Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000178640
Ethics application status
Approved
Date submitted
16/08/2005
Date registered
19/08/2005
Date last updated
19/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing the severity of eczema in infants, children and adolescents: The benefit of a nurse-led clinic.
Scientific title
The benefit of a nurse-led eczema workshop in reducing the severity of eczema in infants, children and adolescents, compared to a dermatologist-led outpatient clinic.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema (atopic eczema, atopic dermatitis) 274 0
Condition category
Condition code
Skin 308 308 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A will attend the study intervention - a nurse-led eczema workshop. The workshop involves extensive education about the nature of eczema and management of eczema at home. The workshop includes the development of an individualised management plan and demonstration of treatments.
Intervention code [1] 202 0
None
Comparator / control treatment
Group B will attend a dermatologist-led outpatient clinic. The outpatient clinic involves a standard consultation with a dermatology registrar, overseen by a dermatologist. Severity of eczema will be measured using the validated SCORAD index at the initial consultation and 4 weeks after the intervention.
Control group
Active

Outcomes
Primary outcome [1] 363 0
Infants, children and adolescents with eczema who participate in a nurse-led eczema workshop as compared to attending a consultant-led outpatient clinic will have a greater reduction in severity of eczema. Severity of eczema will be measured using the validated SCORAD index.
Timepoint [1] 363 0
After 4 weeks following the intervention
Secondary outcome [1] 815 0
To compare eczema treatments pre and post attending the eczema workshop and outpatient clinic.
Timepoint [1] 815 0
Secondary outcome [2] 816 0
To collect information about where participants have accessed information regarding eczema management prior to attending the eczema workshop and outpatient clinic.
Timepoint [2] 816 0

Eligibility
Key inclusion criteria
Infants, children and adolescents (under 16 years of age) attending either an eczema workshop or a dermatology outpatient clinic at the Royal Children's Hospital for management of eczema. All participants will be new referrals i.e. not seen before in the Dermatology Department at the Royal Children's Hospital for management of eczema.
Minimum age
Not stated
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 367 0
Self funded/Unfunded
Name [1] 367 0
Country [1] 367 0
Primary sponsor type
Hospital
Name
Royal Children's Hospital, Melbourne
Address
Country
Australia
Secondary sponsor category [1] 290 0
University
Name [1] 290 0
The University of Melbourne
Address [1] 290 0
Country [1] 290 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1348 0
Royal Children's Hospital
Ethics committee address [1] 1348 0
Ethics committee country [1] 1348 0
Australia
Date submitted for ethics approval [1] 1348 0
Approval date [1] 1348 0
Ethics approval number [1] 1348 0
Ethics committee name [2] 1349 0
The University of Melbourne
Ethics committee address [2] 1349 0
Ethics committee country [2] 1349 0
Australia
Date submitted for ethics approval [2] 1349 0
Approval date [2] 1349 0
Ethics approval number [2] 1349 0

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

Contacts
Principal investigator
Name 35599 0
Address 35599 0
Country 35599 0
Phone 35599 0
Fax 35599 0
Email 35599 0
Contact person for public queries
Name 9391 0
Elizabeth Moore
Address 9391 0
c/o Dermatology Department
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 9391 0
Australia
Phone 9391 0
+61 3 93455510
Fax 9391 0
Email 9391 0
[email protected]
Contact person for scientific queries
Name 319 0
Elizabeth Moore
Address 319 0
c/o Dermatology Department
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 319 0
Australia
Phone 319 0
+61 3 93455510
Fax 319 0
Email 319 0
[email protected]

No information has been provided regarding IPD availability


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.