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
|
|
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. |