Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000515493
Ethics application status
Approved
Date submitted
4/10/2007
Date registered
9/10/2007
Date last updated
24/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Breathe Easier Online: Engaging and re-connecting 'at-risk' children with chronic respiratory illness.
Scientific title
Engaging and re-connecting 'at-risk' children with chronic respiratory illness
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
moderate tracheomalacia 2424 0
asthma 2425 0
bronchiectesis 2426 0
cystic fibrosis 2427 0
Condition category
Condition code
Respiratory 2529 2529 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised to either a weekly 30 minute individual online contact with a psychologist group or a control wait-list group for 9 months and follow up data collection at 12 months.
Intervention code [1] 2146 0
Behaviour
Intervention code [2] 2148 0
Other interventions
Comparator / control treatment
The control wait-list group will be offered the intervention after the initial 12month period.
Control group
Active

Outcomes
Primary outcome [1] 3428 0
Increased physical,mental and social well-being quantified by the completion of questionnaires at 0,6,9 and 12months.
Timepoint [1] 3428 0
At 12months.
Secondary outcome [1] 5693 0
Improvement of adherence to medical therpies.
Timepoint [1] 5693 0
At completion 12 months.

Eligibility
Key inclusion criteria
Children aged between 10-15years of age with chronic respiratory illness who belong to the 'at-risk' group ie single parent families,low socioeconomic class parent with a mental illnes.
Minimum age
10 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children without chronic respiratory illness, those not 'at-risk' and children outside the age bracket.

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)
A black sticker obscures the next treatment group and is only removed once enrolled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants will be stratified by dwelling location and will be computer generated. Allocation to groups will be concealed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2007
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] 2679 0
Charities/Societies/Foundations
Name [1] 2679 0
Telstra Foundation Social Innovation Grants
Country [1] 2679 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Newcombe
Address
School of Social Work and Applied Human Sciences
University of Queensland
St Lucia Q 4072
Country
Australia
Secondary sponsor category [1] 2420 0
Individual
Name [1] 2420 0
Dr Anne Chang
Address [1] 2420 0
Dept of Respiratory Medicine
Level 3 Woolworths Building
Royal Children's Hospital
Herston Rd
HERSTON Q 4029
Country [1] 2420 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4598 0
Royal Children's Hospital Ethics Committee
Ethics committee address [1] 4598 0
Level 3 Foundation Building
Royal Children's Hospital
Herston Rd
HERSTON Q 4029
Ethics committee country [1] 4598 0
Australia
Date submitted for ethics approval [1] 4598 0
Approval date [1] 4598 0
19/09/2007
Ethics approval number [1] 4598 0

Summary
Brief summary
Children with chronic illness sometimes feel disconnected and lonely.
In this study we will evaluate the use of a psycho-social intervention program for 'at-risk' children (ie. child with chronic illness, low socio-economic groups) to improve their sense of well-being, adherence to therapies and health outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28090 0
Address 28090 0
Country 28090 0
Phone 28090 0
Fax 28090 0
Email 28090 0
Contact person for public queries
Name 11247 0
Ms Greta Scrivener
Address 11247 0
Department of Respiratory Medicine
Royal Children's Hospital
Level 3 Woolworths Building
Herston Rd
HERSTON 4029
Country 11247 0
Australia
Phone 11247 0
07 3636 8528
Fax 11247 0
07 3636 1958
Email 11247 0
[email protected]
Contact person for scientific queries
Name 2175 0
Dr Anne Chang
Address 2175 0
Dept of Respiratory Medicine
Level 3 Woolworth's Building
Royal Children's Hospital
Herston Rd
HERSTON Q 4029
Country 2175 0
Australia
Phone 2175 0
61-7-3636 1949
Fax 2175 0
61-7-36361958
Email 2175 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.