PlayPhysio: Making Physio Fun
Condition: Cystic Fibrosis in Children
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      A study to examine if the gamification of routine airway clearance can improve the quality of
      live for young people living with chronic health conditions.
    

Detailed description: 
      CF experts agree that there is a discrepancy between objective and self-reported adherence.
      Thus, an intervention focusing on both long-term, sustainable monitoring as well on enhancing
      and sustaining an efficient rate of respiratory physio is urgently needed. The device under
      investigation here is devoted exactly to this twofold task. Playphysio®(Pp) is a gamification
      system developed by Will Jackson, who has a background in product and software design but
      more importantly is the father of an adolescent girl with CF. The Pp is an electronic monitor
      which can be attached to the outside of an OPEP device. It senses patients' use of the OPEP
      device to enable the individual completing their existing airway clearance therapy to play
      mobile games throughout their treatment. Pp enables the individual to pick from a number of
      games to play whilst completing their normal prescribed airway clearance treatment. The games
      have been designed so that the ideal treatment technique is encouraged and the individual's
      treatment routine is supported with the counting of treatment breaths and prompting a pause
      to carry out their FET and cough. The aim of Pp is to enhance treatment adherence through its
      innovative element: gamification. It also offers objective monitoring of CF physio adherence
      through its technology. The Pp app offers positive feedback following the completion of
      treatment sessions, keeps a record of treatments done and shares this information with the CF
      physiotherapy team.

      A previous study of an earlier Pp device have found good adherence over a 24 week period,
      however only 17/30 participants completed the trial. Qualitative data found positive outcomes
      with 2 participants making the following observations. This was an earlier prototype and
      changes have been made since that time to both the device and the games.

      "I rely on the Playphysio for breathing into his PEP device properly. I can't imagine having
      to go back to the continuous monitoring and timing that used to be required before having
      Playphysio®" "I rely on Playphysio®. it has reduced my stress and time to get him to do it
      properly".

      Children with CF who are using a play physio device, compared with those not using a play
      physio, will have a better experience of airway clearance leading to improved quality of
      life.
    

Intervention name(s): PlayPhysio
Intervention type(s): Device
Intervention description(s): The gamification will be switched on at day 28 for the participants in arm 1. The trial will run for a further 84 days with the mid-point review half way through this section of the trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a single centre, randomised control study with open label participation. Subjects will be randomised 1:1 to either Arm 1 - active arm or Arm 2 - control arm. The trial will last for 4 months 112 days). The first month will be used as a run in period to gather adherence data on both groups with no games available on any of the devices. The gamification will be switched on at day 28 for the participants in arm 1. The trial will run for a further 84 days with the mid-point review half way through this section of the trial.
Arm 1: intervention-Pp plus gamification Arm 2: control- Pp only - Pp acting as adherence monitor only with no feedback given in real time to patient.
Masking: Single (Investigator)
Primary purpose: Other