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Trial registered on ANZCTR
Registration number
ACTRN12610000214033
Ethics application status
Approved
Date submitted
16/06/2009
Date registered
16/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
An online intervention to enagage and re-connect "at-risk" children with chronic respiratory illness: a randomised contolled trial
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Scientific title
Engaging and re-connecting "at-risk" children with chronic respiratory illness: the effects of behavioural education techniques on treatment adherence.
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Secondary ID [1]
1491
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chronic respiratory conditions
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Condition category
Condition code
Respiratory
237364
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0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
self-management, education, behaviour
6 online modules completed over a period of 9 weeks. the answers to the modules are monitored by reseach staff on the project. each module is available once week and is not available until at least one week after previous module is completed. the modules contain social problem solving skills training
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Intervention code [1]
236767
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Behaviour
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Comparator / control treatment
wait-list control will be offered intervention 9 weeks after baseline.
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Control group
Active
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Outcomes
Primary outcome [1]
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social problem solving skills measured uisng standardised questionnaire
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Assessment method [1]
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Timepoint [1]
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baseline, post-intervention, and 6 month post-intervention
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Primary outcome [2]
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psychological well being measured using questionnaires
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Assessment method [2]
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Timepoint [2]
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baseline, post-intervention, and 6 month post-intervention
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Secondary outcome [1]
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functional status measured using spirometry
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Assessment method [1]
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Timepoint [1]
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baseline, post-intervention, and 6 month post-intervention
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Secondary outcome [2]
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treatment adherence measured using self-report diary.
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Assessment method [2]
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Timepoint [2]
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baseline, post-intervention, and 6 month post-intervention
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Eligibility
Key inclusion criteria
socially disadvantaged children and adolescents with a chronic respiratory illness
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Minimum age
10
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
reading difficulties
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
5/08/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Telstra Foundation
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Address [1]
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Telstra Foundation Telstra Community development Fund Locked Bag 5680 Melbourne Victoria 3001
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr Peter Newcombe
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Address
School of Psychology
University of Queensland
St Lucia Queensland 4072
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Prof Anne Chang
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Address [1]
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Dept of Respiratory Medicine Level 3 Woolworths Building Royal Children's Hospital Herston Rd HERSTON Queensland 4029
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Behavioural and Social Sciences Ethical Review Committee
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Ethics committee address [1]
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University of Queensland
St Lucia Queensland 4072
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
239256
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Approval date [1]
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19/11/2008
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Ethics approval number [1]
239256
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2007001706
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Summary
Brief summary
The aim of the current study was to evaluate the efficacy of an online intervention for socially disadvantaged children and adolescents with a chronic respiratory illness, to improve health-related outcomes, including psychological and social well-being. This is the first time an Australian sample has been used. Problem-solving paradigm was used, because children and adolescents with a chronic health condition often engage in risky behaviours due to poor problem-solving skills. Our aim is to provide them with a better way to solve problems relating to their condition and further expanding to other areas of their lives.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Peter Newcombe
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Address
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School of Psychology
University of Queensland
St Lucia Queensland 4072
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Country
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Australia
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Phone
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+61 7 3381 1501
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Peter Newcombe
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Address
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School of Psychology
University of Queensland
St Lucia Queensland 4072
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Country
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Australia
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Phone
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+61 7 3381 1501
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Fax
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Email
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[email protected]
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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.
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