Adults 11 to 17, any sex, with Asthma in Children or Medication Adherence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Comparison of Percentage ICS Adherence Between Groups at 12-weeksPrimary· 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).
Group
Value
95% CI
Control (no Financial Incentive)
56
7 – 87
Intervention (Financial Incentive)
73
23 – 89
Proportion of Participants Achieving Good Asthma Adherence (≥80%)Secondary· 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.
12-weeks
Group
Value
95% CI
Control (no Financial Incentive)
1
Intervention (Financial Incentive)
4
24-weeks
Group
Value
95% CI
Control (no Financial Incentive)
0
Intervention (Financial Incentive)
0
Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS)Secondary· 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.
12-weeks
Group
Value
95% CI
Control (no Financial Incentives)
1
Intervention (Financial Incentives)
2
24-weeks
Group
Value
95% CI
Control (no Financial Incentives)
0
Intervention (Financial Incentives)
1
Asthma ControlSecondary· 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.
0-weeks (baseline)
Group
Value
95% CI
Control (no Financial Incentive)
20.50
12 – 25
Intervention (Financial Incentive)
20.00
10 – 25
12-weeks
Group
Value
95% CI
Control (no Financial Incentive)
21.00
13 – 25
Intervention (Financial Incentive)
23.00
11 – 25
24-weeks
Group
Value
95% CI
Control (no Financial Incentive)
22.50
14 – 25
Intervention (Financial Incentive)
24.00
17 – 25
Exhaled Nitric OxideSecondary· 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.
0-weeks
Group
Value
95% CI
Control (no Financial Incentive)
24
5 – 122
Intervention (Financial Incentive)
51
7 – 300
12-weeks
Group
Value
95% CI
Control (no Financial Incentive)
55.50
8 – 145
Intervention (Financial Incentive)
66.50
23 – 205
24-weeks
Group
Value
95% CI
Control (no Financial Incentive)
46.50
11 – 56
Intervention (Financial Incentive)
102
87 – 121
Brief Illness Perceptions Questionnaire (B-IPQ)Secondary· 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.
0-weeks (baseline)
Group
Value
95% CI
Control (no Financial Incentive)
26
6 – 46
Intervention (Financial Incentive)
33
12 – 49
12-weeks
Group
Value
95% CI
Control (no Financial Incentive)
23.50
9 – 55
Intervention (Financial Incentive)
26
3 – 55
24-weeks
Group
Value
95% CI
Control (no Financial Incentive)
21.00
10 – 25
Intervention (Financial Incentive)
26
2 – 47
HabitSecondary· 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.
0-weeks (baseline)
Group
Value
95% CI
Control (no Financial Incentive)
2.75
± 1.09
Intervention (Financial Incentive)
2.91
± 0.63
12-weeks
Group
Value
95% CI
Control (no Financial Incentive)
2.72
± 0.57
Intervention (Financial Incentive)
2.50
± 0.83
24-weeks
Group
Value
95% CI
Control (no Financial Incentive)
2.69
± 0.87
Intervention (Financial Incentive)
3.06
± 0.69
Self-reported AdherenceSecondary· 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.
0-weeks (baseline)
Group
Value
95% CI
Control (no Financial Incentive)
4.20
2.9 – 4.7
Intervention (Financial Incentive)
4.1
2.6 – 4.7
12-weeks
Group
Value
95% CI
Control (no Financial Incentive)
4.30
2.7 – 4.8
Intervention (Financial Incentive)
4.20
3.00 – 4.90
24-weeks
Group
Value
95% CI
Control (no Financial Incentive)
4.20
3.20 – 4.90
Intervention (Financial Incentive)
4.10
3.10 – 4.90
Change in Percentage ICS Adherence for Control Participants Between 12-weeks and 24-weeksSecondary· 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).
Group
Value
95% CI
12-weeks
56
7 – 87
24-weeks
31.5
3 – 62
Change in Percentage ICS Adherence for Intervention Participants Between 12-weeks and 24-weeksSecondary· 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).
Group
Value
95% CI
12-weeks
73
23 – 89
24-weeks
39
0 – 72
Comparison of Percentage ICS Adherence Between Groups at 24-weeks (Follow-up)Secondary· 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).
Group
Value
95% CI
Control (no Financial Incentive)
31.5
3 – 62
Intervention (Financial Incentive)
39
0 – 72
Total Number of Asthma Attacks Over the Course of the StudySecondary· 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).
Group
Value
95% CI
Control (no Financial Incentive)
1
Intervention (Financial Incentive)
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Throughout study duration: 0-24-weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Imperial College London
Last refreshed: 5 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05322044.