Trial Review

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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
Scientific title
Engaging and re-connecting "at-risk" children with chronic respiratory illness: the effects of behavioural education techniques on treatment adherence.
Secondary ID [1] 1491 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic respiratory conditions 237044 0
Condition category
Condition code
Respiratory 237364 237364 0 0
Asthma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 236767 0
Behaviour
Comparator / control treatment
wait-list control will be offered intervention 9 weeks after baseline.
Control group
Active

Outcomes
Primary outcome [1] 238170 0
social problem solving skills measured uisng standardised questionnaire
Timepoint [1] 238170 0
baseline, post-intervention, and 6 month post-intervention
Primary outcome [2] 258017 0
psychological well being measured using questionnaires
Timepoint [2] 258017 0
baseline, post-intervention, and 6 month post-intervention
Secondary outcome [1] 242453 0
functional status measured using spirometry
Timepoint [1] 242453 0
baseline, post-intervention, and 6 month post-intervention
Secondary outcome [2] 242454 0
treatment adherence measured using self-report diary.
Timepoint [2] 242454 0
baseline, post-intervention, and 6 month post-intervention

Eligibility
Key inclusion criteria
socially disadvantaged children and adolescents with a chronic respiratory illness
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
reading difficulties

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)
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237164 0
Charities/Societies/Foundations
Name [1] 237164 0
Telstra Foundation
Country [1] 237164 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Newcombe
Address
School of Psychology
University of Queensland
St Lucia Queensland 4072
Country
Australia
Secondary sponsor category [1] 4653 0
Individual
Name [1] 4653 0
Prof Anne Chang
Address [1] 4653 0
Dept of Respiratory Medicine Level 3 Woolworths Building Royal Children's Hospital Herston Rd HERSTON Queensland 4029
Country [1] 4653 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239256 0
Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 239256 0
University of Queensland
St Lucia Queensland 4072
Ethics committee country [1] 239256 0
Australia
Date submitted for ethics approval [1] 239256 0
Approval date [1] 239256 0
19/11/2008
Ethics approval number [1] 239256 0
2007001706

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29753 0
Address 29753 0
Country 29753 0
Phone 29753 0
Fax 29753 0
Email 29753 0
Contact person for public queries
Name 13000 0
Dr Peter Newcombe
Address 13000 0
School of Psychology
University of Queensland
St Lucia Queensland 4072
Country 13000 0
Australia
Phone 13000 0
+61 7 3381 1501
Fax 13000 0
Email 13000 0
newc@psy.uq.edu.au
Contact person for scientific queries
Name 3928 0
Dr Peter Newcombe
Address 3928 0
School of Psychology
University of Queensland
St Lucia Queensland 4072
Country 3928 0
Australia
Phone 3928 0
+61 7 3381 1501
Fax 3928 0
Email 3928 0
newc@psy.uq.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.