Financial Incentives to Improve Asthma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2023-09-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma in Children Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control (no financial incentive)

No incentive. Usual care (plus EMD with reminders) for 12-weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention (financial incentive)

Financial incentive dependent upon daily medication adherence (plus EMD with reminders) for 12-weeks.

Group Type EXPERIMENTAL

Financial incentives

Intervention Type BEHAVIORAL

Financial incentives dependent upon adherence will be given to participants alongside additional EMD associated app features for 12-weeks.

Interventions

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Financial incentives

Financial incentives dependent upon adherence will be given to participants alongside additional EMD associated app features for 12-weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No