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An intervention to stop tobacco use among patients suspected of tuberculosis (TB)
ISRCTN ISRCTN08829879
DOI 10.1186/ISRCTN08829879
ClinicalTrials.gov identifier
EudraCT number
Public title An intervention to stop tobacco use among patients suspected of tuberculosis (TB)
Scientific title An intervention to stop tobacco use among patients suspected of tuberculosis (TB): an evaluation of an integrated approach
Acronym TATO
Serial number at source 1
Study hypothesis 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]
Lay summary Not provided at time of registration
Ethics approval Research Ethics Committees of TB programme and Pakistan Medical Research Council, approval pending as of 05/12/2008.
Study design Cluster randomised controlled trial
Countries of recruitment Pakistan
Disease/condition/study domain Tuberculosis and tobacco use
Participants - 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.
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/12/2008
Anticipated end date 30/11/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1100
Interventions 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.
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
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
Sources of funding International Development Research Centre (IDRC) (Canada) (ref: 104825-002)
Trial website
Publications 1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20338041
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23648948
Contact name Dr  Kamran  Siddiqi
  Address Nuffield Centre for International Health and Development
Leeds Institute of Health Sciences
Charles Thackrah Building
101 Clarendon Road
Woodhouse
  City/town Leeds
  Zip/Postcode LS2 9LJ
  Country United Kingdom
Sponsor International Development Research Centre (IDRC) (Canada)
  Address 150 Kent Street
Constitutional Avenue
  City/town Ottawa
  Zip/Postcode K1G 3H9
  Country Canada
  Sponsor website: http://www.idrc.ca/index_en.html
Date applied 05/12/2008
Last edited 16/07/2013
Date ISRCTN assigned 17/03/2009
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