Trial Outcomes & Findings for Financial Incentives to Improve Asthma (NCT NCT05322044)
NCT ID: NCT05322044
Last Updated: 2025-02-05
Results Overview
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).
COMPLETED
NA
32 participants
Comparison between groups at study visit 2 (12-weeks)
2025-02-05
Participant Flow
Participant milestones
| Measure |
Control (no Financial Incentive)
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Financial Incentives to Improve Asthma
Baseline characteristics by cohort
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.31 years
STANDARD_DEVIATION 1.58 • n=99 Participants
|
13.50 years
STANDARD_DEVIATION 1.75 • n=107 Participants
|
13.4 years
STANDARD_DEVIATION 1.64 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed, Mulitple ethnic groups
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian British
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black, African, Caribbean, or Black British
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other ethnic group
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Time since ED presentation
|
35.5 days
n=99 Participants
|
41 days
n=107 Participants
|
41 days
n=206 Participants
|
|
English primary language at home
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Asthma Control Test (ACT)
|
20.5 units on a scale
n=99 Participants
|
20 units on a scale
n=107 Participants
|
20 units on a scale
n=206 Participants
|
|
Maintenance asthma treatment
Clenil modulite
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Maintenance asthma treatment
Symbicort Turbohaler
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Maintenance asthma treatment
Seretide Evohaler
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Maintenance asthma treatment step
Combination (ICS/LABA)
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Maintenance asthma treatment step
ICS-only
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Maintenance and Reliever Treatment (MART) regime
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Multiple daily asthma medications
Asthma maintenance treatment alone
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Multiple daily asthma medications
+ 1 other medication
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Multiple daily asthma medications
+ 2 other medication
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Multiple daily asthma medications
+ 3 other medication
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Medication Adherence Reporting Scale for Asthma (MARS-A)
|
4.20 units on a scale
n=99 Participants
|
4.10 units on a scale
n=107 Participants
|
4.20 units on a scale
n=206 Participants
|
|
Illness perceptions (Brief Illness Perceptions Questionnaire, B-IPQ)
|
26 units on a scale
n=99 Participants
|
33 units on a scale
n=107 Participants
|
32 units on a scale
n=206 Participants
|
|
Habit (Self Report Behavioural Automaticity Index, SRBAI)
|
2.75 units on a scale
STANDARD_DEVIATION 1.09 • n=99 Participants
|
2.91 units on a scale
STANDARD_DEVIATION 0.63 • n=107 Participants
|
2.83 units on a scale
STANDARD_DEVIATION 0.88 • n=206 Participants
|
|
Beliefs in Medicine (BMQ) - Necessity
|
15.19 units on a scale
STANDARD_DEVIATION 3.33 • n=99 Participants
|
14.19 units on a scale
STANDARD_DEVIATION 3.25 • n=107 Participants
|
14.69 units on a scale
STANDARD_DEVIATION 3.28 • n=206 Participants
|
|
Beliefs in Medicine (BMQ) - Concerns
|
15.63 units on a scale
STANDARD_DEVIATION 2.33 • n=99 Participants
|
14.31 units on a scale
STANDARD_DEVIATION 3.42 • n=107 Participants
|
14.97 units on a scale
STANDARD_DEVIATION 2.96 • n=206 Participants
|
|
Beliefs in Medicine (BMQ) - Harm
|
12.5 units on a scale
n=99 Participants
|
12 units on a scale
n=107 Participants
|
12 units on a scale
n=206 Participants
|
|
Beliefs in Medicine (BMQ) - Overuse
|
15 units on a scale
n=99 Participants
|
15 units on a scale
n=107 Participants
|
15 units on a scale
n=206 Participants
|
|
Motivation (adapted Treatment Self-Regulation Questionnaire, TSRQ) - autonomous
|
22.50 units on a scale
n=99 Participants
|
22.50 units on a scale
n=107 Participants
|
22.50 units on a scale
n=206 Participants
|
|
Motivation (adapted Treatment Self-Regulation Questionnaire, TSRQ) - controlled
|
18.19 units on a scale
STANDARD_DEVIATION 5.39 • n=99 Participants
|
16.81 units on a scale
STANDARD_DEVIATION 5.08 • n=107 Participants
|
17.50 units on a scale
STANDARD_DEVIATION 5.20 • n=206 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control (no Financial Incentive)
n=13 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=11 Participants
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.
|
|---|---|---|
|
Comparison of Percentage ICS Adherence Between Groups at 12-weeks
|
56 percentage adherence
Interval 7.0 to 87.0
|
73 percentage adherence
Interval 23.0 to 89.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=13 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=11 Participants
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.
|
|---|---|---|
|
Proportion of Participants Achieving Good Asthma Adherence (≥80%)
12-weeks
|
1 participants
|
4 participants
|
|
Proportion of Participants Achieving Good Asthma Adherence (≥80%)
24-weeks
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=14 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=15 Participants
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.
|
|---|---|---|
|
Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS)
12-weeks
|
1 Participants
|
2 Participants
|
|
Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS)
24-weeks
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Asthma Control
24-weeks
|
22.50 score on a scale
Interval 14.0 to 25.0
|
24.00 score on a scale
Interval 17.0 to 25.0
|
|
Asthma Control
0-weeks (baseline)
|
20.50 score on a scale
Interval 12.0 to 25.0
|
20.00 score on a scale
Interval 10.0 to 25.0
|
|
Asthma Control
12-weeks
|
21.00 score on a scale
Interval 13.0 to 25.0
|
23.00 score on a scale
Interval 11.0 to 25.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=15 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Exhaled Nitric Oxide
0-weeks
|
24 ppb
Interval 5.0 to 122.0
|
51 ppb
Interval 7.0 to 300.0
|
|
Exhaled Nitric Oxide
12-weeks
|
55.50 ppb
Interval 8.0 to 145.0
|
66.50 ppb
Interval 23.0 to 205.0
|
|
Exhaled Nitric Oxide
24-weeks
|
46.50 ppb
Interval 11.0 to 56.0
|
102 ppb
Interval 87.0 to 121.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Brief Illness Perceptions Questionnaire (B-IPQ)
12-weeks
|
23.50 score on a scale
Interval 9.0 to 55.0
|
26 score on a scale
Interval 3.0 to 55.0
|
|
Brief Illness Perceptions Questionnaire (B-IPQ)
24-weeks
|
21.00 score on a scale
Interval 10.0 to 25.0
|
26 score on a scale
Interval 2.0 to 47.0
|
|
Brief Illness Perceptions Questionnaire (B-IPQ)
0-weeks (baseline)
|
26 score on a scale
Interval 6.0 to 46.0
|
33 score on a scale
Interval 12.0 to 49.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Habit
0-weeks (baseline)
|
2.75 score on a scale
Standard Deviation 1.09
|
2.91 score on a scale
Standard Deviation 0.63
|
|
Habit
12-weeks
|
2.72 score on a scale
Standard Deviation 0.57
|
2.50 score on a scale
Standard Deviation 0.83
|
|
Habit
24-weeks
|
2.69 score on a scale
Standard Deviation 0.87
|
3.06 score on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Self-reported Adherence
24-weeks
|
4.20 score on a scale
Interval 3.2 to 4.9
|
4.10 score on a scale
Interval 3.1 to 4.9
|
|
Self-reported Adherence
0-weeks (baseline)
|
4.20 score on a scale
Interval 2.9 to 4.7
|
4.1 score on a scale
Interval 2.6 to 4.7
|
|
Self-reported Adherence
12-weeks
|
4.30 score on a scale
Interval 2.7 to 4.8
|
4.20 score on a scale
Interval 3.0 to 4.9
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control (no Financial Incentive)
n=13 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=12 Participants
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.
|
|---|---|---|
|
Change in Percentage ICS Adherence for Control Participants Between 12-weeks and 24-weeks
|
56 percentage of adherence
Interval 7.0 to 87.0
|
31.5 percentage of adherence
Interval 3.0 to 62.0
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control (no Financial Incentive)
n=11 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=8 Participants
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.
|
|---|---|---|
|
Change in Percentage ICS Adherence for Intervention Participants Between 12-weeks and 24-weeks
|
73 percentage of adherence
Interval 23.0 to 89.0
|
39 percentage of adherence
Interval 0.0 to 72.0
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control (no Financial Incentive)
n=8 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=12 Participants
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.
|
|---|---|---|
|
Comparison of Percentage ICS Adherence Between Groups at 24-weeks (Follow-up)
|
31.5 percentage of adherence
Interval 3.0 to 62.0
|
39 percentage of adherence
Interval 0.0 to 72.0
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control (no Financial Incentive)
n=12 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=13 Participants
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.
|
|---|---|---|
|
Total Number of Asthma Attacks Over the Course of the Study
|
1 Number of attacks
|
3 Number of attacks
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=14 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=15 Participants
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.
|
|---|---|---|
|
Incident Rate Ratio of Asthma Exacerbations
|
NA ratio (unitless number)
Standard Deviation NA
Self-reported number of asthma attacks collected was too low to calculate the incident rate ratio of asthma exacerbations
|
NA ratio (unitless number)
Standard Deviation NA
Self-reported number of asthma attacks collected was too low to calculate the incident rate ratio of asthma exacerbations
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Autonomous Motivation
0-weeks (baseline)
|
22.50 score on a scale
Interval 8.0 to 28.0
|
22.50 score on a scale
Interval 13.0 to 28.0
|
|
Autonomous Motivation
24-weeks
|
26 score on a scale
Interval 14.0 to 27.0
|
21 score on a scale
Interval 6.0 to 27.0
|
|
Autonomous Motivation
12-weeks
|
22 score on a scale
Interval 12.0 to 27.0
|
20 score on a scale
Interval 15.0 to 27.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Controlled Motivation
12-weeks
|
14.73 score on a scale
Standard Deviation 3.51
|
17.07 score on a scale
Standard Deviation 4.73
|
|
Controlled Motivation
24-weeks
|
17.67 score on a scale
Standard Deviation 5.16
|
15.38 score on a scale
Standard Deviation 5.95
|
|
Controlled Motivation
0-weeks (baseline)
|
18.19 score on a scale
Standard Deviation 5.39
|
16.81 score on a scale
Standard Deviation 5.08
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Belief in Medicine Questionnaire (BMQ) - Necessity
0-weeks (baseline)
|
15.19 score on a scale
Standard Deviation 3.33
|
14.19 score on a scale
Standard Deviation 3.25
|
|
Belief in Medicine Questionnaire (BMQ) - Necessity
12-weeks
|
15.53 score on a scale
Standard Deviation 2.89
|
16.21 score on a scale
Standard Deviation 2.33
|
|
Belief in Medicine Questionnaire (BMQ) - Necessity
24-weeks
|
16.17 score on a scale
Standard Deviation 3.25
|
14.38 score on a scale
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Belief in Medicine Questionnaire (BMQ) - Concern
0-weeks (baseline)
|
15.63 score on a scale
Standard Deviation 2.33
|
14.31 score on a scale
Standard Deviation 3.42
|
|
Belief in Medicine Questionnaire (BMQ) - Concern
12-weeks
|
15.33 score on a scale
Standard Deviation 2.74
|
15.64 score on a scale
Standard Deviation 2.53
|
|
Belief in Medicine Questionnaire (BMQ) - Concern
24-weeks
|
16.67 score on a scale
Standard Deviation 3.34
|
15.31 score on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Belief in Medicine Questionnaire (BMQ) - Harm
12-weeks
|
14 score on a scale
Interval 9.0 to 17.0
|
12 score on a scale
Interval 10.0 to 17.0
|
|
Belief in Medicine Questionnaire (BMQ) - Harm
24-weeks
|
12.5 score on a scale
Interval 7.0 to 18.0
|
13 score on a scale
Interval 10.0 to 18.0
|
|
Belief in Medicine Questionnaire (BMQ) - Harm
0-weeks (baseline)
|
12.5 score on a scale
Interval 6.0 to 17.0
|
12 score on a scale
Interval 9.0 to 20.0
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Control (no Financial Incentive)
n=16 Participants
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 Participants
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.
|
|---|---|---|
|
Belief in Medicine Questionnaire (BMQ) - Over-use
0-weeks (baseline)
|
15 score on a scale
Interval 10.0 to 17.0
|
15 score on a scale
Interval 10.0 to 18.0
|
|
Belief in Medicine Questionnaire (BMQ) - Over-use
12-weeks
|
15 score on a scale
Interval 8.0 to 17.0
|
14 score on a scale
Interval 10.0 to 16.0
|
|
Belief in Medicine Questionnaire (BMQ) - Over-use
24-weeks
|
15.5 score on a scale
Interval 8.0 to 17.0
|
14 score on a scale
Interval 10.0 to 18.0
|
Adverse Events
Control (no Financial Incentive)
Intervention (Financial Incentive)
Serious adverse events
| Measure |
Control (no Financial Incentive)
n=16 participants at risk
No incentive. Usual care (plus EMD with reminders) for 12-weeks.
|
Intervention (Financial Incentive)
n=16 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma attack
|
6.2%
1/16 • Number of events 1 • 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)
|
18.8%
3/16 • Number of events 3 • 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)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place