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Remote monitoring & gaming technology for children with CF

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Behavioral

Trial status

Closed to recruitment - in follow up

Participating Centres
Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Not Applicable

Full title

Project Fizzyo: Remote monitoring and gaming technology for improving physiotherapy prescription, adherence and prediction of clinical outcomes in children with cystic fibrosis.

Airway clearance treatments (ACTs) and physical activity can mitigate the progression of CF lung disease, but these routine physiotherapy treatments are burdensome and adherence is low. Traditional research methods have failed to produce credible evidence to guide practice, partly because ‘blinding’ isn’t possible and patient preference can confound results. We have worked with engineers and designers to develop an electronically chipped sensor (Fizzyo sensor) which mounts onto standard widely used airway clearance devices. This sensor monitors breathing during routine airway clearance. Additionally wearable activity trackers can monitor physical activity. We can now facilitate automatic transmission of ACT and physical activity data to clinicians and researchers caring for children with CF. Industry partners (Microsoft) and UCL computer science experts have helped us build an airway clearance and physical activity feedback dashboard app for patients and carers. This team has also developed computer games driven by breathing through an airway clearance device for this app (to enhance treatment enjoyment and adherence). The project will use this technology for passive remote capture and transmission of daily longitudinal data during airway clearance and physical activity to assess impact of different adherence levels on clinical outcomes. Innovative big data analysis methods will be used to find out whether: 1) Children with CF should do regular ACTs or physical activity, and what the minimum effective dose is 2) Physical activity levels have an impact on clinical outcomes 3) Airway clearance or physical activity is more effective in different children (and how to choose) 4) Some ACTs are better than others 5) Airway clearance gaming helps children do treatments more regularly, and whether better adherence improves health 6) Remote monitoring and big data analysis can provide a valuable alternative to traditional research methods and help identify sensitive composite outcome measures for children with mild signs and symptoms.

Trial Reference Number

110390

Trial type

Non-medication

Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment

14 months

Intervention
the name of the treatment or therapy being researched

Physio

Recruitment target
the number of participants who need to be recruited for the trial in the UK

145

Last edited date

17 July 2018

CF sponsor

Cystic Fibrosis Trust Clinical Excellence and Innovation Award

CF sponsor type

Academic

Who can take part?

Top inclusion criteria
  • CF diagnosis
  • Age 6-16
  • Uses airway clearance device for physiotherapy
Top exclusion criteria
  • Research team will need access to clinical records

CF centres running this trial

Closed

Great Ormond Street Hospital

Address

Great Ormond Street London WC1N 3JH

Recruitment starts

September 2018

Recruitment ends

March 2019

Contact

Dawson, Charlotte

Get in touch

Closed

Royal Brompton Hospital

Address

Sydney Street London SW3 6NP

Recruitment starts

November 2018

Recruitment ends

May 2019

Contact

Murray, Nicky

Get in touch