Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000489493
Ethics application status
Approved
Date submitted
14/09/2007
Date registered
21/09/2007
Date last updated
7/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of providing feedback on adherence in childhood asthma
Scientific title
The Asthma Feedback Study - The impact of providing feedback on
adherence in childhood asthma.
Secondary ID [1] 262333 0
Lung function
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood asthma 2379 0
Condition category
Condition code
Respiratory 2481 2481 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adherence of preventive medication will be monitored using an electronic monitoring device (Smirtinhaler, Nexus 6) in a cohort of 100 children aged 6-15 years with asthma. Data from the device may be downloaded and displayed graphically to the participants. The intervention group will receive monthly feedback regarding their us e of preventive medication along with standard asthma care. The control group will have their adherence monitored but this will remain confidential and will not be fedback to the participants.

The trial is likely to take 2 years to complete. Each child will be in the study for 4 months.
Intervention code [1] 2101 0
Treatment: Devices
Comparator / control treatment
The control group will not receive feedback regarding their adherence, their adherence will remain confidential and clinical decisions will be based on reported adherence.
Control group
Active

Outcomes
Primary outcome [1] 3378 0
Adherence
Timepoint [1] 3378 0
Monthly for 4 months
Secondary outcome [1] 5597 0
Asthma control (symptom scores, exacerbation rates and lung function)
Timepoint [1] 5597 0
Monthly for 4 months

Eligibility
Key inclusion criteria
Aged 6 - 15 years, frequent episodic or chronic persistent asthma, taking daily preventive inhaled corticosteroid medication.
Minimum age
6 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other underlying lung disorder, not taking inhaled corticosteroid medication.

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)
Recruitment will be sought from asthma clinic and community referrals.

Group allocation will be by computer randomisation aided by minimisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomisation / minimisation program Minum will be used. Following consent being obtained and enrollment being confirmed, the investigator will enter the data regarding the child into the program (sex, age, lung function and level of maternal education). The computer program will allocate the subject of one of the two groups. This is done essentially randomly but does take into account the balance of othe subjects in the study and is thus not completely random. The invetsigator and parent is unaware of allocation at the time of enrollment and takes no active part in determining into which group the child will be allocated. This method has been selected as the numbers in the trial is relatively small and pure randomisation could by chance result in uneven distribution of subjects with known confounding factors.
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
Recruiting
Date of first participant enrolment
Anticipated
14/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 435 0
4163

Funding & Sponsors
Funding source category [1] 2629 0
Hospital
Name [1] 2629 0
Redland Hospital
Country [1] 2629 0
Australia
Primary sponsor type
Hospital
Name
Redland Hospital
Address
Weippin St, Cleveland, 4163
Country
Australia
Secondary sponsor category [1] 2377 0
None
Name [1] 2377 0
Address [1] 2377 0
Country [1] 2377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4548 0
Bayside Health Service District Human Research Ethics Committee
Ethics committee address [1] 4548 0
Weippin St, Cleveland, 4163
Ethics committee country [1] 4548 0
Australia
Date submitted for ethics approval [1] 4548 0
01/01/2007
Approval date [1] 4548 0
16/03/2007
Ethics approval number [1] 4548 0
2007-01-01

Summary
Brief summary
The purpose of the study is to determine whether the act of measuring and providing feedback on adherence will result in a change in adherence with preventive medication and as a secondary outcome disease control.

Subjects who are aware that their use of medication is being monitored may change their behaviour. Providing feedback may provide them and thier physician with additional information which may improve the accuracy and quality of clinical decisions that are made.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28057 0
Address 28057 0
Country 28057 0
Phone 28057 0
Fax 28057 0
Email 28057 0
Contact person for public queries
Name 11214 0
Scott Burgess
Address 11214 0
Redand Hospital, Weippin St, Cleveland, 4163
Country 11214 0
Australia
Phone 11214 0
07 34883111
Fax 11214 0
Email 11214 0
[email protected]
Contact person for scientific queries
Name 2142 0
Scott Burgess
Address 2142 0
Redand Hospital, Weippin St, Cleveland, 4163
Country 2142 0
Australia
Phone 2142 0
07 34883111
Fax 2142 0
Email 2142 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.