None listed
Conditions
Brief summary
Children with cystic fibrosis (CF) need to spend a lot of time on physiotherapy. Families have very busy lives, and using telehealth may reduce the burden of management, and contribute to improved quality of life. Telehealth offers home management with reduced travel requirements, saving time and money for families, and reducing the risk of hospital-acquired infections. Standards of care recommend that there are no interactions between people with CF due to cross infection risks. Telehealth allows young people with CF to connect with each other, and safely do physiotherapy in a fun & socially supportive environment. Aim: to investigate the clinical effectiveness & impact of a purpose-designed telehealth service (CyFiT) in physiotherapy management of CF. Our proposed research will investigate the comparison between CyFiT Intervention Group and standard outpatient physiotherapy for CF. We hypothesise that there will be no difference in functional activity capacity, hospitalisation rate, or increased cost to health providers between the two groups, but there will be significant differences in quality of life and patient satisfaction measures. Research Design: Randomised controlled trial comparing CyFiT Intervention Group and standard outpatient physiotherapy. Balanced block design; 110 participants. All participants will receive the same physiotherapy care, at the same time that would otherwise occur. The difference is that participants will be randomly assigned to physiotherapy delivered face to face (standard outpatient physiotherapy), or at home through telehealth consultations and online group exercise classes (CyFiT Intervention Group). Participants allocated to the CyFiT Intervention Group will be provided with a Garmin activity tracker. The tracked information will guide clinicians during individual and group sessions, and help identify deteriorations. The trial period will continue for 12 months, after which children will return to standard outpatient physiotherapy care. Methods: All participants in this study will receive 4x1 hour reassessment sessions (at 0, 6, 12, and 18 months post commencing the trial). Appoints will align with their regular multi-disciplinary clinics every three monthly to minimise inconvenience for families. Any additional follow-up physiotherapy will be delivered according to allocation to telehealth or control group. Outcome measures are: - Functional Exercise Capacity - Quality of Life - Quality & Quantity of Social Participation - Adherence to physiotherapy - Hospitalisation Rate - Cost Effectiveness/utility - Perception of Service Previous researchers have commented on the efficacy of telehealth in managing CF. No researchers have directly replaced face to face physiotherapy with a comprehensive telehealth equivalent in an operating CF clinic. Through this trial, researchers will investigate the effectiveness of CyFiT Telehealth to integrate into a contemporary and family centred clinic.
Interventions
All participants Participants will be randomised to either the Standard Control group or the CyFiT Telerehab Group. All participants will partake in four one hour assessment sessions taking place on a six monthly basis from the commencement of the study: initial (0 months), 6 months, 12 months, and 6 months follow up (i.e. 18months post initial commencement). During this time, reassessment of outcome measures will be completed with research clinicians. For patient convenience, reassessments will be scheduled on the day of multi-disciplinary clinic reviews. Participants and families will be notified of their group allocation prior to the initial assessment session. CyFiT Telerehab Group Children will be provided with a consumer-based activity tracker to wear every day, including sleeping. A patient login to the CyFiT Telerehab Online Portal (website) will also be provided to families. During the initial assessment, the research clinician will demonstrate how to use the activity tracker as well as navigating the website. Data collected by the activity tracker will be aggregated to a secure database where summaries are presented via an online dashboards available for patients and treating clinicians. This portal will provide information to the treating clinician to assist them in determining if further physiotherapy intervention is required. Data will be retrieved from activity trackers on a daily bases, however frequency can be increased to every 30 seconds if required. Increased frequency enables clinicians to have access to near-real-time physiological data during real-time video-conference consultations. Additional physiotherapy follow up will be protocol triggered as per standard practice. Common rationales that would indicate a need for further follow up includes: post-inpatient follow-up, equipment reviews post equipment prescription (e.g. changes to positive expiratory pressure mask settings), and adherence based sessions. An additional option for clinician initiated consultation to “at-risk” patients based on deteriorating physiological data aggregated from activity trackers. This information is available to clinicians through a computer based dashboard. Physiotherapy consultations will be delivered via real-time video conferencing into the home with the same rationale as standard care. Intervention group's exercise diary will be replaced by wearable consumer based activity trackers, allowing participants and clinicians to review recent activity progress through online web based portals. Children deemed appropriate can be referred to by treating physiotherapists to a weekly supervised group exercise class where children of similar age and function will undertake group physiotherapy sessions over a multi-point video conference into the home. A physiotherapist will be constantly supervising a class of no more than 6 participants in these classes and providing individualised therapeutic advice during this time. Each session will be 1 hour in duration, and frequency will vary from classes to classes based on individual patient needs via the same rationales for additional physiotherapy follow up. In CyFiT OPS, the intervention period will be divided in to phase one (0-6months) and phase two (6-12months). Phase One Phase one is an opportunity for children and clinical physiotherapists to familiarise themselves with technology (i.e. activity wristbands and eHAB®). During this period, children will only be participating in one-to-one OPS via telehealth in the intervention group as clinically indicated. Treating physiotherapists will have access to health-related information via supplier web portal. Health-related information collected during phase one will enable the research team to derive statistic models to monitor children’s health and better assist clinical decision making. Phase Two Phase two occurs in the last 6 months of the twelve months intervention. In addition to one-to-one OPS via telehealth, physiotherapists can refer children in the CyFiT OPS group to an online group-based exercise class. Group sessions will be delivered using the eHAB systems. Algorithm driven, data analysis using health-related information collected in phase one will be used generate potential risk score and visualised for clinicians for physiotherapists. In this phase, health-related information and risk score will be visualised using the clinician support system, this information will be used to by physiotherapists to assist in clinical decision making such as initiating OPS check-ups.
Sponsors
Study design
Eligibility
Inclusion criteria
Medically Diagnosed with Cystic Fibrosis
Exclusion criteria
Children will be excluded from this study if they present with (i) behavioural or intellectual difficulties that would prevent full participation in face-to-face physiotherapy assessment, or physiotherapy intervention via telehealth, or (ii) an acute or chronic medical co-morbidity that requires more complex and/or frequent medical input.