Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000073303
Ethics application status
Approved
Date submitted
31/01/2008
Date registered
8/02/2008
Date last updated
22/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of Environment on Aboriginal Resilience and Child Health
Scientific title
Randomised Controlled Trial of a Health Broker Intervention to Improve Adherence to the Primary Healthcare Practitioner's Care plan for otitis media in Aboriginal children
Secondary ID [1] 252355 0
SEARCH Intervention
Universal Trial Number (UTN)
Trial acronym
SEARCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis media 2783 0
Condition category
Condition code
Ear 2918 2918 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be given a health broker for the duration of the episode of otitis media (up to a maximum of 4 weeks). The health broker will act as a liaison between the health care providers and the family of the child with otitis media. The health broker will facilitate the family's adherence to the care plan for otitis media by: regular contact as required (e.g., weekly), assisting with travel, assisting with care arrangements for other children, assisting with purchasing antibiotics, assisting with appointment keeping
Intervention code [1] 2522 0
Behaviour
Comparator / control treatment
The control group will receive standard care over the trial period of 4 weeks. There are six Aboriginal Medical Services across NSW which are participating in the trial and start dates will be staggered but in each centre the children will be recruited over 4 weeks and the health broker will be involved for 4 weeks. At the end of the 4 week period of the trial the control group will be offered the health broker but this data will not be part of the intervention analysis.
Control group
Active

Outcomes
Primary outcome [1] 3797 0
Adherence to the primary health care practitioner's written care plan for that episode of otitis media. This will be analysed in terms of adherence to antibiotic therapy and adherence to keeping planned appointments
Timepoint [1] 3797 0
The antibiotic adherence will be measured at the end of the planned antibiotic course. The appointment keeping will be measured at 1 month (retrospectively)
Secondary outcome [1] 6408 0
Ear health status using otoscopy, pneumatic otoscopy, tympanometry, hearing assessment and speech and language testing (1-7 year olds)
Timepoint [1] 6408 0
12 months

Eligibility
Key inclusion criteria
1.Aboriginal and Torres Strait Islander Child
2.From birth to 12 years of age
3.Diagnosed with some form of otitis media
4.Medical practitioner's care plan for the child includes antibiotics or at least one follow-up appointment
Minimum age
0 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Children whose families do not reside in the Aboriginal Medical Service area
2. Children with otitis externa without otitis media
3. Children with their second or subsequent episode of otitis media

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)
Families presenting to participating Aboriginal Medical Services or referred from their medical practitioners will be invited to enrol in SEARCH. Once written consent has been obtained a SEARCH research assistant will contact the George Institute by phone. A pro-forma questionnaire will be completed over the phone in the presence of the family member. The George Institute will randomise the family to either the health broker or control group. The research assistant will record this information in the SEARCH database and inform the family. If the family is allocated to the health broker group the research assistant will inform the health broker as well. The Research assistant have been instructed not to discuss allocation with anyone other than the family member and health broker (for health broker allocations)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Allocation concealment (central randomisation)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 748 0
2770
Recruitment postcode(s) [2] 749 0
2560
Recruitment postcode(s) [3] 750 0
2016
Recruitment postcode(s) [4] 751 0
2650
Recruitment postcode(s) [5] 752 0
2300
Recruitment postcode(s) [6] 753 0
2500

Funding & Sponsors
Funding source category [1] 3044 0
Government body
Name [1] 3044 0
National Health & Medical Research Council
Country [1] 3044 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 2743 0
Other Collaborative groups
Name [1] 2743 0
Aboriginal Health & Medical Research Council
Address [1] 2743 0
PO Box 1565
Strawberry Hills NSW 2012
Country [1] 2743 0
Australia
Other collaborator category [1] 191 0
Government body
Name [1] 191 0
NSW Health
Address [1] 191 0
Macquarie Street
Sydney
Country [1] 191 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4996 0
University of Sydney
Ethics committee address [1] 4996 0
Ethics committee country [1] 4996 0
Australia
Date submitted for ethics approval [1] 4996 0
Approval date [1] 4996 0
14/12/2006
Ethics approval number [1] 4996 0
12-2006/9429

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

Contacts
Principal investigator
Name 28344 0
Prof Jonathan CRAIG
Address 28344 0
The University of Sydney
Country 28344 0
Australia
Phone 28344 0
+61298450000
Fax 28344 0
Email 28344 0
[email protected]
Contact person for public queries
Name 11501 0
Hasantha Gunasekera
Address 11501 0
The Sax Institute
Broadway, Sydney
Country 11501 0
Australia
Phone 11501 0
02 9514 5943
Fax 11501 0
Email 11501 0
[email protected]
Contact person for scientific queries
Name 2429 0
Hasantha Gunasekera
Address 2429 0
The Sax Institute
GPO Box 1614 Sydney 2000
Country 2429 0
Australia
Phone 2429 0
02 9514 5968
Fax 2429 0
Email 2429 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.