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Trial registered on ANZCTR


Registration number
ACTRN12613001353785
Ethics application status
Approved
Date submitted
28/11/2013
Date registered
11/12/2013
Date last updated
11/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of an inhaler with ringtones in children with asthma
Scientific title
The effect of an inhaler with ringtones on asthma control and school attendance in children
Secondary ID [1] 283639 0
Nil known
Universal Trial Number (UTN)
U1111-1150-6466
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma in school-aged children 290578 0
Condition category
Condition code
Respiratory 290970 290970 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Smart Track (Registered Trademark) device with activated LED display and ringtones system enabled.

This device wraps around standard metered-dose inhalers. The intervention group will receive this with the audiovisual functions enabled. The LED screen will display information about the time/date of the last dose taken, and the current time/date. The in-built ringtones will sound once every minute until the inhaler is used or 15 minutes have passed since activation of the ringtone. The ringtone will sound twice daily corresponding to the morning and night doses of the preventer inhaler, at times chosen by the participant. A selection of 14 different ringtones will be available - with a different tone each morning and evening during the week. The Smart Track (Registered Trademark) device also has a monitoring function that records the date and time of actuation of the inhaler and number of doses used on each occasion to allow covert monitoring of inhaler use.

Participants allocated to the intervention group will be followed up for 6 months, with follow-up visits every 2 months. During this 6-month period, they will stay in the group they were allocated to and be expected to use the ringtones Smart Track (Registered Trademark) inhaler.

Participants will remain on the dose that was prescribed by the patient's GP prior to enrolment. All participants will either be on fluticasone or fluticasone and salmeterol depending on their medications prior to enrollment. Patients on treatment with budesonide administered via turbuhaler or beclomethasone via metered dose inhalation will be changed to an equipotent dose of fluticasone propionate. This is also applicable to patients on combination budesonide and eformoterol inhalers (Symbicort (Registered Trademark)) – this will be changed to an equipotent combination product of fluticasone propionate and salmeterol xinafoate (Seretide (Registered Trademark))
Intervention code [1] 288332 0
Treatment: Devices
Comparator / control treatment
Smart Track (Registered Trademark) without the visual display and the ringtones system disabled.

The control group will still receive the Smart Track (Registered Trademark) device but the audiovisual functions will be disabled. This means that the LED screen does not give visual information or feedback on the timing of the most recent dose. The ringtones reminder function will be turned off. The monitoring function remains active to records the date and time of each inhaler actuation.
Control group
Active

Outcomes
Primary outcome [1] 290985 0
Adherence to treatment (Number of prescribed doses taken) as measured by the monitoring function of the Smart Track(R) inhaler.
Timepoint [1] 290985 0
At the end of study (when the final enrolled patient has completed their 6-months follow-up)
Primary outcome [2] 290986 0
Number of days absent from school as determined by parental report
Timepoint [2] 290986 0
At each study visit (2 months, 4 months and 6 months after enrolment)
Secondary outcome [1] 305747 0
Changes in asthma control as measured by the Asthma Morbidity Score and Asthma Control Test
Timepoint [1] 305747 0
Asthma Morbidity Score administered at baseline visit and at 6 months.
Asthma Control Test administered every 2 monthly at the visits (2, 4, 6 months)
Secondary outcome [2] 305748 0
Lung function as measured by FEV1 and FVC (spirometry testing)
Timepoint [2] 305748 0
Assessed at each study visit (2, 4, 6 months)
Secondary outcome [3] 305749 0
Attendance at the hospital Emergency Department (From hospital records)
Timepoint [3] 305749 0
Assessed at end of the study (at 6 months) when the last participant finishes their study visit
Secondary outcome [4] 305750 0
Number of unscheduled doctors visits as reported by the caregiver
Timepoint [4] 305750 0
Assessed at each study visit (2, 4, 6 months)
Secondary outcome [5] 305751 0
Days absent from work by parents / primary caregiver(s) as self-reported by the caregivers
Timepoint [5] 305751 0
Assessed at each study visit (2, 4, 6 months)

Eligibility
Key inclusion criteria
Children will be considered eligible for inclusion if the follow are met:

(1) Aged between 6 and 15 years at the time of admission to Children’s Emergency Department

(2) Present to Children’s Emergency Department at Auckland (Starship) Hospital or Waitemata DHB with a diagnosis of acute asthma.

(3) Currently on treatment with and inhaled corticosteroid (ICS) or are deemed by a paediatrician to require treatment with ICS.
Minimum age
6 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will not be eligible for inclusion in the study if the following apply:
(1) Other diagnosis of chronic lung disease (other than asthma) e.g. bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia
(2) They do not normally reside in Auckland area
(3) Congenital heart disease
(4) Intellectual disability affecting ability to comply with study treatment or procedures. Mild intellectual disability will not be an exclusion criteria
(5) Insufficient English to understand the study and comply with study protocols
(6) Diagnosis of a severe chronic medical condition which leads to impaired immunity and / or increased morbidity

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The daily admission lists to each of the Children's Emergency Departments at ADHB and WDHB will be screened each day for possible eligibility. Hospital notes of those potentially eligible will be reviewed, then the patients contacted to discuss the study. Those who are potentially interested will be emailed or posted participant information sheets, then followed up to confirm interest. If the patient verbally consents, then an appointment time will be arranged for a study visit. The patient will be enrolled after a minimum period of 4 weeks have elapsed since CED admission.

Patients will be randomised at the time of enrolment before their baseline study visit. This randomisation number will be obtained by assigning the next available randomisation number to the patient in ascending order. An opaque envelope with details of the study group that the subject is assigned to will be used to determine which study group the patient is allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation method used will be simple, unrestricted randomisation by computer without stratification as the sample size is suffiiently large
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
Sample size was determined based on the primary outcomes of school attendance and adherence

There were 953 presentations (771 individual patients) to the Children’s Emergency Department at Starship Children’s Hospital in the last year, but only 40% were in the age group that are eligible to take part in this study. This means that there will be approximately 300 children presenting to the Children’s Emergency Department each year who would be eligible to take part in the study. This should be sufficient to allow recruitment of the target sample size of 200 children over 18 months.

The mean number of days lost from school in a sample of asthmatics who were less severe than those in this study, was 22.6 days per year. If the number of days absent from school is log transformed to make the variance independent of the mean, a reduction from 19.5 days to 13.5 days will require 84 in each group for a power of 80% at a 5% level of significance.

If the estimated mean adherence for inhaled steroids (proportion of prescribed doses used) is 50% with a standard deviation of 18 in the control group, then to detect an absolute difference of adherence of 10% at the 5% level of significance with 80% power, 51 participants will be required in each arm of the 2 arm trial.


Statistical analyses will be performed on the intention to treat population and will be based on the data obtained from the 6 month follow up. The data from the two and four month visits will be used in exploratory analyses. Comparisons of the two treatment groups will be conducted using two-sided tests and a 0.05 level of significance will be used, with the null hypothesis being that there is no difference between the two groups in all analyses. A simple linear regression model will be applied for the continuous variables, such as adherence, days off school, morbidity scores, spirometry and days off work by the parents or caregiver. A Poisson regression model will be used to determine if the intervention group has a different proportion of re-attendance at CED than the control group. These models will be used for further exploratory analyses of the data, and potential confounding variables and other variables of interest (such as gender, ethnicity, birth month, centre) will be added to these analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2009
Actual
18/12/2009
Date of last participant enrolment
Anticipated
31/12/2011
Actual
26/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment outside Australia
Country [1] 5655 0
New Zealand
State/province [1] 5655 0
Auckland

Funding & Sponsors
Funding source category [1] 288348 0
Government body
Name [1] 288348 0
Health Research Council of New Zealand
Country [1] 288348 0
New Zealand
Funding source category [2] 288349 0
Charities/Societies/Foundations
Name [2] 288349 0
CURE Kids
Country [2] 288349 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Faculty of Medical and Health Sciences
85 Park Rd
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 287057 0
None
Name [1] 287057 0
Address [1] 287057 0
Country [1] 287057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290233 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 290233 0
Ethics committee country [1] 290233 0
New Zealand
Date submitted for ethics approval [1] 290233 0
Approval date [1] 290233 0
16/03/2009
Ethics approval number [1] 290233 0
NTY/08/12/116

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44486 0
Miss Amy Chan
Address 44486 0
Auckland Hospital Pharmacy Department
Private Bag 92024
Grafton
Auckland 1023
Country 44486 0
New Zealand
Phone 44486 0
+64 9 307 4949 ext 7047
Fax 44486 0
Email 44486 0
a.chan@auckland.ac.nz
Contact person for public queries
Name 44487 0
Ed Mitchell
Address 44487 0
Department of Paediatrics
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country 44487 0
New Zealand
Phone 44487 0
+64 9 373 7999
Fax 44487 0
Email 44487 0
e.mitchell@auckland.ac.nz
Contact person for scientific queries
Name 44488 0
Amy Chan
Address 44488 0
Auckland Hospital Pharmacy Department
Private Bag 92024
Grafton
Auckland 1023
Country 44488 0
New Zealand
Phone 44488 0
+64 9 307 4949 ext 7047
Fax 44488 0
Email 44488 0
a.chan@auckland.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseThe effect of an electronic monitoring device with audiovisual reminder function on adherence to inhaled corticosteroids and school attendance in children with asthma: A randomised controlled trial.2015https://dx.doi.org/10.1016/S2213-2600%2815%2900008-9
EmbaseElectronic adherence monitoring device performance and patient acceptability: a randomized control trial.2017https://dx.doi.org/10.1080/17434440.2017.1322505
N.B. These documents automatically identified may not have been verified by the study sponsor.