Optimising Inhaler Technique and Asthma Self-management in Children and Young People
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Queen's University, Belfast
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Mastery of technique
Study Overview
Brief 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).
Detailed Description
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).
Children with acute wheezing referred to the Safe Asthma Discharge Care Pathway (SADCP) service will be approached for participation. Participants will then be randomised 1:1 to either remain in the SADCP (control) or to receive the v-DOT enhancement (intervention).
All enrolled patients will have an educational session with an asthma nurse using teach back methodology to teach inhaler and/or nasal spray technique and personalised asthma action plan (PAAP). During this session education is given on what asthma is, identifying and avoiding triggers, asthma treatments, and side effects of treatment.
The control participants will have a further assessment and educational sessions using teach back methodology to ensure correct inhaler technique is mastered and understanding of how to action the three zones of the PAAP until they have achieved 'mastery' of the technique and understanding of PAAP.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Mastery of technique
Time Frame: Once mastery of technique established which is defined as 3 consecutive days of correct technique.
Number of days of video directly observed therapy (v-DOT) required to achieve 'mastery' following one initial educational session using teach back methodology for asthma inhaler +/- nasal spray (for those with concomitant allergic rhinitis).
Recruitment rates
Time Frame: Through study recruitment, an average of 1 year.
Recruitment rates and a description of barriers to and how to facilitate.
Technique score
Time Frame: Baseline and 1, 3 and 6 months after achieving technique mastery
Inhaler with or without nasal spray technique at baseline and 1,3 and 6 months after achieving technique mastery. Technique will be scored as a proportion of the correct steps taken (using locally agreed inhaler and nasal spray checklists). Scores range from 0 to 5, with 5 being the maximum and a higher score having a better outcome. This will then be converted to a percentage. Mastery of inhaler technique will be defined as absence of healthcare professional detected errors. The proportion of correct steps taken will be described for each group using descriptive statistical measures. In addition, a global assessment will be made: correct, partially correct and poor technique.
Personalised asthma action plan (PAAP) understanding.
Time Frame: Baseline and 1, 3 and 6 months after achieving technique mastery
Understanding of their personalised asthma action plan will be measured at baseline and 1,3 and 6 months after achieving technique mastery. This will be assessed by asking questions using a pre-defined checklist to clarify if they know which medications they should take every day and what they should do if they become unwell with regards to their treatment regime. Maximum value = 5. Minimum value = 0. A score of 5 means complete understanding of the personalised asthma action plan. A higher score means a better outcome.
Retention rates
Time Frame: At study completion for all participants, up to 2 years.
Patients who complete full follow up and those who withdraw or fail to complete the full study.
Qualitative interviews to identify barriers to using video directly observed therapy (v-DOT)
Time Frame: 3-6 months after achieving mastery of technique.
Barriers to using video directly observed therapy (v-DOT) for example participation rates, technical considerations, ability to correct inhaler error using v-DOT and use of resources.
Secondary Outcomes
- Health service resource use and incremental cost-effectiveness.(Through study completion, up to 1 year.)
- Adherence to inhaled corticosteroid medication.(At baseline following recruitment to the study and 6 months after achieving mastery of technique.)
- Children's asthma control test (c-ACT) score.(At baseline following recruitment to the study and 6 months after achieving mastery of technique.)
- Number of emergency department and out of hours attendances(At baseline following recruitment to the study and 6 months after achieving mastery of technique.)
- Number of admissions with acute wheeze(At baseline following recruitment to the study and 6 months after achieving mastery of technique.)
- Spirometry(At baseline following recruitment to the study and 6 months after achieving mastery of technique.)
- Fractional exhaled nitric oxide (FeNO)(At baseline following recruitment to the study and 6 months after achieving mastery of technique.)
- Number of prescribed oral corticosteroids(At baseline following recruitment to the study and 6 months after achieving mastery of technique.)
- Mini- paediatric quality of life questionnaire score.(At baseline following recruitment to the study and 6 months after achieving mastery of technique.)
Investigators
Dara O'Donoghue
Clinical Senior Lecturer
Queen's University, Belfast