Financial Incentives to Improve Adherence to Inhaled Asthma Medications in Children and Young People With Asthma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Asthma in Children
- Sponsor
- Imperial College London
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Comparison of Percentage ICS Adherence Between Groups at 12-weeks
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The aim of this pilot randomised controlled trial is to assess the effectiveness of a short-term financial incentives intervention at bringing about behaviour change, namely short-medium term improvements in inhaled corticosteroid (ICS) adherence and asthma control in children and young people (CYP) with asthma.
Detailed Description
After obtaining informed consent from parents (and assent from the CYP), CYP will be enrolled in a 24-week programme. All participants will receive an electronic monitoring device (EMD) which will be programmed with twice daily audio-visual reminders and will be required to download the EMD-associated App onto their smartphones. All participants will be required to attend 3 study visits at 0 weeks (baseline), 12-weeks and 24-weeks (follow-up). At baseline participants will be assessed for inhaler technique and given an asthma action plan (if they do not have one already) and will be randomised to either the control group or the intervention group. Intervention period will run between study visit 1 (0-weeks) and study visit 2 (12-weeks). Over the intervention period, participants in the intervention group will use their EMD with reminders, but will also be given financial incentives dependent upon their daily adherence and will have access to some additional EMD-associated app features (including notifications, a reward totaliser and a traffic light calendar to monitor progress). Control group participants will receive their usual care plus the use of EMD with reminders over the intervention period. After the intervention period (at study visit 2), intervention participants will no longer receive rewards or be able to access the additional app features. All participants (control and intervention) will be able to use their EMD with reminders for the final 12-week follow-up period. After completion of the 24-week programme, all participants will be required to return their EMD devices and will be invited to a focus group to share experiences and feedback of the trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent obtained from parent/guardian and assent from child.
- •CYP with doctor diagnosed asthma presenting to Emergency Department (ED) with a severe asthma exacerbation (as defined by ERS/ATS guidelines).
- •Aged between 11 and 17 years old
- •Prescribed maintenance inhaled corticosteroids (ICS) (which can include maintenance and reliever therapy MART) for at least 6-months.
- •Own their own mobile smartphone (running Android 8 or higher, or iOS 13 or higher)
- •Prescribed the following inhalers: Clenil, Flixotide, Symbicort, Seretide
Exclusion Criteria
- •Parent/guardian / CYP unable to provide consent / assent
- •CYP with other, co-existing respiratory conditions
- •Parent/guardian/CYP who are not fluent or able to understand the information provided in English.
- •CYP who are involved in other intervention research studies (including CTIMPs)
Outcomes
Primary Outcomes
Comparison of Percentage ICS Adherence Between Groups at 12-weeks
Time Frame: Comparison between groups at study visit 2 (12-weeks)
Comparison of average % ICS adherence measured by EMD for intervention group participants and average % ICS adherence measured by EMD for control group participants at 12-weeks (post-intervention period). EMD will electronically record date/time of asthma inhaler actuation. Data from EMD will be downloaded at study visit/s. Possible scores: 0% (poor adherence) to 100% (good adherence).
Secondary Outcomes
- Proportion of Participants Achieving Good Asthma Adherence (≥80%)(study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS)(study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Asthma Control(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Exhaled Nitric Oxide(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Brief Illness Perceptions Questionnaire (B-IPQ)(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Habit(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Change in Percentage ICS Adherence for Control Participants Between 12-weeks and 24-weeks(Change in % ICS adherence in control from study visit 2 (12-weeks) to study visit 3 (24-weeks))
- Self-reported Adherence(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Change in Percentage ICS Adherence for Intervention Participants Between 12-weeks and 24-weeks(Change in % ICS adherence in intervention from study visit 2 (12-weeks) to study visit 3 (24-weeks))
- Comparison of Percentage ICS Adherence Between Groups at 24-weeks (Follow-up)(Comparison between groups at 24-weeks (follow-up))
- Total Number of Asthma Attacks Over the Course of the Study(study visit 3 (24-weeks))
- Incident Rate Ratio of Asthma Exacerbations(study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Autonomous Motivation(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Controlled Motivation(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Belief in Medicine Questionnaire (BMQ) - Necessity(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Belief in Medicine Questionnaire (BMQ) - Concern(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Belief in Medicine Questionnaire (BMQ) - Harm(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))
- Belief in Medicine Questionnaire (BMQ) - Over-use(study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks))