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Remote monitoring & gaming technology for improving outcomes in children with cystic fibrosis

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

Project in Setup

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

Study

Full title

Fizzyo trial: Remote monitoring & gaming technology for improving outcomes in children with cystic fibrosis

Remote monitoring and gaming technology for improving physiotherapy prescription, adherence and prediction of clinical outcomes in children with cystic fibrosis. Airway clearance, physical activity and exercise can mitigate the progression of CF lung disease, but routine physiotherapy treatments are burdensome and adherence is low. Traditional research has failed to produce credible evidence to guide practice, partly because ‘blinding’ isn’t possible and patient preference can confound results. Following our involvement with the ‘Big Life Fix’ television series https://youtu.be/d6A8R146JWU (BBC2,2016) we have worked with engineers and designers to develop electronically chipped airway clearance devices and wearable activity trackers to facilitate automatic data transmission to clinicians and researchers caring for children with CF. Industry partners (Microsoft) and UCL computer science experts are helping us develop computer games driven by breathing through an airway clearance device (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, physical activity and exercise to assess impact on clinical outcomes. Innovative big data analysis methods will be used to find out whether: Children with CF should do regular ACTs or exercise, and what the minimum effective dose is physical activity levels have an impact on clinical outcomes airway clearance or exercise is more effective in different children (and how to choose) some airway clearance techniques are better than others airway clearance gaming helps children do treatments more regularly, and whether better adherence improves health alternative to traditional research methods and help identify sensitive composite outcome measures for children with mild signs and symptoms.

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

100

Last edited date

03 October 2017

Sponsor

Cystic Fibrosis Trust Clinical Excellence and Innovation Award

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

Recruiting

Great Ormond Street Hospital

Address

Great Ormond Street London WC1N 3JH

Recruitment ends

June 2018

Contact

Main, Eleanor

Get in touch