Lung age or exhaled CO feedback combined with very brief advice and support for smoking cessation in FYR Macedonia

Effectiveness of combining feedback about lung age or exhaled CO levels with very brief advice (VBA) and support for smoking cessation in primary care compared to giving VBA and support alone

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54228638

Enrollment

1182

Registered

2018-09-07

Start date

2018-09-10

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking cessation Mental and Behavioural Disorders Mental and behavioural disorders due to use of tobacco

Interventions

Participants are individually randomly allocated to one of three study arms: lung age with very brief advice and support to quit smoking

exhaled CO with very brief advice and support to quit smoking

and very brief advice alone and support to quit smoking (control group). Trial arm 1 - Lung age with very brief advice and support to quit smoking: GPs assess lung-age using a microspirometer, and p

‘Advising’ current smokers to stop smoking

and ‘Acting’ to set up appropriate support to quit for those who are willing to make a quit attempt. Support to quit smoking will be provided by the GPs following a protocol adapted from the UK stand

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Current smoker, smoking at least 10 cigarettes (manufactured or roll up) per day 2. Age 35+ years

Exclusion criteria

Exclusion criteria: 1. Deemed unsuitable to participate in the trial by the GP e.g. cognitive impairment, recent bereavement, terminal illness 2. Standard contraindications for spirometry (coughed blood in last month; recent tuberculosis; recent myocardial infarction; recent detached retina; recent major surgery to chest/abdomen/brain/ears/eyes; recent severe angina) 3. Previously received VBA to quit smoking 4. Currently attempting to quit smoking 5. Currently using e-cigarettes or NRT

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 13/11/2020: Proportion of smokers who have quit at 4 weeks (7-day point prevalence, confirmed with salivary cotinine level of: <10 ng/ml; or <100 ng/ml for those who report exposure to second hand cigarette smoke in the home on a daily basis; or =10 ng/ml in those who report using nicotine replacement therapy/e-cigarettes at any timepoint during the study, irrespective of exposure to second hand cigarette smoke) Previous primary outcome measure: Proportion of smokers who have quit at 4 weeks (7-day point prevalence, confirmed with salivary cotinine)	—

Measure

Time frame

Current primary outcome measure as of 13/11/2020: Proportion of smokers who have quit at 4 weeks (7-day point prevalence, confirmed with salivary cotinine level of: <10 ng/ml; or <100 ng/ml for those who report exposure to second hand cigarette smoke in the home on a daily basis; or =10 ng/ml in those who report using nicotine replacement therapy/e-cigarettes at any timepoint during the study, irrespective of exposure to second hand cigarette smoke) Previous primary outcome measure: Proportion of smokers who have quit at 4 weeks (7-day point prevalence, confirmed with salivary cotinine)

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Secondary

Measure	Time frame
Current secondary outcome measures as of 20/05/2020: 1. Proportion who have attempted to quit smoking, measured at 4, 12, and 26 weeks 2. Proportion who have quit smoking at 4, 12, and 26 weeks (self report only) 3. Proportion who have quit smoking at 12 and 26 weeks (7-day point prevalence, self-reported abstinence, confirmed with salivary cotinine level : (1) [<10ng/ml], or (2) <100ng/ml for those who report exposure to second hand cigarette smoke in the home on a daily basis, or (3) =10ng/ml in those who report using Nicotine Replacement Therapy/e-cigarettes at any time point during the study, irrespective of exposure to second hand cigarette smoke). 4. Proportion who have reduced the number of cigarettes they smoke per day at 4, 12, and 26 weeks 5. Motivation to quit (self-reported data, using the Motivation to Stop Smoking Scale) at 4, 12, and 26 weeks 6. Cost-effectiveness 6.1. Cost per additional quitter at 4 weeks (self-report data from EQ5D-5L) 6.2. Cost per quality adjusted life year (QALY) gained at 26 weeks (self-report data from EQ5D-5L) 7. Fidelity, acceptability, feasibility 7.1. Acceptability to the GPs of delivering the intervention (qualitative interviews, following the 1-month recruitment period) 7.2. Acceptability, understanding and response to the intervention of participants (qualitative interviews [after 4 weeks] and trial data [26 weeks]) 7.3. Fidelity to the delivery of the intervention, using trial data and qualitative interview (collected over 26 weeks) Exploratory outcomes: 8. In a sub-sample, proportion who have quit smoking at 4, 12, and 26 weeks confirmed with CO monitor tests (7-day point prevalence self-reported abstinence with an exhaled CO reading of <10ppm) in order to avoid affecting patients’ motivation. The results will be concealed from participants unless a reading has already been taken earlier that day. 9. In a sub-sample, proportion who have quit at 4, 12, and 26 weeks (7-day point prevalence self-reported abstinence	—

Measure

Time frame

Current secondary outcome measures as of 20/05/2020: 1. Proportion who have attempted to quit smoking, measured at 4, 12, and 26 weeks 2. Proportion who have quit smoking at 4, 12, and 26 weeks (self report only) 3. Proportion who have quit smoking at 12 and 26 weeks (7-day point prevalence, self-reported abstinence, confirmed with salivary cotinine level : (1) [<10ng/ml], or (2) <100ng/ml for those who report exposure to second hand cigarette smoke in the home on a daily basis, or (3) =10ng/ml in those who report using Nicotine Replacement Therapy/e-cigarettes at any time point during the study, irrespective of exposure to second hand cigarette smoke). 4. Proportion who have reduced the number of cigarettes they smoke per day at 4, 12, and 26 weeks 5. Motivation to quit (self-reported data, using the Motivation to Stop Smoking Scale) at 4, 12, and 26 weeks 6. Cost-effectiveness 6.1. Cost per additional quitter at 4 weeks (self-report data from EQ5D-5L) 6.2. Cost per quality adjusted life year (QALY) gained at 26 weeks (self-report data from EQ5D-5L) 7. Fidelity, acceptability, feasibility 7.1. Acceptability to the GPs of delivering the intervention (qualitative interviews, following the 1-month recruitment period) 7.2. Acceptability, understanding and response to the intervention of participants (qualitative interviews [after 4 weeks] and trial data [26 weeks]) 7.3. Fidelity to the delivery of the intervention, using trial data and qualitative interview (collected over 26 weeks) Exploratory outcomes: 8. In a sub-sample, proportion who have quit smoking at 4, 12, and 26 weeks confirmed with CO monitor tests (7-day point prevalence self-reported abstinence with an exhaled CO reading of <10ppm) in order to avoid affecting patients’ motivation. The results will be concealed from participants unless a reading has already been taken earlier that day. 9. In a sub-sample, proportion who have quit at 4, 12, and 26 weeks (7-day point prevalence self-reported abstinence

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Countries

Macedonia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026