Optimising Inhaler Technique and Asthma Self-management in Children and Young People
NCT Number: NCT06531096
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma in Children
Interventions: BEHAVIORAL: v-DOT
Sponsor: Queen's University, Belfast
Sex: ALL
Age: CHILD
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-11-17
Completion Date: 2024-09-01
Locations: Belfast Health and Social care trust, Belfast, BT12 6BA, United Kingdom

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).

Primary Outcome Measures: Mastery of 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)., Once mastery of technique established which is defined as 3 consecutive days of correct technique.|Technique score, 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., Baseline and 1, 3 and 6 months after achieving technique mastery|Personalised asthma action plan (PAAP) understanding., 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., Baseline and 1, 3 and 6 months after achieving technique mastery|Recruitment rates, Recruitment rates and a description of barriers to and how to facilitate., Through study recruitment, an average of 1 year.|Retention rates, Patients who complete full follow up and those who withdraw or fail to complete the full study., At study completion for all participants, up to 2 years.|Qualitative interviews to identify barriers to using video directly observed therapy (v-DOT), 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., 3-6 months after achieving mastery of technique.
Secondary Outcome Measures: Health service resource use and incremental cost-effectiveness., 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)., Through study completion, up to 1 year.|Spirometry, Each child who is old enough to perform spirometry in clinic will have their FEV1 and FVC measured using standardised spirometry equipment. The forced expiratory volume in 1 second (FEV1) is the volume of air exhaled in the first second during forced exhalation after maximal inspiration. Forced vital capacity (FVC), the maximum amount of air that can be exhaled when blowing out as fast as possible. Expressed in litres. This will then be converted to a percentage predicted when compared to others of the same sex, height and weight and expressed as a percentage. A higher percentage meaning better outcomes., At baseline following recruitment to the study and 6 months after achieving mastery of technique.|Fractional exhaled nitric oxide (FeNO), Each child who is old enough to perform spirometry in clinic will have their Fractional exhaled nitric oxide (FeNO) measured using standardised equipment. Result expressed as parts per billion. Minimum value of 0. No maximum value cut off defined. A higher value means worse outcomes., At baseline following recruitment to the study and 6 months after achieving mastery of technique.|Number of prescribed oral corticosteroids, Number of prescribed oral corticosteroids in previous 12 months prior to recruitment and since achieving mastery of technique., At baseline following recruitment to the study and 6 months after achieving mastery of technique.|Number of emergency department and out of hours attendances, Number of emergency department and out of hours attendances with acute wheeze in previous 12 months prior to recruitment and since achieving mastery of technique., At baseline following recruitment to the study and 6 months after achieving mastery of technique.|Number of admissions with acute wheeze, Number of admissions with acute wheeze in previous 12 months prior to recruitment and the 6 months since achieving mastery of technique. Including length of stay in hospital., At baseline following recruitment to the study and 6 months after achieving mastery of technique.|Adherence to inhaled corticosteroid medication., Adherence to inhaled corticosteroid medication (as determined by General Practitioner prescription pick-ups) and analysed using the medication refill adherence approach. Medication refill adherence is the total days supply divided by the total number of days of study participation and multiplied by 100 to provide a percentage adherence value. Minimum value is 0% and maximum is 100%. A value of 100% having the best outcome., At baseline following recruitment to the study and 6 months after achieving mastery of technique.|Children's asthma control test (c-ACT) score., A validated questionnaire which is scored from 0 to 27. A higher score has a better outcome. A score of 19 or lower means the child's asthma has not been well controlled., At baseline following recruitment to the study and 6 months after achieving mastery of technique.|Mini- paediatric quality of life questionnaire score., A validated quality of life questionnaire. Scored from 13 (minimum score) to 91 (maximum score). A higher scores means a better outcome/ less impact on their quality of life., At baseline following recruitment to the study and 6 months after achieving mastery of technique.