Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531096
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2023-12-04
Brief Title:
Optimising Inhaler Technique and Asthma Self-management in Children and Young People
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimising Inhaler Technique and Asthma Self-management in Children and Young People
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 andor 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 andor 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 patients 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 patients 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
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 11 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 andor 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 andor 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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None