Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000125820
Ethics application status
Approved
Date submitted
24/01/2012
Date registered
25/01/2012
Date last updated
25/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Reminder Asthma Management Program
Scientific title
Reminder Asthma Management Program (RAMP) to improve adherence with preventive asthma medication
Secondary ID [1] 279790 0
None
Universal Trial Number (UTN)
Trial acronym
RAMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 285668 0
Condition category
Condition code
Respiratory 285851 285851 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two components to this trial:

1. Observational: A population of children with poorly controlled asthma despite optimal treatment (prescription of an inhaled corticosteroid at a dose of Flixotide 500 ug/day or equivalent AND either a long acting beta agonist or Montelukast, typically Seretide 500ug per day) will be studied. This will include measuring adherence with preventive medication using an electronic monitoring device. A number of questionnaires will also be used to explore a number of treatment, psychological and demographic variables. The observational period will be for one month.

2. A RCT investigating whether using an electronic monitoring device with a reminder function and reporting adherence data back to the patient improves adherence. During the second month of the trial half the subjects will have the reminder function turned on and will receive feedback on their adherence with their preventive medication. A direct coparison of adherence will occur for one month. The control group will continue to receive standard care during the second month. In the third month the control group will be exposed to the intervention. Adherence will be measured using an electronic monitoring device attached to the patient's preventive medication. All doses taken during the study will be recorded. Thus in summary, the intervention group will have one month of being monitored and two months of intervention. The control group will have two months of monitoring followed by one month of intervention.
Intervention code [1] 284109 0
Treatment: Other
Intervention code [2] 284121 0
Prevention
Comparator / control treatment
Standard asthma management (education and preventive medication delivered through a multidisciplinary asthma clinic)
Control group
Active

Outcomes
Primary outcome [1] 286355 0
The primary outcome is adherence with preventive asthma medication. This will be based upon data from the electronic monitoring device (EMD), the Smartinhaler, attached to the patient's preventive medication. The EMD records a time stamp each time a dose is taken and these data can be downloaded at a subsequent review. All subjects will be prescribed the same medication (Seretide 125/25ug two puffs twice daily). "Dose adherence" refers to the percentage of doses taken within the allotted time period (ie two doses recorded either between midnight and midday for the morning dose and midday and midnight for the evening dose).
Timepoint [1] 286355 0
Adherence will be measured in all subjects during the first month of the study and all subjects will receive the same management.

During the second month half the subjects will be exposed to the intervention and the other half will act as a control group. Adherence will be measured and compared between the two groups during the second month.

During the third month the control group will be exposed to the intervention. This is not a true cross over trial as during the third month the intervention group may continue to be exposed to the intervention if this has proved to be helpful to them.
Secondary outcome [1] 295652 0
Asthma control (ACT or C-ACT control questionnaires, scores of <19 will be used to indicate sub-optimal control)
Timepoint [1] 295652 0
One month (second month of the trial). The score will be assessed at the second visit (this questionnaire asks about asthma symtoms over the previous 4 weeks)
Secondary outcome [2] 295668 0
Quality of life (Juniper's self reports asthma quality of life scale)
Timepoint [2] 295668 0
One month (second month of the trial). This questionnaire will be completed at baseline and at the end of the second month. A comparison will be made between the two groups and also a comparison between the baseline and subsequent scores.
Secondary outcome [3] 295669 0
Lung function (FEV1 and bronchodilator response)
Timepoint [3] 295669 0
One month (second month of the trial). Lung function testing will occur at each visit. A comparison will be made between the two groups and also a comparison between the baseline and subsequent values.

Eligibility
Key inclusion criteria
Asthma which is poorly control (abnormal lung function and / or reduced asthma control based on standardised questionnaires) despite Seretide 500 micrograms per day.
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Another significant lung condition.

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)
Children attending an asthma clinic will be approached to enrol in the study. Following providing informed consent subjects will be provided with a study pack that will contain a study number in a sealed opaque envelope. The person enrolling subjects will not be aware of allocation at the time the patient is recruited. The number will be linked to an allocation to either the intervention or control group. Subjects will be allocated in random blocks of variable size.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be performed by an independent person using a random number generator with blocks of variable size.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The intervention group will have one month of being monitored and two months of intervention. The control group will have two months of monitoring followed by one month of intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284567 0
Hospital
Name [1] 284567 0
Redland Hospital
Country [1] 284567 0
Australia
Primary sponsor type
Hospital
Name
Redland Hospital
Address
Weippin Street
Cleveland Queensland 4163
Country
Australia
Secondary sponsor category [1] 283487 0
None
Name [1] 283487 0
Address [1] 283487 0
Country [1] 283487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286553 0
Mater Hospital HREC
Ethics committee address [1] 286553 0
Mater Hospital
South brisbane Queensland 4101
Ethics committee country [1] 286553 0
Australia
Date submitted for ethics approval [1] 286553 0
Approval date [1] 286553 0
11/11/2011
Ethics approval number [1] 286553 0
1786C

Summary
Brief summary
This trial has two aims:

1. To determine the characteristics of children who have poorly controlled asthma despite optimal management.

2. Whether using an electronic monitoring device (Smart-inhaler) which includes a reminder function and which can be used to provide feedback on adherenve improves adherence with preventive medication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33676 0
Address 33676 0
Country 33676 0
Phone 33676 0
Fax 33676 0
Email 33676 0
Contact person for public queries
Name 16923 0
Scott Burgess
Address 16923 0
Mater Children's Hospital
Raymond Terrace
South brisbane Queensland 4101
Country 16923 0
Australia
Phone 16923 0
+61 7 31638382
Fax 16923 0
+61 7 31638366
Email 16923 0
[email protected]
Contact person for scientific queries
Name 7851 0
Scott Burgess
Address 7851 0
Mater Children's Hospital
Raymond Terrace
South brisbane Queensland 4101
Country 7851 0
Australia
Phone 7851 0
+61 7 3163 8382
Fax 7851 0
+61 7 31638366
Email 7851 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.