Clinical trial NCT05322044: Financial Incentives to Improve Asthma
Official title: Financial Incentives to Improve Adherence to Inhaled Asthma Medications in Children and Young People With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Medication Adherence
Keywords: Electronic monitoring device
Financial incentives
Reminders
Asthma control
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 32
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of Percentage ICS Adherence Between Groups at 12-weeks
timeFrame: Comparison between groups at study visit 2 (12-weeks)
Secondary outcomes:
measure: Proportion of Participants Achieving Good Asthma Adherence (≥80%)
timeFrame: study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS)
timeFrame: study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Asthma Control
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Exhaled Nitric Oxide
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Brief Illness Perceptions Questionnaire (B-IPQ)
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Habit
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Self-reported Adherence
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Change in Percentage ICS Adherence for Control Participants Between 12-weeks and 24-weeks
timeFrame: Change in % ICS adherence in control from study visit 2 (12-weeks) to study visit 3 (24-weeks)
measure: Change in Percentage ICS Adherence for Intervention Participants Between 12-weeks and 24-weeks
timeFrame: Change in % ICS adherence in intervention from study visit 2 (12-weeks) to study visit 3 (24-weeks)
measure: Comparison of Percentage ICS Adherence Between Groups at 24-weeks (Follow-up)
timeFrame: Comparison between groups at 24-weeks (follow-up)
measure: Total Number of Asthma Attacks Over the Course of the Study
timeFrame: study visit 3 (24-weeks)
measure: Incident Rate Ratio of Asthma Exacerbations
timeFrame: study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Autonomous Motivation
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Controlled Motivation
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Belief in Medicine Questionnaire (BMQ) - Necessity
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Belief in Medicine Questionnaire (BMQ) - Concern
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Belief in Medicine Questionnaire (BMQ) - Harm
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
measure: Belief in Medicine Questionnaire (BMQ) - Over-use
timeFrame: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
affiliation: Imperial College London
name: Ian Maconochie
role: PRINCIPAL_INVESTIGATOR
References: