Home Monitoring to Predict Exacerbation in Cystic Fibrosis (SmartCare)

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB23 3RE
    • Papworth Hospital NHS Trust
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
      • Papworth Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observation; Adult Cystic Fibrosis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	6 months

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Collaborators: King's College Hospital NHS Trust; The Leeds Teaching Hospitals NHS Trust; University Hospital Southampton NHS Foundation Trust; University Hospitals Bristol and Weston NHS Foundation Trust; Microsoft Research; Frimley Park Hospital NHS Trust; Cystic Fibrosis Trust; Royal Brompton & Harefield
• Investigators: Principal Investigator: Andres Floto, Prof, Papworth Hospital NHS

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: PO1955