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

NCT06531096 | Active Not Recruiting

• 1 other identifier: 293828
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Health service resource use and incremental cost-effectiveness.

  Through study completion, up to 1 year.

• 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.

• Number of emergency department and out of hours attendances

  At baseline following recruitment to the study and 6 months after achieving mastery of technique.

Study Arms (2)

Intervention group- v-DOT

EXPERIMENTAL

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).

Behavioral: v-DOT

Control group- standard care

NO 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 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.

Interventions

v-DOT BEHAVIORAL

Video directly observed therapy

Intervention group- v-DOT

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• rd 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Belfast Health and Social care trust

Belfast, BT12 6BA, United Kingdom

Location

Study Officials

• Dara O'Donoghue, MD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Senior Lecturer

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: July 31, 2024
• Study Start: November 17, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)