Clinical trial NCT06531096: Optimising Inhaler Technique and Asthma Self-management in Children and Young People
Official title: Optimising Inhaler Technique and Asthma Self-management in Children and Young People
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

The intervention group will immediately have the v-DOT App downloaded to their phone or tablet and will be instructed on how to take and upload audio-videos of themselves or their child taking their inhaler and/or nasal spray. The use of v-DOT to upload audio videos with feedback will continue until the patient has uploaded 3 consecutive days of correct technique (up to a maximum of 21 days). Reminders will be sent via email if the patient fails to upload any videos for 24 hours to serve as a prompt for uploading the daily videos.

It is not possible to blind either the participants or the assessors due to the nature of the intervention itself. As this is a pilot study, no sample size has been calculated. A convenience sample will be enrolled over the course of 6-9 months.

Mastery of inhaler technique will be defined as absence of healthcare professional detected errors. Inhaler technique and nasal spray technique will be scored on locally agreed checklists, informed by a scoping review on how inhaler technique is assessed in children and young people and reviewed by the local Asthma multidisciplinary team to agree critical steps. These checklists have been adapted to include "critical errors" in the steps. In addition, a global assessment will be made: correct, partially correct and poor technique. Scoring of inhaler technique will be performed independently by two members of the research team to account for inter-observer variability.

All participants (control and intervention) will be followed up at 1 month, 3 months and 6 months after achieving mastery of technique.

Teaching of the unique personalised asthma action plan (PAAP) is an integral part of the teach back process at the safe asthma discharge care pathway service. The investigators will assess new patient's understanding of their PAAP as they enter the SADCP (prior to education) and compare this to their understanding at follow up. The investigators will compare long term PAAP understanding of the control group (who will have received additional teach back sessions) to the intervention group (who will have received only 1 teach back session). The investigators will also compare patient's understanding of their PAAP with clinical outcomes.

In order to determine if v-DOT has promise of being cost effective in comparison to standard care, a within-study cost-effectiveness analysis will be conducted from the provider perspective (health services).

To explore potential reasons for poor inhaler technique, incorrect implementation of personalised asthma action plans and potential barriers encountered and to evaluate the experiences of the participants to determine if they feel that this method of teaching and monitoring technique is acceptable, participants will be invited to participate in semi-structured interviews.

Eligibility criteria: 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.

Primary outcomes:
measure: Mastery of technique
timeFrame: Once mastery of technique established which is defined as 3 consecutive days of correct technique.
measure: Technique score
timeFrame: Baseline and 1, 3 and 6 months after achieving technique mastery
measure: Personalised asthma action plan (PAAP) understanding.
timeFrame: Baseline and 1, 3 and 6 months after achieving technique mastery
measure: Recruitment rates
timeFrame: Through study recruitment, an average of 1 year.
measure: Retention rates
timeFrame: At study completion for all participants, up to 2 years.
measure: Qualitative interviews to identify barriers to using video directly observed therapy (v-DOT)
timeFrame: 3-6 months after achieving mastery of technique.
Secondary outcomes:
measure: Health service resource use and incremental cost-effectiveness.
timeFrame: Through study completion, up to 1 year.
measure: Spirometry
timeFrame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
measure: Number of prescribed oral corticosteroids
timeFrame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
measure: Number of emergency department and out of hours attendances
timeFrame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
measure: Number of admissions with acute wheeze
timeFrame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
measure: Adherence to inhaled corticosteroid medication.
timeFrame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
measure: Children's asthma control test (c-ACT) score.
timeFrame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
measure: Mini- paediatric quality of life questionnaire score.
timeFrame: At baseline following recruitment to the study and 6 months after achieving mastery of technique.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Health and Social care trust
Study officials:
affiliation: Queen's University, Belfast
name: Dara O'Donoghue, MD
role: PRINCIPAL_INVESTIGATOR
References: