Dataset Information

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

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.

SUBMITTER: Lang RL

PROVIDER: S-EPMC6344991 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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

Lang Ray Lei RL Wilson Christine C Stockton Kellie K Russell Trevor T Johnston Leanne Marie LM

BMC pulmonary medicine 20190124 1

<h4>Background</h4>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 ...[more]

PMID: 30678670

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Project description:IntroductionDaily physiotherapy is believed to mitigate the progression of cystic fibrosis (CF) lung disease. However, physiotherapy airway clearance techniques (ACTs) are burdensome and the evidence guiding practice remains weak. This paper describes the protocol for Project Fizzyo, which uses innovative technology and analysis methods to remotely capture longitudinal daily data from physiotherapy treatments to measure adherence and prospectively evaluate associations with clinical outcomes.Methods and analysisA cohort of 145 children and young people with CF aged 6-16 years were recruited. Each participant will record their usual physiotherapy sessions daily for 16 months, using remote monitoring sensors: (1) a bespoke ACT sensor, inserted into their usual ACT device and (2) a Fitbit Alta HR activity tracker. Real-time breath pressure during ACTs, and heart rate and daily step counts (Fitbit) are synced using specific software applications. An interrupted time-series design will facilitate evaluation of ACT interventions (feedback and ACT-driven gaming). Baseline, mid and endpoint assessments of spirometry, exercise capacity and quality of life and longitudinal clinical record data will also be collected.This large dataset will be analysed in R using big data analytics approaches. Distinct ACT and physical activity adherence profiles will be identified, using cluster analysis to define groups of individuals based on measured characteristics and any relationships to clinical profiles assessed. Changes in adherence to physiotherapy over time or in relation to ACT interventions will be quantified and evaluated in relation to clinical outcomes.Ethics and disseminationEthical approval for this study (IRAS: 228625) was granted by the London-Brighton and Sussex NREC (18/LO/1038). Findings will be disseminated via peer-reviewed publications, at conferences and via CF clinical networks. The statistical code will be published in the Fizzyo GitHub repository and the dataset stored in the Great Ormond Street Hospital Digital Research Environment.Trial registration numberISRCTN51624752; Pre-results.

Project description:BackgroundIn this pilot study we investigated daytime variation of multiple breath nitrogen washout (N2MBW) measures in children with clinically stable cystic fibrosis. To our knowledge the effect of time-of-day on multiple breath washout measures in patients with cystic fibrosis has not previously been reported. Furthermore, we assessed the influence of chest physiotherapy on N2MBW measures.MethodsTen school children with cystic fibrosis performed N2MBW followed by spirometry and plethysmography in the morning and afternoon at three visits that were one month apart. Chest physiotherapy was performed immediately before the afternoon measurements at visit 2 and immediately before morning and afternoon measurements at visit 3. The influence of time-of-day and chest physiotherapy on the measures was evaluated using linear mixed models.ResultsThere were adequate quality data from 8 children with median age (range) 9.6 (6.0; 15.1) years. Baseline lung clearance index (LCI) (range) was 9.0 (7.1; 13.0) and baseline FEV1% predicted was 97.5 (78.5; 117.9). No N2MBW measures were significantly influenced by time-of-day or chest physiotherapy. LCI (95% confidence interval) decreased non-significantly 0.05 (-0.32; 0.22) during the day and increased non-significantly 0.08 (-0.26; 0.42) after chest physiotherapy. All spirometric measures were unaffected by time-of-day and chest physiotherapy. For plethysmographic measures FRCpleth decreased significantly (p<0.01) 110 mL during the day, whereas a borderline significant (p = 0.046) decrease in ΔFRCpleth-MBW during the day and a borderline significant (p = 0.03) increase in TLC after CPT were observed.ConclusionThis study demonstrated that the time-of-day as well as chest physiotherapy performed immediately prior to N2MBW had no consistent or significant influence on N2MBW measures. However, we emphasize that further studies of the effect of both daytime variation and the effect of chest physiotherapy on multiple breath washout measures are warranted.

Project description:IntroductionOutpatient care for children and adolescents with chronic conditions needs to be continuous and programmed, encompassing comprehensive care, with periodically scheduled consultations, exams, and procedures, to promote quality of life and reduce mortality. In the context of the new coronavirus pandemic, however, outpatient care for children and adolescents with chronic conditions, in person, was hampered in favor of social isolation, a necessary sanitary measure to reduce and prevent the spread of Coronavirus Disease 2019. In response to this need, studies suggest telehealth in pediatrics as a fertile and expanding field especially in times of pandemics. Here, we aimed to map the evidence related to telehealth in outpatient care for children and adolescents with chronic conditions during the COVID-19 pandemic, to identify which strategies were implemented and their impacts on the continuity of care.MethodsA scoping review protocol is reported and guided by the Scoping Reviews Manual of the Joanna Briggs Institute. The search for evidence will cover the following databases: MEDLINE/PubMed, Cochrane Libary; Embase; Web of Science; Scopus; Cinahl and PsycINFO, plus additional sources, such as The British Library, Google Scholar, and Preprints [medRXiv]. No date or language restrictions will be employed in this scoping review. Two independent researchers will conduct the search strategy, study selection, data charting, and data synthesis.ResultsThe findings will be presented through tables, charts, narrative summaries, and assessed based on the type of data charted as well as outcomes. Additionally, the meaning of these findings will be considered as they relate to the guiding question, the characterization and measurement of the impact of different telehealth modalities used in outpatient care for children and adolescents with chronic conditions during the COVID-19 pandemic, and the implications for practice and further research.DiscussionTo the best of our knowledge, this will be the first scoping review to look specifically at the telehealth modalities to be used in outpatient care for children and adolescents with chronic conditions during the COVID-19 pandemic. We expect that our results will be of interest to practitioners as well as researchers concerned with this particular emerging issue in the pandemic context. Also, the plans for the dissemination of this study comprise peer-reviewed publication and conference presentations.Trial registrationOpen Science Framework Registration: osf.io/5pqgu.

Dataset Information

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

Publications

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

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