Financial Incentives to Improve Asthma (FINA)

  • STATUS
    Recruiting
  • End date
    Dec 10, 2023
  • participants needed
    50
  • sponsor
    Imperial College London
Updated on 4 October 2022

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.

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.

Details
Condition Asthma in Children, Medication Adherence
Treatment Financial incentives
Clinical Study IdentifierNCT05322044
SponsorImperial College London
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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