Condition category
Infections and Infestations
Date applied
05/12/2008
Date assigned
17/03/2009
Last edited
16/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kamran Siddiqi

ORCID ID

Contact details

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

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 measures

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

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

http://www.idrc.ca/index_en.html

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, 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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes