Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000291280
Ethics application status
Approved
Date submitted
27/10/2017
Date registered
26/02/2018
Date last updated
28/03/2019
Date data sharing statement initially provided
28/03/2019
Date results provided
28/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of quit smoking motivation with carbon monoxide feedback module (COQUIT) among college smoker in Selangor
Scientific title
Effectiveness of quit smoking motivation with carbon monoxide feedback module (COQUIT) among college smoker in Selangor
Secondary ID [1] 291753 0
None
Universal Trial Number (UTN)
U1111-1202-5287
Trial acronym
COQUIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nicotine addiction 304842 0
Condition category
Condition code
Public Health 304144 304144 0 0
Epidemiology
Mental Health 305539 305539 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The feedback mechanism consists of expired carbon monoxide measurement result using mobile phone application. The iCO Smokelyzer (Bedfront Scientific Ltd., Rochester, UK) will be used to measure the carbon monoxide level. First, the participant carbon monoxide level will be measured on one to one basis. The CO reading will be record directly into the iPad together with explained feedback about the result interpretation. For each test, a disposable cardboard and alcohol-free wipes will be used to clean the device for disinfection procedure. The result of the CO will be emailed to the participants. The measurement of the expired carbon monoxide will be done by the principal investigator. The feedback of the measurement to the smokers to increase their motivation for intention to quit smoking.

. The brief advice consists of motivational intervention based on “5 R’s”; relevance, risks, rewards, roadblocks, and repetition. This 5R’s was based on the National Clinical Practice Guidelines as described below. The brief motivation will be delivered by the trained counsellor on a one to one basis. The 5R motivational intervention will consist of 10 minutes of intervention based on the module from Ministry of Health (MOH) manual for quit smoking clinic. The 5R theme are as below:

Relevance
• Encourage the patient to indicate why quitting is personally relevant, being as specific as possible. Motivational information has the greatest impact if it is relevant to a patient’s disease status or risk, family or social situation (e.g. having children in home)


Risks
• The staff will as the patient to identify potential negative consequences of tobacco use. The staff may suggest and highlight those that seem most relevant to the patient. The staff will emphasize that switching to low-tar/low nicotine cigarette or other forms of tobacco will still have similar risks. Example of risks are:
Short-term risks: Shortness of breath, exacerbation of asthma, harm to pregnancy, impotence, infertility, increased serum carbon monoxide.


Rewards
• The staff will ask the patient to identify potential benefits of stopping tobacco use. The staff may suggest and highlight those that seem most relevant to the patient. Examples of rewards follow such as improved health, save money, feel better about yourself and not worry about exposing others to smoke.

Roadblocks
• The staff will ask the patient to identify barriers to quitting and note elements of treatment (problem solving, pharmacotherapy) that could address barriers. Typical barriers might include: withdrawal symptoms, fear of failure and weight gain.


Repetition
• The motivational intervention should be repeated every time an unmotivated patient visits the counsellor. Tobacco users who have failed in previous quit attempts should be told that most people make repeated quit attempts before they are successful.

The 5R Motivational module will be given together with the carbon monoxide feedback module. To ensure adherence to the intervention the college administrator will ask to ensure students participation in the program. The control group will only received the 5R motivational module only without the carbon monoxide feedback module.
Intervention code [1] 299492 0
Treatment: Devices
Comparator / control treatment
Standard brief 5R motivation module to the smokers to motivate their intention to quit smoking.
Control group
Active

Outcomes
Primary outcome [1] 303801 0
The primary outcome measure are stage of changes based on the Transtheoretical Model that will be measure using validated questionnaire. Each participant will be contacted during each follow up timepoint. The questionnaire has been translated and validated in Malay language.
Yasin, S. M., Taib, K. M., & Zaki, R. A. (2011). Reliability and construct validity of the Bahasa Malaysia version of transtheoretical model (TTM) questionnaire for smoking cessation and relapse among Malaysian adult. Asian Pacific J Cancer Prev, 12, 1439-1443.
Timepoint [1] 303801 0
The primary timepoints is at 1 month post intervention follow by 3 month and 6 month post intervention.
Secondary outcome [1] 340201 0
The secondary outcome measured are smoking characteristics consist of any quit attempt define as 24 hour not smoking. The outcome will be measured using questionnaire. All participants will be contacted during each follow up time point. The questionnaire will be specifically develop for this study.
Timepoint [1] 340201 0
1 month , 3 month and 6 month post intervention.
Secondary outcome [2] 340202 0
The other secondary outcome measured are smoking characteristics consist of number of cigarette smoker per day and smoking habit. The outcome will be measured using questionnaire. All participants will be contacted during each follow up time point. The questionnaire will be specifically develop for this study.
Timepoint [2] 340202 0
1 month, 3 month and 6 month post intervention.

Eligibility
Key inclusion criteria
i) Students at Community College in Selangor, Malaysia.
ii) Age between 18 to 24 years old.
iii) Currently smokes either every day or some days.
iv) Smokers at the stage of pre-contemplation and contemplation phase.
v) Understand English.
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Smokers at the stage of preparation, action or maintenances phase.
ii) Smokers currently on smoking cessation program or self-quit attempt.
iii) Smokers with lung or heart diseases as reported.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be done through online website random sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Cluster randomisation, There are 10 college communities throughout the study area. The colleges are randomised to either intervention or control arm.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size calculation for a cluster randomization must be inflated by the design effect or inflation factor. However, in this study the number of cluster is fixed to 10 campuses. Thus, according to Hemming et al., 2011, for cluster randomized controlled trial with fixed number of cluster, the required sample size per arm for a trial with pre-specified power 1 – ß, to detect a difference of d, is nc such that:
nc = ni [ 1 + (m-1) p]
=[ni(k)(1- p)] / [k- ni(p)]
Where ni is the sample size required under individual randomization, k is the number of cluster available which is fix to 5 per arm, p is the intra-cluster correlation which is 0.005 based on study by Suen et al. 2016. The corresponding number of individuals in each of the k clusters is also known as the cluster size, m:
m = ni [1- p] / [k- ni(p)]

The sample size for individual randomization nI was calculated based on Lwanga and Lemeshow, 1990 formula as shown in Figure 2 below. It is based on 80% power with Type 1 error rate (=0.05) to detect a medium effect size for group proportion differences in primary outcomes (motivation) in a two-tailed comparison. The sample size calculated was based on the optimum level based on other studies as described in Table 1 below. Sample size was also chosen considering practicality.

ni = [zav(2pa(1-pa)) + zbv(p1(1-p1))+(p2(1-p2))]^2/ (p1-p2)^2
Figure 2. Sample size formula
p1 = 0.227 (Proportion of change in motivation among intervention group based on Choi et al., 2013)
p2 = 0.059 (Proportion of change in motivation among control group based on Choi et al., 2013)
pa = (0.227 + 0.059) / 2 = 0.143

za = 1.96 at 95% Confidence interval
zb = 0.842
ni = 67
Sample size per arm for cluster RCT = ni (k) [1- p] / [k- ni(p)] = [67 (5) (1-0.005)}/ [5 –(67 x0.005)] = 71.5 ~ 72

The attrition rates in smoking cessation study was reported to be high. Based on a systematic review by Belita and Sidani (2015) the attrition rate in smoking study ranges from 10.8% to 77%. This study expected the lowest range of 10% attrition rate considering that it will be conducted in an enclosed institution.
Taking into account of 10% attrition = 79.2 ~ 80
Total n for the 2-arm study = 80 x 2 = 160
Final sample size = 160
160/10 cluster =16 per cluster

Data will be checked for normality first via graphical assessment and normality test. The characteristics of the participant will be described for four purposes; to ensure generalizability of the results, demonstrating the randomization technique done has led to comparability between the two arms, to adjust the main intervention effects for variables or covariates that are known to be strongly correlated to the outcome and finally for subgroup analysis later. Baseline analysis will be conducted using chi square test and independent t-test or Mann Whitney u test for all categorical and continuous variables respectively.

The primary outcome is the motivational stage of smokers which will be re categorized into binary category either changes of stage or no changes of stage. The changes are defined as increase of motivational stage. In this instance, the secondary outcome will be mean number of cigarette per day, quit smoking attempt, number of quit smoking attempt will be then adjusted to the baseline factors.

In order to answer the second and third research hypothesis, the data are measure longitudinally (repeated measure). For repeated measure data analysis, multilevel modelling or repeated measure analysis of covariance (RM-ANOVA) can be used. However, due to stringent assumptions in RM-ANOVA, multilevel modelling will be used. Multilevel modelling employs the marginal model technique and one of the most popular method for estimating marginal models is GEE approach (Liang and Zeger, 1986). Multivariate analysis will be used to compare the outcome between the groups controlling for other covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/04/2018
Actual
16/04/2018
Date of last participant enrolment
Anticipated
11/05/2018
Actual
11/05/2018
Date of last data collection
Anticipated
12/11/2018
Actual
12/11/2018
Sample size
Target
160
Accrual to date
Final
116
Recruitment outside Australia
Country [1] 9325 0
Malaysia
State/province [1] 9325 0
Selangor

Funding & Sponsors
Funding source category [1] 296251 0
University
Name [1] 296251 0
Universiti Putra Malaysia (UPM)
Country [1] 296251 0
Malaysia
Primary sponsor type
University
Name
Universiti Putra Malaysia
Address
Universiti Putra Malaysia, Serdang, 43400,Selangor, Malaysia.
Country
Malaysia
Secondary sponsor category [1] 297971 0
None
Name [1] 297971 0
Address [1] 297971 0
Country [1] 297971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297489 0
ETHIC COMMITTEE FOR RESEARCH INVOLVING HUMAN SUBJECT
Ethics committee address [1] 297489 0
Ethics committee country [1] 297489 0
Malaysia
Date submitted for ethics approval [1] 297489 0
04/04/2017
Approval date [1] 297489 0
26/04/2017
Ethics approval number [1] 297489 0
UPM/TNCPI/RMC/JKEUPM/1.4.18.2 (JKEUPM)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74202 0
Dr Muhammad Adil Zainal Abidin
Address 74202 0
Department of Community Health, Faculty of Medicines and Health Sciences,
Universiti Putra Malaysia, Serdang, 43400,Selangor, Malaysia.
Country 74202 0
Malaysia
Phone 74202 0
+60142102021
Fax 74202 0
Email 74202 0
[email protected]
Contact person for public queries
Name 74203 0
muhammad adil zainal abidin
Address 74203 0
Department of Community Health, Faculty of Medicines and Health Sciences,
Universiti Putra Malaysia, Serdang, 43400,Selangor, Malaysia.
Country 74203 0
Malaysia
Phone 74203 0
+60142102021
Fax 74203 0
Email 74203 0
[email protected]
Contact person for scientific queries
Name 74204 0
muhammad adil zainal abidin
Address 74204 0
Department of Community Health, Faculty of Medicines and Health Sciences,
Universiti Putra Malaysia, Serdang, 43400,Selangor, Malaysia.
Country 74204 0
Malaysia
Phone 74204 0
+60142102021
Fax 74204 0
Email 74204 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
ethical ownership of data belongs to the government


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1176Ethical approval    372786-(Uploaded-28-01-2019-12-38-09)-Study-related document.JPG



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBiomedical risk assessment as an aid for smoking cessation.2019https://dx.doi.org/10.1002/14651858.CD004705.pub5
N.B. These documents automatically identified may not have been verified by the study sponsor.