CyFiT telehealth: protocol for a randomised controlled trial of an online outpatient physiotherapy service for children with cystic fibrosis

BackgroundTelehealth and telemonitoring is an emerging area of study in people with cystic fibrosis (CF), with the potential of increasing access to care, and minimising infection control risks to patients without compromising their health outcomes. To date, limited evidence is available to support the use of telehealth in paediatric population with CF in a clinical setting. This study aims to investigate the utility of a multimodal telehealth-based outpatient physiotherapy service and assess its effect on quality of life, functional exercise capacity, hospital admission and intravenous antibiotic requirements, lung function, processes of care, participation in activities of daily living, and health economics associated with operating an innovative service.MethodThis single centre, prospective, parallel, randomised, controlled, non-inferiority trial aims to recruit 110 children with CF between the ages 8 to 18years of age. Participants will be randomised to the Usual Outpatient Physiotherapy Service group (Usual OPS) or the telehealth intervention group (CyFiT OPS). Quality of life, participation in activity of daily living, functional exercise capacity and patient perception of care will be examined every six months using the Cystic Fibrosis Questionnaire-Revised (CFQ-R), Children's Assessment of Participation and Enjoyment (CAPE), Preferences for Activities of Children (PAC) questionnaire, Modified Shuttle Test-25 (MST25), and Measure of Process of Care (MPOC-20) questionnaire. Physiological measurements collected during routine clinical visits such as spirometry, body weight and height, information will be retrospectively retrieved via a chart review at the end of the study.DiscussionWe anticipate that this multi-modal telehealth service will deliver a comparable service to traditional face-to-face models. An alternative to existing outpatient physiotherapy services may potentially increase patient options for access to care and patient-orientated outcomes such as quality of life. If deemed appropriate, the new model of care can be integrated into clinical practice immediately.Trial registrationThis trial is registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12617001035314) last updated 17th July 2018.

背景 远程医疗和远程监测是囊性纤维化（CF）患者研究的一个新兴领域，它有可能增加获得医疗服务的机会，并在不影响患者健康结果的情况下将感染控制风险降至最低。到目前为止，在临床环境中支持在儿童囊性纤维化患者中使用远程医疗的证据有限。本研究旨在调查基于多模式远程医疗的门诊物理治疗服务的效用，并评估其对生活质量、功能运动能力、住院情况和静脉抗生素需求、肺功能、护理过程、参与日常生活活动以及与运营创新服务相关的卫生经济学的影响。 方法 这项单中心、前瞻性、平行、随机、对照、非劣效性试验旨在招募110名8至18岁的囊性纤维化儿童。参与者将被随机分配到常规门诊物理治疗服务组（常规OPS）或远程医疗干预组（CyFiT OPS）。将使用囊性纤维化问卷修订版（CFQ - R）、儿童参与和享受评估（CAPE）、儿童活动偏好（PAC）问卷、改良穿梭试验 - 25（MST25）以及护理过程测量（MPOC - 20）问卷每六个月检查一次生活质量、参与日常生活活动情况、功能运动能力以及患者对护理的感知。在常规临床就诊期间收集的生理测量数据，如肺活量测定、体重和身高等信息，将在研究结束时通过病历回顾进行追溯获取。 讨论 我们预计这种多模式远程医疗服务将提供与传统面对面模式相当的服务。现有门诊物理治疗服务的一种替代方案可能会增加患者获得医疗服务的选择以及以患者为导向的结果，如生活质量。如果合适，这种新的护理模式可以立即融入临床实践。 试验注册 该试验已在澳大利亚和新西兰临床试验注册中心（ACTRN12617001035314）注册，最后更新于2018年7月17日。