None listed
Conditions
Brief summary
Asthma is the most common long-term condition in childhood, affecting 1 in 4 children in New Zealand. Although there are many effective treatments for asthma, many children continue to have troublesome symptoms. The main reason for this is that many children do not use their inhalers as prescribed by the doctor – i.e. they are “non-adherent” – particularly with their use of ‘preventers’ which need to be used regularly if they are to work. The aim of the study is to investigate whether the use of an inhaler with an in-built ringtone system that sounds twice a day is effective in reminding patients to use their inhaler and if this leads to better adherence and control of asthma. The study will enrol 220 participants, aged 6 to 15 years, who present to the Children’s Emergency Department at Starship Children’s Hospital with an asthma attack. Half of the children will be given inhalers with the electronic reminder on, and the other half with the electronic reminder turned off. They will be followed for 6 months with lung function, use of reliever medication and asthma symptoms being assessed.
Interventions
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 rin
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))
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 15 Years
Healthy volunteers
No
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.
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
Outcome results
None listed