Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ANZCTR |
Last refreshed on:
|
15 July 2019 |
Main ID: |
ACTRN12618000291280 |
Date of registration:
|
26/02/2018 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
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 |
Date of first enrolment:
|
16/04/2018 |
Target sample size:
|
160 |
Recruitment status: |
Completed |
URL:
|
https://anzctr.org.au/ACTRN12618000291280.aspx |
Study type:
|
Interventional |
Study design:
|
Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
Malaysia
| | | | | | | |
Contacts
|
Name:
|
Dr muhammad adil zainal abidin
|
Address:
|
Department of Community Health, Faculty of Medicines and Health Sciences,
Universiti Putra Malaysia, Serdang, 43400,Selangor, Malaysia.
Malaysia |
Telephone:
|
+60142102021 |
Email:
|
adilzainal@gmail.com |
Affiliation:
|
|
|
Name:
|
Dr muhammad adil zainal abidin
|
Address:
|
Department of Community Health, Faculty of Medicines and Health Sciences,
Universiti Putra Malaysia, Serdang, 43400,Selangor, Malaysia.
Malaysia |
Telephone:
|
+60142102021 |
Email:
|
adilzainal@gmail.com |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
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.
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.
Age minimum:
18 Years
Age maximum:
24 Years
Gender:
Both males and females
|
Health Condition(s) or Problem(s) studied
|
Public Health - Epidemiology
|
nicotine addiction; nicotine addiction
|
Mental Health - Addiction
|
Intervention(s)
|
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,
|
Primary Outcome(s)
|
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.[The primary timepoints is at 1 month post intervention follow by 3 month and 6 month post intervention.]
|
Secondary Outcome(s)
|
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.[1 month , 3 month and 6 month post intervention.]
|
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.[1 month, 3 month and 6 month post intervention.]
|
Source(s) of Monetary Support
|
Universiti Putra Malaysia (UPM)
|
Ethics review
|
Status: Approved
Approval date:
Contact:
ETHIC COMMITTEE FOR RESEARCH INVOLVING HUMAN SUBJECT
|
Results
|
Results available:
|
Yes |
Date Posted:
|
28/03/2019 |
Date Completed:
|
12/11/2018 |
URL:
|
|
|
|