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| ID | Type | Description | Link |
|---|---|---|---|
| 306829 | Other Identifier | IRAS |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (no financial incentive) | No Intervention | No incentive. Usual care (plus EMD with reminders) for 12-weeks. | |
| Intervention (financial incentive) | Experimental | Financial incentive dependent upon daily medication adherence (plus EMD with reminders) for 12-weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial incentives | Behavioral | Financial incentives dependent upon adherence will be given to participants alongside additional EMD associated app features for 12-weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Comparison between groups at study visit 2 (12-weeks) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Maconochie | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mary's Hospital | London | W2 1NY | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (no Financial Incentive) | No incentive. Usual care (plus EMD with reminders) for 12-weeks. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (no Financial Incentive) | No incentive. Usual care (plus EMD with reminders) for 12-weeks. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Full Range | percentage adherence | Comparison between groups at study visit 2 (12-weeks) |
|
Throughout study duration: 0-24-weeks
It was unlikely any participants were at risk throughout this study as it was an interventional study using adherence monitoring and reminders (plus financial incentives for intervention participants)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (no Financial Incentive) | No incentive. Usual care (plus EMD with reminders) for 12-weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma attack | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Number of asthma attacks were primarily data collected as an outcome measures for this study, but are also detailed here. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Louise Fleming | Imperial College London | 02073528121 | 2938 | l.fleming@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2023 | Jul 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| 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. | 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) |
| 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. | 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 (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. | 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 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. | 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 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 % ICS adherence in control from study visit 2 (12-weeks) to study visit 3 (24-weeks) |
| 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). | 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) | 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) |
| 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. | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
| 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. | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
| 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 | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
| 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 | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
| 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 | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
| 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 | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Time since ED presentation | Median | Full Range | days |
|
| English primary language at home | Count of Participants | Participants |
|
| Asthma Control Test (ACT) | Asthma Control Test (ACT) is a questionnaire measuring asthma control over the past 4-weeks. It consists of 5 questions, each of which are scored using a 5 point Likert scale. A total score is calculated; the minimum possible score is 5 and maximum possible score is 25; a score of 19 and below indicates poor asthma control. | Median | Full Range | units on a scale |
|
| Maintenance asthma treatment | Count of Participants | Participants |
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| Maintenance asthma treatment step | Count of Participants | Participants |
|
| Maintenance and Reliever Treatment (MART) regime | Count of Participants | Participants |
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| Multiple daily asthma medications | Count of Participants | Participants |
|
| Medication Adherence Reporting Scale for Asthma (MARS-A) | Medication Adherence Reporting Scale for Asthma (MARS-A) is a measure of maintenance treatment adherence. It consists of 10 questions, each question is scored using a Likert scale of 1-5. An average score from all questions is calculated. A minimum possible score is 1 and a maximum score is 5; a score of 4.5 and above indicates high levels of maintenance treatment adherence. | Median | Full Range | units on a scale |
|
| Illness perceptions (Brief Illness Perceptions Questionnaire, B-IPQ) | Brief Illness Perceptions Questionnaire (B-IPQ) is a measure of illness perceptions. It consists of 8 questions, each question is score on a scale of 0-10 and overall score is calculated. Minimum score is 0 and maximum score is 80. Those with a higher overall score perceive their illness as more threatening. | Median | Full Range | units on a scale |
|
| Habit (Self Report Behavioural Automaticity Index, SRBAI) | Self-Report Behavioural Automaticity Index (SRBAI) is a measure of habit. It consists of 4 questions, each question is scored using a Likert scale of 1-5. The average of all questions is calculated, minimum score of 1 and maximum score of 5 and higher scores indicate stronger habit. | Mean | Standard Deviation | units on a scale |
|
| Beliefs in Medicine (BMQ) - Necessity | Belief in Medicines Questionnaire (BMQ) is a questionnaire to measure beliefs about medicines. It consists of 18 questions, each question is scores using a Likert scale of 1-5. The BMQ is interpreted in 4 sub-sets. 'Necessity' is a sub-set which is calculated from total of questions 1-5 (minimum score 5, maximum score 25), a higher score indicates high levels of belief in the need for medicines. | Mean | Standard Deviation | units on a scale |
|
| Beliefs in Medicine (BMQ) - Concerns | Belief in Medicines Questionnaire (BMQ) is a questionnaire to measure beliefs about medicines. It consists of 18 questions, each question is scores using a Likert scale of 1-5. The BMQ is interpreted in 4 sub-sets. 'Concerns' is a sub-set which is calculated from total of questions 6-10 (minimum score 5, maximum score 25), a higher score indicates high levels of belief in concern of medicines. | Mean | Standard Deviation | units on a scale |
|
| Beliefs in Medicine (BMQ) - Harm | Belief in Medicines Questionnaire (BMQ) is a questionnaire to measure beliefs about medicines. It consists of 18 questions, each question is scores using a Likert scale of 1-5. The BMQ is interpreted in 4 sub-sets. 'Harm' is a sub-set which is calculated from an average of questions 11-14 (minimum score 4, maximum score 20), a higher score indicates high levels of belief in the harm for medicines. | Median | Full Range | units on a scale |
|
| Beliefs in Medicine (BMQ) - Overuse | Belief in Medicines Questionnaire (BMQ) is a questionnaire to measure beliefs about medicines. It consists of 18 questions, each question is scores using a Likert scale of 1-5. The BMQ is interpreted in 4 sub-sets. 'Overuse' is a sub-set which is calculated from total of questions 15-18 (minimum score 4, maximum 20), a higher score indicates high levels of belief in the overuse of medicines. | Median | Full Range | units on a scale |
|
| Motivation (adapted Treatment Self-Regulation Questionnaire, TSRQ) - autonomous | Treatment Self-Regulation Questionnaire (TSRQ) was adapted for this study to measure autonomous and controlled motivation. It consists of 8 questions, each question is scored using a Likert scale of 1-7. Autonomous motivation is measured from 4 questions and controlled motivation is measured from the other 4 questions; a total score is calculated with a minimum of 4 and a maximum of 28. The motivation component with the highest total score (e.g., autonomous or controlled) reflects whether an individual is more motivated by external or internal sources. | Median | Full Range | units on a scale |
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| Motivation (adapted Treatment Self-Regulation Questionnaire, TSRQ) - controlled | Treatment Self-Regulation Questionnaire (TSRQ) was adapted for this study to measure autonomous and controlled motivation. It consists of 8 questions, each question is scored using a Likert scale of 1-7. Autonomous motivation is measured from 4 questions and controlled motivation is measured from the other 4 questions; a total score is calculated with a minimum of 4 and a maximum of 28. The motivation component with the highest total score (e.g., autonomous or controlled) reflects whether an individual is more motivated by external or internal sources. | Mean | Standard Deviation | units on a scale |
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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.
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| 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. | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Number | participants | study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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. | Number of participants decreased between 12- and 24-weeks due to participant withdrawal | Posted | Count of Participants | Participants | study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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. | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Median | Full Range | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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. | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Median | Full Range | ppb | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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. | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Median | Full Range | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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. | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Mean | Standard Deviation | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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. | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Median | Full Range | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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). | Posted | Median | Full Range | percentage of adherence | Change in % ICS adherence in control from study visit 2 (12-weeks) to study visit 3 (24-weeks) |
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| 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). | Posted | Median | Full Range | percentage of adherence | Change in % ICS adherence in intervention from study visit 2 (12-weeks) to study visit 3 (24-weeks) |
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| 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). | Posted | Median | Full Range | percentage of adherence | Comparison between groups at 24-weeks (follow-up) |
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| 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). | Posted | Number | Number of attacks | study visit 3 (24-weeks) |
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| 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. | Self-reported number of asthma attacks collected was too low to calculate the incident rate ratio of asthma exacerbations. | Posted | Mean | Standard Deviation | ratio (unitless number) | study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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. | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Median | Full Range | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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. | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Mean | Standard Deviation | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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 | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Mean | Standard Deviation | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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 | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Mean | Standard Deviation | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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 | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Median | Full Range | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 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 | Participant numbers decrease between baseline, 12-weeks and 24-weeks due to participant withdrawal | Posted | Median | Full Range | score on a scale | study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks) |
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| 0 |
| 16 |
| 1 |
| 16 |
| 0 |
| 16 |
| EG001 | 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. | 0 | 16 | 3 | 16 | 0 | 16 |
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Not provided
Not provided
Not provided
| D001519 | Behavior |
| 24-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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| 12-weeks |
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| 24-weeks |
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