Condition category
Mental and Behavioural Disorders
Date applied
04/09/2018
Date assigned
07/09/2018
Last edited
18/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Smoking is a major problem in Macedonia, with rates of smoking having increased over the last few decades. Smoking increases the risk of developing a number of health conditions, and is the leading cause of chronic disease. The benefits of smoking cessation are well established. However, no organised smoking cessation programmes are available in Macedonia, and pharmacotherapy (drug treatment) is limited in availability and accessibility due to its high costs. Currently, there are a few projects being rolled out in Macedonia which focus on providing smoking cessation support, one of which involves GPs offering very brief advice and support to quit smoking. It is important to understand the methods that can encourage people in Macedonia to quit smoking that are also feasible and cost-effective in this setting. The aim of this study is to compare the effectiveness and cost effectiveness of stand-alone very brief smoking cessation advice and support, to the same support with additional feedback about lung age or exhaled CO measurement.

Who can participate?
Current smokers, smoking at least 10 cigarettes (manufactured or roll up) per day, who are aged 35 or over

What does the study involve?
Participants are randomly allocated to one of the three groups: feedback about lung age with very brief advice and support to quit smoking; feedback about exhaled CO with very brief advice and support to quit smoking; or very brief advice and support to quit smoking. Participants are followed up after 4, 12 and 26 weeks to ask whether they have stopped smoking.

What are the possible benefits and risks of participating?
This research will help to understand what type of smoking cessation support is useful in Macedonia. If the results from the study show that such support is beneficial among smokers in Macedonia, it could influence policy and help improve future outcomes for people in Macedonia. The interventions (microspirometry and exhaled CO) and questionnaires pose limited risk to participants. Furthermore, participants will not be recruited if they should not have spirometry for medical reasons. In the event that participants are identified as having any clinical issues or needs through the research, they will be managed by their GP based on the standard clinical practice in Macedonia.

Where is the study run from?
Medical Faculty Skopje (Macedonia)

When is the study starting and how long is it expected to run for?
June 2017 to May 2020

Who is funding the study?
National Institute for Health Research (NIHR), using Official Development Assistance (ODA) funding

Who is the main contact?
Radmila Ristovska

Trial website

Contact information

Type

Scientific

Primary contact

Dr Radmila Ristovska

ORCID ID

Contact details

Medical Faculty Skopje
Centre for Family Medicine
Ss. Cyril and Methodius University
St. 50 Divizija no.6
Skopje
1000
Macedonia

Type

Scientific

Additional contact

Dr Andy Dickens

ORCID ID

http://orcid.org/0000-0002-7591-8129

Contact details

Lead Research Fellow
Breathe Well programme (Global COPD)
Institute of Applied Health Research
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol v1.0

Study information

Scientific title

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

Acronym

Smoking cessation in Macedonia (Breathe Well)

Study hypothesis

Objectives:
1. Assess the effectiveness of combining feedback about lung age or exhaled CO levels with very brief advice (VBA) and support for smoking cessation compared to giving VBA and support alone
2. Conduct a process evaluation informed by MRC process evaluation guidance to understand:
2.1. Fidelity by GPs in delivery of the intervention
2.2. Acceptability to GPs of delivering the intervention
2.3. Participant understanding, acceptability and responses to the intervention
3. Estimate the cost-effectiveness of both interventions compared with VBA and support alone

Ethics approval

Current ethics approval as of 20/05/2020:
1. Initially approved 21/05/2018, first amendment did not need approval, second amendment approved 10/06/2019, Human Research Ethics Committee at the UKIM medical faculty (University of Ss. Cyril and Methodius, Str. 50 Divizija No.6, 1000, Skopje, Republic of North Macedonia; stambolievas@yahoo.com; +389 70 227 402), ref: 03-223719
2. Initially approved 05/10/2018, first amendment approved 15/05/2019, second amendment 28/05/2019, University of Birmingham STEM International Trials Sub-committee (University of Birmingham, Birmingham, UK B15 2TT; aer-ethics@contacts.bham.ac.uk; +44 121 414 8825), ref: ERN_18-1240A


Previous ethics approval:
1. Human Research Ethics Committee at the UKIM medical faculty, Skopje, Macedonia, 21/05/2018
2. University of Birmingham STEM International Trials Sub-committee - approval pending

Study design

Multicentre non-blinded three-armed randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Smoking cessation

Intervention

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 provide the reading to participants as a motivational tool to stop smoking. This is combined with very brief advice for smoking cessation with support to quit smoking for those who choose to quit.

Trial arm 2 - Exhaled CO with very brief advice and support to quit smoking:
GPs measure participant exhaled CO levels, and this is fed-back to participants as a motivator to stop smoking. This is combined with very brief advice for smoking cessation with support to quit smoking and repeated exhaled CO measurements for those who choose to quit.

Trial arm 3 - Very brief advice alone and support to quit smoking:
GPs deliver VBA which includes: ‘Asking’ patient’s smoking status; ‘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 standard treatment programme for smoking cessation with support sessions at quit date, then 1, 2, 4 and 8-12 weeks post-quit date. During these visits, patients will receive advice about medication, how to deal with cravings and withdrawal symptoms and behavioural support.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Proportion of smokers who have quit at 4 weeks (7-day point prevalence, confirmed with salivary cotinine)

Secondary outcome measures

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, confirmed with salivary cotinine level of: (1) <10ng/ml, or (2) <100ng/ml for those who report exposure to second hand cigarette smoke indoors in the last 4 days, or (3) ≥10ng/ml in those who report using nicotine replacement therapy/e-cigarettes in the last 4 days, irrespective of exposure to second hand cigarette smoke)



Previous secondary outcome measures:
Secondary effectiveness outcomes
1. Proportion who have attempted to quit smoking at 4, 12 and 26 weeks (self-reported data from study questionnaires)
2. Proportion who have quit smoking at 12 and 26 weeks (7-day point prevalence, prolonged abstinence with smoking induction period of 3 weeks post randomisation, confirmed with salivary cotinine)
3. Proportion who have reduced the number of cigarettes they smoke per day at 4, 12 and 26 weeks (self-reported data from study questionnaires)
4. Motivation to quit at 4, 12, 26 weeks (self-reported data, using the Motivation to Stop Smoking Scale)

Cost effectiveness outcomes:
1. Cost per additional quitter at 4 weeks (self-report data from EQ5D-5L)
2. Cost per quality adjusted life year (QALY) gained at 26 weeks (self-report data from EQ5D-5L)

Process evaluation measures:
1. Acceptability to the GPs of delivering the intervention (qualitative interviews, following the 1-month recruitment period)
2. Acceptability, understanding and response to the intervention of participants (qualitative interviews [after 4 weeks] and trial data [26 weeks])
3. Fidelity to the delivery of the intervention, using trial data and qualitative interview (collected over 26 weeks)

Overall trial start date

01/06/2017

Overall trial end date

25/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

1182 participants

Total final enrolment

1366

Participant 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

Recruitment start date

10/09/2018

Recruitment end date

11/11/2019

Locations

Countries of recruitment

Macedonia

Trial participating centre

Medical Faculty Skopje, Ss. Cyril and Methodius University
Centre for Family Medicine St. 50 Divizija no.6
Skopje
1000
Macedonia

Sponsor information

Organisation

Medical Faculty Skopje, Ss. Cyril and Methodius University

Sponsor details

St. 50 Divizija no.6
Skopje
1000
Macedonia

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research, Official Development Assistance (ODA) funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The plan is to publish the study protocol in a peer-reviewed journal. The study results will also be published in a peer-reviewed scientific journal and presented at an international conference. Web-links to publications will be provided on the Breathe Well website (https://www.birmingham.ac.uk/breathewell).

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rachel Jordan (r.e.jordan@bham.ac.uk
Type of data: individual participant data, quantitative (anonymised)
When the data will become available: December 2020
Access criteria for sharing data:
1. With whom: academics
2. For what types of analyses: observational/meta-analyses
3. By what mechanism: data acquisition forms will be available from the Investigator. Submitted forms will be reviewed by the Programme Directors, before contacting the applicant directly
Participant consent: Participant consent will be obtained to release anonymous data to other researchers
Data anonymization: all identifiable data will be removed prior to sharing data with other researchers

Intention to publish date

31/05/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/06/2020: Uploaded statistical analysis plan ISRCTN54228638_SAP_v1.0_09Apr20 (not peer reviewed). 11/06/2020: The total final enrolment number has been added. 20/05/2020: The following changes have been made: 1. The recruitment end date has been changed from 31/03/2019 to 11/11/2019. 2. The overall trial end date has been changed from 30/09/2019 to 25/05/2020. 3. The intention to publish date has been changed from 31/12/2018 to 31/05/2021. 4. The target number of participants and the total target enrolment have been updated from "885" to "1182". 5. The ethics approval has been updated. 6. The secondary outcome measures have been updated. 7. Uploaded protocol version 3.0, 17 May 2019 (not peer-reviewed). 8. The plain English summary has been updated to reflect the changes above. 30/04/2019: Internal review.