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OpenTrials
Completed

NCT Number: NCT02416375

Home Monitoring to Predict Exacerbation in Cystic Fibrosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Papworth Hospital NHS Trust, Cambridge, Cambridgeshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Collaborators

  • Cystic Fibrosis Trust
  • Frimley Park Hospital NHS Trust
  • King's College Hospital NHS Trust
  • Microsoft Research
  • Royal Brompton & Harefield
  • The Leeds Teaching Hospitals NHS Trust
  • University Hospital Southampton NHS Foundation Trust
  • University Hospitals Bristol and Weston NHS Foundation Trust

Registry information

Official study title

A Standardized Multi-centre Analysis of Remote Monitoring in Cystic Fibrosis Adult Patients to Reduce Pulmonary Exacerbations

Acronym: SmartCare

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 15, 2015
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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