PlayPhysio: Making Physio Fun

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study to Determine the Impact Gamification of Routine Airway Clearance Has on the Quality of Life for Children and Young People With Cystic Fibrosis

Conditions
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Cystic Fibrosis in Children

Intervention / Treatment
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* Device: PlayPhysio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has confirmed diagnosis of cystic fibrosis as determined by the investigator Under care of Alder Hey Cystic Fibrosis Team (local or network care) Subjects 6 years-11 years, 8 months of age, inclusive, on the date of the informed consent Using a compatible OPEP device for daily airway clearance Exclusion Criteria: Incompatible device for airway clearance Outside of recruiting age

Ages Eligible for Study
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Minimum Age: 72 Months
Maximum Age: 140 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1:<br>Gamification | Device: PlayPhysio<br>* 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.<br>|
| No Intervention: Arm 2<br>Monitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to treatment | This external pilot open randomised controlled trial will generate data examining study feasibility and specifically data on accrual, adherence and outcome measure stability. It is anticipated that data collected will inform power calculations for a future randomised controlled trial. The aim of this subsequent definitive study will be to determine whether Playphysio® with gamification in children with CF is more effective than standard therapy in improving adherence and quality of life. The pilot trial will also be used to gain experience about the use and the satisfaction of the Pp device among young patients. | Duration of study (4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystic Fibrosis Questionnaire-Revised (CFQ-R) | This is a disease-specific health-related quality of life (HRQOL) measure and the relevant measure. An change in score indicating improved quality of life would be a positive outcome. Score range = 0-100 and a higher score indicates higher health related quality of life. | Duration of study (4 months) | 
| Patient Satisfaction | Questionnaire - an demonstration of high patient satisfaction would be a positive outcome. | Duration of study (4 months) | 
| Spriometry | Lung function as performed for clinical practice (FEV1 and FVC) | Duration of study (4 months) |