PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Mon, 14 Jan :12:22 GMT) CTRI Number Last Modified On 25/08/2011 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/10/ [Registered on: 11/10/2011] - Trial Registered Retrospectively Yes Interventional Behavioral Randomized, Parallel Group, Active Controlled Trial A clinical trial to study the effects of two methods of treating tobacco dependence viz. Health education and Cognitive Behaviour therapy at Tamilnadu Government Dental College and hospital, Comparison of various treatment modalities for tobacco cessation at Tamilnadu Government Dental College and Hospital, Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Dr Leena Selvamary A Phone Phone Resident Service Post Graduate Government Dental College and Hospital, 3 29, west girija nagar, Kolathur, -99 leenaselvamary@yahoo.com Details Contact Person (Scientific Query) Dr MBAswath Narayanan Professor and Head of the Department Government Dental College and Hospital, 3 mban1965@yahoo.com Details Contact Person (Public Query) Dr Leena Selvamary A Resident Service Post Graduate Government Dental College and Hospital, 3 29, west girija nagar, Kolathur, -99 page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Phone leenaselvamary@yahoo.com Source of Monetary or Material Support > Department of Public health Dentistry, Tamilnadu Government Dental college and hospital Type of Sponsor List of Countries of Principal Investigator Leena Selvamary A Primary Sponsor Details Leena Selvamary Room no 10, Department of Public Health Dentistry, Tamilnadu Government dental college and hospital, chennai Other [Department of Public health Dentistry, Tamilnadu Government Dental college and hospital] of Site Site Phone// Department of public health dentistry Room No 10, Department of Public health Dentistry, Tamilnadu Government dental college and Hospital, leenaselvamary@yaho o.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethical Committee, Tamilnadu Government Dental college and hospital, chennai Status Not Applicable Health Type Patients Approved 11/08/2011 Yes Date No Date Specified Condition Tobacco using patients Type Details Intervention Health Education with Cognitive behaviour therapy in tobacco cesstion Health education consists of assessing the Knowledge of the patients regarding the tobacco related deaths, chemical constituents of tobacco, health hazards associated with tobacco use, COTPA act 2003 using a pretested questionnaire. It also assesses the extra social support, Knowledge of passive smoking, cost analysis for tobacco use in the past, Decisional balance for quitting page 2 / 5

3 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking tobacco, Alcohol usage with tobacco, previous attempts to quit and confidence rating scale used for rating the confidence to quit. Health education is provided to all the patients entering the first session (1st visit). Cognitive Behaviour therapy involves assessing the daily routine the habit is conditioned to, associated withdrawal problems, training the patients for coping skills for managing the withdrawal problems and preventing relapse. Cognitive behaviour therapy is given to the patients randomly allocated to the arm in the 2nd visit (2nd weeek from the date of initial visit) Comparator Agent Health Education alone Health education consists of assessing the Knowledge of the patients regarding the tobacco related deaths, chemical constituents of tobacco, health hazards associated with tobacco use, COTPA act 2003 using a pretested questionnaire. It also assesses the extra social support, Knowledge of passive smoking, cost analysis for tobacco use in the past, Decisional balance for quitting tobacco, Alcohol usage with tobacco, previous attempts to quit and confidence rating scale used for rating the confidence to quit. Health education is provided to all the patients entering the first session (1st visit). Age From Age To Gender Details Details Year(s) Year(s) Both Computer generated randomization An Open list of random numbers Participant Blinded Inclusion Criteria All the tobacco users (both smoking and smokeless form) reporting at the Department of Public Health Dentistry, Tamil Nadu Governmant Dental College and Hospital, Exclusion Criteria 1. Patients who are deaf and dumb. 2. Patients who are mentally challenged or under treatment for psychiatric disorders page 3 / 5

4 Primary Outcome Outcome Timepoints Self reported quit attempt,(24 hour abstinence from tobacco usage), point prevalence abstinence (7 days abstinence from tobacco usage), continuous abstinence (complete abstinence from tobacco usage)and relapse rates Validation of self report using Cotinine test At II session (2nd - 4th week)-self reported quit attempt is assessed. At III session (6th week)- Quit attempt if any, point prevalence abstinence is assesed. At IV session (12th week)- Quit attempt / relapse if any, point prevalence abstinence continuous abstinence ar assessed. At V session (24th week) Quit attempt / relapse if any, point prevalence abstinence continuous abstinence ar assessed along with validation of self report using Cotinine test Secondary Outcome Outcome Timepoints validation of self report quit, and knowledge attitude and practice of tobacco smoking among tobacco users after 6 months of follow up from the date of recruitment Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=170 Sample Size from =170 N/A 01/04/2011 No Date Specified Years=0 Months=8 Days=0 Not Applicable Open to Recruitment study not completed for publishing the data The sample comprises of 170 tobacco users referred for tobacco cessation counseling to the Department of Public Health Dentistry, Tamil Nadu Government Dental College and Hospital,. Study procedure is explained to the patients and written informed consent obtained. Before starting the actual study the individual is randomly selected from the referred patients. In the second stage patients satisfieng the inclusion criteria are randomly (computer generated randomisation) allocated to one of the two groups viz Health education group / health education with cognitive behavior therapy. Case record consists of the demographic data, chief complaint, medical and dental history, tobacco use status, knowledge, attitude & practice of tobacco usage and addiction scores in Fagerstroms addiction scale. Health education therapy involves usage of posters and video as education aids, advice to quit, things to be done on quit date & a pamphlet page 4 / 5

5 Powered by TCPDF ( PDF of Trial having written instructions of the things to do is handed over to the patients. Now the randomly selected individuals are sent to the second stage of the study, ie, cognitive behavior therapy which involves the identification of high risk situations and withdrawal problems associated with tobacco dependence and training for coping skills to overcome addiction. Age, sex, socio - economic status, form of tobacco usage, alcohol usage, stage of motivation and Fagerstroms addiction scores are matched between the two groups. Patients are followed up for 6 months from the date of first visit to assess quit attempt, point prevalence abstinence, continuous abstinence and relapse rates in each follow up visit in both the intervention groups. The self reported quit rates are validated using the standardized cotinine test. Data analysis is done to find the efficacy of the treatment modalities using chi square test. page 5 / 5