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临床试验/NCT05469711
NCT05469711已完成不适用

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

Alder Hey Children's NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Adherence to treatment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

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

入排标准

年龄范围
72 Months 至 140 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Incompatible device for airway clearance Outside of recruiting age

结局指标

主要结局

Adherence to treatment

时间窗: 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.

次要结局

  • Patient Satisfaction(Duration of study (4 months))
  • Cystic Fibrosis Questionnaire-Revised (CFQ-R)(Duration of study (4 months))
  • Spriometry(Duration of study (4 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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