Optimising Inhaler Technique and Asthma Self-management in Children and Young People

NCT ID: NCT06531096

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2024-09-01

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.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group- v-DOT

The intervention group will have the v-DOT (video directly observed therapy) 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 audio videos will be time/date stamped and forwarded to the secure repository. Depending on the prescribed frequency of the preventer asthma and allergic rhinitis inhalers or sprays these audio videos will be uploaded once or twice-daily. These videos will be reviewed every morning by the lead researcher (trained in inhaler and nasal spray technique assessment and training) who will provide feedback via email or an instant messenger service. Videos will be evaluated using an inhaler/ nasal spray checklist.

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).

Group Type: EXPERIMENTAL

v-DOT

Intervention Type: BEHAVIORAL

Video directly observed therapy

Control group- standard care

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 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 their PAAP.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

v-DOT

Video directly observed therapy

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Dara O'Donoghue

Clinical Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dara O'Donoghue, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Belfast Health and Social care trust

Belfast, , United Kingdom

Countries

United Kingdom

Other Identifiers

293828

Identifier Type: -

Identifier Source: org_study_id