Asthma in Children, Medication Adherence
Conditions
Keywords
Electronic monitoring device, Financial incentives, Reminders, Asthma control
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.
Interventions
BEHAVIORALFinancial incentives
Financial incentives dependent upon adherence will be given to participants alongside additional EMD associated app features for 12-weeks.
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Percentage ICS Adherence Between Groups at 12-weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS) | study visit 2 (12-weeks) and study visit 3 (24-weeks) | Numbers of 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. |
| Asthma Control | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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. |
| Exhaled Nitric Oxide | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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. |
| Brief Illness Perceptions Questionnaire (B-IPQ) | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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 which are scored on a Likert scale 0-10 scoring system and an overall score is calculated. Minimum score is 0 and maximum score is 80. Overall score indicates degree in which illness is perceived threatening - higher scorer = more threatening view. |
| Habit | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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 (1) - strongly disagree (5). An average of all 4 questions is calculated (minimum score 1, maximum score 5), 1 means no habit and 5 means strong habit. |
| Self-reported Adherence | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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 Likert scale. An average of all items is calculated, minimum score 1 and maximum score 5. A score of 4.5 and above indicates high adherence. |
| 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) | Change in % ICS adherence for control group between 12-weeks and 24-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). |
| 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) | Change in % ICS adherence for intervention group between 12-weeks and 24-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). |
| Proportion of Participants Achieving Good Asthma Adherence (≥80%) | study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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. |
| Total Number of Asthma Attacks Over the Course of the Study | study visit 3 (24-weeks) | Self-report measure of the number of asthma attacks from the start of the study (0-weeks) until end of study (24-weeks). |
| Incident Rate Ratio of Asthma Exacerbations | study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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. |
| Autonomous Motivation | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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. All items are scores on a scale of 0 (not at all true) and 7 (very true). A total score is calculated from all 4 questions, minimum score 4 and maximum score 28. A higher 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. |
| Controlled Motivation | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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 controlled motivation. All items are scores on a scale of 0 (not at all true) and 7 (very true). A total score is calculated from all 4 questions, minimum score 4 and maximum score 28. A higher 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. |
| Belief in Medicine Questionnaire (BMQ) - Necessity | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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. Total scores for Necessity: 5 = low belief in need for medicine; 25 = high belief in need for medicine |
| Belief in Medicine Questionnaire (BMQ) - Concern | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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. Total score for concern: 5 = low belief in concern of medicine; 25 = high belief in concern of medicine |
| Belief in Medicine Questionnaire (BMQ) - Harm | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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. Total harm score: 4 = low belief in harm of medicine; 20 = high belief in harm of medicine |
| Belief in Medicine Questionnaire (BMQ) - Over-use | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) | 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. Total over-use score: 4 = low belief in medicine over-use; 20 = high belief in medicine over-use |
| Comparison of Percentage ICS Adherence Between Groups at 24-weeks (Follow-up) | Comparison 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). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control (no Financial Incentive) No incentive. Usual care (plus EMD with reminders) for 12-weeks. | 16 |
| Intervention (Financial Incentive) Financial incentive dependent upon daily medication adherence (plus EMD with reminders) for 12-weeks.
Financial incentives: Financial incentives dependent upon adherence will be given to participants alongside additional EMD associated app features for 12-weeks. | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Control (no Financial Incentive) | Total | Intervention (Financial Incentive) |
|---|---|---|---|
| Age, Continuous | 13.31 years STANDARD_DEVIATION 1.58 | 13.4 years STANDARD_DEVIATION 1.64 | 13.50 years STANDARD_DEVIATION 1.75 |
| Asthma Control Test (ACT) | 20.5 units on a scale | 20 units on a scale | 20 units on a scale |
| Beliefs in Medicine (BMQ) - Concerns | 15.63 units on a scale STANDARD_DEVIATION 2.33 | 14.97 units on a scale STANDARD_DEVIATION 2.96 | 14.31 units on a scale STANDARD_DEVIATION 3.42 |
| Beliefs in Medicine (BMQ) - Harm | 12.5 units on a scale | 12 units on a scale | 12 units on a scale |
| Beliefs in Medicine (BMQ) - Necessity | 15.19 units on a scale STANDARD_DEVIATION 3.33 | 14.69 units on a scale STANDARD_DEVIATION 3.28 | 14.19 units on a scale STANDARD_DEVIATION 3.25 |
| Beliefs in Medicine (BMQ) - Overuse | 15 units on a scale | 15 units on a scale | 15 units on a scale |
| English primary language at home | 11 Participants | 25 Participants | 14 Participants |
| Habit (Self Report Behavioural Automaticity Index, SRBAI) | 2.75 units on a scale STANDARD_DEVIATION 1.09 | 2.83 units on a scale STANDARD_DEVIATION 0.88 | 2.91 units on a scale STANDARD_DEVIATION 0.63 |
| Illness perceptions (Brief Illness Perceptions Questionnaire, B-IPQ) | 26 units on a scale | 32 units on a scale | 33 units on a scale |
| Maintenance and Reliever Treatment (MART) regime | 0 Participants | 3 Participants | 3 Participants |
| Maintenance asthma treatment Clenil modulite | 4 Participants | 15 Participants | 11 Participants |
| Maintenance asthma treatment Seretide Evohaler | 6 Participants | 7 Participants | 1 Participants |
| Maintenance asthma treatment Symbicort Turbohaler | 6 Participants | 10 Participants | 4 Participants |
| Maintenance asthma treatment step Combination (ICS/LABA) | 12 Participants | 17 Participants | 5 Participants |
| Maintenance asthma treatment step ICS-only | 4 Participants | 15 Participants | 11 Participants |
| Medication Adherence Reporting Scale for Asthma (MARS-A) | 4.20 units on a scale | 4.20 units on a scale | 4.10 units on a scale |
| Motivation (adapted Treatment Self-Regulation Questionnaire, TSRQ) - autonomous | 22.50 units on a scale | 22.50 units on a scale | 22.50 units on a scale |
| Motivation (adapted Treatment Self-Regulation Questionnaire, TSRQ) - controlled | 18.19 units on a scale STANDARD_DEVIATION 5.39 | 17.50 units on a scale STANDARD_DEVIATION 5.2 | 16.81 units on a scale STANDARD_DEVIATION 5.08 |
| Multiple daily asthma medications + 1 other medication | 5 Participants | 8 Participants | 3 Participants |
| Multiple daily asthma medications + 2 other medication | 3 Participants | 3 Participants | 0 Participants |
| Multiple daily asthma medications + 3 other medication | 0 Participants | 1 Participants | 1 Participants |
| Multiple daily asthma medications Asthma maintenance treatment alone | 8 Participants | 20 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian or Asian British | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Black, African, Caribbean, or Black British | 5 Participants | 10 Participants | 5 Participants |
| Race/Ethnicity, Customized Mixed, Mulitple ethnic groups | 4 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Other ethnic group | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 21 Participants | 11 Participants |
| Time since ED presentation | 35.5 days | 41 days | 41 days |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 1 / 16 | 3 / 16 |
Outcome results
Primary
Comparison of Percentage ICS Adherence Between Groups at 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).
Time frame: Comparison between groups at study visit 2 (12-weeks)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (no Financial Incentive) | Comparison of Percentage ICS Adherence Between Groups at 12-weeks | 56 percentage adherence |
| Intervention (Financial Incentive) | Comparison of Percentage ICS Adherence Between Groups at 12-weeks | 73 percentage adherence |
Secondary
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.
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (no Financial Incentive) | Asthma Control | 24-weeks | 22.50 score on a scale |
| Control (no Financial Incentive) | Asthma Control | 12-weeks | 21.00 score on a scale |
| Control (no Financial Incentive) | Asthma Control | 0-weeks (baseline) | 20.50 score on a scale |
| Intervention (Financial Incentive) | Asthma Control | 24-weeks | 24.00 score on a scale |
| Intervention (Financial Incentive) | Asthma Control | 12-weeks | 23.00 score on a scale |
| Intervention (Financial Incentive) | Asthma Control | 0-weeks (baseline) | 20.00 score on a scale |
Secondary
Autonomous 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. All items are scores on a scale of 0 (not at all true) and 7 (very true). A total score is calculated from all 4 questions, minimum score 4 and maximum score 28. A higher 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.
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (no Financial Incentive) | Autonomous Motivation | 0-weeks (baseline) | 22.50 score on a scale |
| Control (no Financial Incentive) | Autonomous Motivation | 12-weeks | 22 score on a scale |
| Control (no Financial Incentive) | Autonomous Motivation | 24-weeks | 26 score on a scale |
| Intervention (Financial Incentive) | Autonomous Motivation | 0-weeks (baseline) | 22.50 score on a scale |
| Intervention (Financial Incentive) | Autonomous Motivation | 12-weeks | 20 score on a scale |
| Intervention (Financial Incentive) | Autonomous Motivation | 24-weeks | 21 score on a scale |
Secondary
Belief in Medicine Questionnaire (BMQ) - Concern
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. Total score for concern: 5 = low belief in concern of medicine; 25 = high belief in concern of medicine
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Concern | 0-weeks (baseline) | 15.63 score on a scale | Standard Deviation 2.33 |
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Concern | 12-weeks | 15.33 score on a scale | Standard Deviation 2.74 |
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Concern | 24-weeks | 16.67 score on a scale | Standard Deviation 3.34 |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Concern | 0-weeks (baseline) | 14.31 score on a scale | Standard Deviation 3.42 |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Concern | 12-weeks | 15.64 score on a scale | Standard Deviation 2.53 |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Concern | 24-weeks | 15.31 score on a scale | Standard Deviation 2.63 |
Secondary
Belief in Medicine Questionnaire (BMQ) - Harm
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. Total harm score: 4 = low belief in harm of medicine; 20 = high belief in harm of medicine
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Harm | 0-weeks (baseline) | 12.5 score on a scale |
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Harm | 12-weeks | 14 score on a scale |
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Harm | 24-weeks | 12.5 score on a scale |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Harm | 0-weeks (baseline) | 12 score on a scale |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Harm | 12-weeks | 12 score on a scale |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Harm | 24-weeks | 13 score on a scale |
Secondary
Belief in Medicine Questionnaire (BMQ) - Necessity
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. Total scores for Necessity: 5 = low belief in need for medicine; 25 = high belief in need for medicine
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Necessity | 0-weeks (baseline) | 15.19 score on a scale | Standard Deviation 3.33 |
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Necessity | 12-weeks | 15.53 score on a scale | Standard Deviation 2.89 |
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Necessity | 24-weeks | 16.17 score on a scale | Standard Deviation 3.25 |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Necessity | 0-weeks (baseline) | 14.19 score on a scale | Standard Deviation 3.25 |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Necessity | 12-weeks | 16.21 score on a scale | Standard Deviation 2.33 |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Necessity | 24-weeks | 14.38 score on a scale | Standard Deviation 3.25 |
Secondary
Belief in Medicine Questionnaire (BMQ) - Over-use
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. Total over-use score: 4 = low belief in medicine over-use; 20 = high belief in medicine over-use
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Over-use | 0-weeks (baseline) | 15 score on a scale |
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Over-use | 12-weeks | 15 score on a scale |
| Control (no Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Over-use | 24-weeks | 15.5 score on a scale |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Over-use | 0-weeks (baseline) | 15 score on a scale |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Over-use | 12-weeks | 14 score on a scale |
| Intervention (Financial Incentive) | Belief in Medicine Questionnaire (BMQ) - Over-use | 24-weeks | 14 score on a scale |
Secondary
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 which are scored on a Likert scale 0-10 scoring system and an overall score is calculated. Minimum score is 0 and maximum score is 80. Overall score indicates degree in which illness is perceived threatening - higher scorer = more threatening view.
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (no Financial Incentive) | Brief Illness Perceptions Questionnaire (B-IPQ) | 0-weeks (baseline) | 26 score on a scale |
| Control (no Financial Incentive) | Brief Illness Perceptions Questionnaire (B-IPQ) | 12-weeks | 23.50 score on a scale |
| Control (no Financial Incentive) | Brief Illness Perceptions Questionnaire (B-IPQ) | 24-weeks | 21.00 score on a scale |
| Intervention (Financial Incentive) | Brief Illness Perceptions Questionnaire (B-IPQ) | 0-weeks (baseline) | 33 score on a scale |
| Intervention (Financial Incentive) | Brief Illness Perceptions Questionnaire (B-IPQ) | 12-weeks | 26 score on a scale |
| Intervention (Financial Incentive) | Brief Illness Perceptions Questionnaire (B-IPQ) | 24-weeks | 26 score on a scale |
Secondary
Change in Percentage ICS Adherence for Control Participants Between 12-weeks and 24-weeks
Change in % ICS adherence for control group between 12-weeks and 24-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).
Time frame: Change in % ICS adherence in control from study visit 2 (12-weeks) to study visit 3 (24-weeks)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (no Financial Incentive) | Change in Percentage ICS Adherence for Control Participants Between 12-weeks and 24-weeks | 56 percentage of adherence |
| Intervention (Financial Incentive) | Change in Percentage ICS Adherence for Control Participants Between 12-weeks and 24-weeks | 31.5 percentage of adherence |
Secondary
Change in Percentage ICS Adherence for Intervention Participants Between 12-weeks and 24-weeks
Change in % ICS adherence for intervention group between 12-weeks and 24-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).
Time frame: Change in % ICS adherence in intervention from study visit 2 (12-weeks) to study visit 3 (24-weeks)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (no Financial Incentive) | Change in Percentage ICS Adherence for Intervention Participants Between 12-weeks and 24-weeks | 73 percentage of adherence |
| Intervention (Financial Incentive) | Change in Percentage ICS Adherence for Intervention Participants Between 12-weeks and 24-weeks | 39 percentage of adherence |
Secondary
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).
Time frame: Comparison between groups at 24-weeks (follow-up)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (no Financial Incentive) | Comparison of Percentage ICS Adherence Between Groups at 24-weeks (Follow-up) | 31.5 percentage of adherence |
| Intervention (Financial Incentive) | Comparison of Percentage ICS Adherence Between Groups at 24-weeks (Follow-up) | 39 percentage of adherence |
Secondary
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 controlled motivation. All items are scores on a scale of 0 (not at all true) and 7 (very true). A total score is calculated from all 4 questions, minimum score 4 and maximum score 28. A higher 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.
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (no Financial Incentive) | Controlled Motivation | 0-weeks (baseline) | 18.19 score on a scale | Standard Deviation 5.39 |
| Control (no Financial Incentive) | Controlled Motivation | 12-weeks | 14.73 score on a scale | Standard Deviation 3.51 |
| Control (no Financial Incentive) | Controlled Motivation | 24-weeks | 17.67 score on a scale | Standard Deviation 5.16 |
| Intervention (Financial Incentive) | Controlled Motivation | 0-weeks (baseline) | 16.81 score on a scale | Standard Deviation 5.08 |
| Intervention (Financial Incentive) | Controlled Motivation | 12-weeks | 17.07 score on a scale | Standard Deviation 4.73 |
| Intervention (Financial Incentive) | Controlled Motivation | 24-weeks | 15.38 score on a scale | Standard Deviation 5.95 |
Secondary
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.
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (no Financial Incentive) | Exhaled Nitric Oxide | 0-weeks | 24 ppb |
| Control (no Financial Incentive) | Exhaled Nitric Oxide | 12-weeks | 55.50 ppb |
| Control (no Financial Incentive) | Exhaled Nitric Oxide | 24-weeks | 46.50 ppb |
| Intervention (Financial Incentive) | Exhaled Nitric Oxide | 0-weeks | 51 ppb |
| Intervention (Financial Incentive) | Exhaled Nitric Oxide | 12-weeks | 66.50 ppb |
| Intervention (Financial Incentive) | Exhaled Nitric Oxide | 24-weeks | 102 ppb |
Secondary
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 (1) - strongly disagree (5). An average of all 4 questions is calculated (minimum score 1, maximum score 5), 1 means no habit and 5 means strong habit.
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (no Financial Incentive) | Habit | 0-weeks (baseline) | 2.75 score on a scale | Standard Deviation 1.09 |
| Control (no Financial Incentive) | Habit | 12-weeks | 2.72 score on a scale | Standard Deviation 0.57 |
| Control (no Financial Incentive) | Habit | 24-weeks | 2.69 score on a scale | Standard Deviation 0.87 |
| Intervention (Financial Incentive) | Habit | 0-weeks (baseline) | 2.91 score on a scale | Standard Deviation 0.63 |
| Intervention (Financial Incentive) | Habit | 12-weeks | 2.50 score on a scale | Standard Deviation 0.83 |
| Intervention (Financial Incentive) | Habit | 24-weeks | 3.06 score on a scale | Standard Deviation 0.69 |
Secondary
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.
Time frame: study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Self-reported number of asthma attacks collected was too low to calculate the incident rate ratio of asthma exacerbations.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control (no Financial Incentive) | Incident Rate Ratio of Asthma Exacerbations | NA ratio (unitless number) |
| Intervention (Financial Incentive) | Incident Rate Ratio of Asthma Exacerbations | NA ratio (unitless number) |
Secondary
Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS)
Numbers of 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.
Time frame: study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Number of participants decreased between 12- and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control (no Financial Incentive) | Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS) | 12-weeks | 1 Participants |
| Control (no Financial Incentive) | Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS) | 24-weeks | 0 Participants |
| Intervention (Financial Incentive) | Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS) | 12-weeks | 2 Participants |
| Intervention (Financial Incentive) | Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS) | 24-weeks | 1 Participants |
Secondary
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.
Time frame: study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (no Financial Incentive) | Proportion of Participants Achieving Good Asthma Adherence (≥80%) | 12-weeks | 1 participants |
| Control (no Financial Incentive) | Proportion of Participants Achieving Good Asthma Adherence (≥80%) | 24-weeks | 0 participants |
| Intervention (Financial Incentive) | Proportion of Participants Achieving Good Asthma Adherence (≥80%) | 12-weeks | 4 participants |
| Intervention (Financial Incentive) | Proportion of Participants Achieving Good Asthma Adherence (≥80%) | 24-weeks | 0 participants |
Secondary
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 Likert scale. An average of all items is calculated, minimum score 1 and maximum score 5. A score of 4.5 and above indicates high adherence.
Time frame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Population: Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (no Financial Incentive) | Self-reported Adherence | 0-weeks (baseline) | 4.20 score on a scale |
| Control (no Financial Incentive) | Self-reported Adherence | 12-weeks | 4.30 score on a scale |
| Control (no Financial Incentive) | Self-reported Adherence | 24-weeks | 4.20 score on a scale |
| Intervention (Financial Incentive) | Self-reported Adherence | 0-weeks (baseline) | 4.1 score on a scale |
| Intervention (Financial Incentive) | Self-reported Adherence | 12-weeks | 4.20 score on a scale |
| Intervention (Financial Incentive) | Self-reported Adherence | 24-weeks | 4.10 score on a scale |
Secondary
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).
Time frame: study visit 3 (24-weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control (no Financial Incentive) | Total Number of Asthma Attacks Over the Course of the Study | 1 Number of attacks |
| Intervention (Financial Incentive) | Total Number of Asthma Attacks Over the Course of the Study | 3 Number of attacks |