An intervention to stop tobacco use among patients suspected of tuberculosis (TB)

ISRCTN	ISRCTN08829879
DOI	https://doi.org/10.1186/ISRCTN08829879
Protocol serial number	1
Sponsor	International Development Research Centre (IDRC) (Canada)
Funder	International Development Research Centre (IDRC) (Canada) (ref: 104825-002)

Submission date: 05/12/2008
Registration date: 17/03/2009
Last edited: 16/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kamran Siddiqi
Scientific

Nuffield Centre for International Health and Development
Leeds Institute of Health Sciences
Charles Thackrah Building
101 Clarendon Road
Woodhouse
Leeds
LS2 9LJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An intervention to stop tobacco use among patients suspected of tuberculosis (TB): an evaluation of an integrated approach
Study acronym	TATO
Study objectives	1. What is the effect of an intervention, based on the World Health Organization (WHO) 'five steps to quit' model and consisting of training of health professionals, a desk-guide, a desktop patient education tool and leaflet, on patients' point and continuous abstinence from tobacco use? [Effect evaluation] 2. To what extent do the health professionals communicate risks of tobacco use and benefits of its cessation to their patients? What are their experiences and opinions about this strategy? [Process evaluation] 3. How do patients experience the intervention for tobacco addiction? [Ethical evaluation] 4. What is the incremental cost-effectiveness ratio of the intervention for tobacco addiction compared to usual care? [Economic evaluation]
Ethics approval(s)	Research Ethics Committees of TB programme and Pakistan Medical Research Council, approval pending as of 05/12/2008.
Health condition(s) or problem(s) studied	Tuberculosis and tobacco use
Intervention	A total of 22 primary care health centres will be selected (11 each for control and intervention arms) and 50 patients recruited with suspected tuberculosis in each of these centres. In the intervention arm, recruited patients will be given the 'five steps to quit' model. This is based on the evidence-based recommendations for treatment of tobacco addiction published by WHO in 2001. Participants will be: 1. Asked about the status of nicotine use 2. Advised about the benefits of stopping nicotine use 3. Assessed for their motivation to stop its use 4. Assisted in stop attempts through various therapeutic options 5. Provided with an information leaflet 6. Asked to arrange a follow-up In the control arm, patients will be provided with education leaflets only. The trial will continue for six months and a review at 1 and 6 months will take place to assess smoking status and clinical outcomes in both arms.
Intervention type	Other
Primary outcome measure(s)	1. Point abstinence at 4 weeks: the proportion of trial participants who have completely given up all forms of nicotine use at four weeks after the completion of NRT, bupropion and/or brief counselling therapy 2. Continuous abstinence up to 6 months: proportion of trial participants who remained abstinent from 4 weeks onwards up to six months 3. We will also measure tobacco use, e.g. number of cigarettes smoked per day to estimate any reduction in tobacco use secondary to the intervention
Key secondary outcome measure(s)	1. Incidence of various adverse affects secondary to therapy 2. Economic outcomes assessed in terms of healthcare cost to get one person to stop smoking at four weeks. Healthcare cost will include the treatment cost, the average duration of health professionals' time spent with the patients during assessment, advice and counselling. 3. Process outcomes include: 3.1. The proportion of tobacco users who decide to quit and registered to receive 'five steps to quit' intervention 3.2. The proportion of people registered who continue follow-up for the full period planned
Completion date	30/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1100
Key inclusion criteria	In each health centre, we will approach adult patients (greater than or equal to 18 years, either sex), who cough for three or more weeks and are therefore suspected and screened for pulmonary tuberculosis.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/12/2008
Date of final enrolment	30/11/2011

Locations

Countries of recruitment

United Kingdom
England
Pakistan

Study participating centre

Nuffield Centre for International Health and Development

Leeds
LS2 9LJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/05/2013		Yes	No
Protocol article	protocol	25/03/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes