Optimising Inhaler Technique and Asthma Self-management in Children and Young People (NCT06531096) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Optimising Inhaler Technique and Asthma Self-management in Children and Young People
United Kingdom45 participantsStarted 2022-11-17
Plain-language summary
The aim of this randomised pilot study is to explore ways to optimise a care pathway that results in children and young people with asthma being better trained in the basics of asthma care and better able to apply self-management at the earliest possible stage.
This will involve comparing a novel augmented teaching method (Video directly observed therapy (v-DOT)) with standard training in achieving and sustaining mastery of inhaler and nasal spray technique and the understanding of a personalised asthma action plan (PAAP).
Who can participate
Age range
1 Year – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1-15 years of age (up to 16th birthday)
* Established asthmatic children (prescribed an inhaled corticosteroid preventer), who have been admitted or referred for paediatric ward review or attended A\&E with their 2nd acute wheeze episode within a 6-month period.
* Established asthmatic children (prescribed an inhaled corticosteroid preventer), with inadequate control whom medical staff feel would benefit from further education.
* 3rd viral induced wheezing episode within 6 months, in those already prescribed an inhaled corticosteroid preventer (but not formally 'asthma').
* English and non-English speaking children and young people will be eligible as we have access to translation services that are already utilised at our asthma clinics.
Exclusion Criteria:
* Children who have previously received intervention through the safe asthma discharge care pathway service.
* \< 1 year of age.
* Children and young people with cough but no wheeze.
* Those children who are referred to paediatric asthma clinic or nurse led asthma clinic, where they have received teach back training on inhaler technique/nasal spray technique and PAAP training.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mastery of technique
Timeframe: Once mastery of technique established which is defined as 3 consecutive days of correct technique.
2
Technique score
Timeframe: Baseline and 1, 3 and 6 months after achieving technique mastery
3
Personalised asthma action plan (PAAP) understanding.
Timeframe: Baseline and 1, 3 and 6 months after achieving technique mastery
4
Recruitment rates
Timeframe: Through study recruitment, an average of 1 year.
5
Retention rates
Timeframe: At study completion for all participants, up to 2 years.
6
Qualitative interviews to identify barriers to using video directly observed therapy (v-DOT)
Timeframe: 3-6 months after achieving mastery of technique.