Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000545460
Ethics application status
Approved
Date submitted
2/05/2025
Date registered
29/05/2025
Date last updated
29/05/2025
Date data sharing statement initially provided
29/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
RESP-ACT: Boosting respiratory health for kids with cerebral palsy
Scientific title
RESP-ACT: An implementation study of an individualized, multi-disciplinary, coordinated service model to boost respiratory health for kids with cerebral palsy
Secondary ID [1] 314291 0
WACRF2023-24/1
Universal Trial Number (UTN)
U1111-1322-1913
Trial acronym
RESP-ACT
Linked study record
This is a follow-up trial to ACTRN12620000114943.

Health condition
Health condition(s) or problem(s) studied:
Respiratory disease 337232 0
Cerebral palsy 337588 0
Condition category
Condition code
Respiratory 333641 333641 0 0
Other respiratory disorders / diseases
Neurological 333932 333932 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All treatments and medications are those already being offered by the children’s hospital and disability service providers. There are no novel treatments or medications being used in this trial. The RESP-ACT intervention programme only uses and coordinates access to existing treatments and medications in a systematic way to enhance children’s respiratory health.

PHYSICAL OR INFORMATIONAL MATERIALS: Physical materials will be existing resources used to assess and treat children with respiratory conditions (including videofluoroscopy, sleep studies, chest imaging, bone density scans, sputum cultures, medications). Informational materials about respiratory health in children with cerebral palsy will be prepared in consultation with families and clinicians during the trial period by meeting with teams of clinicians from relevant disciplines to plan materials and submitting proposed plans to consumer advisors. The number and duration of meetings will vary, but we anticipate at least 2 meetings with each discipline and multiple drafts circulated by email until mutually acceptable versions of the resources are completed.

PROCEDURES: The RESP-ACT innovation will be based on the Consensus Statement for the Prevention and Management of Respiratory disease in Children with CP1 and follow the published RESP-ACT protocol.2

Interventions will depend on individual needs, as identified by a comprehensive assessment which will be conducted within the first month after enrolment (up to 5 hours per child). Interventions may include mealtime management, medical interventions, physiotherapy interventions, and programmes with physical activity, as well as dental and dietetic care. Frequency of intervention will depend on individual needs and goals, For example, in an acute episode, a child may be seen more frequently (up to three times per week). Whereas when well this may be less frequent and up to a month between interventions.

Parents will be educated to recognize symptoms of respiratory exacerbation, and the team will respond to any requests from parents to review the children when these symptoms occur or when the children get sick.

Interventions will be dependent on identified risk factors. Mealtime management interventions will include texture modifications, positioning, and nutrition. Medical interventions will include the management of motor disorder and its complications, posterior drooling, unsafe swallowing (oropharyngeal dysphagia), reflux, malnutrition, recurrent respiratory symptoms, and epilepsy. Exercise interventions will be aimed at improving or maintaining lung health. Some interventions, for example chest physiotherapy, requires specialised training to be safe and effective in children with CP, particularly if they have difficulties with retained secretions. If a child is requiring active chest physiotherapy, these interventions will be undertaken by a physiotherapist especially employed for the RESP-ACT program. Children who are at risk of deterioration with any intervention will be seen in the hospital setting if required. A dentist will monitor oral health. A dietitian will prepare a dietary plan to ensure adequate nutrition.

The deliverers of the innovation will meet weekly to discuss the children’s treatment plans, and some children and their families will receive additional advice and/or changes to their treatments following each meeting. This may include additional face to face interventions, with the frequency dependent on each child/caregiver need. A programme nurse will be responsible for coordinating appointments and intervention recommendations and providing education and training.

A multi-faceted implementation strategy will be delivered by the research team to specialist clinicians at Perth Children’s Hospital (PCH), GPs, and multidisciplinary community therapy providers to children with CP to:
1. support them to identify children with CP at risk of respiratory disease and refer them to the RESP-ACT programme;
2. identify clinicians’ role in the prevention and treatment of respiratory disease in children with CP at risk of respiratory disease; and
3. clarify communication strategies between treating clinicians and service providers.

The primary implementation strategies will include education, training, tailored strategies to address community referral barriers, creation of a learning collaborative across the health and community services, team facilitation, and audit and feedback to build clinicians’ capabilities, opportunities and motivations to deliver RESP-ACT recommendations within their routine care

WHO WILL DELIVER THE INTERVENTION: Respiratory physicians, paediatricians, respiratory physiotherapists, dentists, and dietitians already employed within the children’s hospital. In community disability service providers, speech pathologists, physiotherapists, occupational therapists and general practitioners.

MODE OF DELIVERY: For children enrolled in the study, interventions will be face to face, with the possibility of consultations by phone or videocall.

For clinicians enrolled as deliverers: Resources and workshops will be delivered online or face to face. Workshops for clinicians lasting 90 minutes or 3 hours will be offered before the commencement of the trial period, and continue into its early months. Each clinician will attend only one workshop, and workshops will be tailored to professions and presented by a research team member from the relevant profession (physiotherapist, doctor, speech pathologist, dietitian). Clinicians will have access to research intervention staff for ongoing professional support, and at the end of the study an outcome will be to develop an ongoing “community of practice” to support sustainability of the model of care.

NUMBER OF TIMES: This is not prescribed for the RESP-ACT intervention. The number of times will depend on results of assessments and vary between children. The trial period is 12 months, but the plan is to embed RESP-ACT within health services long-term.

LOCATIONS: Interventions will be delivered at the children’s hospital. The multidisciplinary team will provide preventative care in the children’s home or community if it is safe to do so.

PERSONALIZATION: The intervention is personalized. Treatment will be adapted to the individual child, based on a comprehensive assessment of respiratory risk factors leading to individualized care plans based on the child’s individual profile.

FIDELITY: Intervention adherence or fidelity will be assessed by the types of service delivered, as recorded by deliverers of the innovation in the medical record, and by qualitative interviews with the deliverers and parents after 6 months. The medical record will be audited against a checklist of RESP-ACT criteria to be met. Dose delivered will be assessed by the occasions of service or number of hours service delivery to the children, as recorded by clinicians.

REFERENCES
1. Gibson N, Blackmore AM, Chang AB, et al. Prevention and management of respiratory disease in young people with cerebral palsy: consensus statement. Dev Med Child Neurol 2021;63:172-182.
2. Marpole R, Blackmore AM, Wilson AC, et al. Can RESPiratory hospital Admissions in children with cerebral palsy be reduced? A feasibility randomised Controlled Trial pilot study protocol (RESP-ACT). BMJ Open 2024;14:e076730.
Intervention code [1] 330901 0
Prevention
Intervention code [2] 330902 0
Treatment: Drugs
Intervention code [3] 330903 0
Treatment: Other
Comparator / control treatment
No control group.

Numbers of respiratory hospital admissions and Emergency Department presentations (from PCH Business Intelligence Unit data) in the 12 months before RESP-ACT will be compared with those in the 12 months during RESP-ACT implementation.
Control group
Historical

Outcomes
Primary outcome [1] 341224 0
Number of hospital days
Timepoint [1] 341224 0
1) 12 months before the trial 2) 12 months of the trial
Primary outcome [2] 341225 0
Number of presentations to emergency department
Timepoint [2] 341225 0
1) 12 months before the trial 2) 12 months of the trial
Secondary outcome [1] 446805 0
Reach: number of children whose families are invited into the programme
Timepoint [1] 446805 0
conclusion of 12 months of trial
Secondary outcome [2] 446806 0
Adoption: number of children who commenced the programme
Timepoint [2] 446806 0
conclusion of 12 months of trial
Secondary outcome [3] 446808 0
Dose delivered: occasions of service or number of hours service delivery to the children
Timepoint [3] 446808 0
conclusion of 12 months of trial
Secondary outcome [4] 446809 0
Fidelity; types of service delivered
Timepoint [4] 446809 0
conclusion of 12 months of trial
Secondary outcome [5] 446810 0
Sustainability: number of deliverers trained to deliver the RESP-ACT
Timepoint [5] 446810 0
Pre-trial workshop(s)
Secondary outcome [6] 446811 0
Sustainability: number of clinicians delivering RESP-ACT after 18 months
Timepoint [6] 446811 0
6 month follow-up following 12-month trial
Secondary outcome [7] 446812 0
Sustainability: number of community providers involved in the RESP-ACT programme
Timepoint [7] 446812 0
Workshop(s) End of 12-month trial
Secondary outcome [8] 446813 0
Implementation costs: costs of treatments, assessments, and respiratory healthcare usage
Timepoint [8] 446813 0
conclusion of 12 months of trial

Eligibility
Key inclusion criteria
The target group are children with CP, aged 0–16 years at risk of respiratory disease.
Children are “at risk of respiratory disease” defined as having any of the risk factors checklist that we developed from a prospective longitudinal study of children with CP.1-3 The risk factors are as follows:
1. Gross Motor Function Classification System (GMFCS) Level V
2. At least one respiratory hospital admission in the previous year
3. At least 2 courses of antibiotics for respiratory disease in the previous year
4. Oropharyngeal dysphagia (requires food or drinks with modified texture OR uses a tube OR coughs and chokes on saliva)
5. Frequent respiratory symptoms (daily cough or weekly sounding chesty or phlegmy or wheezy)
6. Mealtime respiratory symptoms when well (gurgly voice, wheezing, coughing, sneezing, choking)
7. Gastro-oesophageal reflux disease (now or previously)
8. Current seizures
9. Snoring every night

References
1. Blackmore AM, Bear N, Blair E, et al. Factors Associated with Respiratory Illness in Children and Young Adults with Cerebral Palsy. J Pediatr 2016;168:151-157.e151.
2. Blackmore AM, Bear N, Blair E, et al. Predicting respiratory hospital admissions in young people with cerebral palsy. Arch Dis Child 2018;103:1119-1124.
3. Blackmore AM, Bear N, Langdon K, Moshovis L, Gibson N, Wilson A. Respiratory hospital admissions and emergency department visits in young people with cerebral palsy: 5-year follow-up. Arch Dis Child 2020;105:1126-1127.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if:
• they have severe respiratory disease requiring oxygen or ventilatory support. These children are likely to be receiving respiratory interventions under respiratory teams.
• they have had tracheostomy,
• they are in palliative care with restrictions to active management outside of end-of-life care,
• they live outside the metropolitan area, or
• their home environment is deemed unsafe for clinicians.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A historical control will be used: number of hospital days and presentations to Emergency Department during the 12 months before the trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to represent:
• number of hospital days during the 12 months before and during the program;
• number of presentations to emergency department during the 12 months before and during the program;
• number of children whose families are invited into the programme;
• number of children who commenced the programme;
• types of service delivered;
• number of deliverers trained to deliver the RESP-ACT programme;
• number of clinicians delivering RESP-ACT after 18 months; and
• number of community providers involved in the RESP-ACT programme.

Characteristics of participants presenting for respiratory hospital admission or ED presentation overall and by clinical scenario will be recorded. Numbers of respiratory hospital admissions and ED presentations in the 12 months before RESP-ACT will be compared with those in the 12 months during RESP-ACT implementation. We will also explore the impact of risk factors (epilepsy, dysphagia, dental health, and GMFCS level) on respiratory hospital admission and ED presentation outcomes, and examine how associations differ between participants who received RESP-ACT as implemented and those who did not (e.g., if they weren’t referred or declined to receive the service). Appropriate regression modelling will be utilised for the effectiveness analyses (eg Poisson regression for evaluating associations with the number of admissions or presentations, or logistic regression when analysing the occurrence of any respiratory hospital admission/ED presentation).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27817 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 44011 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318808 0
Government body
Name [1] 318808 0
Western Australian Child Research Fund
Country [1] 318808 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 321256 0
None
Name [1] 321256 0
Address [1] 321256 0
Country [1] 321256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317419 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 317419 0
Ethics committee country [1] 317419 0
Australia
Date submitted for ethics approval [1] 317419 0
15/11/2024
Approval date [1] 317419 0
13/12/2024
Ethics approval number [1] 317419 0
RGS0000007314

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140994 0
Dr Noula Gibson
Address 140994 0
Perth Children's Hospital, 15 Hospital Avenue, Nedlands, Western Australia, 6000
Country 140994 0
Australia
Phone 140994 0
+61 411588917
Fax 140994 0
Email 140994 0
[email protected]
Contact person for public queries
Name 140995 0
Noula Gibson
Address 140995 0
Perth Children's Hospital, 15 Hospital Avenue, Nedlands, Western Australia, 6000
Country 140995 0
Australia
Phone 140995 0
+61 411588917
Fax 140995 0
Email 140995 0
[email protected]
Contact person for scientific queries
Name 140996 0
Noula Gibson
Address 140996 0
Perth Children's Hospital, 15 Hospital Avenue, Nedlands, Western Australia, 6000
Country 140996 0
Australia
Phone 140996 0
+61 411588917
Fax 140996 0
Email 140996 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers

• Individual data and be accessed by treating clinicians as long as permission has been granted by the participant as per usual hospital policy for sharing participant information with third parties.

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol

• Only those individuals who have consented for their individual data to be shared will be shared to researchers.

What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.