PlayPhysio: Making Physio Fun

NCT05469711 | Completed

• 1 other identifier: 295971
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cystic Fibrosis Questionnaire-Revised (CFQ-R)

  Duration of study (4 months)

• Patient Satisfaction

  Duration of study (4 months)

• Spriometry

  Duration of study (4 months)

Study Arms (2)

Arm 1:

EXPERIMENTAL

Gamification

Device: PlayPhysio

Arm 2

NO INTERVENTION

Monitoring

Interventions

PlayPhysio 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 1:

Eligibility Criteria

• Age: 72 Months - 140 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Incompatible device for airway clearance Outside of recruiting age

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Study Sites (1)

Alder Hey Children's NHS Foundation Trust

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

Study Officials

• Adam Walsh, BSc

  Clinical Specialist Physiotherapist in Cystic Fibrosis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: July 22, 2022
• Study Start: February 1, 2022
• Primary Completion: February 11, 2023
• Study Completion: February 11, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)