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21 March 2013
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| [ Print-friendly version ] |
| Smoking Prevention in South Asia |
| ISRCTN | ISRCTN83630841 |
| DOI | 10.1186/ISRCTN83630841 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Smoking Prevention in South Asia |
| Scientific title | A pilot individual randomized controlled trial empowering tuberculosis patients to architect smoke free homes |
| Acronym | SPISA |
| Serial number at source | 4-87/12/NBC-100/RDC/ |
| Study hypothesis | The study hypothesis is to improve tuberculosis (TB) outcomes among those TB patients that are exposed to second hand smoke and reduce the risk of TB transmission to other members of the household by encouraging families to make homes smoke free. |
| Lay summary |
Background and study aims
This initial study is focused on testing the feasibility and reliability of an intervention to help empower newly diagnosed patients of tuberculosis (TB) of lungs, who are non- smokers but are exposed to second hand smoke at home, to architect smoke free homes. The level of exposure to second hand smoke will be measured through urine cotinine tests. According to the guidelines issued by the National Tuberculosis Program in Pakistan, all newly diagnosed patients of tuberculosis undergo routine examination/care and a course of anti TB drugs spanning six months. The TB patients return to the hospital each month for examination and free anti TB drugs. The main aim of the study is to develop a behaviour change intervention “Smoke Free Homes” designed on theories of behaviour change and aimed at encouraging families of newly registered TB patients to implement smoking restrictions at home. Who can participate? You can enter this study if: • You are a newly diagnosed case of pulmonary tuberculosis • You are 10 years old or older. • You are a non smoker. • You have at least one smoker residing in your home. You cannot enter this study if: • You have TB of any part of the body other than lungs. • You are an old case of TB of lungs. • You are younger than 10 years. • You are a smoker. • You do not have a smoker residing in your home. What does the study involve? All eligible patients will be randomized to the following two arms: Arm 1: Individual Based Care (SFH materials- flip chart and pamphlet) Arm 2: Individual Based Care (SFH materials) plus Supplementary Support (mobile phone text message ‘SMS’ to smoker at home OR letter on weekly basis) Each eligible patient will voluntarily submit a urine sample for testing level of cotinine, to confirm second hand exposure to tobacco smoke. The research team will collect another urine sample at the end of second month to compare against the baseline. The research team will use Nic alert dip sticks to measure the cotinine level in urine- level 1 and 2 indicate exposure to tobacco smoke while level 0 indicates no exposure. The research team will also record the TB outcomes of each patient at six months. The national TB guidelines say nothing to educate TB patients to protect themselves from second hand tobacco smoke. Previous studies haven confirmed a strong association between exposure to second hand smoke and poor TB outcomes. What are the possible benefits and risks of participating? You will not have any monetary benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. However, you will receive useful information that will have good impact on your TB treatment. Also the results of the study will be used to design a feasible ‘Smoke Free Home’ intervention to help people with TB of lungs to protect themselves from exposure to second hand smoke. As there are no treatments in this study, there are no side effects. Where is the study run from? • District Rawalpindi • District Sialkot Punjab Province, Pakistan When is the study starting and how long is it expected to run for? The recruitment started in November 2012 and the study will run till April 2013. Who is funding the study? NHS Leeds, UK Who is the main contact? Dr Nauman Safdar shine.org.pk@gmail.com |
| Ethics approval | National Bioethics Committee (NBC) Pakistan , August 2012, 4-87/12/NBC-100/RDC/ |
| Study design | Small-scale pilot individual randomised controlled trial |
| Countries of recruitment | Pakistan |
| Disease/condition/study domain | Prevention of exposure to second hand smoke in the home |
| Participants - inclusion criteria |
1. Sould be a registered case of new pulmonary TB, either sputum smear positive or negative ( new TB patients are defined as those who have no history of prior TB treatment or who received less than 1 month of anti-TB drugs, regardless of whether their smear or
culture results are positive or not). 2. Aged more than 10 years, no upper age limit 3. Should be a non-smoker 4. Have not taken part in a ‘Smoke Free Homes’ activity before 5. Residing within the same district 6. Lives with at least one other person who smokes tobacco |
| Participants - exclusion criteria |
1. Not a new pulmonary TB case
2. Patient is a smoker confirmed by carbon monoxide (CO) meter 3. Has taken part in a ‘Smoke Free Homes’ activity before 4. Residing in another district 5. Aged less than 10 years 6. Does not live with a person who smokes tobacco on a regular basis 7. Patient does not consent to participate in the study |
| Anticipated start date | 01/11/2012 |
| Anticipated end date | 30/04/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 75-150 |
| Interventions |
Individual Based Care (Smoke Free Home materials-A flip chart and pamphlet based on taxonomy of behaviour change (Michie et al) to empower TB patients’ to architect SFH and Supplementary Support (mobile phone text message ‘SMS’ to smoker at home OR letter on weekly basis)
All eligible patients will be randomized to the following two arms: Arm 1: Individual Based Care (SFH materials- flip chart and pamphlet) Arm 2: Individual Based Care (SFH materials) plus Supplementary Support (mobile phone text message ‘SMS’ to smoker at home OR letter on weekly basis) The research assistant, after registering the TB patient, will deliver the information in the flip chart and provide a pamphlet and explain its use. He will also arrange for the urine cotinine test. However he himself will be blinded to the result of the test. He will follow up the patient after one month and deliver the intervention again. In case the patient is randomized to the Arm 2, the co-investigator will send weekly text messages to the smoker at home, for 8 weeks. The research assistant will be blinded to this intervention. The research assistant will follow up the patients once he/she returns for the second time in the second month. This time the research assistant will deliver the intervention again and arrange for the urine cotinine test. The research assistant will conduct a third follow up in the 6th month and also note the TB outcome for the patient. |
| Primary outcome measure(s) | Smoke free home of non-smoker TB patient by validating through urine cotinine test, measured twice, first at baseline when the TB patient is registered and then at the second monthly follow up. |
| Secondary outcome measure(s) |
1. TB patients cure rates measured in the sixth month during the third follow-up by noting the TB outcome.
2. In addition we will measure a number of other variables, which will be built into our trial registration form, gender, urban/rural, barriers, recruitment rates, rate and reasons for refusal, etc 3. Implementation of smoking restrictions as measured by questionnaires before and after intervention |
| Sources of funding | NHS Leeds (UK) ref: R14401 |
| Trial website | |
| Publications | |
| Contact name | Dr Raana Zahid |
| Address |
House 862
Street 13 C Sector E-11/4 NPF |
| City/town | Islamabad |
| Zip/Postcode | 44000 |
| Country | Pakistan |
| Tel | +92 512228894 |
| dr_raana@yahoo.com | |
| Sponsor | University of York (UK) |
| Address | Heslington |
| City/town | York |
| Zip/Postcode | YO10 5DD |
| Country | United Kingdom |
| Tel | +44 (0)1904 320 000 |
| Fax | +44 (0)1904 323 433 |
| kamran.siddiqi@york.ac.uk | |
| Sponsor website: | http://www.york.ac.uk |
| Date applied | 18/01/2013 |
| Last edited | 05/02/2013 |
| Date ISRCTN assigned | 05/02/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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