Andres Floto, Prof Papworth Hospital NHS
PRS Account Papworth Hospital NHS Foundation Trust
Verification Date February 2016