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Asthma in ChildrenFINANCT05322044

Financial Incentives to Improve Asthma

A study testing Financial incentives in people with Asthma in Children and Medication Adherence, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Asthma in Children, Medication Adherence
What is being tested?
Financial incentives
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited Kingdom
Study dates
18 Jul 2022to 28 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • St Mary's Hospital

    London, W2 1NY

Other trials in United Kingdom

About this study

Official title: Financial Incentives to Improve Adherence to Inhaled Asthma Medications in Children and Young People With Asthma

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.

Read the 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.

Being tested
Financial incentives
Keywords
Electronic monitoring device, Financial incentives, Reminders, Asthma control
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Financial incentivesBehavioural

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

Study groups in NCT05322044
Study groupRoleWhat they receive
Control (no financial incentive)No interventionNo incentive. Usual care (plus EMD with reminders) for 12-weeks.
Intervention (financial incentive)ExperimentalFinancial incentive dependent upon daily medication adherence (plus EMD with reminders) for 12-weeks.
Receives: Behavioral: Financial incentives

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of Percentage ICS Adherence Between Groups at 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).

    Measured: Comparison between groups at study visit 2 (12-weeks)

Secondary outcomes (18)
  1. Proportion of Participants Achieving Good Asthma Adherence (≥80%)

    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.

    Measured: study visit 2 (12-weeks) and study visit 3 (24-weeks)

  2. Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS)

    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.

    Measured: study visit 2 (12-weeks) and study visit 3 (24-weeks)

  3. Asthma Control

    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.

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  4. Exhaled Nitric Oxide

    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.

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  5. Brief Illness Perceptions Questionnaire (B-IPQ)

    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.

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  6. Habit

    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.

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  7. Self-reported Adherence

    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.

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  8. Change in Percentage ICS Adherence for Control Participants Between 12-weeks and 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).

    Measured: Change in % ICS adherence in control from study visit 2 (12-weeks) to study visit 3 (24-weeks)

  9. Change in Percentage ICS Adherence for Intervention Participants Between 12-weeks and 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).

    Measured: Change in % ICS adherence in intervention from study visit 2 (12-weeks) to study visit 3 (24-weeks)

  10. Comparison of Percentage ICS Adherence 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).

    Measured: Comparison between groups at 24-weeks (follow-up)

  11. Total Number of Asthma Attacks Over the Course of the Study

    Self-report measure of the number of asthma attacks from the start of the study (0-weeks) until end of study (24-weeks).

    Measured: study visit 3 (24-weeks)

  12. 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.

    Measured: study visit 2 (12-weeks) and study visit 3 (24-weeks)

  13. Autonomous Motivation

    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.

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  14. Controlled Motivation

    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.

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  15. Belief in Medicine Questionnaire (BMQ) - Necessity

    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

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  16. Belief in Medicine Questionnaire (BMQ) - Concern

    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

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  17. Belief in Medicine Questionnaire (BMQ) - Harm

    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

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  18. Belief in Medicine Questionnaire (BMQ) - Over-use

    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

    Measured: study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study start18 Jul 2022
  3. Primary completion11 Jul 2023
  4. Study completion28 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05322044
Sponsor's protocol ID
22SM7433
Other IDs
306829
Acronym
FINA
Status last verified
Feb 2025
First submitted
16 Mar 2022
Last updated
5 Feb 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hine J, Bush A, De Simoni A, Griffiths C, Judah G, Fleming L. Financial INcentives to improve Asthma (FINA): a pilot RCT to improve medication adherence for children and young people with asthma. Arch Dis Child. 2026 Oct 7:archdischild-2026-331320. doi: 10.1136/archdischild-2026-331320. Online ahead of print.

    PubMed 42843968

Questions about this trial

What is this clinical trial studying?

A study testing Financial incentives in people with Asthma in Children and Medication Adherence, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Percentage ICS Adherence Between Groups at 12-weeks (time frame: Comparison between groups at study visit 2 (12-weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05322044, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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