ABSTRACT: BACKGROUND:Telehealth 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. METHOD:This single centre, prospective, parallel, randomised, controlled, non-inferiority trial aims to recruit 110 children with CF between the ages 8 to 18?years 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. DISCUSSION:We 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 REGISTRATION:This trial is registered with the Australian and New Zealand Clinical Trial Registry ( ACTRN12617001035314 ) last updated 17th July 2018.
