PlayPhysio: Making Physio Fun

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis in Children
• Intervention / Treatment: Device: PlayPhysio

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L12 2AP
      • Alder Hey Children's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Gamification	Device: PlayPhysio; 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.
No Intervention: Arm 2; Monitoring

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Alder Hey Children's NHS Foundation Trust
• Investigators: Principal Investigator: Adam Walsh, BSc, Clinical Specialist Physiotherapist in Cystic Fibrosis

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): February 11, 2023
• Study Completion (Actual): February 11, 2023

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

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: 295971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No