Financial Incentives to Improve Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Financial Incentives to Improve Adherence to Inhaled Asthma Medications in Children and Young People With Asthma

Conditions
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Asthma in Children, Medication Adherence

Intervention / Treatment
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* Behavioral: Financial incentives


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (no financial incentive)<br>No incentive. Usual care (plus EMD with reminders) for 12-weeks. | |
| Experimental: Intervention (financial incentive)<br>Financial incentive dependent upon daily medication adherence (plus EMD with reminders) for 12-weeks. | Behavioral: Financial incentives<br>* Financial incentives dependent upon adherence will be given to participants alongside additional EMD associated app features for 12-weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of percentage ICS adherence between groups at 12-weeks | Average % ICS adherence measured by EMD. 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). | Comparison between groups at study visit 2 (12-weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving good asthma adherence (≥80%) | The proportion of participants is defined as number of participants achieving an average % ICS adherence measured by EMD of 80% and above from each group (intervention or control)bat study visit 2 and study visit 3. Within and between group comparisons between groups will be explored. | study visit 2 (12-weeks) and study visit 3 (24-weeks) | 
| Time to next asthma exacerbation needing a course of oral corticosteroids (OCS) | Numbers of days since previous study visit until time of next asthma exacerbations will be recorded by self-report from parents/child at study visit 2 and 3. Within and between group comparisons between groups will be explored. | study visit 2 (12-weeks) and study visit 3 (24-weeks) | 
| Asthma Control | Measured by validated, self-report Asthma Control Test (ACT). Minimum score of 0 - maximum score of 25. Higher scores = well controlled asthma. Within and between group comparisons between groups will be explored at all study visits. | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 
| Exhaled nitric oxide | Measured by FENO which measures nitric oxide level in parts per billion (PPB) in the air you slowly exhale out of child's lungs to be completed by child at each study visit. For children, <20 ppb is low/normal and >35ppb is high. Within and between group comparisons between groups will be explored. | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 
| Belief in Medicine Questionnaire (BMQ) | A self-report validated questionnaire to explore the child's belief in their asthma medicines will be conducted at each study visit. Within and between group comparisons between groups will be explored. The questionnaire is split into 1) BMQ specific (medicines prescribed to child) that has 10 items and 2) BMQ - general (medicines in general) that has 8 items - all with a likert scale response of strongly agree - strongly disagree. Questions can be grouped into: necessity, concern, harm and over-use. | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 
| Brief Illness Perceptions Questionnaire (B-IPQ) | A self-report validated questionnaire to explore the child's perceptions of their asthma will be conducted at each study visit. Within and between group comparisons between groups will be explored. The B-IPQ has 8 items with a 0-10 scoring system. Overall score indicates degree in which illness is perceived threatening - higher scorer = more threatening view. | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 
| Habit | Measured by validated questionnaire the self-report behavioural automaticity index (SRBAI) to be conducted at each study visit. Within and between group comparisons between groups will be explored. The questionnaire has 4-questions which are rated on a likert scale of strongly agree - strongly disagree. | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 
| Autonomous and controlled motivation | Measured by an adaptation of the Treatment Self-Regulation Questionnaire (TSRQ) for the purpose of this study. Within and between group comparisons will be explored. There are 4 items for autonomous motivation and 4 items for controlled motivation. All items are scores on a scale of 0 (not at all true) and 7 (very true). A high score = higher motivation in either domain. Addition of 2 questions for intervention group only on a similar scoring scale (0 = not at all true - 7 = very true) about the influence of incentives over motivation which will be reported descriptively. | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 
| Self-reported adherence | Measured by the validated Medication Adherence Report Scale for Asthma (MARS-A) questionnaire. Within and between group comparisons will be explored. Comparisons against EMD record of adherence will be explored. Questionnaire has 10 items on a scale of 1 = always to 5 = never. Higher score = more adherent. | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 
| Change in percentage ICS adherence | Average % ICS adherence measured by EMD. 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). | Change in % ICS adherence in groups from study visit 2 (12-weeks) to study visit 3 (24-weeks) | 
| Comparison of percentage ICS adherence between groups at 24-weeks (follow-up) | Average % ICS adherence measured by EMD. 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). | Comparison between groups at 24-weeks (follow-up) | 
| Total number of asthma attacks over the course of the study | Self-report measure of the number of asthma attacks from the start of the study (0-weeks) until end of study (24-weeks). | study visit 3 (24-weeks) | 
| Incident rate ratio of asthma exacerbations | Calculation of incident rate ratio of asthma exacerbations based upon self-report number of asthma attacks at study visit 2 and study visit 3 and total number of attacks at 24-weeks | study visit 2 (12-weeks) and study visit 3 (24-weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic monitoring device, Financial incentives, Reminders, Asthma control