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
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 design | Cluster randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/12/2008 |
Completion date | 30/11/2011 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
- England
- Pakistan
- United Kingdom
Study participating centre
Nuffield Centre for International Health and Development
Leeds
LS2 9LJ
United Kingdom
LS2 9LJ
United Kingdom
Sponsor information
International Development Research Centre (IDRC) (Canada)
Research organisation
Research organisation
150 Kent Street
Constitutional Avenue
Ottawa
K1G 3H9
Canada
Website | http://www.idrc.ca/index_en.html |
---|---|
https://ror.org/0445x0472 |
Funders
Funder type
Research organisation
International Development Research Centre (IDRC) (Canada) (ref: 104825-002)
Government organisation / Local government
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |