Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
An intervention to stop tobacco use among patients suspected of tuberculosis (TB): an evaluation of an integrated approach
Acronym
TATO
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]
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/12/2008
Overall trial end date
30/11/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1100
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/12/2008
Recruitment end date
30/11/2011
Locations
Countries of recruitment
Pakistan
Trial participating centre
Nuffield Centre for International Health and Development
Leeds
LS2 9LJ
United Kingdom
Sponsor information
Organisation
International Development Research Centre (IDRC) (Canada)
Sponsor details
150 Kent Street
Constitutional Avenue
Ottawa
K1G 3H9
Canada
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
International Development Research Centre (IDRC) (Canada) (ref: 104825-002)
Alternative name(s)
Centre de recherches pour le développement international, Centre de recherches pour le développement international, IDRC
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20338041
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23648948
Publication citations
-
Protocol
Siddiqi K, Khan A, Ahmad M, Shafiq-ur-Rehman, An intervention to stop smoking among patients suspected of TB--evaluation of an integrated approach., BMC Public Health, 2010, 10, 160, doi: 10.1186/1471-2458-10-160.
-
Results
Siddiqi K, Khan A, Ahmad M, Dogar O, Kanaan M, Newell JN, Thomson H, Action to stop smoking in suspected tuberculosis (ASSIST) in Pakistan: a cluster randomized, controlled trial., Ann. Intern. Med., 2013, 158, 9, 667-675, doi: 10.7326/0003-4819-158-9-201305070-00006.