Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001035314
Ethics application status
Approved
Date submitted
10/07/2017
Date registered
17/07/2017
Date last updated
25/03/2021
Date data sharing statement initially provided
25/03/2021
Date results information initially provided
25/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
CyFiT Telerehabilitation: Technology based physiotherapy for peer driven participation in therapy, and quality of life.
Scientific title
CyFiT Telerehabilitation: Investigation into the efficacy of a telehealth physiotherapy intervention on quality of life and community participation for school-aged children with cystic fibrosis, a randomised controlled trial
Secondary ID [1] 292411 0
N/A
Universal Trial Number (UTN)
Trial acronym
CyFiT = CyFiT Telerehabilitation Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
 303878 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303236 303236 0 0
Physiotherapy
Human Genetics and Inherited Disorders 303331 303331 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298507 0
Rehabilitation
Intervention code [2] 298581 0
Treatment: Other
Comparator / control treatment
Children allocated to the control group will receive current standard of physiotherapy care from Lady Cilento Children's Hospital

Standard Control Group
Children and family will participate in the initial assessment by research clinician.
Additional physiotherapy follow up outside these clinics will be provided at Lady Cilento Children's Hospital if a child's condition warrants additional physiotherapy interventions. A home exercise program will be performed independently and recorded via a self-reported paper-based exercise diary. Further physiotherapy follow up will be indicated to families during 3-monthly multi-disciplinary reviews, or follow up consultations post inpatient stay; rationale for frequency, dose and care plan will be individually reasoned by treated clinician on individual patient-to-patient basis. Common rationales that would indicate a need for further follow up includes: post-inpatient follow-up, fine-tuning of home therapy sessions, equipment reviews when new equipment is prescribed (e.g. changes to positive expiratory pressure mask settings), and adherence based sessions.
Control group
Active

Outcomes
Primary outcome [1] 302618 0
Cystic Fibrosis Questionnaire - Revised (CFQ-R) a quality of life measure for young people and families with CF
Timepoint [1] 302618 0
Every 6 Months for 18 months, Baseline (0 month), 6 months, 12 months and 18 months post-intervention commencement,.
Secondary outcome [1] 336529 0
Hospitalisation Rate:
Number of inpatient days spent during the 12 months period of intervention. This will be accessed by the review of medical records
Timepoint [1] 336529 0
At 12 months post intervention commencement
Secondary outcome [2] 336530 0
Self reported activity and cough questionnaire. This questionnaire was developed specially for this study prior to the commencement of recruitment and has not been used previously.
Timepoint [2] 336530 0
Weekly across 12 months
Secondary outcome [3] 336531 0
Measure of Processes of Care (MPOC) assessment will be used to assess quality of care provided by the health service from a patient's perspective
Timepoint [3] 336531 0
Every 6 Months for 18 months, Baseline (0 month), 6 months, 12 months and 18 months post-intervention commencement,. This is a standardized questionnaire which patients will fill out on re-assessment sessions for the trial
Secondary outcome [4] 336532 0
CAPE-PAC Assessment measures the quantity of participation in activities of daily living. This outcome will complement Outcome 5 to provide quality and quantity of social participation
Timepoint [4] 336532 0
Every 6 Months for 18 months, Baseline (0 month), 6 months, 12 months and 18 months post-intervention commencement,. This is a standardized questionnaire which patients will fill out on re-assessment sessions for the trial
Secondary outcome [5] 336534 0
Economic Feasibility will be assessed using medical record, as well as patient information such as time off work/school for clinical visit, travel costs, cost of equipment/connection costs to determine an overall cost of service, this will then be analyses in context of all other outcome measures such as quality of life (Cystic Fibrosis Questionnaire - Revised), physical function (Modified Shuttle Test), and participation (CAPE-PAC and Life-H Assessment) to enable the calculation of quality-adjusted life years and enable cost-utility and/or cost-benefit statistical analysis.
Timepoint [5] 336534 0
At 12 months post intervention commencement
Secondary outcome [6] 336867 0
Adherence to exercise therapy, clinical consultation visits.
Data from activity trackers, medical record, and record generated from clinical consultations will be used to determine patient adherence to physiotherapy exercises, and adherence to physiotherapy consultations
Timepoint [6] 336867 0
At 12 months post intervention commencement
Secondary outcome [7] 349615 0
Modified Shuttle Walk Test is a standardised functional exercise capacity test for young people with CF.
Timepoint [7] 349615 0
Every 6 Months for 18 months, Baseline (0 month), 6 months, 12 months and 18 months post-intervention commencement.

Eligibility
Key inclusion criteria
Medically Diagnosed with Cystic Fibrosis
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once eight participants are recruited, each participants will be randomly assigned to either CyFiT Telerehab arm or the Standard Control Arm via drawing of one of the opaque envelopes. This process will continue until 110 participants are recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence will be generated via https://sealedenvelope.com/simple-randomiser/v1/lists by an un-blinded investigator will generate a random list to either allocating into CyFiT Intervention Group or Standard Outpatient Group.
The outcome (above) will be written in a piece of paper and concealed inside a sequentially numbered, opaque envelope and stored securely offsite.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed by the chief investigator using SPSS statistical software. Primary analysis will use the intention to treat principle, using the last observation recorded for participants who withdraw from the program. Baseline data will be statistically analysed through a linear model to establish any difference between the groups at baseline. If characteristics are not comparable at baseline, they will be modelled as covariates in subsequent analyses in order to adjust their possible confounding effects. Linear mixed models will be used to evaluate the effectiveness of the CyFiT intervention compared to the standard care control on the primary outcome (e.g. Modified Shuttle Test and Cystic Fibrosis Questionnaire – Revised). Linear mixed models take into account variation in individuals over time, are able to manage missing data without excluding participants for further analysis and examine changes in the outcomes over time as well as across the two groups. Significance will be set at p<0.05. Residuals of the fitted models will be examined to ensure that all required assumptions are met.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2017
Actual
5/02/2018
Date of last participant enrolment
Anticipated
28/12/2018
Actual
21/12/2018
Date of last data collection
Anticipated
1/07/2019
Actual
10/02/2020
Sample size
Target
110
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8462 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 16546 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 296873 0
Government body
Name [1] 296873 0
Health Practitioner Research Scheme 2017 Funding Round - Department of Health Allied Health Professions' Office of Queensland (Queensland Health)
Country [1] 296873 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Health and Rehabilitation Sciences
Building 84A
The University of Queensland
Queensland, St Lucia 4072
Country
Australia
Secondary sponsor category [1] 295877 0
Hospital
Name [1] 295877 0
Lady Cilento Children's Hospital
Address [1] 295877 0
501 Stanley Street
South Brisbane, QLD, 4101
Country [1] 295877 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298099 0
Children’s Health Queensland
Ethics committee address [1] 298099 0
Human Research Ethics Committee
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 298099 0
Australia
Date submitted for ethics approval [1] 298099 0
05/06/2017
Approval date [1] 298099 0
19/07/2017
Ethics approval number [1] 298099 0
HREC/17/QRCH/124

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75986 0
Mr Ray Lang
Address 75986 0
School of Health and Rehabilitation Sciences
Building 84A
The University of Queensland
St Lucia, QLD, 4072
Country 75986 0
Australia
Phone 75986 0
+614 22 193 168
Fax 75986 0
Email 75986 0
lei.lang@uqconnect.edu.au
Contact person for public queries
Name 75987 0
Mr Ray Lang
Address 75987 0
School of Health and Rehabilitation Sciences
Building 84A
The University of Queensland
St Lucia, QLD, 4072
Country 75987 0
Australia
Phone 75987 0
+614 22 193 168
Fax 75987 0
Email 75987 0
lei.lang@uqconnect.edu.au
Contact person for scientific queries
Name 75988 0
Mr Ray Lang
Address 75988 0
School of Health and Rehabilitation Sciences
Building 84A
The University of Queensland
St Lucia, QLD, 4072
Country 75988 0
Australia
Phone 75988 0
+614 22 193 168
Fax 75988 0
Email 75988 0
lei.lang@uqconnect.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCyFiT telehealth: Protocol for a randomised controlled trial of an online outpatient physiotherapy service for children with cystic fibrosis.2019https://dx.doi.org/10.1186/s12890-019-0784-z
N.B. These documents automatically identified may not have been verified by the study sponsor.