PROTOCOL
A pilot randomized controlled trial on the effectiveness of a ‘lung age’ intervention on smoking cessation: study protocol Imran Muhammad, Wenqi Mok, Hai Moy Toh, Daniel Sii & Wenru Wang Accepted for publication 20 April 2015
Correspondence to W. Wang: e-mail: [email protected] Imran Muhammad BSc RN Staff Nurse Khoo Teck Puat Hospital, Singapore Wenqi Mok BSc RN Staff Nurse Khoo Teck Puat Hospital, Singapore Hai Moy Toh MN RN Advanced Practice Nurse Khoo Teck Puat Hospital, Singapore Daniel Sii DN RN Staff Nurse Khoo Teck Puat Hospital, Singapore Wenru Wang PhD RN Assistant Professor Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
M U H A M M A D I . , M O K W . , T O H H . M . , S I I D . & W A N G W . ( 2 0 1 5 ) A pilot randomized controlled trial on the effectiveness of a ‘lung age’ intervention on smoking cessation: study protocol. Journal of Advanced Nursing 71(10), 2426– 2434. doi: 10.1111/jan.12689
Abstract Aim. To evaluate the effectiveness of the ‘lung age’ intervention on smoking cessation rates, smoking abstinence self-efficacy, nicotine dependence and behavioural change among the smoking population in Singapore. Background. Tobacco use has been linked to several preventable chronic diseases, such as cardiovascular diseases, stroke, cancers and respiratory diseases. Despite numerous health education attempts to promote smoking cessation, there has been a sustained increase in smoking rates worldwide, including in Singapore. Design. A pilot randomized controlled trial. Methods. A convenience sample of 108 smoking individuals 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. Outcome measures include smoking cessation rates, smoking abstinence self-efficacy, nicotine dependence and assessment of the stages of behavioural change. Data will be collected at the baseline and again at the 3and 6-month follow-ups. Discussion. This study offers an additional intervention to improve smoking cessation rates in Singapore. It aims to reduce or delay the onset of smokingrelated chronic diseases such as coronary heart diseases and cancer, which would eventually reduce the healthcare burden in an increasingly ageing society. Trial registration number: ISRCTN15839687. Keywords: lung age, lung function test, nursing, smoking, smoking cessation
2426
© 2015 John Wiley & Sons Ltd
JAN: PROTOCOL
Why is this research needed? • Despite numerous health education attempts to promote smoking cessation, there has been a sustained increase in smoking rates worldwide, including in Singapore. • This study will add on to the limited evidence available on the effectiveness of lung age education as a smoking cessation intervention. • This study will explore the feasibility of lung age intervention as a smoking cessation tool for nurses.
Introduction Tobacco use has been linked to several preventable chronic diseases, such as cardiovascular diseases, stroke, cancers and respiratory diseases. The World Health Organization classifies individuals who smoke at least once a day as daily smokers. According to the National Health Survey (2010) in Singapore, 143% of the population smoked daily. Among this group, 247% were males and 42% females, averaging between 10 and 15 cigarette sticks per day. Additionally, approximately seven people die prematurely from smoking-related diseases each day. The top three reasons for smoking were for relaxation, stress relief and addiction. Despite numerous health education attempts to promote smoking cessation in Singapore, there has been a sustained increase in smoking rates from 126% in 2004 to 143% in 2010 (National Health Survey 2010).
Background Smoking has been widely seen as an adverse contributor to health risks and diseases. The benefits of smoking cessation are widely known. However, there remain a multitude of reasons for the persistence of smoking, including peer pressure, social demands, stress, parental smoking and the sheer pleasure that the habit brings about (Ogden 2007). Another major reason for continued smoking is nicotine addiction and the resulting withdrawal symptoms such as irritability and headaches that impede attempts to quit (Spek et al. 2013). In Singapore, smoking cessation programmes are offered through various venues such as inpatient or outpatient referrals in hospital, polyclinics and pharmacies located in communities. There is also the Health Promotion Board Quitline that smokers can use to assist with smoking cessation. Doctors, nurses, psychologists and pharmacists operate these programmes, which include smoking cessation counselling, prescription of nicotine replacement therapy and cognitive behavioural therapy (CBT). However, uptake © 2015 John Wiley & Sons Ltd
Effectiveness of a ‘lung age’ on smoking cessation
of these programmes is often low, with several smokers citing work and home commitments, as well as the cost and timing of the sessions as factors preventing them from participating. There are three major quitting methods: cold turkey, slow reduction and pharmacological measures. Adding smoking cessation counselling has been found to significantly increase smoking cessation rates (Buffels et al. 2006, Deane & Stevermer 2008). Recently, there has been an attempt to introduce biomarkers to present smokers with convincing evidence of the harmful effects of smoking in an attempt to get them to quit smoking (Lipkus & Prokhorov 2007, Deane & Stevermer 2008). Biomarkers that have been used include spirometry, exhaled carbon monoxide measurement, ultrasound of femoral and carotid arteries, and genetic susceptibility to lung cancer (Bednarek et al. 2006, Buffels et al. 2006, Bize et al. 2012). The lung function test, specifically information about lung age, is used as part of the effort to promote smoking cessation. Lung age refers to the average forced expiratory volume (FEV1) of a non-smoker. This is then compared with that of the person being tested (Deane & Stevermer 2008). The primary aim was to use spirometry results to demonstrate the premature lung damage that results from smoking (Enright 2012). Participants from one study highlighted that the lung age findings provided an additional impetus to quit smoking, especially for those who were already contemplating doing so (Wells & de Lusignan 2003). Lung age can be interpreted graphically using the Fletcher and Peto (1977) diagram or calculated using the spirometric lung age estimation equation by Morris and Temple (1985). A randomized controlled trial (RCT) study demonstrated a quit rate of 136% using lung age as an intervention compared with 64% in the control group, which received only their FEV1 findings (Parkes et al. 2008). It also appears that normal spirometry values can motivate smokers to quit smoking even when there is close to minimal damage to their respiratory health (Zirlik et al. 2014). The challenges cited for implementing spirometry to determine lung age include the cost of obtaining a spirometer, which ranges from $1000 to $2600, the staff training required to use the spirometry and the time taken to perform and interpret spirometry results per participant (3045 minutes). These factors make its implementation seem unattractive (Deane & Stevermer 2008, Rytila et al. 2008). However, an inexpensive hand-held spirometer could be used to obtain FEV1, which could then be converted to lung age using the formula. This could overcome the aforementioned challenges. 2427
I. Muhammad et al.
to stronger intentions to change their behaviour (i.e. behavioural intentions) and eventually quit smoking (i.e. behaviour). Figure 1 provides a diagrammatic explanation of the concept.
More studies are required to validate effectiveness of using lung age as a smoking cessation tool (Deane & Stevermer 2008, Toda et al. 2009, Oh et al. 2014), especially in an Asian society such as Singapore. To our knowledge, this study on using lung age to assist in smoking cessation in the community would be the first of its nature in Singapore. This study intends to introduce an additional intervention to enhance efforts to improve smoking cessation rates in Singapore. This is consistent with efforts to curb the increase in chronic diseases that would eventually reduce the healthcare burden and defray healthcare costs in an increasingly ageing society.
The study
Theoretical framework
Objectives
The protection motivation theory (PMT) developed by Rogers (1975), which is an expansion of the health belief model, will guide the study. PMT consists of five components: severity, susceptibility and fear relating to threat appraisal (appraising external threats), and response effectiveness and self-efficacy relating to coping appraisal (self-appraisal). These components are used to predict the individual’s behaviour to adapt to or avoid health behaviour (Ogden 2007). If applied to smoking cessation, PMT would make the following predictions: using lung age value, participants with abnormal values would be educated on the negative impact of smoking on their physical health. This would increase their fear and influence the individual’s perception about the severity of their smoking behaviour (i.e. perceived severity), eventually increasing their belief that they are likely to be susceptible to diseases such as COPD (i.e. perceived susceptibility). However, with smoking cessation counselling, the individual would be confident that they could quit smoking (i.e. self-efficacy), which would have beneficial consequences (i.e. response effectiveness), leading
Aim The aim of the study was to examine the feasibility and effectiveness of using lung age intervention on smoking cessation rates.
• •
To explore the feasibility of applying the lung age intervention among the smoking population in Singapore. To evaluate the effectiveness of the lung age intervention on smoking cessation rates, smoking abstinence self-efficacy and nicotine dependence among this population group.
Hypotheses Study participants will be randomized into a control group and an experimental group, and only participants in the experimental group will receive the ‘lung age’ intervention. It is hypothesized that when compared with the control group, participants in the experimental group will report significantly:
• • •
Higher smoking cessation rates. Stronger abstinence from smoking. Lower nicotine dependence and advancements in the stage of behavioural change.
Severity Susceptibility
Threat appraisal
Fear Behavioural Intentions
Behaviour
Self-efficacy Coping appraisal Responsive effectiveness
Figure 1 Protection motivation theory diagram. 2428
© 2015 John Wiley & Sons Ltd
JAN: PROTOCOL
Design/methodology A randomized controlled trial (RCT) will be used in this study. After baseline measurements and smoking cessation counselling is completed, all eligible participants will be randomized through the allocation of a specific number generated by the SPSS software to place them into the intervention or control group.
Participants A tertiary public hospital conducts population health screenings. Attendees who are currently smoking will be recruited by convenience sampling to participate in the study. The following study criteria have taken into account the contraindications for a spirometry test for the safety of participants (McClure et al. 2010, Zirlik et al. 2014). The inclusion criteria are: (1) currently smoking; (2) aged 35 years and above; (3) able to read and/or speak in English and/or Mandarin. The exclusion criteria are: (1) known history of major psychiatric illness; (2) history of respiratory-related diseases: COPD, asthma, bronchiectasis; (3) ejection fraction
A pilot randomized controlled trial on the effectiveness of a ‘lung age’ intervention on smoking cessation: study protocol Imran Muhammad, Wenqi Mok, Hai Moy Toh, Daniel Sii & Wenru Wang Accepted for publication 20 April 2015
Correspondence to W. Wang: e-mail: [email protected] Imran Muhammad BSc RN Staff Nurse Khoo Teck Puat Hospital, Singapore Wenqi Mok BSc RN Staff Nurse Khoo Teck Puat Hospital, Singapore Hai Moy Toh MN RN Advanced Practice Nurse Khoo Teck Puat Hospital, Singapore Daniel Sii DN RN Staff Nurse Khoo Teck Puat Hospital, Singapore Wenru Wang PhD RN Assistant Professor Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
M U H A M M A D I . , M O K W . , T O H H . M . , S I I D . & W A N G W . ( 2 0 1 5 ) A pilot randomized controlled trial on the effectiveness of a ‘lung age’ intervention on smoking cessation: study protocol. Journal of Advanced Nursing 71(10), 2426– 2434. doi: 10.1111/jan.12689
Abstract Aim. To evaluate the effectiveness of the ‘lung age’ intervention on smoking cessation rates, smoking abstinence self-efficacy, nicotine dependence and behavioural change among the smoking population in Singapore. Background. Tobacco use has been linked to several preventable chronic diseases, such as cardiovascular diseases, stroke, cancers and respiratory diseases. Despite numerous health education attempts to promote smoking cessation, there has been a sustained increase in smoking rates worldwide, including in Singapore. Design. A pilot randomized controlled trial. Methods. A convenience sample of 108 smoking individuals 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. Outcome measures include smoking cessation rates, smoking abstinence self-efficacy, nicotine dependence and assessment of the stages of behavioural change. Data will be collected at the baseline and again at the 3and 6-month follow-ups. Discussion. This study offers an additional intervention to improve smoking cessation rates in Singapore. It aims to reduce or delay the onset of smokingrelated chronic diseases such as coronary heart diseases and cancer, which would eventually reduce the healthcare burden in an increasingly ageing society. Trial registration number: ISRCTN15839687. Keywords: lung age, lung function test, nursing, smoking, smoking cessation
2426
© 2015 John Wiley & Sons Ltd
JAN: PROTOCOL
Why is this research needed? • Despite numerous health education attempts to promote smoking cessation, there has been a sustained increase in smoking rates worldwide, including in Singapore. • This study will add on to the limited evidence available on the effectiveness of lung age education as a smoking cessation intervention. • This study will explore the feasibility of lung age intervention as a smoking cessation tool for nurses.
Introduction Tobacco use has been linked to several preventable chronic diseases, such as cardiovascular diseases, stroke, cancers and respiratory diseases. The World Health Organization classifies individuals who smoke at least once a day as daily smokers. According to the National Health Survey (2010) in Singapore, 143% of the population smoked daily. Among this group, 247% were males and 42% females, averaging between 10 and 15 cigarette sticks per day. Additionally, approximately seven people die prematurely from smoking-related diseases each day. The top three reasons for smoking were for relaxation, stress relief and addiction. Despite numerous health education attempts to promote smoking cessation in Singapore, there has been a sustained increase in smoking rates from 126% in 2004 to 143% in 2010 (National Health Survey 2010).
Background Smoking has been widely seen as an adverse contributor to health risks and diseases. The benefits of smoking cessation are widely known. However, there remain a multitude of reasons for the persistence of smoking, including peer pressure, social demands, stress, parental smoking and the sheer pleasure that the habit brings about (Ogden 2007). Another major reason for continued smoking is nicotine addiction and the resulting withdrawal symptoms such as irritability and headaches that impede attempts to quit (Spek et al. 2013). In Singapore, smoking cessation programmes are offered through various venues such as inpatient or outpatient referrals in hospital, polyclinics and pharmacies located in communities. There is also the Health Promotion Board Quitline that smokers can use to assist with smoking cessation. Doctors, nurses, psychologists and pharmacists operate these programmes, which include smoking cessation counselling, prescription of nicotine replacement therapy and cognitive behavioural therapy (CBT). However, uptake © 2015 John Wiley & Sons Ltd
Effectiveness of a ‘lung age’ on smoking cessation
of these programmes is often low, with several smokers citing work and home commitments, as well as the cost and timing of the sessions as factors preventing them from participating. There are three major quitting methods: cold turkey, slow reduction and pharmacological measures. Adding smoking cessation counselling has been found to significantly increase smoking cessation rates (Buffels et al. 2006, Deane & Stevermer 2008). Recently, there has been an attempt to introduce biomarkers to present smokers with convincing evidence of the harmful effects of smoking in an attempt to get them to quit smoking (Lipkus & Prokhorov 2007, Deane & Stevermer 2008). Biomarkers that have been used include spirometry, exhaled carbon monoxide measurement, ultrasound of femoral and carotid arteries, and genetic susceptibility to lung cancer (Bednarek et al. 2006, Buffels et al. 2006, Bize et al. 2012). The lung function test, specifically information about lung age, is used as part of the effort to promote smoking cessation. Lung age refers to the average forced expiratory volume (FEV1) of a non-smoker. This is then compared with that of the person being tested (Deane & Stevermer 2008). The primary aim was to use spirometry results to demonstrate the premature lung damage that results from smoking (Enright 2012). Participants from one study highlighted that the lung age findings provided an additional impetus to quit smoking, especially for those who were already contemplating doing so (Wells & de Lusignan 2003). Lung age can be interpreted graphically using the Fletcher and Peto (1977) diagram or calculated using the spirometric lung age estimation equation by Morris and Temple (1985). A randomized controlled trial (RCT) study demonstrated a quit rate of 136% using lung age as an intervention compared with 64% in the control group, which received only their FEV1 findings (Parkes et al. 2008). It also appears that normal spirometry values can motivate smokers to quit smoking even when there is close to minimal damage to their respiratory health (Zirlik et al. 2014). The challenges cited for implementing spirometry to determine lung age include the cost of obtaining a spirometer, which ranges from $1000 to $2600, the staff training required to use the spirometry and the time taken to perform and interpret spirometry results per participant (3045 minutes). These factors make its implementation seem unattractive (Deane & Stevermer 2008, Rytila et al. 2008). However, an inexpensive hand-held spirometer could be used to obtain FEV1, which could then be converted to lung age using the formula. This could overcome the aforementioned challenges. 2427
I. Muhammad et al.
to stronger intentions to change their behaviour (i.e. behavioural intentions) and eventually quit smoking (i.e. behaviour). Figure 1 provides a diagrammatic explanation of the concept.
More studies are required to validate effectiveness of using lung age as a smoking cessation tool (Deane & Stevermer 2008, Toda et al. 2009, Oh et al. 2014), especially in an Asian society such as Singapore. To our knowledge, this study on using lung age to assist in smoking cessation in the community would be the first of its nature in Singapore. This study intends to introduce an additional intervention to enhance efforts to improve smoking cessation rates in Singapore. This is consistent with efforts to curb the increase in chronic diseases that would eventually reduce the healthcare burden and defray healthcare costs in an increasingly ageing society.
The study
Theoretical framework
Objectives
The protection motivation theory (PMT) developed by Rogers (1975), which is an expansion of the health belief model, will guide the study. PMT consists of five components: severity, susceptibility and fear relating to threat appraisal (appraising external threats), and response effectiveness and self-efficacy relating to coping appraisal (self-appraisal). These components are used to predict the individual’s behaviour to adapt to or avoid health behaviour (Ogden 2007). If applied to smoking cessation, PMT would make the following predictions: using lung age value, participants with abnormal values would be educated on the negative impact of smoking on their physical health. This would increase their fear and influence the individual’s perception about the severity of their smoking behaviour (i.e. perceived severity), eventually increasing their belief that they are likely to be susceptible to diseases such as COPD (i.e. perceived susceptibility). However, with smoking cessation counselling, the individual would be confident that they could quit smoking (i.e. self-efficacy), which would have beneficial consequences (i.e. response effectiveness), leading
Aim The aim of the study was to examine the feasibility and effectiveness of using lung age intervention on smoking cessation rates.
• •
To explore the feasibility of applying the lung age intervention among the smoking population in Singapore. To evaluate the effectiveness of the lung age intervention on smoking cessation rates, smoking abstinence self-efficacy and nicotine dependence among this population group.
Hypotheses Study participants will be randomized into a control group and an experimental group, and only participants in the experimental group will receive the ‘lung age’ intervention. It is hypothesized that when compared with the control group, participants in the experimental group will report significantly:
• • •
Higher smoking cessation rates. Stronger abstinence from smoking. Lower nicotine dependence and advancements in the stage of behavioural change.
Severity Susceptibility
Threat appraisal
Fear Behavioural Intentions
Behaviour
Self-efficacy Coping appraisal Responsive effectiveness
Figure 1 Protection motivation theory diagram. 2428
© 2015 John Wiley & Sons Ltd
JAN: PROTOCOL
Design/methodology A randomized controlled trial (RCT) will be used in this study. After baseline measurements and smoking cessation counselling is completed, all eligible participants will be randomized through the allocation of a specific number generated by the SPSS software to place them into the intervention or control group.
Participants A tertiary public hospital conducts population health screenings. Attendees who are currently smoking will be recruited by convenience sampling to participate in the study. The following study criteria have taken into account the contraindications for a spirometry test for the safety of participants (McClure et al. 2010, Zirlik et al. 2014). The inclusion criteria are: (1) currently smoking; (2) aged 35 years and above; (3) able to read and/or speak in English and/or Mandarin. The exclusion criteria are: (1) known history of major psychiatric illness; (2) history of respiratory-related diseases: COPD, asthma, bronchiectasis; (3) ejection fraction
