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Trial registered on ANZCTR


Registration number
ACTRN12618000940279
Ethics application status
Approved
Date submitted
28/05/2018
Date registered
4/06/2018
Date last updated
31/05/2019
Date data sharing statement initially provided
31/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the effect of early eczema education, in the form of a series of video's and pamphlet, on eczema severity in children < 6 years of age.
Scientific title
Determining if the implementation of educational videos and pamphlet, aimed at parents of children with eczema, result in improved eczema severity when compared to standard care.
Secondary ID [1] 295025 0
N/A
Universal Trial Number (UTN)
Trial acronym
EEE (Triple E project)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Eczema 308045 0
Condition category
Condition code
Skin 307097 307097 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention:
This study will utilise eczema educational videos and pamphlets made at FSH, specifically for FSH patients. Three videos will be produced, 1) What is eczema and common myths, 2) Bathing and Moisturising and 3) Corticosteroid use. The pamphlet will consist of a doubled-sided document, which will act as a quick reference guide to parents on daily eczema management.

The educational video's are a combination of animation and live demonstration.

After randomisation, parent/s or carer/s of patients randomised to intervention group will be emailed links to the three videos and pamphlet, along with date and time of their clinic review in 4 weeks time. Each video will be approximately 3 minutes long and parents can access these in their own time, as many times as required in the 4 week period prior to clinic review. Children are not expected to watch the video's but are able to if interested. The pamphlet can be downloaded, printed and used as a quick daily reference.

Parents will fill in a questionnaire at the completion of the study regarding the education materials, if and when they where accessed, frequency, time after recruitment when accessed. This will also serve as an evaluation of the educational materials from the parents perspective.
Intervention code [1] 301360 0
Treatment: Other
Comparator / control treatment
Participants will be recruited from the waiting list for Allergy/Immunology paediatric clinics at Fiona Stanley Hospital (FSH). This will include patients awaiting review for food allergies who are highlighted as having eczema upon referral. They will be seen for the purpose of this project and will also be seen by the clinic for which they have been referred e.g. Allergy/immunology. Recruitment will include any patient less than 6 years of age with any degree of eczema. They will be contacted and if agreeable consented in the same phone call, along with baseline POEM score. They will then be randomised to education intervention versus standard care and seen in clinic 4 weeks later.

Standard care means they will receive no additional education whilst waiting clinic review 4 weeks after randomisation.
Control group
Active

Outcomes
Primary outcome [1] 306056 0
The primary aim of the Triple E project is to determine if early eczema education results in improved eczema severity, as determined by a change in Patient-Orientated Eczema Measure (POEM) score from baseline to the clinic appointment (4 weeks later), versus those receiving standard care.
Timepoint [1] 306056 0
4 weeks after randomisation into intervention (receiving video and pamphlet education) versus standard care groups
Secondary outcome [1] 347448 0
Clinician reported objective eczema severity score using the Eczema Area and Severity Index (EASI) score.
Timepoint [1] 347448 0
4 weeks after randomisation into intervention (receiving video and pamphlet education) versus standard care groups

Eligibility
Key inclusion criteria
1) Children with eczema referred to a WA public hospital service.
2) Children less than 6 years of age
3) Parents able to access educational information online.
Minimum age
0 Months
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Participants/parents identified as requiring an interpreter on their referral form (written material and videos will be produced in English).
2) Parents or guardians are unable to access educational information online.
3) Children > 6 years of age
4) Children without eczema


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)
We will have 3 boxes, labelled for each of the severity levels (mild, moderate, severe). Inside each box will be concealed envelopes, inside the envelopes will be a piece of paper with either intervention or standard care written on them. There will be an even number of both in every box. The unblinded study member will select envelop and email the participant with links to videos and pamphlet, plus time and date of clinical appointment or just the time and date of clinic appointment if allocated to standard care. Allocation will be recorded via a secure Excel spreadsheet.

Clinician reviewing patient and performing EASI in clinic will be blinded to patients group allocation to minimise bias. Unfortunately, we cannot conduct a double-blind study as the participant must actively participate in the intervention, and thus it is not possible to blind them.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised to intervention versus control groups after consent and the baseline POEM score is obtained. Patients will be stratified depending on severity banding as per POEM score – 0<7 (mild); 8-16 (Moderate); >17(severe) and randomised based on these bands to ensure there are equal numbers of patients in each severity group randomised to both the intervention and control group. Randomisation schedule will be performed by an unblinded member of the study team. This will be simple randomisation with block stratification for disease severity.
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
The primary outcome will be evaluated using a t-test to compare the mean change in POEM score between the two groups. Subgroup analyses stratified by baseline severity band will also be performed to investigate whether the intervention is more or less effective for different severity levels.

For the secondary outcomes, subjective POEM scores and objective EASI scores will be compared using Pearson correlation. Analysis of covariance (ANCOVA) will be used to compare the mean post intervention EASI scores between the intervention group and the standard care group, conditioning on baseline POEM score. Other factors such as age and sex will be adjusted for in the analysis to account for any imbalances between the groups.

The only similar published study of online video resources for patients with atopic dermatitis (Armstrong et al 2010) reported a mean decrease in POEM of 3.3 post-intervention (standard deviation 3.15), compared with a reduction of 1.03 + 3.75 in the control (printed pamphlet) group. In our study, the control group will receive no educational information prior to clinic and therefore we do not anticipate a reduction in POEM between baseline and clinic review. As noted, the MIC for POEM has previously been reported as 3. Therefore, assuming a difference in mean reduction in POEM between the groups of 3 with standard deviation of 3.15, in order to have 80% power to detect this difference between intervention group scores and standard care group scores (p<0.05) 20 subjects per group are required. Allowing for 10% loss to follow up, we propose to recruit a total of 44 subjects.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
2/10/2018
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
30/09/2019
Actual
Sample size
Target
44
Accrual to date
36
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11008 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 22799 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 299605 0
Government body
Name [1] 299605 0
WA health department
Country [1] 299605 0
Australia
Primary sponsor type
Government body
Name
Child and adolescent health services
Address
15 Hospital Ave
Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 298926 0
None
Name [1] 298926 0
Address [1] 298926 0
Country [1] 298926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300508 0
Child and adolescent health ethics committee
Ethics committee address [1] 300508 0
Ethics committee country [1] 300508 0
Australia
Date submitted for ethics approval [1] 300508 0
20/03/2018
Approval date [1] 300508 0
19/04/2018
Ethics approval number [1] 300508 0
RGS00000001013

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

Contacts
Principal investigator
Name 83882 0
Dr Samara Baldwin
Address 83882 0
Immunology/Paediatrics Department
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia, 6150
Country 83882 0
Australia
Phone 83882 0
+61401862779
Fax 83882 0
Email 83882 0
samara.baldwin@health.wa.gov.au
Contact person for public queries
Name 83883 0
Samara Baldwin
Address 83883 0
Immunology/Paediatrics Department
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia, 6150
Country 83883 0
Australia
Phone 83883 0
+6161522222
Fax 83883 0
Email 83883 0
samara.baldwin@health.wa.gov.au
Contact person for scientific queries
Name 83884 0
Samara Baldwin
Address 83884 0
Immunology/Paediatrics Department
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia, 6150
Country 83884 0
Australia
Phone 83884 0
+61401862779
Fax 83884 0
Email 83884 0
samara.baldwin@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not relevant for this study


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.