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CTRI Number  CTRI/2012/04/002600 [Registered on: 25/04/2012] Trial Registered Prospectively
Last Modified On: 26/04/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on success of two different types of intervention for stopping smoking in hospital patients. 
Scientific Title of Study   Effectiveness of smoking cessation interventions for inpatients during and post hospitalization period 
Trial Acronym  SCIEN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MayamolPradeep 
Designation  Sr. Lecturer 
Affiliation  Academy of Medical Sciences 
Address  Dept of Community Medicine, Academy of Medical sciences, Pariyaram, Kannur, Kerala
F-5, D Type Quarters, Pariyaram Medical College Campus
Kannur
KERALA
670503
India 
Phone  91-9446358365  
Fax  0497-2808111  
Email  pradeepmayamol@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A K Jayasree 
Designation  Asso. Prof & HOD 
Affiliation  Supervisor of the study and head of Department 
Address  Department of Community Medicine ACME, Pariyaram
B II Quarters, ACME, Paraiyaram Medical college campus
Kannur
KERALA
670503
India 
Phone  09446420557  
Fax  0497-2808111  
Email  akjayasree@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr A K Jayasree 
Designation  Asso. Prof & HOD 
Affiliation   
Address  Department of Community Medicine ACME, Pariyaram
B II Quarters, ACME, Paraiyaram Medical college campus
Ernakulam
KERALA
670503
India 
Phone  09446420557  
Fax  0497-2808111  
Email  akjayasree@gmail.com  
 
Source of Monetary or Material Support  
ASCEND Research Network, Monash University, Australia 
 
Primary Sponsor  
Name  Sree Chithira Thirunal Institute of Medical Sciences and Technology 
Address  Thiruvananthapuram, Near Govt Medical College, Pin 695011 Pariayaram, Kannur, Kerala  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Quit Tobacco India Project  national institute of health Sree Chitra thirunal institute of Medical sciences Thiruvananthapuram  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mayamol pradeep  KCHC hospital, Behaviour Modification Centre, Level 3, Near ENT OPD  Pariyaram, Kanuur, Kerala Pin 670503
Kannur
KERALA 
91-9446358365
0497-2808111
pradeepmayamol@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Academy of medical sciences Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  medical condition for the person has sought admission for treatment,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Brief advice delivered by Doctors  Intensive intervention to the cases and brief intervention to the controls 
Intervention  Intensive intervention  Intensive intervention consists of advice from the physician, 2 pamphlets (on ill effects of tobacco and benefits of cessation)given, 3 bed side counselling followed by 30 minutes in depth counselling at BMC, followed by counsellor iniiiated 7 follow up calls in the next two months aimed at cessation and its maintenance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  current smokers as (1) in patients should have a minimum stay of 36 hours in this hospital. (2) who are above 18 years and below 65 years (3)only males  
 
ExclusionCriteria 
Details  3) should not have a medical history of substance abuse except alcohol use, do not have psychiatric disorders, or medically unstable, or cognitively disabled  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Smoking Quit Status, Change in the stages of readiness in trans theoretical model, reduction in the number of cigarettes or bidi smoked  at 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in number of cigarettes, bidis etc. Change in the stages of readiness   3 months, 6 months, one year 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/05/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Tobacco use continues to be a major public health problem despite of efforts to control.  When a smoker stops his habit, it brings substantial benefits in terms of reduced chances for developing diseases, improved health and savings. Majority of smokers admit that they want to quit the habit eventually. Admission to hospital provides an opportunity to help people stop smoking.  It is not clear which approaches to smoking cessation are the most effective in the hospital setting and which factors help them to be smoke free for long duration. Though there are studies in other countries, there are few such studies in Indian context. The proposed   study intends to evaluate the effectiveness of intensive intervention for smoking cessation among inpatients. Multi health providers like Physicians, nurses, counselors will be involved in the process of delivering the cessation service. A standardized module will be prepared for this. The primary outcome expected is the quit status of the smoker.  It will be assessed as 7 day point prevalence at six month follow up.

The secondary outcome is the reduction in the number of cigarettes. If the service is found to be effective, health care institutions can emulate this and policy can be framed to integrate smoking cessation as part of health care.

              Primary aims

    To assess the effectiveness of intensive counselling for smoking   cessation initiated in hospitalized patients as compared to   brief advice.

      Secondary aims

  •          To find out the stage of change after 3 and 6 month follow up period in intervention and control group.
  •          To assess the   predictive factors for smoking cessation   in the study population.

 Hypotheses

 Intensive intervention including, after discharge follow up for a short period  viz 2 months for smoking cessation among hospitalized patients have better efficacy when compared to brief advice by doctors. 

 
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