Trial from ANZCTR


Trial ID ACTRN12605000718640
Trial Status: Registered
Date Submitted: 1/11/2005
Date Registered: 7/11/2005
Retrospectively registered

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Public title A randomised controlled study on education intervention for childhood asthma
by Aboriginal and Torres Strait Islander Health Workers
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Asthma 868 0
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Condition category: Condition code:
Respiratory Asthma
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935 935 0 0

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Descriptions 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).
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Intervention Code:
Treatment: Other 746 0
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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).
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Control group Active
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Primary Outcome: Number of unscheduled hospital/doctor visits due to asthma exacerbation during the 12 months follow up period. 1230 0
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Timepoint: Primary outcome will be measured at the end of the follow up period through medical chart review. 1230 0
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Secondary Outcome: 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. 2236 0
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Timepoint: 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. 2236 0
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Secondary Outcome: Functional severity score : we will use questions related to the functional severity score designed by Rosier et al. 2237 0
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Timepoint: 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. 2237 0
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Secondary Outcome: 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?). 2238 0
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Timepoint: 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. 2238 0
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Secondary Outcome: Number of days missed school due to asthma. 2239 0
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Timepoint: 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. 2239 0
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Secondary Outcome: Number of exacerbations of asthma. 2240 0
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Timepoint: 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. 2240 0
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Secondary Outcome: Number of unscheduled hospital/doctor visits (through a medical chart review). 2241 0
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Timepoint: 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. 2241 0
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Secondary Outcome: Spirometry results (for those over 6 years). 2242 0
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Timepoint: 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. 2242 0
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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.
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Minimum age Not stated
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Maximum age 18 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria No exclusion criteria
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Study type Interventional
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Purpose of the study Educational / counselling / training
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3 / Phase 4
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Anticipated date of first participant enrolment 1/01/2005
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 100
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Recruitment status Recruiting
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 1032 0
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Name: Rural Health Support, Education and Training Program Grant (Commonwealth Government) 1032 0
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Address: 1032 0
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Country: Australia 1032 0
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Funding Source: Charities/Societies/Foundations 1033 0
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Name: Telstra Foundation 1033 0
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Address: 1033 0
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Country: Australia 1033 0
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Funding Source: Charities/Societies/Foundations 1034 0
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Name: Royal Childrens Hospital Foundation 1034 0
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Address: 1034 0
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Country: Australia 1034 0
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Funding Source: Government body 1035 0
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Name: NHMRC (project grant) 1035 0
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Address: 1035 0
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Country: Australia 1035 0
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Primary Sponsor Charities/Societies/Foundations
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Name: Telstra Foundation, the Royal Childrens Hospital Foundation
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Country: Australia
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Secondary Sponsor: Government body 897 0
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Name: NHMRC (project grant) 897 0
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Address: 897 0
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Country: Australia 897 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Queensland Institute of Medical Research 2333 0
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Country: Australia 2333 0
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Approval Date: 2333 0
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HREC: 2333 0
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Ethics Committee name: Royal Childrens Hospital 2334 0
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Address: Brisbane 2334 0
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Country: Australia 2334 0
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Approval Date: 2334 0
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Submitted Date: 2334 0
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HREC: 2334 0
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Brief summary Our specific aim is to examine the effect of health worker education intervention on asthma outcomes using a randomised controlled trial. All children involved in the study will receive routine culturally appropriate intervention and thus the community will benefit in general. Additional asthma education by health workers using education material specially developed for the region can directly and indirectly improve the care of children with asthma ultimately with better asthma outcomes. Assuming the study hypothesis is correct, that children who receive additional asthma education by health worker have better asthma outcomes, the possible beneficial outcomes (educational interventions for improved asthma control) of this study can significantly affect rural communities at the regional and potentially national levels. In addition, a culturally appropriate method to reinforce asthma education could be used in the wider Indigenous community to improve asthma outcomes.
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Trial website
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Principal Investigator
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Contact person for public queries
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Name: Patricia C Valery
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Address: Queensland Institute of Medical Research 300 Herston Road Herston QLD 4029
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Country: Australia
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Tel: +61 7 33620224
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Fax: +61 7 38453502
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Email: Patricia.Valery@qimr.edu.au
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Contact person for scientific queries
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Name: Patricia C Valery
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Address: Queensland Institute of Medical Research 300 Herston Road Herston QLD 4029
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Country: Australia
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Email: Patricia.Valery@qimr.edu.au
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