Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000718640
Ethics application status
Approved
Date submitted
1/11/2005
Date registered
7/11/2005
Date last updated
7/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled study on education intervention for childhood asthma
by Aboriginal and Torres Strait Islander Health Workers
Scientific title
A randomised controlled study on education intervention for childhood asthma
by Aboriginal and Torres Strait Islander Health Workers aiming at reducing the number of unscheduled hospital/doctor visits due to asthma exacerbation during the 12 months follow up period.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 868 0
Condition category
Condition code
Respiratory 935 935 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Additional asthma education intervention by local Health Workers with children and their parents. Children selected to receive the extra education will have additional visits from the health worker for their asthma. The children selected to receive the intervention (additional asthma education) will receive a personalised child friendly booklet and will have three visits from the health worker for their asthma (about 1 month, 3 months and 6 months after the clinical consultation). All children will be followed up for 12 months (from the day of 1st clinical assessment).
Intervention code [1] 746 0
Treatment: Other
Comparator / control treatment
No additional education (children will receive the usual information about asthma at the consultation). The Control group (no additional education) will not receive a personalised child friendly booklet and will not be visited by health workers. All children will be followed up for 12 months (from the day of 1st clinical assessment).
Control group
Active

Outcomes
Primary outcome [1] 1230 0
Number of unscheduled hospital/doctor visits due to asthma exacerbation during the 12 months follow up period.
Timepoint [1] 1230 0
Primary outcome will be measured at the end of the follow up period through medical chart review.
Secondary outcome [1] 2236 0
Quality of life: we will use the Paediatric Asthma Quality of Life Questionnaire that has been shown to have good measurement properties and is valid both as an evaluative and a discriminative instrument capturing aspects of asthma most important to the patient and adding additional information to conventional clinical outcomes.
Timepoint [1] 2236 0
Secondary outcomes will be measured at the end of the follow-up period (12 months from the 1st clinically re-accessed) when the child is clinically reassessed.
Secondary outcome [2] 2237 0
Functional severity score : we will use questions related to the functional severity score designed by Rosier et al.
Timepoint [2] 2237 0
Secondary outcomes will be measured at the end of the follow-up period (12 months from the 1st clinically re-accessed) when the child is clinically reassessed.
Secondary outcome [3] 2238 0
If the child is on regular medications for asthma, basic knowledge of medications and the delivery technique of the child will be assessed. Basic knowledge on medications of all parents and children aged 11 or more years, will be assessed by a score of 1-5 in each of the 3 categories: (a) name of medications, (b) dose of medications, (c) how drugs work. - medication use - Asthma Action Plan (readily available, can parent interpret?).
Timepoint [3] 2238 0
Secondary outcomes will be measured at the end of the follow-up period (12 months from the 1st clinically re-accessed) when the child is clinically reassessed.
Secondary outcome [4] 2239 0
Number of days missed school due to asthma.
Timepoint [4] 2239 0
Secondary outcomes will be measured at the end of the follow-up period (12 months from the 1st clinically re-accessed) when the child is clinically reassessed.
Secondary outcome [5] 2240 0
Number of exacerbations of asthma.
Timepoint [5] 2240 0
Secondary outcomes will be measured at the end of the follow-up period (12 months from the 1st clinically re-accessed) when the child is clinically reassessed.
Secondary outcome [6] 2241 0
Number of unscheduled hospital/doctor visits (through a medical chart review).
Timepoint [6] 2241 0
Secondary outcomes will be measured at the end of the follow-up period (12 months from the 1st clinically re-accessed) when the child is clinically reassessed.
Secondary outcome [7] 2242 0
Spirometry results (for those over 6 years).
Timepoint [7] 2242 0
Secondary outcomes will be measured at the end of the follow-up period (12 months from the 1st clinically re-accessed) when the child is clinically reassessed.

Eligibility
Key inclusion criteria
All children seen by the research team diagnosed with asthma will be eligible to take part in the study. After fully informed consent is obtained from the parent(s), the child will be randomly allocated to one of the two treatment regimes.
Minimum age
Not stated
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children will be randomly selected to be included in the intervention arm of this study. Informed consent will be obtained by a member of the research team from the carer(s) before enrolment. Children enrolled into the study will be randomised to one of the two groups (no additional intervention or additional education). Each child will be allocated to the next treatment regimen on a list, which will be previously generated, in random order, at the Queensland Institute of Medical Research, Queensland. A black sticker will obscure the next treatment group and will only be removed after enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permutated block design by computer generation. Informed consent will be obtained before enrolment. Children will be randomized within strata of age.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2005
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] 1032 0
Government body
Name [1] 1032 0
Rural Health Support, Education and Training Program Grant (Commonwealth Government)
Country [1] 1032 0
Australia
Funding source category [2] 1033 0
Charities/Societies/Foundations
Name [2] 1033 0
Telstra Foundation
Country [2] 1033 0
Australia
Funding source category [3] 1034 0
Charities/Societies/Foundations
Name [3] 1034 0
Royal Childrens Hospital Foundation
Country [3] 1034 0
Australia
Funding source category [4] 1035 0
Government body
Name [4] 1035 0
NHMRC (project grant)
Country [4] 1035 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telstra Foundation, the Royal Childrens Hospital Foundation
Address
Country
Australia
Secondary sponsor category [1] 897 0
Government body
Name [1] 897 0
NHMRC (project grant)
Address [1] 897 0
Country [1] 897 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2333 0
Queensland Institute of Medical Research
Ethics committee address [1] 2333 0
Ethics committee country [1] 2333 0
Australia
Date submitted for ethics approval [1] 2333 0
Approval date [1] 2333 0
Ethics approval number [1] 2333 0
Ethics committee name [2] 2334 0
Royal Childrens Hospital
Ethics committee address [2] 2334 0
Ethics committee country [2] 2334 0
Australia
Date submitted for ethics approval [2] 2334 0
Approval date [2] 2334 0
Ethics approval number [2] 2334 0

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

Contacts
Principal investigator
Name 35805 0
Address 35805 0
Country 35805 0
Phone 35805 0
Fax 35805 0
Email 35805 0
Contact person for public queries
Name 9935 0
Patricia C Valery
Address 9935 0
Queensland Institute of Medical Research
300 Herston Road
Herston QLD 4029
Country 9935 0
Australia
Phone 9935 0
+61 7 33620224
Fax 9935 0
+61 7 38453502
Email 9935 0
Patricia.Valery@qimr.edu.au
Contact person for scientific queries
Name 863 0
Patricia C Valery
Address 863 0
Queensland Institute of Medical Research
300 Herston Road
Herston QLD 4029
Country 863 0
Australia
Phone 863 0
+61 7 33620224
Fax 863 0
+61 7 38453502
Email 863 0
Patricia.Valery@qimr.edu.au

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.