Plain English Summary
Background and study aims
There is a link between tobacco use and several preventable chronic diseases such as cardiovascular diseases, stroke, cancers (lung cancer) and respiratory diseases (chronic obstructive pulmonary disease and asthma). There have been many attempts to help people stop smoking but smoking rates are increasing worldwide, including in Singapore. The aim of this initial study is to assess whether a ‘lung age’ intervention (using a device called a MICROLAB MK8 ML3500 spirometer) can have an impact on smoking cessation rates, smoking abstinence and nicotine dependence among the smoking community in Singapore.
Who can participate?
Adults aged 35 and above and who are smokers.
What does the study involve?
Participants will be randomly allocated to one of two groups: participants in the experimental group will receive a ‘lung age’ intervention, consisting of lung age determination and education as well as smoking cessation advice, while the researchers will provide those in the control group with the usual smoking education.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Khoo Teck Puat Hospital, Singapore
When is the study starting and how long is it expected to run for?
From September 2014 to September 2015
Who is funding the study?
Alexandra Health National Medical Research Centre (Singapore)
Who is the main contact?
Mr Imran Muhammad
Trial website
Contact information
Type
Scientific
Primary contact
Dr. Wang Wenru
ORCID ID
Contact details
Alice Lee Centre for Nursing Studies
NUS
Yong Loo Lin School of Medicine - Clinical Research Centre (MD11)
10 Medical Drive
Singapore
117597
Sint Maarten (Dutch part)
Type
Public
Additional contact
Mr. Imran Muhammad
ORCID ID
Contact details
Khoo Teck Puat Hospital
90 Yishun Central
Singapore
768828
Singapore
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A pilot randomised controlled trial on the effectiveness of a ‘lung age’ intervention on smoking cessation rate in a Singaporean community
Acronym
Study hypothesis
Tobacco use has been linked to several preventable chronic diseases, such as cardiovascular diseases, stroke, cancers including lung cancer and respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) and Asthma. Despite numerous health education attempts to promote smoking cessation, there has been a sustained increase in smoking rates worldwide, including in Singapore. More studies are required to validate the effectiveness of using a lung age intervention as a smoking cessation tool, especially in an Asian society such as Singapore.
When compared with the control group, participants in the experimental group will report significantly higher smoking cessation rates, stronger abstinence towards smoking, lower nicotine dependence and advancement in the stage of behavioural change.
Ethics approval
Singapore National Health Group Domain Specific Review Board (DSRB) - Domain F NHG DSRB, 04/09/2014, ref: 2014/00711
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
N/A
Condition
Smoking cessation
Intervention
A convenience sample of 108 participants will be recruited from population health screenings conducted by a tertiary public hospital in Singapore with 54 participants in the experimental group and 54 in the control group. Participants in the experimental group will receive a Lung age intervention, consisting of lung age determination and education as well as smoking cessation advice, while the researchers will provide those in the control group with the usual smoking education.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. To explore the feasibility of applying the “lung age” intervention among the smoking community in Singapore.
2. To evaluate the effectiveness of the “lung age’ intervention on smoking cessation rates, smoking abstinence self-efficacy and nicotine dependence and among this group of population. Data will be collected at the baseline and again at the third and sixth month follow-ups. Data will be analysed using IBM SPSS 22.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
04/09/2014
Overall trial end date
03/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Currently smoking
2. Aged 35 years old and above
3. Able to read and/or speak in English and/or Mandarin
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
54 participants in Intervention group, 54 participants in control group
Participant exclusion criteria
1. Have a known history of major psychiatric illness
2. History of Respiratory related diseases: COPD, asthma, bronchioectasis
3. Ejection fraction <40 %, or diagnosed with congestive cardiac failure
4. Diagnosed with acute myocardial infarction within 1 month
5. Diagnosed with fluid overload / acute pulmonary oedema
6. Receiving oxygen therapy
7, Recent eye/thoracic/abdominal surgery
8. Chest/abdominal/oral and facial pain
9. Hyperventilation syndrome
Recruitment start date
01/11/2014
Recruitment end date
30/03/2015
Locations
Countries of recruitment
Singapore
Trial participating centre
Khoo Teck Puat Hospital
90 Yishun Central
Singapore
Singapore 768828
Singapore
Funders
Funder type
Research council
Funder name
Alexandra Health NMRC Centre Grant Pitch For Fund 2014
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We aim to publish our Research Protocol by end of March 2015 (Target Journal: Journal of Advanced Nursing). We aim to publish the final study findings in October 2015.
Study findings shall also be relayed to hospital healthcare providers (Khoo Teck Puat Hospital) and community partners that have helped us recruit participants.
Intention to publish date
31/12/2015
Participant level data
Available on request
Basic results (scientific)
Publication list