Effectiveness of a ‘lung age’ intervention on smoking cessation rate in a Singaporean community

ISRCTN	ISRCTN11953002
DOI	https://doi.org/10.1186/ISRCTN11953002
Secondary identifying numbers	N/A

Submission date: 31/01/2015
Registration date: 26/02/2015
Last edited: 18/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mr Wang Wenru
Scientific

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)

Mr Imran Muhammad
Public

Khoo Teck Puat Hospital
90 Yishun Central
Singapore
768828
Singapore

Study information

Study design	Pilot randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Prevention
Participant information sheet	N/A
Scientific title	A pilot randomised controlled trial on the effectiveness of a ‘lung age’ intervention on smoking cessation rate in a Singaporean community
Study objectives	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(s)	Singapore National Health Group Domain Specific Review Board (DSRB) - Domain F NHG DSRB, 04/09/2014, ref: 2014/00711
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
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 study start date	04/09/2014
Completion date	03/09/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	54 participants in Intervention group, 54 participants in control group
Key inclusion criteria	1. Currently smoking 2. Aged 35 years old and above 3. Able to read and/or speak in English and/or Mandarin
Key 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
Date of first enrolment	01/11/2014
Date of final enrolment	30/03/2015

Locations

Countries of recruitment

Singapore

Study participating centre

Khoo Teck Puat Hospital

90 Yishun Central
Singapore
Singapore 768828
Singapore

Sponsor information

Alexandra Health National Medical Research Centre - Centre Grant Pitch For Fund 2014
Hospital/treatment centre

Khoo Teck Puat Hospital
90 Yishun Central
Singapore
768828
Singapore

Funders

Funder type

Research council

Alexandra Health NMRC Centre Grant Pitch For Fund 2014

No information available

Results and Publications

Intention to publish date	31/12/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/05/2015	18/02/2022	Yes	No

Editorial Notes

18/02/2022: Publication reference added.