Effectiveness of a personalised smoking cessation smartphone app among Malaysian adult smokers
| ISRCTN | ISRCTN91299538 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91299538 |
| Secondary identifying numbers | Medical Research Ethics Committee, University of Malaya Medical Centre (MREC UMMC), Malaysia MREC ID No: 2022428-11196; National Medical Research Register, Malaysia NMRR Research ID: RSCH ID-22-03835-EYB |
- Submission date
- 13/01/2023
- Registration date
- 02/03/2023
- Last edited
- 13/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
GEMPAQ V2.0 is the enhanced version of a smoking cessation smartphone app that has been designed and developed by the Nicotine Addiction Research Group (NARCC), University of Malaya Centre for Addiction Sciences (UMCAS) for Android smartphone version 5.0 and above, according to user-centered design processes. The smoking cessation app has been specifically tailored to suit the smoker’s need to quit smoking based on the Big Five Personality traits which are Extroversion (E), Agreeableness (A), Conscientiousness (C), Neuroticism (N), Openness to Experience (O). GEMPAQ V2.0 is an evidence-based, prevention-focused, cost-effective (free) and scalable intervention to reduce smoking, which is a major modifiable behavioural noncommunicable disease risk factor.
The aim of this study is to evaluate the effectiveness of GEMPAQ V2.0. Today, advances in mobile technologies can help overcome obstacles to smoking cessation such as accessibility and adherence. The rise of smartphone usage has made low-intensity interventions such as the smartphone app a readily acceptable self-help tool. Mobile or smartphone apps may assist in smoking cessation through behavioural modification, dissemination of information and advice on medication usage.
It is hoped that GEMPAQ V2.0 will help smokers find suitable smoking cessation app modules to aid them in smoking reduction and/or cessation. Available in both Bahasa Malaysia and English, GEMPAQ V2.0 directs smokers to the appropriate smoking cessation strategy based on their personalities and preferences. The information from this study will help in treating future patients to quit smoking.
Who can participate?
Adult smokers aged 18 years and above who smoke cigarettes at least monthly and have smoked 100 or more cigarettes in their lifetime, and intend to quit smoking in the next 30 days
What does the study involve?
Before starting the study, the researchers will make sure that participants are suitable and eligible to participate in this study and confirm their age, whether they are a smoker or not, and have an Android smartphone. Participants will be guided to download, install and use all features in the apps as stated in the module, then they use the application accordingly. There are no specific restrictions in this study and participants can continue their normal daily routine.
What are the possible benefits and risks of participating?
It is hoped that the GEMPAQ V2.0 will help smokers find a suitable smoking cessation module to aid them in smoking reduction and/or cessation.
There is no side effect to your health by taking part in this study. However, the smartphone’s performance might be slower as the app is downloaded. The app consumes 25MB of the smartphone’s storage.
Where is the study run from?
Universiti Malaya (Malaysia)
When is the study starting and how long is it expected to run for?
February 2022 to September 2024
Who is funding the study?
Universiti Malaya’s grant: Malaysia's Tobacco Control Policy Evaluation Program Grant RU001A-2021 (Malaysia)
Who is the main contact?
Professor Dr Yee Hway Ann @ Anne Yee, anne.yee@monash.edu
Contact information
Public, Scientific, Principal Investigator
Jeffrey Cheah School of Medicine and Health Sciences
Clinical School Johor Bahru
Monash University Malaysia
No. 8, Masjid Sultan Abu Bakar
Johor Bahru
80100
Malaysia
 ORCID ID |
0000-0002-9835-6798 |
|---|---|
| Phone | +60 (0)7 2190600 |
| anne.yee@monash.edu |
Study information
| Study design | Single-centre three-month double-blinded randomized controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact annyee17@um.edu.my to request a participant information sheet |
| Scientific title | A randomized controlled pilot trial of a personalised version compared to a basic (reduced) Smoking Cessation Smartphone App – GEMPAQ V2.0 “Getting Every Smoker to Participate and Quit” among Malaysian adult smokers |
| Study acronym | GRCT V2.0 (GEMPAQ Randomized Controlled Trial V2.0) |
| Study hypothesis | It is hypothesized that smokers using personalised GEMPAQ V2.0 as a smoking cessation app intervention will have higher 30-day point prevalence abstinence (PPA) after 3 months than those using the basic (reduced) GEMPAQ V2.0 version. |
| Ethics approval(s) | Approved 03/08/2022, Medical Research Ethics Committee, University of Malaya Medical Centre (MREC UMMC; 3rd floor, Menara Utama, Pusat Perubatan Universiti Malaya, 59100 Kuala Lumpur, Malaysia; +60 (0)3 7949 3209 / 2251 / 8473 / 4656; ummc-mrec@ummc.edu.my), ref: 2022428-11196 |
| Condition | Smoking cessation |
| Intervention | Up to 286 eligible participants will be screened and randomly assigned to the two arms of this study. Intervention arm: personalized GEMPAQ V2.0 app version (smoking cessation smartphone app) – two auto-released modules based on the personality of the participant Control arm: basic (reduced) GEMPAQ V2.0 app version (smoking cessation smartphone app) – just the Information and Tips module. Participants will have an equal probability of being allocated to the intervention or control group using a computer-generated simple randomization procedure via Microsoft Excel. Simple random allocation of individuals between the different intervention groups will be carried out most conveniently by using a computer. For example, in Microsoft Excel, the instruction ‘= RANDBETWEEN (1,3)’ will produce a random number between 1 and 3, i.e. each of the numbers 1, 2, or 3 has an equal chance of being generated. Participants will be blinded to group allocation and will not be aware of the control or intervention condition throughout the trial. Investigators will also be blinded to group allocation until the completion of the trial after the initial analysis of the primary and secondary outcomes. This study will evaluate the efficacy of the GEMPAQ V2.0 app in smoking reduction and cessation as well as the usability and level of engagement among smokers. A two-arm parallel RCT will be conducted to evaluate the GEMPAQ V2.0 app. The primary aim of this initial evaluation will be to determine the efficacy of the personalised GEMPAQ V2.0 app version in reducing smoking prevalence among smoking adults after 3 months. Secondary aims include examining the usability and level of engagement of end-users. More proximal outcome measures of cessation behaviour will be examined as well. Two modules based on the personality of the participant will be automatically released upon completion of the personality questionnaire which will be administered online at GEMPAQ V2.0 start-up. The control group will be exposed to a basic (reduced) GEMPAQ V2.0 app version. Follow-up will be done for 30-day point prevalence quit rates upon completing the intervention 3-month period. Investigators and data collectors will be blinded to the group assignments. The protocol is in accord with the CONSORT-EHEALTH checklist. All self-reporting survey questionnaires will be administered online via the GEMPAQ V2.0 app according to: 1. Demographic, Fagerström Test for Nicotine Dependence (FNTD), Personality (Mini IPIP), Cessation behaviour at Baseline 2. Fagerström Test for Nicotine Dependence (FNTD) at end of 1st month (30 days) 3. Fagerström Test for Nicotine Dependence (FNTD) at end of 2nd month (60 days) 4. Fagerström Test for Nicotine Dependence (FNTD), Nicotine Withdrawal, Cessation behaviour, mHealth App Usability (MAUQ) Questionnaire: Ease of Use, Interface and Satisfaction, Usefulness at end of 3rd month (90 days) |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Nicotine dependence is measured using Fagerström Test for Nicotine Dependence (FNTD) at baseline and end of 1, 2 and 3 months 2. Smoking abstinence in the last 30 days will be asked at the end of 3 months |
| Secondary outcome measures | Usability, level of engagement and satisfaction of GEMPAQ® V2.0 usage is measured using mHealth App Usability (MAUQ): Ease of Use, Interface and Satisfaction, Usefulness at the end of 3 months |
| Overall study start date | 22/02/2022 |
| Overall study end date | 28/09/2024 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 286 |
| Total final enrolment | 152 |
| Participant inclusion criteria | 1. Participants aged 18 years and above 2. Participant volunteers and provides consent 3. Participant has the intention to quit smoking in the next 30 days 4. Participant owns an Android version 5.0 or above smartphone 5. Participant is able to communicate in Bahasa Malaysia and/or English |
| Participant exclusion criteria | 1. Participants who are unfit or chronically ill 2. Participating in another smoking cessation programme |
| Recruitment start date | 01/03/2023 |
| Recruitment end date | 31/12/2024 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
50603
Malaysia
Sponsor information
University/education
Jln Professor Diraja Ungku Aziz
Centre of Epidemiological & Evidence-Based Practice
Department of Social & Preventive Medicine
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)379673797 |
|---|---|
| inakamaludin@um.edu.my | |
| Website | https://www.um.edu.my/ |
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 31/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Associate Professor Dr Anne Yee (annyee17@um.edu.my). The type of data that will be shared: Anonymized data Dates of availability: After completion and publication of the study, after 31/08/2025. Whether consent from participants was required and obtained: Consent will be obtained. Comments on data anonymization: Data shared will be coded, with no PHI included. Any ethical or legal restrictions: Approval of the request and execution of all applicable agreements (i.e. any material transfer agreement) are prerequisites to the sharing of data with the requesting party. Any additional comments: No. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 13/05/2025 | No | No |
Additional files
Editorial Notes
13/05/2025: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. Contact details updated.
19/02/2025: The following changes were made to the trial record:
1. The contact details were updated.
2. The overall end date was changed from 28/02/2025 to 28/09/2024.
3. The total final enrolment was added.
4. The plain English summary was updated to reflect these changes.
05/04/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/05/2024 to 31/12/2024.
2. The overall end date was changed from 31/08/2024 to 28/02/2025.
3. The plain English summary was updated to reflect these changes.
17/01/2023: Trial's existence confirmed by the Medical Research Ethics Committee, University of Malaya Medical Centre.
