Cystic Fibrosis in ChildrenNCT05469711
PlayPhysio: Making Physio Fun
A study testing PlayPhysio in people with Cystic Fibrosis in Children, run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 72 to 140 months
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- PlayPhysio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2022to 11 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 to 140 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Incompatible device for airway clearance Outside of recruiting age
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Alder Hey Children's NHS Foundation Trust
Liverpool, Merseyside, L12 2AP
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- PlayPhysio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlayPhysioDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: | Experimental | Gamification Receives: Device: PlayPhysio |
| Arm 2 | No intervention | Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of study (4 months)
Secondary outcomes (3)
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.
Measured: Duration of study (4 months)
Patient Satisfaction
Questionnaire - an demonstration of high patient satisfaction would be a positive outcome.
Measured: Duration of study (4 months)
Spriometry
Lung function as performed for clinical practice (FEV1 and FVC)
Measured: Duration of study (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Feb 2022
- Primary completion11 Feb 2023
- Study completion11 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alder Hey Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Walsh, BSc, Principal investigator, Clinical Specialist Physiotherapist in Cystic Fibrosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469711
- Sponsor's protocol ID
- 295971
- Status last verified
- Jan 2024
- First submitted
- 8 Oct 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05469711
- Acronym / sponsor ID
- 295971
- Conditions
- Cystic Fibrosis in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Alder Hey Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 11 Feb 2023 (actual)
- Study completion
- 11 Feb 2023 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: | Experimental | Device: PlayPhysioGamification |
| Arm 2 | No intervention | –Monitoring |
Who may qualify
- Ages
- 72 to 140 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Incompatible device for airway clearance Outside of recruiting age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlayPhysioThe 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. | Device | Arm 1: |
Primary outcome
Adherence to treatment
Time frame: Duration of study (4 months)
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.
3 secondary outcomes
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: Duration of study (4 months)
Patient Satisfaction
Time frame: Duration of study (4 months)
Spriometry
Time frame: Duration of study (4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Walsh, BSc principal investigator
Clinical Specialist Physiotherapist in Cystic Fibrosis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlayPhysio in people with Cystic Fibrosis in Children, run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to treatment (time frame: Duration of study (4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.