Financial Incentives to Improve Adherence to Inhaled Asthma Medications in Children and Young People With Asthma
Phase: NA
Conditions: Asthma in Children, Medication Adherence
Sponsor: Imperial College London

 
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Protocol for non-CTIMPs 
 
FINA (Financial INcentives to improve 
Asthma) 
 
 
 
 
Financial incentives to improve adherence to inhaled asthma 
medications in children and young people with asthma.  
 
 
 
Version 9. 16.01.2023 
 
 
 
 
MAIN SPONSOR: Imperial College London 
 
FUNDERS: Asthma UK Centre of Applied Research (AUKCAR) 
 
IRAS Project ID: 306829 
REC reference: 22-LO-0267 
NCT05322044 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
Dr Louise Fleming 
Chief Investigator 
16/01/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Management Group 
 
Chief Investigator: Dr Louise Fleming 
 
Principal Investigator: Dr Ian Maconochie 
 
Co-investigators: Jasmine Hine, Professor Andy Bush, Dr Anna De Simoni, 
Professor Chris Griffiths, Dr Gaby Judah 
 
Study Management: Jasmine Hine 
 
 
Study Coordination Centre  
 
For general queries, supply of study documentation, and collection of data, please 
contact: 
 
Study Coordinator: Jasmine Hine 
Address: Children’s Clinical Research Facility (CCRF), St Mary’s Hospital, Imperial 
College Healthcare NHS Trust, Praed Street, London, W2 1NY  
 
 
 
 
 
 
 
 
 
Tel: (personal) +44 7513 571753 / (study) +44 7514 311503  
Email: (personal) j.hine21@imperial.ac.uk / (study) fina.study@imperial.ac.uk 
 
 
Clinical Queries 
 
Clinical queries should be directed to the Chief Investigator who will direct the query 
to the appropriate person. 
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further 
information regarding the sponsorship conditions, please contact the Head of 
Regulatory Compliance at: 
 
 
 
Research Governance and Integrity Team 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 1862 

 
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Imperial College - Research Governance and Integrity Team (RGIT) Website 
 
 
 
 
Funder 
 
This project will be funded as part of a PhD studentship with funding from Asthma 
UK Centre of Applied Research (AUKCAR). 
 
 
 
Asthma UK Centre of Applied Research (AUKCAR) 
https://www.ed.ac.uk/usher/aukcar 
 
 
 
This protocol describes the financial incentives to improve 
asthma study and provides information about procedures for entering participants. Every care was taken 
in its drafting, but corrections or amendments may be necessary. These will be circulated to 
investigators in the study.  Problems relating to this study should be referred, in the first instance, to the 
Chief Investigator.  
 
This study will adhere to the principles outlined in the UK Policy Frame Work for Health and Social Care 
Research. It will be conducted in compliance with the protocol, the Data Protection Act and other 
regulatory requirements as appropriate.  
 
 

 
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Table of Contents                                                             Page No 
1. 
INTRODUCTION 
7 
1.1. 
BACKGROUND 
7 
1.2. 
RATIONALE FOR CURRENT STUDY 
8 
2. 
STUDY AIMS AND OBJECTIVES 
9 
3. 
STUDY DESIGN 
11 
3.1. 
STUDY OUTCOME MEASURES 
17 
4. 
PARTICIPANT ENTRY 
17 
4.1. 
PRE-REGISTRATION EVALUATIONS 
17 
4.2. 
INCLUSION CRITERIA 
18 
4.3. 
EXCLUSION CRITERIA 
18 
4.4. 
WITHDRAWAL CRITERIA 
18 
5. 
ADVERSE EVENTS 
19 
5.1. 
DEFINITIONS 
19 
5.2. 
REPORTING PROCEDURES 
19 
6. 
ASSESSMENT AND FOLLOW-UP 
20 
7. 
STATISTICS AND DATA ANALYSIS 
23 
8. 
REGULATORY ISSUES 
24 
8.1. 
ETHICS APPROVAL 
24 
8.2. 
CONSENT 
24 
8.3. 
CONFIDENTIALITY 
24 
8.4. 
INDEMNITY 
25 
8.5. 
SPONSOR 
25 
8.6. 
FUNDING 
25 
8.7. 
AUDITS 
25 
9. 
STUDY MANAGEMENT 
25 
10. 
PUBLICATION POLICY 
25 
11. 
REFERENCES 
26 
APPENDIX: 
29 
 
 
 

 
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GLOSSARY OF ABBREVIATIONS 
 
AE 
Adverse Event 
ACT 
Asthma Control Test  
ATS 
American Thoracic Society 
B-IPQ 
Brief Illness Perceptions Questionnaire 
BMQ 
Belief in Medicines Questionnaire 
CI 
Chief Investigator 
CYP 
Children and Young People 
ED 
Emergency Department 
EMDs 
Electronic Monitoring Device/s 
ERS 
European Respiratory Society 
FENO 
Fractional Exhaled Nitric Oxide 
ICS 
Inhaled Corticosteroids 
MART 
Maintenance and Reliever Therapy 
MARS-A 
Medication Adherence Report Scale for Asthma 
OCS 
Oral Corticosteroids 
PAPA 
Perceptions and Practicalities Approach 
PIS 
Participant Information Sheet 
RCT 
Randomised Controlled Trial 
REC 
Research Ethics Committee 
SAR 
Serious Adverse Reaction 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
SRBAI 
Self-report Behavioural Automaticity Index 
TSRQ 
Treatment Self-Regulation Questionnaire 
 
KEYWORDS 
Financial incentives 
Electronic monitoring device (EMD) 
Asthma 
Adherence 
Asthma control 
Children and young people 
 
 
 

 
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STUDY SUMMARY 
 
TITLE Financial incentives to improve adherence to inhaled asthma medications in 
children and young people (CYP) with asthma.  
DESIGN Pilot randomised controlled trial (RCT) 
AIMS To assess the effectiveness of a short-term financial incentives-based 
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. 
 
OUTCOME MEASURES Primary outcome:  
• 
Percentage ICS adherence (measured by EMD record of inhaler 
actuation%) 
Secondary outcomes:  
• 
Proportion of participants achieving good asthma adherence (≥80%) 
• 
Time to next asthma exacerbation needing a course of oral 
corticosteroids (OCS) 
• 
Total number of severe exacerbations  
• 
Asthma control (Asthma Control Test, ACT) 
• 
Exhaled nitric oxide (FENO) 
• 
Belief in Medicine Questionnaire (BMQ) 
• 
Brief Illness Perceptions Questionnaire (B-IPQ) 
• 
Habit (self-report behavioural automaticity index, SRBAI) 
• 
Autonomous/controlled motivation (adapted from the Treatment Self-
Regulation Questionnaire, TSRQ, for the purpose of this study)  
• 
Self-report adherence (Medication Adherence Report Scale for 
Asthma, MARS-A) 
 
POPULATION CYP aged 11-17 years with an asthma diagnosis 
ELIGIBILITY 
• 
CYP aged between 11-17 years old 
• 
A doctor diagnosis of asthma  
• 
Presenting to an emergency department (ED) with a severe 
exacerbation of asthma (defined by ERS/ATS guidelines*)  
• Own their own smartphone (running Android 8 or higher, or iOS 13 or 
higher) 
• 
Prescribed maintenance inhaled corticosteroids (ICS) (which can 
include maintenance and reliever therapy (MART)) for at least 6-
months.  
• 
Prescribed one of the following inhalers: Clenil, Flixotide, Symbicort, 
Seretide.  
DURATION  Up to 24-weeks (participants will also be involved in a focus group at the end 
of the study period) 
 
* Severe exacerbation of asthma: Asthma attack requiring a course of systemic corticosteroids (either 
prednisolone or dexamethasone), or hospital admission 1 

 
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1. INTRODUCTION  
 
1.1. 
BACKGROUND 
 
Approximately 1.1 million United Kingdom (UK) children have asthma, making the disease 
one of the most common chronic conditions2,3. Asthma can be fatal if poorly managed or 
uncontrolled4 and unfortunately, the UK has some of the worst outcomes for asthma5. Most 
children with asthma are prescribed low-dose inhaled corticosteroids (ICS), but not all have 
good control resulting in persistent and frequent exacerbations of symptoms and escalation 
of treatment6. Poor adherence to medication ICS significantly contributes to poor asthma 
control7. Good adherence is considered >80%8,9 but children with asthma often have 
adherence rates of <50%10. Although in some cases ICS is wrongly or over-prescribed 
providing rational as to why adherence is low, the figures are still concerning and need 
addressing.  
 
Electronic monitoring devices (EMDs) are not only seen as the ‘gold standard’ tool for 
measuring adherence as they electronically record inhaler actuation, but they have also 
been used as an intervention tool to improve medication adherence. EMDs can be 
programmed to deliver audio-visual reminders, which often result in improved short-term 
adherence, but no significant changes to clinical outcomes or sustained behaviour 
change11,12.   
 
The perceptions and practicalities approach13 (PAPA) suggests medication adherence can 
be divided into two fundamental constructs: 1) unintentional adherence (practical factors 
such as capacity and resources) and 2) intentional adherence (perceptual factors such as 
motivations and beliefs). Previous EMD interventions have not targeted both unintentional 
and intentional adherence which could explain the lack of sustained change in adherence.  
 
Additionally, adhering to medication regimes is heavily reliant upon developing a habit14. A 
habit usually forms through the consistent repetition of a desired behaviour until it is 
performed automatically, without the need for strong intentions to perform the behaviour15. 
Habitual behaviours are important as they are more likely to be sustained over the long term.  
Rewards may reinforce behaviours, and therefore strengthen habit formation. While there is 
evidence that autonomous motivation (compared with controlled)16 is more effective at 
supporting habit formation, the exact nature of what counts as a reward to support habit 
formation is not well established. Autonomous motivation refers to being self-motivated 
compared to controlled motivation which refers to being motivated from external sources. 
 
Therefore, to address the above, it is proposed that adding an additional behavioural 
strategy, alongside the electronic reminders, may be effective at bringing sustained long-
term effects of adherence by successfully targeting the underlying motivations to adhere.  
 
Financial incentives are a widely used behavioural strategy throughout health and research 
settings. They can help reinforce behaviours and are successful at improving health 
behaviours in adult populations such as smoking cessation, vaccination uptake and physical 
activity17 and at improving medication adherence with for example anti-psychotics18, 
statins19, antihypertensive20 and HIV medications21.  
 
Financial incentive studies are limited, but are increasing in children. A narrative review by 
Kenyon and colleagues22 discusses design and effectiveness of randomized trials using 

 
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financial incentives to promote healthy behaviours specifically in children. Studies included 
focused on healthy eating (with interventions delivered within schools), preventing repeat 
adolescent pregnancies and diabetes management. All studies showed improvements in 
behaviour change but with mixed results at follow-up assessments.  
 
The use of financial incentives to improve diabetes management is of particular interest 
because, as with asthma, outcomes are related to medication adherence. One non-
randomised study found short-term financial incentives encouraged sustained behaviour 
change in adolescents with diabetes23. A randomised trial with a similar population 
conducted in 201724 showed improved adherence to self-monitoring compared to controls at 
6-month follow-up, yet there was no significant difference in clinical outcomes (HbA1c) at 
both 3-month and 6-month follow-up. A second randomised trial conducted in 201925, 
similarly with an adolescent population again showed improved adherence to self-monitoring 
compared to control but with significantly improved clinical outcomes (HbA1c) at 3-month 
follow-up.  
 
 
1.2. 
RATIONALE FOR CURRENT STUDY 
 
In paediatric asthma, there are currently no randomised trials that explore the effectiveness 
of using financial incentives for improving medication adherence. A US proof-of-concept 
study that used electronic reminders coupled with financial incentives improved adherence 
to asthma medications in 12 African American adolescents26. Participants were provided 
with a smartphone and an EMD (with associated App) to provide visual reminders, positive 
reinforcement (e.g., shooting a basket game and positive text messages when dose is 
taken) plus rewards (short-term: accessories to decorate personal app avatar and long-term: 
1$ per inhaler dose). Both adherence and asthma control (measured by the asthma control 
test ACT) improved across the 8-week period. 
 
Similarly, a feasibility study conducted by ourselves found the use of financial incentives to 
be feasible and acceptable for improving adherence in paediatric asthma27. Adolescents 
diagnosed with asthma, who had poor medication adherence (<80%) and poor asthma 
control were recruited from an outpatient asthma clinic. Twelve adolescents were invited to 
take part and 10 were recruited (7 males, 3 females, 12-16 years) to a 24-week intervention 
that consisted of eight weeks of electronic reminders and financial incentives related to their 
adherence (£1 per morning dosage, £1 per evening dosage, capped at £2 per day). Eight 
out of 10 adolescents provided adherence measurements up to the final study visit. Three 
adolescents successfully paired their mobile app and EMD up to the final study visit which 
was associated with improved adherence. The 7 adolescents unable to pair their mobile app 
and EMD had no change in adherence. Overall, adherence did not significantly change. Exit 
interviews with adolescents revealed reminders and incentives were welcomed but issues 
with the technology was frustrating. Adolescents also commented that the intervention was 
useful by promoting self-monitoring and increasing motivation to take medication.  
 
These findings within asthma warrant the further exploration of this intervention design using 
financial incentives with the inclusion of a larger sample size and randomisation. In addition, 
to explore the potential mediators of sustained behaviour change, motivation and the key 
feature of habit, automaticity, will be tracked in this study. 
 
 
 

 
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1.2.1 Hypothesis 
The overarching hypothesis of this study is that a short-term intervention consisting of financial 
incentives will lead to behaviour change and improved ICS adherence and asthma control, in 
the short-medium term, in CYP with asthma. 
 
 
2. STUDY AIMS AND OBJECTIVES 
 
2.1 Aims 
 
1. To assess the effectiveness of a short-term financial incentives-based intervention at 
bringing about behaviour change and improving ICS adherence and asthma control, 
in the short-medium term, in CYP with asthma. 
2. To assess the feasibility of study processes, randomisation, and outcome 
assessments. 
3. To generate pilot data that can be used to inform the power calculation and design of 
a definitive RCT of financial incentives in children with asthma. 
 
 
2.2 Objectives 
 
1. To recruit children and young people aged between 11-17 years with asthma and 
measure adherence using EMDs (programmed with reminders) and a self-report 
measure (MARS-A) during a 12-week intervention period when financial incentives 
are given and compare to a group given an EMD (programmed with reminders) only, 
and to continue to measure adherence during a subsequent 12-week period (when 
no financial incentives are given) to assess whether financial incentives lead to 
continued better adherence in the short-medium term compared to the control group. 
2. To measure asthma outcomes (number of severe exacerbations, time to 
exacerbation, asthma symptoms and if feasible given COVID-19 constraints, exhaled 
nitric oxide) at baseline, 12-weeks, and 24-weeks to assess whether financial 
incentives lead to short-medium term changes in a range of asthma control 
measures compared to the control group.  
3. To measure habit (using the self-report behavioural automaticity index, SRBAI) and 
autonomous/controlled motivation (using a questionnaire adapted from the Treatment 
Self-Regulation Questionnaire (TSRQ)) at baseline, 12-weeks, and 24-weeks to 

 
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assess whether financial incentives lead to short-medium term changes in 
medication taking habits and motivations compared to the control group. 
4. To measure beliefs in medicine (using Beliefs in Medicines Questionnaire, BMQ) and 
perceptions of illness (using the Brief-Illness Perceptions Questionnaire, B-IPQ) at 
baseline, 12-weeks, and 24-weeks to assess whether financial incentives lead to 
short-medium term changes in beliefs and perceptions regarding medication and 
illness and compared to the control group.  
5. To conduct focus groups with participants from both the intervention and the control 
group and interviews with parents/guardians using a topic guide to obtain feedback of 
the trial and inform the design of a larger RCT.  
 
 

 
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3. STUDY DESIGN  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Visit 3: Focus groups (optional)  
o
All participants will be invited to a 
focus group to share their feedback 
of the trial. 
o
Up to 10 participants per focus 
group 
o
Focus groups with participants from 
intervention group and control group 
will be conducted separately.  
Children and young people having attended the Emergency Department post-attack who fit the 
inclusion criteria for financial incentives study (n=50) 
Visit 1: Baseline assessment (n=50), 0 weeks 
o
Informed consent obtained 
o
EMD (Hailie® sensor) issued, and set-up information provided about the 
device, Hailie® associated app downloaded to CYP’s smartphone 
o
Demographic/asthma history information and GP contact details obtained 
o
Asthma UK action plan provided, and inhaler technique assessed 
o
Asthma control (ACT) 
o
Inflammation, exhaled nitric oxide (FENO) 
o
SRBAI questionnaire 
o
BMQ questionnaire 
o
B-IPQ questionnaire 
o
Adapted TSRQ questionnaire  
o
Self-report adherence (MARS-A) 
Participants (n=50) to be randomly allocated to either the control group (n=25) 
or the financial incentives-based intervention (n=25) 
CONTROL GROUP (n=25) 
o
Hailie® sensor (with 
reminders) use for 12-
weeks 
 
FINANCIAL INCENTIVES-BASED INTERVENTION GROUP (n=25) 
o
Hailie® sensor (with reminders) use for 12-weeks  
o
Financial incentives-based intervention for 12-weeks 
ICS adherence % downloaded virtually by researchers from Hailie® App via web 
portal (at 4 weeks, 8 weeks) to assess reward value. Child will be sent ‘One4all’ 
voucher reward at these time points. 
Visit 2: Reassessment (n=50), 12-weeks 
 
 
o
ICS adherence % 
o
Asthma history since visit 1 and inhaler technique educational video shown. 
o
Asthma control (ACT) 
o
Inflammation, exhaled nitric oxide (FENO) 
o
SRBAI questionnaire 
o
BMQ questionnaire 
o
B-IPQ questionnaire 
o
Adapted TSRQ questionnaire 
o
Self-report adherence (MARS-A) 
*Financial incentives-based intervention stopped. No more rewards. Child will be sent 
‘One4all’ voucher reward after study visit.  
Visit 3: Reassessment (n=50), 24-weeks 
o
ICS adherence % 
o
Asthma history since visit 2 and inhaler 
technique educational video shown. 
o
Asthma control (ACT) 
o
Inflammation, exhaled nitric oxide (FENO) 
o
SRBAI questionnaire 
o
BMQ questionnaire 
o
B-IPQ questionnaire 
o
Adapted TSRQ questionnaire 
o
Self-report adherence (MARS-A) 
Parents/CYP to return Hailie® devices. 
ALL PARTICIPANTS (n=50) FOLLOW-UP PERIOD 
o
Home electronic monitoring (Hailie® with reminders) for a further 12-weeks 

 
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This will be a pilot RCT of a financial incentives-based intervention. All CYP will be recruited 
from London Hospital Emergency Departments (EDs) including: St Mary’s Hospital (Imperial 
College Healthcare NHS Trust); Chelsea and Westminster Hospital (Chelsea and 
Westminter Hospital NHS Foundation Trust); University College Hospital (University College 
London Hospital NHS Foundation Trust); Whittington Hospital (Whittington Health NHS 
Trust; The Royal London Hospital (Barts Health NHS Trust); The Hillingdon Hospital 
(Hillingdon Hospitals NHS Trust); Royal Brompton Hospital and Evelina Children’s Hospital 
(Guy's and St Thomas' NHS Foundation Trust) 
A list of ED attendees will be reviewed every week by the direct care team and those coded 
for acute asthma who fulfil the eligibility criteria will be identified and sent an automated 
WhatsApp/SMS message with a link to the study. If they are interested in participating, they 
will be asked to enter their contact details which will then be shared with the study 
coordinator. The study coordinator will then contact potential participants with further study 
information. The link to the study will also be provided on posters which will be displayed in 
the EDs and on leaflets which will be given to potential participants at the time of their 
attendance. For those CYP who have a post attack follow up review (either in person, via 
telephone or video platform) the study will be introduced by the clinician carrying out the 
review and if the CYP and their parent are interested permission will be obtained to share 
their contact details with the study coordinator.  
No patient identifiable information will be accessed by the research team without prior 
consent. 
 
If interested in the study, the study coordinator will provide parents with an information sheet 
as well as an age-appropriate version of the information sheet for CYP. Parents/CYP will 
have the opportunity to read the information and to ask any questions they have. The 
consent form, which will involve age-appropriate assent from the CYP, will be completed 
electronically via a Qualtrics link sent to parents (via email/SMS/WhatsApp). The first study 
visit will be arranged between 2-12 weeks post presentation to the department with asthma 
attack.  
 
Fifty participants will be enrolled in the 24-week programme and will be randomly assigned 
to either the financial incentives-based intervention group or the control group using the 
online service Sealed EnvelopeTM  which will allocate participants to each group on a 1:1 

 
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basis. Participants will be told which group they have been randomly assigned to during 
study visit 1.  
 
For all participants, there will be a total of 3 study visits: at baseline (0-weeks), at 12-weeks 
and at 24-weeks. All study visits will take place at the Children’s Clinical Research Facility 
(CCRF) at St Mary’s Hospital, Imperial College Healthcare NHS Trust. Due to the continued 
COVID-19 restrictions, remote study visits will be offered to participants through Microsoft 
Teams (joining link will be sent to parents electronically) and an option for study visits to be 
conducted (by the study coordinator) at participant’s homes will also be available, if 
necessary. However, due to financial constraints, we would not be able to perform FENO 
remotely, so it will be removed as a secondary outcome measure in this event. All study 
visits will include the collection of asthma-related clinical data, questionnaire data and 
adherence data which will be described in detail below.  
 
All CYP’s GP’s will be informed of the CYP’s involvement in the study and a summary of 
results from each study visit will be sent to the CYP’s GP. Information shared in this 
summary will include ACT score, FENO and adherence data. This summary will also be sent 
to parents. It is important to note that the study team will not be managing the CYP’s asthma 
or intervening if their adherence is poor – this will be made clear to parents/guardians and 
CYP and it will be suggested they contact their GP or asthma nurse if there are any 
concerns throughout the study.  
 
All CYP will be issued with an EMD (Hailie® sensor, Adherium, New Zealand) which 
attaches to their usual inhalers to electronically record inhaler actuation to provide % 
adherence data.  
 
All CYP will be required to download the Hailie® associated app on their smartphones and to 
sync their Hailie® sensor with the associated app, via Bluetooth. The Hailie® sensor will 
detect medication usage from the attached preventer inhaler and send this to the Hailie® 
associated app on the CYP’s smartphone, also via Bluetooth. The Hailie® associated app 
will then automatically upload (via WIFI/data connection) the medication usage data to the 
secure cloud-based Hailie® web portal where the research team will be able to view the data 
(see image below).  
 
 

 
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All CYP will regularly charge and sync their Hailie® device to ensure all data are collected 
accurately, they will be prompted to do this throughout the study through app notifications. 
Parents/guardians/CYP will be asked to inform a member of the study team if there are any 
issues with their EMDs so this can be sorted as soon as possible.  
 
All CYP’s Hailie® devices or smartphones will be programmed with both morning and 
evening audio-visual reminders across the 24-week period. CYP will choose the time of their 
reminders which will be recorded by the researcher.  
 
There will be no covert adherence monitoring and CYP’s adherence data will be downloaded 
and viewed by the study coordinator before/at each study visit (study visit 2, 12-weeks and 
study visit 3, 24-weeks). For those in the intervention group, adherence data will also be 
downloaded and viewed at 4-weeks, 8-weeks to calculate reward amount given only.  
 
At the end of the 24-week programme, all participants will be invited to join a focus group 
discussion (which will either be in-person at the CCRF or virtually via Microsoft teams) with 
other CYP from the study. There will be up to 10 participants per focus group and numbers 
will be dependent upon participant availability. Focus groups with participants from the 
intervention group and with participants from the control group will be conducted separately. 
Focus groups will be optional for participants. Parents/guardians will also be invited to take 
part in an interview in person / via email or telephone to obtain their feedback about the 
programme. These interviews will be optional and will last approximately 45minutes. 

 
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Interviews will be conducted at study visit 3 and will be conducted in person or virtually (via 
telephone or via Microsoft Teams, dependent upon preference).  
 
 
STUDY VISIT 1: 
Prior to any tests, it will be ensured that all parents/CYP understand all the information 
provided and have electronically signed the informed consent form.  
 
Participants will be given the Hailie® sensor and shown how to use this, as described above. 
Participants will be assessed and given guidance on their inhaler technique and will be 
provided with an Asthma UK children’s asthma plan (unless already in receipt of an asthma 
plan, see appendix for plan) which will be conducted by a clinical research nurse. 
 
The following information will be collected from all CYP; demographics, asthma history, 
asthma adherence (measured by self-report, MARS-A), asthma control (measured by ACT 
questionnaire, FENO – which will be measured by the child breathing out slowly though a 
mouthpiece where the nitric oxide from the breath will be measured the sensor and 
computer) and behavioural/psychological data (measured by BMQ, B-IPQ, SRBAI, TSRQ-
adapted for this study).  
 
Participants will be randomly assigned to either the 1) control group (n=25) or to the 2) 
financial incentives-based intervention group (n=25). Participants will be told which group 
they have been randomly assigned to during this visit. 
 
1. Control group (n=25): 
Participants will receive their usual care plus electronic reminders. Participants will not be 
required to do anything additional as part of this group.  
 
2. Financial incentives-based intervention (n=25): 
Participants will be provided with a summary information sheet regarding the intervention 
programme and will be given the time to read through this and to ask any questions. 
Participants will receive gain-framed financial incentives based upon frequency of 
ICS adherence (£1 per morning dose and £1 per evening dose / maximum £2 per day 
regardless of prescription / £168 maximum per participant during the 12-week period). 
Participants will not be able to earn more money by taking their inhaler more than 

 
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prescribed. Participants will be able to see how much money they have earned in real-time 
by an in-app totaliser which increases by £1 every time the EMD recognises the morning or 
evening dose has been taken when the Hailie® sensor and the app are synced. Participants 
will receive their money (in form of an ‘One4all’ voucher) in 4-weekly instalments (at 4-
weeks, 8-weeks, and 12-weeks / total £56 per each 4-week period). The ‘One4all’ voucher 
will be sent to the child’s smartphone via text message. Participants will receive regular 
messages updating them on their progress in terms of financial incentives. Messages will be 
delivered as notifications via the app and will be seen on participants’ smartphones. 
Participants will also be able to monitor their adherence in an in-app calendar that follows a 
traffic-light coding system to display daily adherence (e.g., red if no doses taken, orange if 
some taken and green if all inhaler puffs are taken per day).  
During this intervention period, participant’s Hailie® adherence data will also be 
downloaded and viewed via the Hailie® web portal virtually by the study coordinator at 4-
weeks and 8-weeks (in addition to being downloaded at 12-weeks, study visit 2 and 24-
weeks, study visit 3) to assess reward amount given.   
 
STUDY VISIT 2: 
The following information will be collected from all participants; asthma history, asthma 
control (ACT questionnaire, FENO), asthma adherence (self-report, MARS-A and 
electronically from Hailie®) and behavioural/psychological data (BMQ, B-IPQ, SRBAI, 
TSRQ-adapted). All participant’s Hailie® adherence data will also be downloaded. 
 
1. Control group (n=25): 
 
Participants will continue to receive their usual care plus the electronic reminders. 
Participants will not be required to do anything additional.  
 
2. Financial incentives-based intervention (n=25): 
 
Participants will receive their final instalment of financial incentives and the financial 
incentives-based intervention will stop. Participants will no longer receive any financial 
incentives/rewards and will no longer have access to the in-app totaliser, the weekly 
messages, and the in-app traffic light calendar. Participants will continue to use their Hailie® 
device (with the programmed reminders) for the remaining 12-weeks of the study. 
 

 
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STUDY VISIT 3: 
The following information will be collected from all participants; asthma history, asthma 
control (ACT questionnaire, FENO) asthma adherence (self-report, MARS and electronic 
from Hailie) and behavioural/psychological data (BMQ, B-IPQ, SRBAI, TSRQ-adapted). All 
participant’s Hailie® adherence data will also be downloaded. 
 
Participants will be asked to return their Hailie® device and will no longer be required to 
monitor their adherence.  
 
Participants will be invited to take part in a focus group discussion (which will either be in-
person at the CCRF or virtually via Microsoft teams) to discuss their perceptions of the trial 
and to obtain feedback. Focus groups will be optional for participants. Parents/guardians will 
also be invited to an optional interview to their feedback of the trial.  
 
 
3.1. 
STUDY OUTCOME MEASURES 
 
Primary outcome:  
• 
ICS adherence (measured by EMD record of inhaler actuation%) 
 
Secondary outcome:  
• 
Proportion of participants achieving good asthma adherence (≥80%) 
• 
Time to next asthma exacerbation needing a course of oral corticosteroids (OCS) 
• 
Total number of severe exacerbations (incident rate ratio) 
• 
Asthma control (measured by asthma control test (ACT)) 
• 
FENO  
• 
Habit (measured by Self-Report Behavioural Automaticity Index, SRBAI) 
• 
Belief in Medicines Questionnaire (BMQ) 
• 
Brief Illness Perception Questionnaire (B-IPQ) 
• 
Autonomous/controlled motivation (adapted from the Treatment Self-Regulation 
Questionnaire, TSRQ)  
• 
Self-report adherence (Medication Adherence Report Scale for Asthma, MARS-A) 
 
 
4. PARTICIPANT ENTRY 
 
4.1. 
PRE-REGISTRATION EVALUATIONS  
 
Participants must be contactable by telephone/email and able to receive written information. 
No pre-registration tests are required.  
 
Prior to any study procedures, informed consent from the parent/guardian and assent from 
the child or young person will be obtained. The child and their parent/guardian will be given 

 
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adequate time to decide whether or not they wish to participate. The child and their 
parent/guardian should understand that their refusal to participate in the study will not affect 
their subsequent medical care and if they do consent, they may withdraw at any point 
without affecting their care.  For parents and guardians participating in the subsequent 
interviews, they are free to withdraw at any time and without giving a reason before the 
interview. Otherwise, all data will be kept once collected as it will be anonymous.   
 
 
4.2. 
INCLUSION CRITERIA  
 
Inclusion criteria are:  
• 
Informed consent obtained from parent/guardian and assent from the child. 
• 
Children or young person with doctor diagnosed asthma presenting to Emergency 
Departments (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: 
o Clenil 
o Flixotide 
o Symbicort 
o Seretide 
 
 
4.3. 
EXCLUSION CRITERIA 
 
Exclusion criteria are: 
• 
Parent/guardian unable to provide consent / CYP unable to provide 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) 
 
 
4.4. 
WITHDRAWAL CRITERIA  
 
CYP will be withdrawn from the study if CYP/parent/guardian refuse or withdraw their 
consent to participate in the study. Parent/guardian/CYP can refuse intervention, adherence 
monitoring or any study tests/questionnaires at any time without any negative 
consequences. Participation or withdrawal in the study will not affect the patient's clinical 
care and participants will not be prevented from receiving any treatment that may be 
required without participating in the study.  
 
We don't anticipate any reason to stop the trial or other research early. 

 
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Any data already collected from a participant who decides to withdraw from the study will be kept. If 
a participant decides to withdraw from the study, data already collected until that point in the study 
will be used.  
 
 
5. ADVERSE EVENTS  
 
5.1. 
DEFINITIONS  
 
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect 
that: 
• 
Results in death 
• 
Is life-threatening – refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
• 
Requires 
hospitalisation, 
or 
prolongation 
of 
existing 
inpatients’ 
hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of 
the other outcomes listed in the definition above, should also be considered serious. 
 
5.2. 
REPORTING PROCEDURES  
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
5.3.1 Non serious AEs 
All such events, whether expected or not, should be recorded- it should be specified if only 
some non-serious AEs will be recorded, any reporting should be consistent with the purpose 
of the trial end points.  
 
Potential AEs and known complications: 
  
Procedure 
Known complications 
n/a 
n/a 
 
5.3.2 Serious AEs 

 
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An SAE form should be completed and emailed to the Chief Investigator within 24 hours.  
However, relapse and death due to asthma and hospitalisations for elective treatment of a 
pre-existing condition do not need reporting as SAEs. 
 
All SAEs should be reported to the London-Bloomsbury REC where in the opinion of the Chief 
Investigator, the event was: 
• 
‘related’, ie resulted from the administration of any of the research procedures; 
and 
• 
‘unexpected’, ie an event that is not listed in the protocol as an expected 
occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all related and unexpected SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
RGIT@imperial.ac.uk 
CI email (and contact details below) 
Please send SAE forms to: Dr Louise Fleming 
Tel: +44 (0)20 7352 8121 ext 2938 / Email: l.fleming@imperial.ac.uk  
(Mon to Fri 09.00 – 17.00) 
 
6. ASSESSMENT AND FOLLOW-UP  
 
The following data will be collected at each study visit.  
 
Study 
visit 1 
(0wks) 
Study 
visit 2 
(12wks) 
Study 
visit 3 
(24wks) 
Study enrolment 
(1) Participant informed consent (and assent from CYP) (n=50) 
(2) Information and provision of Hailie® device (n=50) 
(3) Randomisation to intervention (n=25) or to control group (n=25) 
 
X 
X 
X 
 
 
Inhaler technique 
X 
X 
X 
Asthma UK Action plan 
X 
 
 
Demographic information  
X 
 
 
Asthma characteristics/history  
X 
X 
X 
Control group (n=25) 
Electronic monitoring device (programmed with morning and 
evening reminders) 
 
 
 

 
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Financial incentives-based group (n=25) 
Electronic monitoring device (programmed with morning and 
evening reminders) 
Financial incentives (with in-app totaliser, in-app messages 
recording progress and in-app traffic light calendar) 
 
 
 
Asthma measures  
(1) ICS adherence % 
(2) Asthma control (ACT) 
(3) Exhaled nitric oxide (FENO) 
(4) Self-report adherence (MARS) 
 
 
- 
X 
X 
X 
 
 
X 
X 
X 
X 
 
 
X 
X 
X 
X 
Behavioural/psychological measures 
(1) Habit (SRBAI) 
(2) Belief in Medicines Questionnaire (BMQ) 
(3) Brief illness Perceptions Questionnaire (B-IPQ) 
(4) Autonomous/Controlled motivation (adapted from TSRQ)  
 
X 
X 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
 
Incidental findings 
 
We don’t anticipate there to be any incidental findings within this study. However, in the 
event of any incidental findings, the research team will inform the participant (and their 
parent/guardian) and will encourage them to inform and discuss findings with their GP. The 
summary of results from each study visit will also be sent to the GP after each study visit.  
 
Study completion 
 
Study end is defined as once all contactable participants have had their third and final 
research visit (the last research visit of the last subject recruited) and completion of the final 
focus groups for those involved.  
 
All data will be stored for 10 years following completion of the study. At study completion, 
participants will continue to receive their usual care.  
 
 
Follow-up contact 
 
No further contact from the research team directly related to this study is anticipated 
following completion. Participants will continue to receive their routine care as per prior to 
enrollment in this project. 
 
 
 
 
 
 
 

 
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7. STATISTICS AND DATA ANALYSIS 
 
7.1 
Data management 
 
Data entry will be collected by the study coordinator (Jasmine Hine) and the data analysis 
will be conducted by the study coordinator with assistance from the chief Investigator (Dr 
Louise Fleming). 
All collected data will be entered onto an electronic database (REDCap/Excel) held on a 
secure Imperial College London server.  
 
7.2 
Statistical methods and sample size 
 
As this is a pilot study, a formal sample size calculation is not required. However, the 
estimated sample size of 50 participants in total is based upon a calculation from un-
published adherence data obtained from Royal Brompton Hospital from 400 children. Mean 
adherence in the sample was 65% (SD 22%). A Cochrane review28 of adherence 
interventions to ICS for asthma found that electronic trackers or reminders led to better 
adherence of 19% (95% CI 14.47 to 25.26).   Based upon this information, to give 80% 
power to achieve a 19% difference between the intervention group and controls, 21 
participants are required per group. The target of 25 per group accounts for participant drop-
out. This is supported by evidence that as a pilot study, 25 participants per group, with a total 
of 50 participants is sufficient29. 
 
Data analysis will be conducted using the Statistical Package for the Social Services 
(SPSS). Statistical analysis of quantitative, normally distributed data will be reported with 
means ± standard deviations (SD) and non-parametric data will be reported as medians with 
interquartile range. Data will be tested for normality using visual inspection, histograms, and 
Kolmogorov-Smirnov testing. Parametric tests will be used where possible for normally 
distributed data and logarithmically transformed data, otherwise appropriate non-parametric 
tests shall be used. The significance levels for all tests will be set at <0.5. 
Categorical data will be reported as proportions. Comparative analysis of variance between 
2 groups for continuous data will be performed using the student’s t test for normally 
distributed data and the Mann Whitney U tests for non-normally distributed data and for 
more than 2 groups the ANOVA or Kruskal Wallis respectively. A comparison of the 
proportions between groups will be performed using the Pearson Chi 2 tests. Within group 
analysis the ANOVA test will also be used. 
Questionnaire data will be used alongside group comparisons to observe any notable 
changes or differences between groups. 
Qualitative data obtained from the focus groups will be thematically analysed. An 
independent researcher will aid with the facilitation/analysis of qualitative aspect of the study 
to ensure there is no bias.  
 
 

 
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8. REGULATORY ISSUES  
 
8.1. 
ETHICS APPROVAL  
The Study Coordination Centre has obtained approval from the London-Bloomsbury Research 
Ethics Committee (REC) and Health Research Authority (HRA). The study must also receive 
confirmation of capacity and capability from each participating NHS Trust before accepting 
participants into the study or any research activity is carried out. The study will be conducted 
in accordance with the recommendations for physicians involved in research on human 
subjects adopted by the 18th World Medical Assembly, Helsinki 1964, and later revisions. 
 
For participants involved in the financial incentives-based intervention, the financial incentives 
are gain-framed so participants will be rewarded dependent upon adherence behaviour, the 
reward will not be removed.  
 
The clinical tests (FENO) may be familiar to participants. It is often used as routine care in 
many clinics. The test is very basic and will be fully described to the child.  
 
The behavioural/psychological questionnaires (including SRBAI, BMQ, B-IPQ and adapted 
TSRQ), the self-report adherence questionnaire (MARS-A) and the focus group discussion 
will involve simple questions that should not be distressing.  
 
Participants can refuse to answer any questions at any point.  
 
All questionnaires are included in the appendix.  
 
 
 
8.2. 
CONSENT   
 
Consent to enter the study must be sought from both parent/guardian and assent obtained from 
the CYP.  Consent/assent must be sought only after a full explanation has been given, an 
information leaflet offered and time allowed for consideration.  Signed participant 
consent/assent should be obtained.  The right of the participant to refuse to participate without 
giving reasons must be respected. All participants are free to withdraw at any time from the 
protocol treatment without giving reasons and without prejudicing further treatment. 
 
Consent will also be obtained separately from parents/guardians who will be taking part in the 
interviews.   
 
 
8.3. 
CONFIDENTIALITY  
 
The Chief Investigator will preserve the confidentiality of participants taking part in the 
study and is registered under the Data Protection Act. 
 
Data will be pseudonymised. 
 
 
 

 
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8.4. 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance 
policies which apply to this study. 
 
 
8.5. 
SPONSOR  
Imperial College London will act as the main Sponsor for this study. Delegated 
responsibilities will be assigned to the NHS trusts taking part in this study.   
 
 
8.6. 
FUNDING  
Imperial College London and AUKCAR are funding this study.  
 
Finances: 
• 
Awaiting quote from Adherium, New Zealand (regarding the Hailie sensors) 
• 
Up to £168/participant (n=25) in financial incentives-based intervention group = 
£4,200 
• 
Reimbursement costs for travel and for refreshments will be provided to 
parents/guardians/CYP who attend any study visits in person at the CCRF, St Mary’s 
Hospital. 
 
 
8.7. 
AUDITS   
The study may be subject to audit by Imperial College London under their remit as 
sponsor and other regulatory bodies to ensure adherence to GCP and the UK Policy 
Frame Work for Health and Social Care Research.  
 
 
 
9. STUDY MANAGEMENT  
 
The day-to-day management of the study will be co-ordinated through Jasmine Hine 
(CCRF, St Mary’s Hospital, Imperial College London Healthcare Trust).  
 
 
10. PUBLICATION POLICY  
 
The results of this study will be presented at national and international scientific 
meetings to audiences of both paediatric and adult respiratory, allergy and general 
physicians. All results will be submitted for publication in peer-reviewed medical journals 
using open access policies where applicable. We will also use appropriate patient facing 
social media and channels via Imperial College Public Relations team and AUKCAR 
communications team to disseminate results. Results will also be included in a submitted 
PhD thesis submission to Imperial College London and will be detailed on the AUKCAR 
website/newsletters.  
 

 
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11. REFERENCES  
 
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TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, 
Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, 
Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic 
Society/European Respiratory Society Task Force on Asthma Control and 
Exacerbations. An official American Thoracic Society/European Respiratory Society 
statement: asthma control and exacerbations: standardizing endpoints for clinical 
asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;1;180(1): 59-99. 
doi: 10.1164/rccm.200801-060ST. 
2. Asthma UK. Asthma facts and statistics. Available from: 
www.asthma.org.uk/about/media/facts-and-statistics/ [Accessed 7th July 2021]. 
3. National Health Service (NHS). Childhood asthma. Available from: 
www.england.nhs.uk/childhood-asthma/ [Accessed 27th August 2021]. 
4. World Health Organization. Asthma. Available from: www.who.int/news-room/fact-
sheets/detail/asthma [Accessed 27th August 2021]. 
5. Royal College of Physicians. Why asthma still kills: the National Review of Asthma 
Deaths (NRAD) Confidential Enquiry report. London: RCP. 2014. 
6. Bracken M, Fleming L, Hall P, Van Stiphout N, Bossley C, Biggart E, et al. The 
importance of nurse-led home visits in the assessment of children with problematic 
asthma. Archives of Disease in Childhood. 2009;94(10): 780-784. doi: 
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7. Jentzsch NS, Camargos P, Sarinho ES, Bousquet J. Adherence rate to 
beclomethasone dipropionate and the level of asthma control. Respiratory Medicine. 
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8. Santos Pde M, D’Oliveira A Jr, Noblat Lde A, Machado AS, Noblat ACB, Cruz AA. 
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1002. doi: 10.1590/s1806-37132008001200003. 
9. Klok T, Kaptein AA, Duiverman EJ, Brand PL. Long-term adherence to inhaled 
corticosteroids in children with asthma: Observational study. Respiratory medicine. 
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11. Chan AH, Stewart AW, Harrison J, Camargo CA Jr, Black PN, Mitchell EA. The effect 
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12. Morton RW, Elphick HE, Rigby AS, Daw WJ, King DA, Smith LJ, et al. STAAR: a 
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13. Horne R. Compliance, adherence and concordance. In Pharmacy Practice, 2001. Ed. 
by KMG Taylor & G Harding. London: Taylor & Francis 
14. Phillips LA, Cohen J, Burns E, Abrams J, Renninger S. Self-management of chronic 
illness: the role of 'habit' versus reflective factors in exercise and medication 
adherence. J Behav Med. 2016;39(6): 1076-1091. doi: 10.1007/s10865-016-9732-z. 
15. Gardner B, Lally P, Wardle J. Making health habitual: the psychology of 'habit-
formation' and general practice. Br J Gen Pract. 2012; 62(605): 664-6. doi: 
10.3399/bjgp12X659466.  
16. Judah, G., Gardner, B., Kenward, M.G. et al. Exploratory study of the impact of 
perceived reward on habit formation. BMC Psychol. 2018; 6(62). doi: 
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17. Giles EL, Robalino S, McColl E, Sniehotta FF, Adams J. The effectiveness of 
financial incentives for health behaviour change: systematic review and meta-
analysis. PLoS One. 2014;9(3): e90347. doi: 10.1371/journal.pone.0090347. 
18. Priebe S, Yeeles K, Bremner S, Lauber, Edlridge S, Ashby D et al. Effectiveness of 
financial incentives to imnprove adherence to maintenance treatment with 
antipsychotics: cluster randomised controlled trial. BMJ. 2013; 347: f5847. 
doi:10.1136/bmj.f5847. 
19. Barankay I, Reese PP, Putt ME, et al. Effect of Patient Financial Incentives on Statin 
Adherence and Lipid Control: A Randomized Clinical Trial. JAMA Network 
Open. 2020;3(10): e2019429. doi: 10.1001/jamanetworkopen.2020.19429. 
20. Petry NM, Alessi SM, Byrne S, White WB. Reinforcing adherence to antihypertensive 
medications. Journal of Clinical Hypertension (Greenwich). 2015;17(1): 33-8. doi: 
10.1111/jch.12441. 
21. Sorensen JL, Haug NA, Delucchi KL, Gruber V, Kletter E, Batki S, et al. Voucher 
reinforcement improves medication adherence in HIV-positive methadone patients. 
Drug and Alcohol Dependence. 2007;88(1): 54–63. 
doi: 10.1016/j.drugalcdep.2006.09.019 
22. Kenyon CC, Flaherty C, Floyd GC, Jenssen BP, Miller VA. Promoting Healthy 
Childhood Behaviors With Financial Incentives: A Narrative Review of Key 
Considerations and Design Features for Future Research. Acad Pediatr. 2021;15: 
S1876-2859(21)00428-9. doi: 10.1016/j.acap.2021.08.010.  
23. Petry NM, Cengiz E, Wagner JA, Weyman K, Tichy E, Tamborlane WV. Testing for 
Rewards: A Pilot Study to Improve Type 1 Diabetes Management in Adolescents. 
Diabetes Care. 2015;38(10): 1952-1954. doi: 10.2337/dc15-0765.  
24. Wong CA, Miller VA, Murphy K, et al. Effect of financial incen- tives on glucose 
monitoring adherence and glycemic control among adolescents and young adults 
with type 1 diabetes: a randomized clinical trial. JAMA Pediatr. 2017;171: 1176–
1183. https://doi.org/ 10.1001/jamapediatrics.2017.3233.  
25. Wagner JA, Petry NM, Weyman K, et al. Glucose management for rewards: a 
randomized trial to improve glucose monitoring and asso- ciated self-management 
behaviors in adolescents with type 1 diabetes. Pediatr Diabetes. 2019;20: 997–1006. 
https://doi.org/10.1111/ pedi.12889.  
26. Mosnaim G, Li H, Martin M, Richardson D, Belice PJ, Avery E, Silberstein A, Leigh J, 
Kenyon R, Jones S, Bender B, Powell LH. A tailored mobile health intervention to 
improve adherence and asthma control in minority adolescents. Journal of Allergy 
and Clinical Immunology: In Practice. 2015;3(2): 288-290. doi: 
10.1016/j.jaip.2014.10.011. 
27. De Simoni A, Fleming L, Holliday L, et al. Electronic reminders and rewards to 
improve adherence to inhaled asthma treatment in adolescents: a non-randomised 
feasibility study in tertiary care. BMJ Open 2021;11:e053268. doi: 10.1136/bmjopen-
2021-053268. 

 
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28. Normansell R, Kew KM, Stovold E. Interventions to improve adherence to inhaled 
steroids for asthma. Cochrane Database Syst Rev. 2017;4(4):CD012226. doi: 
10.1002/14651858.CD012226.pub2. 
29. Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the 
design of intervention trials with continuous outcomes. Clinical Epidemiology. 
2018;10: 153-157. doi: 10.2147/CLEP.S146397 
 
 
 
 

 
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APPENDIX:  
 
1. Questionnaires to be used in this study 
a. Asthma Control Test (ACT) 
b. Brief Illness Perceptions Questionnaire (B-IPQ) 
c. Belief in Medicines Questionnaire (BMQ) 
d. Self-Report Behavioural Automaticity Index (SRBAI) 
e. Medication Adherence Report Scale for Asthma (MARS-A) 
f. Autonomous/Controlled Motivation questionnaire (Adapted from the 
Treatment Self-Regulation Questionnaire for the purpose of this study)  
 
2. Asthma UK Children’s asthma plan 
 
 

 
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1.Questionnaires to be used in this study 
 
a. Asthma control test (ACT) 
 
 
1. 
In the past 4 weeks, how much of the time did your asthma keep you from getting as much done at work, school or home? 
 
All of the time 
(1) 
Most of the time 
(2) 
Some of the time 
(3) 
A little of the time 
(4) 
None of the time 
(5) 
SCORE 
 
 
2. 
During the past 4 weeks, how often have you had shortness of breath? 
 
More than once a 
day 
 
Once a day 
3 to 6 times a week 
Once or twice a week 
Not at all 
SCORE 
 
 
3. 
During the past 4 weeks, how often did your asthma symptoms (wheezing, coughing, shortness of breath, chest tightness or pain) 
wake you up at night or earlier than usual in the morning? 
 
4 or more nights a 
week 
2 or 3 nights a week 
Once a week 
Once or twice in the 
past 4 weeks 
Not at all 
SCORE 
 
 
4. 
During the past 4 weeks, how often did you have to use your rescue (blue) inhaler or nebuliser medication? 
 
3 or more times a 
day 
1 or 2 times a day 
2 or 3 times per week 
Once a week or less 
Not at all 
SCORE 
 
 
5. 
How would you rate your asthma control over the past 4 weeks? 
 
Not controlled at all 
Poorly controlled 
Somewhat controlled 
Well controlled 
Completely controlled 
SCORE 
 
TOTAL SCORE 
 
Completed by (circle):  
child / parent / both  
 
 
 
 
 
 
 
 
 
 
 

 
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b. Brief Illness Perceptions Questionnaire (B-IPQ) 
 
 
 
 
 
 

 
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c. Beliefs about Medicines Questionnaire (BMQ) 
(©R Horne) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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d. Self-report Behavioural Automaticity Index (SRBAI) 
 
 
 
Habit questionnaire – Self-report Behavioural Automaticity Index (SRBAI) 
 
These questions are all about your taking of your preventer inhaler on a regular basis. 
 
1. Taking my preventer inhaler in the morning and in the evening is something I do 
automatically  
 
 
 
 
Strongly agree       
             Agree   
                  Uncertain              Disagree  
               Strongly disagree 
 
 
2. Taking my preventer inhaler in the morning and in the evening is something I do without 
having to consciously remember 
 
 
 
 
 
Strongly agree       
             Agree   
                  Uncertain              Disagree  
               Strongly disagree 
 
 
3. Taking my preventer inhaler in the morning and in the evening is something I do without 
thinking 
 
 
 
 
 
Strongly agree       
             Agree   
                  Uncertain              Disagree  
               Strongly disagree 
 
 
4. Taking my preventer inhaler in the morning and in the evening is something I start doing 
before I realise I’m doing it  
 
 
 
 
 
Strongly agree       
             Agree   
                  Uncertain              Disagree  
               Strongly disagree 
 
 
 
 
Gardner, B., Abraham, C., Lally, P., & de Bruijn, G. J. (2012). Towards parsimony in habit measurement: Testing the convergent and 
predictive validity of an automaticity subscale of the Self-Report Habit Index. International Journal of Behavioral Nutrition and Physical 
Activity, 9(1), 1-12 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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e. Medication Adherence Report Scale for Asthma (MARS-A) 
 
 
Medication Adherence Report Scale for Asthma (MARS-A) 
 
Many people find a way of using their medication which suits them 
 
This may differ from the instructions on the label or from what their doctor has said 
 
We would like you to answer a few questions about how you use your medicines 
 
Here are some of the ways people have said that they use their medicines.  
 
For each statement please tick the box which best applies to you: 
 
 
Your own way of using your 
medicines 
Always 
Often 
Sometimes 
Rarely 
Never 
1 
2 
3 
4 
5 
I only use my steroid (preventer) 
inhaler when I need it 
 
 
 
 
 
 
I only use it when I feel breathless 
 
 
 
 
 
 
I decide to miss out a dose 
 
 
 
 
 
 
I try to avoid using it  
 
 
 
 
 
 
I forget to take it 
 
 
 
 
 
 
I alter the dose 
 
 
 
 
 
 
I stop taking it for a while 
 
 
 
 
 
 
I use it as a reserve, if my other 
treatment doesn’t work 
 
 
 
 
 
 
I use it before doing something which 
might make me breathless 
 
 
 
 
 
 
I take less than instructed 
 
 
 
 
 
 
 
(©R Horne) 
 
 
Cohen JL, Mann DM, Wisnivesky JP, Home R, Leventhal H, Musumeci-Szabó TJ, Halm EA. Assessing the validity of self-
reported medication adherence among inner-city asthmatic adults: the Medication Adherence Report Scale for Asthma. Ann 
Allergy Asthma Immunol. 2009 Oct;103(4):325-31. doi: 10.1016/s1081-1206(10)60532-7. 
 
 
 
 
 
 
 

 
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f. Autonomous/Controlled Motivation questionnaire (Adapted from the Treatment 
Self-Regulation Questionnaire (TSRQ) for the purpose of this study)  
 
 
 
Autonomous/controlled motivation (adapted from the Treatment Self-Regulation 
Questionnaire, TSRQ, for the purpose of this study) 
 
The following question relates to the reasons why you would take your asthma 
preventer inhaler.  
 
Different people have different reasons for doing that, and we want to know how true 
each of the following reasons is for you. All 8 response are to the same question.  
 
Please indicate the extent to which each reason is true for you, using the following 7-
point scale:  
 
 
 
 
 
 
I take my asthma preventer inhaler because… 
 
1. I would feel in the wrong if I did not take my inhaler  
 
 
 
 
 
2. I personally believe it is the best thing for my health.  
 
 
 
 
 
 
3. Others would be upset with me if I did not take my inhaler  
 
 
 
 
 
 
4. I believe it is very important for many aspects of my life.  
 

 
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5. I would feel bad about myself if I did not take my inhaler  
 
 
 
 
 
6. It is an important choice I really want to make.  
 
 
 
 
 
7. It is very important for being as healthy as possible.  
 
 
 
 
 
 
8. I want others to see I can do it. 
 
 
 
 
 
 
 
 
INTERVENTION GROUP ONLY 
 
1. I take my asthma preventer inhaler to get the incentive 
 
 
 
 
 
 
2. The reason why I take my asthma preventer inhaler is to get the reward 
 

 
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Adapted for this study from TSRQ, accessed from: https://selfdeterminationtheory.org/, Healthcare, Self-determination theory 
packet (Geoffrey C. Williams, Richard M. Ryan, & Edward L. Deci), first used for “behaving in a healthy way” by Williams, Grow, 
Freedman, Ryan & Deci (1996). 
 
 
 
 

 
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2.Asthma UK Children’s asthma plan 
 

 
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