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

ISRCTN ISRCTN08829879
DOI https://doi.org/10.1186/ISRCTN08829879
Secondary identifying numbers 1
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

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn intervention to stop tobacco use among patients suspected of tuberculosis (TB): an evaluation of an integrated approach
Study acronymTATO
Study objectives1. 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) studiedTuberculosis and tobacco use
InterventionA 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 typeOther
Primary outcome measure1. 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 measures1. 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
Overall study start date01/12/2008
Completion date30/11/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1100
Key inclusion criteriaIn 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 criteriaDoes not meet inclusion criteria
Date of first enrolment01/12/2008
Date of final enrolment30/11/2011

Locations

Countries of recruitment

  • England
  • Pakistan
  • United Kingdom

Study participating centre

Nuffield Centre for International Health and Development
Leeds
LS2 9LJ
United Kingdom

Sponsor information

International Development Research Centre (IDRC) (Canada)
Research organisation

150 Kent Street
Constitutional Avenue
Ottawa
K1G 3H9
Canada

Website http://www.idrc.ca/index_en.html
ROR logo "ROR" https://ror.org/0445x0472

Funders

Funder type

Research organisation

International Development Research Centre (IDRC) (Canada) (ref: 104825-002)
Government organisation / Local government
Alternative name(s)
Centre de recherches pour le développement international, IDRC, CRDI
Location
Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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