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Trial registered on ANZCTR


Registration number
ACTRN12618001302246
Ethics application status
Approved
Date submitted
30/07/2018
Date registered
2/08/2018
Date last updated
21/10/2019
Date data sharing statement initially provided
1/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact on the Provision of Pre-school Wheeze Action Plan on the Quality of Care in Children less than 6 years old with Wheezing
Scientific title
Impact on the Provision of Pre-school Wheeze Action Plan on the Quality of Care in Children less than 6 years old with Wheezing
Secondary ID [1] 295662 0
None
Universal Trial Number (UTN)
U1111-1218-3026
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preschool wheeze 309072 0
Asthma 309084 0
Viral induced wheeze 309085 0
Condition category
Condition code
Respiratory 307955 307955 0 0
Asthma
Respiratory 307960 307960 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children who are less than 6 years old who present with wheezing to the Emergency Department, or admitted to Children’s ward or Paediatric Short Stay Unit, will be recruited by medical or nursing staff. Each child will then be randomly assigned to provision of either Asthma Action Plan (AAP) or Pre-school Wheeze Action Plan (PSWAP). Discharge instructions will be given according to the action plan each child has been assigned to. The discharging medical or nursing staff will then answer a 5-minute questionnaire to determine satisfaction and ease of discharge instructions. The family of each child will be contacted at 2 weeks, 6 weeks, and then 3 months via telephone to answer a 5-minute questionnaire to determine parent satisfaction & understanding of their child’s condition in relation to the action plan, as well as adherence to the action plan.
Intervention code [1] 302013 0
Treatment: Other
Comparator / control treatment
Asthma action plan, template derived from standardized asthma action plan that is used state wide.
The headings of this paln incude when to administer ventolin when well, unwell or recognition of danger signs and critical asthma.
Asthma action plan is usually administerd by nursing or medical staff at the time of presentation to emergency department or admission to the paediatric short stay unit or paediatric ward.
Asthma action plan or the intervention (Preschool wheeze action plan) is a written document that will be provided at the initial contact with participants.
Patients that do not consent to be part of the study will still be provided with an Asthma action plan as standard practice of the hosptial.
Control group
Active

Outcomes
Primary outcome [1] 306931 0
Patient understanding in administering treatment for wheeze symptoms assessed via telephone questionaire at 2 weeks, 6 weeks and 3 months following enrollment in the study.

Questionaires were designed specifically for this study.
Timepoint [1] 306931 0
2 week
6 week
3 month (primary endpoint)
Primary outcome [2] 306971 0
Patient satisfication with using the written plan for administering salbutamol for wheeze symptoms assessed via telephone questionaire at 2 weeks, 6 weeks and 3 months following enrollment in study.

Questionaires were designed specifically for this study.
Timepoint [2] 306971 0
2 weeks
6 weeks
3 months (primary endpoint)
Secondary outcome [1] 350150 0
Medical or nursing staff satisfaction of providing education for wheeze symptoms by questionaire post administering plan and education.

Questionaire was designed specifically for this study.
Timepoint [1] 350150 0
Post administering plan and education at the time of discharge from hospital.
Secondary outcome [2] 350167 0
Administration of oral steroids based on parental reporting through telephone questionaire at 2 weeks, 6 weeks and 3 months following enrollment in the study.

Questionaires were designed specifically for this study.
Timepoint [2] 350167 0
2 week
6 week
3 month

Eligibility
Key inclusion criteria
Children less than 6 years of age
Presents with primary complaint of wheezing
Present to The Northern Hospital Emergency Department, Paediatric Short Stay Unit, or Children’s Ward.
Minimum age
9 Months
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children more than 6 years of age
Those who are maintained on inhaled corticosteroids or other preventor medications
Wheezing that is concomitant with other disease entities such as bronchiolitis or pneumonia
Those who decline to participate
Non english speaking background

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)
A computer randomization software program (in house software) will be used to generate a sequential list of participants (identified by study number) randomized to either of the 2 study groups. Prior to the study commencing, this randomized list will be used to prepare a set of ordered, sealed envelopes, each containing the appropriate action plan and medical staff questionnaire.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer randomization software program (in house software) will be used to generate a sequential list of participants (identified by study number) randomized to either of the 2 study groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE ESTIMATION & JUSTIFICATION
It is anticipated that 300 children will be required for meaningful statistical analysis. This number is in excess of the power calculations as indicated below.
POWER CALCULATIONS
Questionnaire on Satisfaction.
•It is assumed that the questions will have a rating scale of from 1 to 4 and that significance will be assessed via a comparison of means. Using a random number generator, 100 values were generated between 1 and 4, The mean was 2.41 and SD was 0.12. Calculations using the UCSF Clinical and Translational Science Institute Sample Size Calculator:
•Alpha (2 tailed) = 0.05, beta = 0.2 and a SD of 0.12, a sample size of 90 for both intervention and control groups gave an effect size of 0.05. This corresponds to there being sufficient power in a sample size of 90 to detect a difference of 2% between the intervention and control groups.
•A sample size of 90 is consistent with similar prospective studies in which a patient satisfaction survey was performed (1).

Comparison of visits to GPs and ED following a wheeze exacerbation.
•This data will result in 2 frequency distributions (1 for the intervention, 1 for the control), for 1, 2, 3 or 4 or more visits within a specified period.
•At a basic level this will allow a categorical comparison between groups for each number of visits, most likely via Chi Square.
•Using the UCSF Clinical and Translational Science Institute Sample Size Calculator:
•Alpha (2 tailed) = 0.05, beta = 0.2, proportions in both groups = 0.5, baseline risk = 0.3 and an OR of 0.5, calculated a sample size needed of 202. This corresponds to there being sufficient power in a sample size of 202 to detect a 50% reduction in GP attendances in the intervention group when compared to control for one of the frequency categories (eg 1 visit to a GP or ED following an exacerbation). Depending on the strength of study findings, the above frequency categories may need be combined to provide adequate power.
•A sample size of 200 is consistent with similar prospective studies in which ED visits were reduced by altered strategies (2).

References
1. Middleton WD, Payne WT, Teefey SA, Hildebolt CF, Rubin DA, Yamaguchi K., Sonography and MRI of the shoulder: comparison of patient satisfaction. AJR Am J Roentgenol. 2004 Nov;183(5):1449-52.
2. Tatis V, Remache D, DiMango E. Results of a culturally directed asthma intervention program in an inner-city Latino community. Chest. 2005;128:1163-1167

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/06/2018
Date of last participant enrolment
Anticipated
13/09/2019
Actual
14/05/2019
Date of last data collection
Anticipated
13/12/2019
Actual
14/08/2019
Sample size
Target
300
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11541 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 23569 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 300243 0
Hospital
Name [1] 300243 0
The Northern Hospital
Country [1] 300243 0
Australia
Primary sponsor type
Hospital
Name
Northern Health
Address
185 Cooper St,
Epping 3076
VICTORIA
Country
Australia
Secondary sponsor category [1] 299663 0
None
Name [1] 299663 0
Address [1] 299663 0
Country [1] 299663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301066 0
Austin Health Human Research Ethic Committee
Ethics committee address [1] 301066 0
Office for Research
Austin Hospital
L8 Harold Stokes Building
145 Studley Road
PO BOX 5555 Heidelberg
VICTORIA, 3084
Ethics committee country [1] 301066 0
Australia
Date submitted for ethics approval [1] 301066 0
04/04/2018
Approval date [1] 301066 0
23/05/2018
Ethics approval number [1] 301066 0
LNR/18/Austin/176

Summary
Brief summary
Wheezing is a common presentation in young children. The 2 most common conditions that can cause wheezing are asthma and viral- induced wheeze (caused by viruses). However, in pre-school children (less than 6 years old), the diagnosis of asthma can often be very controversial as majority of the patients who present with pre-school wheeze do not develop asthma. However, it is still highly recommended that these groups of children be provided with an asthma action plan for symptom management in the community. Currently at The Northern Hospital and other units, children who are diagnosed with a viral-induced wheeze are given an asthma action plan prior to going home. This has not only caused confusion amongst parents as to the diagnosis and management of their child’s wheezing, but causes a lot of difficulty on the part of the medical and nursing staff in explaining how their child does not have a diagnosis of asthma. In this project, we aim to determine if providing the parents with a PRE-SCHOOL WHEEZE ACTION PLAN is less confusing guide for parents in managing their child’s symptoms at home.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85762 0
A/Prof Wei Qi Fan
Address 85762 0
The Northern Hospital
185 Cooper St,
Epping, VIC 3076
Country 85762 0
Australia
Phone 85762 0
+61 3 8405 8000
Fax 85762 0
Email 85762 0
[email protected]
Contact person for public queries
Name 85763 0
Sarah Sattar
Address 85763 0
The Northern Hospital
185 Cooper St,
Epping, VIC 3076
Country 85763 0
Australia
Phone 85763 0
+61 419733397
Fax 85763 0
Email 85763 0
[email protected]
Contact person for scientific queries
Name 85764 0
Czarina Calderon
Address 85764 0
The Northern Hospital
185 Cooper St,
Epping, VIC 3076
Country 85764 0
Australia
Phone 85764 0
+61 3 8405 8000
Fax 85764 0
Email 85764 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3553Study protocol  [email protected]
3554Informed consent form  [email protected]
3555Ethical approval  [email protected]



Results publications and other study-related documents

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