Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trial
Abstract Background To reduce the global burden of tobacco use, clinical guidelines support behavioral therapy and pharmacotherapy as preferred interventions for tobacco cessation. The evidence-based behavioral interventions has consistently shown to be impactful in community settings; however, its...
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| Format: | Article |
| Language: | English |
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BMC
2022-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06673-3 |
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| author | Priyanka Dhawan Sonu Goel Ashutosh Aggarwal Abhishek Ghosh Rajesh Vijayvergiya Bikash Medhi Dheeraj Khurana Roshan Verma |
| author_facet | Priyanka Dhawan Sonu Goel Ashutosh Aggarwal Abhishek Ghosh Rajesh Vijayvergiya Bikash Medhi Dheeraj Khurana Roshan Verma |
| author_sort | Priyanka Dhawan |
| collection | DOAJ |
| description | Abstract Background To reduce the global burden of tobacco use, clinical guidelines support behavioral therapy and pharmacotherapy as preferred interventions for tobacco cessation. The evidence-based behavioral interventions has consistently shown to be impactful in community settings; however, its efficacy has not been established in hospital settings. The current study aims to investigate impact of trans-theoretical-based behavioral intervention package on tobacco users suffering from non-communicable diseases attending tertiary care settings of North India. Methods/design A two-arm randomized controlled trial (RCT) in a tertiary healthcare hospital will be performed. A total of 360 tobacco users attending NCD clinics in four departments, cardiology, neurology, pulmonary medicine, and ENT (otolaryngology), will be recruited over a period of 3 months. After ascertaining the eligibility criteria, they will be followed up to 6 months (1, 3, 6) for their tobacco use status, readiness to quit, nicotine dependence, stage of behavior change, and self-reported and biochemical validation (urine cotinine) for tobacco abstinence. Assignment of intervention including allocation concealment, sequence generation, and blinding will be done as per SPIRIT guidelines for RCT protocols. Discussion As no strong evidence exists about the effectiveness of tobacco cessation intervention in tertiary settings, the current study will build evidence about the similar interventions in such settings. Trial registration CTRI/2019/09/021406. |
| first_indexed | 2024-04-12T23:02:04Z |
| format | Article |
| id | doaj.art-1f26a5ba404d432ea3f76247641b47aa |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T23:02:04Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-1f26a5ba404d432ea3f76247641b47aa2022-12-22T03:13:00ZengBMCTrials1745-62152022-09-0123111110.1186/s13063-022-06673-3Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trialPriyanka Dhawan0Sonu Goel1Ashutosh Aggarwal2Abhishek Ghosh3Rajesh Vijayvergiya4Bikash Medhi5Dheeraj Khurana6Roshan Verma7Department of Community Medicine & School of Public Health, PGIMERDepartment of Community Medicine & School of Public Health, PGIMERDepartment of Pulmonary Medicine, PGIMERDepartment of Psychiatry, PGIMERDepartment of Cardiology, PGIMERDepartment of Pharmacology, PGIMERDepartment of Neurology, PGIMERDepartment of Otolaryngology, PGIMERAbstract Background To reduce the global burden of tobacco use, clinical guidelines support behavioral therapy and pharmacotherapy as preferred interventions for tobacco cessation. The evidence-based behavioral interventions has consistently shown to be impactful in community settings; however, its efficacy has not been established in hospital settings. The current study aims to investigate impact of trans-theoretical-based behavioral intervention package on tobacco users suffering from non-communicable diseases attending tertiary care settings of North India. Methods/design A two-arm randomized controlled trial (RCT) in a tertiary healthcare hospital will be performed. A total of 360 tobacco users attending NCD clinics in four departments, cardiology, neurology, pulmonary medicine, and ENT (otolaryngology), will be recruited over a period of 3 months. After ascertaining the eligibility criteria, they will be followed up to 6 months (1, 3, 6) for their tobacco use status, readiness to quit, nicotine dependence, stage of behavior change, and self-reported and biochemical validation (urine cotinine) for tobacco abstinence. Assignment of intervention including allocation concealment, sequence generation, and blinding will be done as per SPIRIT guidelines for RCT protocols. Discussion As no strong evidence exists about the effectiveness of tobacco cessation intervention in tertiary settings, the current study will build evidence about the similar interventions in such settings. Trial registration CTRI/2019/09/021406.https://doi.org/10.1186/s13063-022-06673-3Behavioral therapyTobacco cessationTertiary care settingRandomized controlled trial |
| spellingShingle | Priyanka Dhawan Sonu Goel Ashutosh Aggarwal Abhishek Ghosh Rajesh Vijayvergiya Bikash Medhi Dheeraj Khurana Roshan Verma Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trial Trials Behavioral therapy Tobacco cessation Tertiary care setting Randomized controlled trial |
| title | Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trial |
| title_full | Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trial |
| title_fullStr | Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trial |
| title_full_unstemmed | Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trial |
| title_short | Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trial |
| title_sort | comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of north india protocol for a two arm randomized controlled trial |
| topic | Behavioral therapy Tobacco cessation Tertiary care setting Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-022-06673-3 |
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