PlayPhysio: Making Physio Fun

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-02-11

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.

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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.

Conditions

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Cystic Fibrosis in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Subjects will receive notification to their device on day 1 of the run in period informing them of their group allocation Investigators (PI and CI) will be blinded as to patient allocation. Sub-investigator will be familiar with Playphysio device and will NOT be blinded. This investigator will not be involved in recording of any data but will be available to assist with technical issues faced by patients and provide standard clinical reviews.

Statistician will be blinded to group allocation Playphysio team will not be blinded and will be able to assist with Playphysio queries that arise

Study Groups

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Arm 1:

Gamification

Group Type EXPERIMENTAL

PlayPhysio

Intervention Type DEVICE

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 2

Monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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