Developing and evaluating a mobile phone-based early alert system using high-resolution air quality forecast to improve asthma control in Malaysia
| ISRCTN | ISRCTN14489433 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14489433 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | AC23007, NIHR 132826 |
| Sponsor | Accord (United Kingdom) |
| Funder | NIHR Global Health Research Unit on Respiratory Health (RESPIRE) |
- Submission date
- 05/04/2023
- Registration date
- 01/08/2023
- Last edited
- 02/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Outdoor air pollution, particularly haze, is common in Southeast Asia, including Malaysia. Haze has been associated with increased asthma exacerbations.
A prior feasibility study was funded by the UK NIHR Global Health Research Unit on Respiratory Health (RESPIRE) conducted in Klang Valley, Malaysia. The study showed that with every increase in inhalable airborne particulate matter with a diameter of 10 microns or less (PM10) there was an 8.7% increased risk of asthma exacerbation and the exacerbation was likely to occur 2 days after exposure. In the RESPIRE Klang Asthma Cohort study, 65.9% of the surveyed adult asthma patients reported having poor asthma control; 51% of the surveyed adult patients reported haze as a trigger for asthma exacerbation. Exposure to haze was found to be significantly associated with poorly controlled asthma. With these findings, the team propose to develop and evaluate a mobile-phone-based early warning system as an individual intervention to improve asthma control. Patients will be alerted of anticipated air pollution episodes so that they can take measures to prevent acute asthma exacerbation. The study aims to develop a high-resolution air quality model for a 2-day forecast for the local priority air pollutants in the Klang District, Malaysia; to adapt and refine the mobile health application; and, to undertake a pilot study to assess the feasibility of utilising a mobile health application with air quality indicators as an early warning system to support asthma self-management.
Who can participate?
Adult patients aged over 18 years old who live in the study location and have reported poor asthma control and exacerbation aggravated by haze
What does the study involve?
Participants will be allocated to either the control group or to the intervention group. All participants (intervention and control group) will receive asthma self-management education before the allocation of groups. For the control group, participants will be asked to follow their usual care for asthma at the clinic. The research staff of this study will carry out follow-up assessments at 1, 3, 6 and 12 months to monitor your asthma status. For the intervention group, participants will be asked to install a mobile app on their phones. After installing the app, the research staff will explain on how to utilise it in the intervention group. To ensure participants' identity is non-identifiable when using the app, they will be given a code to log in before using the app. The research staff will demonstrate how to keep track of their asthma symptoms and how to use asthma action plans. Participants will learn about air quality, weather forecasts, and health-risk messages. Follow-up assessments will be carried out by research staff at 1, 3, 6 and 12 months.
What are the possible benefits and risks of participating?
There may or may not be any benefits to the participants. The results of this study will help to improve asthma control in adults with asthma compared to usual care, particularly during pollution using a mobile health app with a high-resolution air quality forecast as an early alert system to support asthma self-management to improve patient asthma control. Participants will be able to contribute significantly to the development of an intervention to improve asthma self-management during pollution. The researcher will also be able to contribute to the larger body of medical knowledge in the field of asthma self-management. There is no foreseeable risk involved in this study except the time to help with the interview.
Where is the study run from?
Department of Primary Care Medicine, Faculty of Medicine, Universiti Malaya (Malaysia)
When is the study starting and how long is it expected to run for?
December 2022 to June 2026
Who is funding the study?
NIHR Global Health Research Unit on Respiratory Health (RESPIRE) (UK)
Who is the main contact?
nhrita@um.edu.my (Malaysia)
Contact information
Principal investigator
Department of Primary Care Medicine
Faculty of Medicine
Universiti Malaya
Kuala Lumpur
50603
Malaysia
 ORCID ID |
0000-0001-9610-467X |
|---|---|
| Phone | +60379502306 |
| nhrita@um.edu.my |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomized controlled trial |
| Secondary study design | Pilot randomized controlled trial |
| Study type | Participant information sheet |
| Scientific title | Developing and evaluating a mobile phone-based early alert system using high-resolution air quality forecast to improve asthma control in Malaysia |
| Study acronym | AQAapp |
| Study objectives | Is a mobile phone-based early alert system using high-resolution air quality forecast effective in improving asthma control during increased outdoor pollution? |
| Ethics approval(s) |
Approved 30/05/2023, Edinburgh Medical Research Ethics Committee (None provided, Edinburgh, None provided, United Kingdom; None provided; emrec@ed.ac.uk), ref: EMREC-RESPIRE-23-05 |
| Health condition(s) or problem(s) studied | Improving asthma control among adult patients with asthma during increased outdoor pollution |
| Intervention | A mobile phone-based early alert system using high-resolution air quality forecast |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mobile telephone-based healthcare application |
| Primary outcome measure(s) |
Asthma control measured using the Global Initiative for Asthma (GINA) Asthma Symptoms Control scoring at 1, 3, 6 and 12 months |
| Key secondary outcome measure(s) |
Clinical endpoints assessed at baseline, 1, 3, 6 and 12 months: |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Adult patients aged 18 years old and above with physician-diagnosed asthma and receiving asthma treatment in the previous year 2. Adult patients who live in Klang District for the duration of the study 3. Patients who had reported poor asthma control and exacerbation aggravated by haze (findings from baseline study in RESPIRE 1) 4. Patients who are on controller medication (e.g., an inhaled corticosteroid (ICS), inhaled combination ICS/long-acting beta-agonists (LABA), leukotriene receptor antagonist (LTRA)) 5. Patients who own and are able to use a smartphone 6. Patients who are able to understand the Malay/English language 7. Patients who are willing and able to give consent to participate in the study |
| Key exclusion criteria | 1. Patients below 18 years of age 2. Patients who have respiratory symptoms (e.g., cough, breathlessness, wheezing) due to other conditions for example established physician diagnoses of: 2.1. Respiratory infection e.g., pneumonia, tuberculosis (but not having underlying asthma) 2.2. Chronic obstructive pulmonary diseases 2.3. Congenital heart disease 2.4. Heart, liver or renal failure 2.5. Gastro-esophageal reflux 2.6. Active life-threatening malignancy and those receiving palliative care 3. Patients who have disabilities (physical/psychological) that may interfere with the completion of the study 4. Patients who are unwilling or unable to provide written informed consent (e.g. cognitive impairment) |
| Date of first enrolment | 12/11/2024 |
| Date of final enrolment | 20/03/2026 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Klang
Selangor
42000
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/analysed will be de-identified before publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/12/2025: The following changes were made to the trial record:
1. The date of final enrolment was changed from 01/12/2025 to 20/03/2026
2. The completion date was changed from 01/12/2025 to 30/06/2026
12/12/2024: The following changes were made to the study record:
1. The acronym was changed from AQFAC to AQAapp.
2. The recruitment start date was changed from 03/01/2024 to 12/11/2024.
3. The recruitment end date was changed from 31/12/2024 to 01/12/2025.
4. The overall study end date was changed from 01/06/2025 to 01/12/2025.
16/06/2023: Trial's existence confirmed by the Edinburgh Medical Research Ethics Committee (EMREC) (UK).
