ISRCTN ISRCTN18284682
DOI https://doi.org/10.1186/ISRCTN18284682
Secondary identifying numbers AC22181
Submission date
20/10/2023
Registration date
23/10/2023
Last edited
09/04/2025
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
One out of every eleven kids in Malaysia has asthma, and asthma symptoms or attacks can happen at any time. The World Health Organization (WHO) suggests that it's crucial to support children with asthma and give school staff training on how to help during asthma emergencies. A review by Cochrane found that school staff who got asthma training followed asthma guidelines better and were more prepared to assist students with asthma. This is important because following a school asthma plan and helping children with asthma can reduce health problems and even save lives.

We discovered that school staff don't know much about asthma and are often unprepared to assist students, especially in asthma emergencies. To help kids with asthma at school, we created the CuT-AsthMa program and introduced a plan for how to handle asthma in schools to the staff. The program for school staff includes basic asthma education and first aid training for asthma emergencies. In our feasibility study, we received positive feedback from the school staff and a good level of participation. So, we want to see how effective this program is when it's implemented in government primary schools in the Klang District, Malaysia.

Who can participate?
This is a pilot cluster randomised controlled trial comparing a school-based asthma training programme versus a general health education among school staff in government primary schools in Klang District, Malaysia.

What does the study involve?
We will randomize four schools out of 23 primary schools under Klang District Education Office. Two schools will be in the control group while the other two will be in the intervention group. The control group will be receiving a general health education sessions. The intervention group will be receiving a school-based asthma training programme. The duration of the entire research will be 12 months.

The session for the school-based asthma training programme with the school staff will last about 2 hours. After delivering the programme, we will use a mixed-methods approach to measure the study outcomes. Quantitative method for outcomes 1-4, and qualitative method for outcomes 2-4. The study outcomes are:
1. Asthma knowledge of government primary school staff
2. Feasibility of implementing the programme among school staff and healthcare professionals
3. Feasibility of conducting a cluster randomised controlled trial in government primary schools
4. Usability of the programme among school staff and healthcare professionals.

What are the possible benefits and risks of participating?
A possible benefit of this study is that school staff will learn about asthma, which may improve their general knowledge. There are no foreseeable risks in participating in this study.

Where is the study run from?
1. Universiti Malaya (Malaysia)
2. University of Edinburgh (UK)

When is the study starting and how long is it expected to run for?
July 2022 to June 2026

Who is funding the study?
This research was funded by the UK National Institute for Health and Care Research (NIHR) (Global Health Research Unit on Respiratory Health (RESPIRE); 16/136/109 and NIHR132826) via the University of Edinburgh in the United Kingdom.

Who is the main contact?
Dr Siti Nurkamilla Ramdzan, sitinurkamilla@um.edu.my

Study website

Contact information

Dr Siti Nurkamilla Ramdzan
Public, Scientific, Principal Investigator

Department of Primary Care Medicine, Faculty of Medicine, Universiti Malaya
Kuala Lumpur
50603
Malaysia

ORCiD logoORCID ID 0000-0002-4427-3778
Phone +603 79492306
Email sitinurkamilla@um.edu.my

Study information

Study designPilot cluster randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice, School
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleRevitalising Asthma Care and Treatment (ReACT) School-based asthma programme versus general health programme to improve asthma knowledge among primary school teachers in Malaysia: A cluster randomised controlled trial.
Study acronymReACT School
Study hypothesisSchool staff's who receive a school-based asthma training program (intervention group) will improve their knowledge on asthma compared to school staff who receive a general health education session.
Ethics approval(s)

Approved 06/10/2023, Medical Research and Ethics Committee (MREC) (National Institutes of Health (NIH) Block A, Level 2, No 1, Jalan Setia Murni U13/52, Seksyen U13, Setia Alam, Shah Alam, 40170, Malaysia; +60 3-3362 8398; mrecsec@nih.gov.my), ref: NMRR ID-23-02544-O1O

ConditionImproving asthma knowledge of government primary school staff
InterventionThis is a pilot cluster randomised controlled trial comparing a school-based asthma training programme versus a general health education among school staff in government primary schools in Klang District, Malaysia.
The randomisation is at the school level and will be done using a computer generated system which will allocate 2 schools to intervention and 2 schools to control.

Intervention
All school staff in the intervention schools will be invited to participate in this study. Participants will receive a 2-hour training session on a school-based asthma training programme which include the provision of asthma education and training of first aid asthma care using a generic school asthma action plan.
The participants will be followed up at 1,3, 6 and 12 months.

Control
All school staff in the control schools will be invited to participate in this study. Participants will receive a 2-hour training session on general health education such as personal hygiene, prevention of infectious control and safety in school.
The participants will be followed up at 1,3, 6 and 12 months.
Intervention typeBehavioural
Primary outcome measureAsthma knowledge using the Newcastle Asthma Knowledge Questionnaire at baseline, 1,3, 6 and 12 months.
Secondary outcome measures1. Evaluation of the reaction to the teaching using a questionnaire survey with a Likert scale 1-5 (1=very poor, 5=very good) will be carried out to explore the acceptability and feasibility of the programme measure within 1-month post receiving intervention or control
2. Evaluation of the learning using focus group discussions will be used to gain further insights into the impact of the training, the participants’ confidence and how helpful they perceive the training in supporting asthma of children at schools at 1-month and 12-months post-intervention or control
3. Evaluation of behaviour using a survey form to collect past experiences of supporting the care of children with asthma at baseline, 1-month, 3-months and 12-months
Overall study start date01/07/2022
Overall study end date30/06/2026

Eligibility

Participant type(s)Employee
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants4 clusters, 2 intervention and 2 control. Estimated number in each cluster is 15-20 participants.
Participant inclusion criteriaInclusion criteria for cluster:
1. Government primary school
2. The number of school staff in the school is between 50-100 (considering 20% non-participation and 5% attrition rate, as well as resources available)
3. Schools within the catchment area of the Klang school health service
4. Schools willing to participate in the study

Inclusion criteria for participants:
1. All school staff at selected schools (intervention and control).
2. School staff (teachers, school administrator in-charge of health and other staff) with a role of caring for children.
3. School staff willing and able to provide written informed consent.
Participant exclusion criteriaExclusion criteria for cluster
1.- Schools that do not want to participate in the study
2. Vernacular schools (these schools are conducted in different languages other than the national language e.g. Mandarin or Tamil) are excluded due potential language barriers
3. Schools unwilling or unable to provide consent.
Recruitment start date02/01/2024
Recruitment end date31/12/2024

Locations

Countries of recruitment

  • Malaysia

Study participating centres

Sekolah Kebangsaan Klang
Jalan Dato' Hamzah
Klang
41000
Malaysia
SEKOLAH KEBANGSAAN TELOK GADONG
JALAN YADI 41250 KLANG
KLANG
41250
Malaysia
SEKOLAH KEBANGSAAN TELOK MENEGON
BATU 3, JALAN KOTA RAJA 41000 KLANG
KLANG
41000
Malaysia
SEKOLAH KEBANGSAAN BATU BELAH
JALAN RANTAU PANJANG 42100 KLANG
KLANG
42100
Malaysia
SEKOLAH KEBANGSAAN KG RAJA UDA
JALAN KENANGA, KG RAJA UDA 42000 PELABUHAN KLANG
PELABUHAN KLANG
42000
Malaysia
SEKOLAH KEBANGSAAN PANDAMARAN JAYA
JALAN 12, PANDAMARAN JAYA 42000 PELABUHAN KLANG
PELABUHAN KLANG
42000
Malaysia
SEKOLAH KEBANGSAAN KG JOHAN SETIA
JALAN JOHAN SETIA OFF JALAN LANGAT 41200 KLANG
KLANG
41200
Malaysia
SEKOLAH KEBANGSAAN KG PENDAMAR
KAMPUNG PENDAMAR
KLANG
41200
Malaysia
SEKOLAH KEBANGSAAN TELOK GONG
KG NELAYAN, TELOK GONG 42000 PELABUHAN KLANG
PELABUHAN KLANG
42000
Malaysia
SEKOLAH KEBANGSAAN TAMAN KLANG JAYA
JALAN SERULING 56, OFF JALAN LANGAT 41200 KLANG
KLANG
41200
Malaysia
SEKOLAH KEBANGSAAN TELOK PULAI
TAMAN BERTEK 41100 KLANG
KLANG
41100
Malaysia
SEKOLAH KEBANGSAAN PELABUHAN UTARA
BANDAR BARU SULTAN SULEIMAN 42000 PELABUHAN KLANG
PELABUHAN KLANG
42000
Malaysia
SEKOLAH KEBANGSAAN ABDUL SAMAT
BATU 11, JALAN KAPAR 42200 KAPAR
KAPAR
42200
Malaysia
SEKOLAH KEBANGSAAN KAMPUNG IDAMAN
JALAN IDAMAN 17 42000 PELABUHAN KLANG
PELABUHAN KLANG
42000
Malaysia
SEKOLAH KEBANGSAAN TAMAN KLANG UTAMA
JALAN HAJI SIRAT 42100 KLANG
KLANG
42100
Malaysia
SEKOLAH KEBANGSAAN KAMPUNG JAWA
JALAN KOTA RAJA, KAMPUNG JAWA 41000 KLANG
KLANG
41000
Malaysia
SEKOLAH KEBANGSAAN BUKIT TINGGI
BANDAR BUKIT TINGGI 41200 KLANG
KLANG
41200
Malaysia
SEKOLAH KEBANGSAAN MERU (2)
JALAN PAIP, PEKAN MERU 41050 KLANG
KLANG
41050
Malaysia
SEKOLAH KEBANGSAAN SUNGAI KAPAR INDAH
JLN SUNGAI KAPAR INDAH 6, TMN SUNGAI KAPAR INDAH 42200 KAPAR, KLANG
KLANG
42200
Malaysia
SEKOLAH KEBANGSAAN KOTA KEMUNING
JALAN ANGGERIK ARANDA 31/8, KOTA KEMUNING 40460 SHAH ALAM
HAH ALAM
40460 S
Malaysia
SEKOLAH KEBANGSAAN KAMPUNG JAWA 2
JALAN KOTA RAJA 41000 KLANG
KLANG
41000
Malaysia
SEKOLAH KEBANGSAAN METHODIST
JALAN ORKID 42000 PELABUHAN KLANG
PELABUHAN KLANG
42000
Malaysia
SEKOLAH KEBANGSAAN PEREMPUAN METHODIST
JALAN RAYA BARAT 41000 KLANG
KLANG
41000
Malaysia
BUKIT KUDA HEALTH CLINIC
Jalan Batu Tiga Lama, Kawasan 15, 41300 Klang, Selangor
KLANG
41300
Malaysia
Bandar Botanik Health Clinic
Jalan Langat, Bandar Botanik, 41200 Klang, Selangor
Klang
41200
Malaysia

Sponsor information

University of Edinburgh
University/education

ACCORD
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Email enquiries@accord.scot
Website https://www.accord.scot/
ROR logo "ROR" https://ror.org/01nrxwf90

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planThe results of this study will be written up as a publication in high-impact peer-reviewed journals or conference presentations. The dissemination of research results will be distributed at the end of the study.
IPD sharing planThe datasets generated during and/or analyzed during the current study will be stored in the publicly available repository at the University of Edinburgh (DataVault or DataShare) and Universiti Malaya (https://researchdata.um.edu.my/)

Editorial Notes

09/04/2025: The overall study end date was changed from 30/04/2025 to 30/06/2026.
23/10/2023: Trial's existence confirmed by University of Edinburgh.