FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/04/013514 [Registered on: 27/04/2018] Trial Registered Prospectively
Last Modified On: 25/04/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomised control trial evaluating the effectiveness of a medical student guided tobacco cessation program for hospitalised smokers in India. 
Scientific Title of Study   Medical Student Counselling for Hospitalized Patients Addicted to Tobacco: The MS-CHAT Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharav Shah 
Designation  National Consultant 
Affiliation  Alcohol and Drug Information Center, India 
Address  Alcohol and Drug Information Center, TC 3/98, Pattom Post, Trivandrum, Kerala

Thiruvananthapuram
KERALA
695004
India 
Phone    
Fax    
Email  dharavshah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dharav Shah 
Designation  National Consultant 
Affiliation  Alcohol and Drug Information Center, India 
Address  Alcohol and Drug Information Center, TC 3/98, Pattom Post, Trivandrum, Kerala

Thiruvananthapuram
KERALA
695004
India 
Phone    
Fax    
Email  dharavshah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dharav Shah 
Designation  National Consultant 
Affiliation  Alcohol and Drug Information Center, India 
Address  Alcohol and Drug Information Center, TC 3/98, Pattom Post, Trivandrum, Kerala

Thiruvananthapuram
KERALA
695004
India 
Phone    
Fax    
Email  dharavshah@gmail.com  
 
Source of Monetary or Material Support  
SEHAT India- Society for Enhanced Health and Access to treatments 
 
Primary Sponsor  
Name  SEHAT India 
Address  Ward No 4, Dhalkhola, West Bengal, India 
Type of Sponsor  Other [Non governmental organisation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anwith HS  Kempegowda Institue of Medical Sciences  Department of Community Medicine, KIMS, Banashankari 2nd stage, Bangalore 560 070
Bangalore
KARNATAKA 
9844467237

anwith2006@gmail.com 
Dr Anusha Prabhakaran  Paramukhswami Medical Colege  Department of Psychiatry, Gokal Nagar, Karamsad, Anand, Gujarat 388325
Anand
GUJARAT 
9825757797

anushamcp@charutarhealth.org 
Dr Subhashini Ganeshan  PSG Institute of Medical Sciences and Research  Department of Community Medicine, PSG IMSR, Off Avanashi Road, Peelamedu, Coimbatore-641 004 Tamil Nadu, INDIA
Coimbatore
TAMIL NADU 
9840377520

drsubhiganesan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
IEC Karamsad Medical College, Gujarat  Submittted/Under Review 
IEC KIMS Bangalore  Approved 
IEC PSG IMSR Coimbatore  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Hospitalised patients who smoke tobacco,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Behavioural intervention for tobacco cessation  Trained medical students will meet with patients for one inpatient counselling session while hospitalised (for a recommended duration of 15-20 minutes). They will then follow up with these patients for 3 telephone counselling sessions of 15 minutes each, for about 2 months. For nicotine replacement therapy (NRT), nicotine gum will be recommended at 2mg or 4mg PO every 2 hours, based on the number of cigarettes smoked a day and time to first cigarette smoked. NRT will be recommended for the first 2-3 months depending on patient preference.  
Comparator Agent  Standard Hospital Practice  Control patients receive cessation counselling with or without pharmacotherapy upon the discretion of the physician primarily incharge of their care while hospitalised. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients age 18-70 years old, who are admitted to the medical, cardiology and /or pulmonology wards.
2. Patients must be current smokers (cigarettes and/or bidis) at the time of admission or report having smoked at all in the last 4 weeks prior to admission (to account for changes in behaviour during illness).
3. Patients living within 10 Km radius of the hospital.
 
 
ExclusionCriteria 
Details  1. Unwilling to participate
2. Patients who use any form of non-smoked tobacco will be excluded. If the required sample size is not met because of this exclusion criteria, smokers who concurrently chew tobacco will be included.
3. Patients who are concurrently alcohol dependent, current cannabis or psychotropic drug users as per ICD 10.
4. Patients who do not have a telephone/ unable to follow up
5. Patients unable to understand the local/common language
6. Patients with psychiatric conditions rendering them incapable of interacting with the providers
7. Medically unstable patients
8. Patients with expected hospital stay <24 hours
9. Patients with life expectancy < 12 months
10. Pregnant patients
11. Patients currently participating in a tobacco cessation program
12. Prior participation in this trial during another hospitalisation
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patients will be asked to report abstinence from smoking over the past 7 days; this will be confirmed by exhaled carbon monoxide breath testing.


 
6 months from enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
Medical student knowledge before and 6 weeks after the training workshop.
 
6 weeks 
 
Target Sample Size   Total Sample Size="864"
Sample Size from India="864" 
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)   30/04/2018 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The adverse outcomes associated with tobacco use are well documented and include an increased risk of cardiovascular diseases, cancers, respiratory diseases, adverse effects in pregnancy and oral diseases. One-half of all smokers will die prematurely as a consequence of their tobacco use. Tobacco cessation substantially reduces the risk of death associated with smoking and interventions to quit smoking are both efficacious and cost-effective. Every hospitalisation provides an opportunity to perform these interventions. Counselling for smoking cessation needs to be started during the hospitalisation and should be continued for at least a month after discharge to be effective. To address the twin problems of inadequate medical student training and lack of systematic counselling of hospitalized smokers, we designed a study to implement a smoking cessation training module for medical students, which will include a component of practical training amongst hospitalized smokers. We hypothesise that this training module will simultaneously result in improved quit rates amongst hospitalized smokers and improve medical student knowledge and comfort with counselling.


MEDICAL STUDENT TRAINING:

Students at each site will sit through a workshop conducted by a psychiatrist educator. There will be a didactic lecture, followed by group role-playing scenarios for 1–2 hours (students split into pairs and enact different scenarios), with peer and proctor feedback. Students who complete the workshop and test out using a questionnaire will be inducted into the trial.


PATIENT COUNSELLING:

A site coordinator will be recruited separately and trained. He/she will approach all patients in medicine, cardiology and/or pulmonology wards, who are eligible for the study. Consented patients will be stratified based on the centre and randomly assigned to intervention and control arms. Participating medical students will offer inpatient counselling to patients in the intervention arm once during their hospitalisation (recommended duration of 15-20 minutes). 


Pharmacotherapy:

Medical students are allowed to decide if their patients are eligible for Nicotine Replacement Therapy (nicotine gum and/or patch). These products can be purchased from the local pharmacy upon discharge after approval by the attending physician/resident involved in the patient’s care. Patients will be advised not to use the gum or patch until after the quit date.

 

Follow up:

Students will then follow up with their patients and provide telephone counselling (a minimum of 3 sessions of 15 mins each over 2 months). At each session, the student will assess the patient’s motivation and discuss relevant themes. He/she will also maintain patient information in a workbook.


The control patients will not receive specialised counselling. For these patients, smoking cessation advice and referring to counselling are left at the discretion of the treating physician. The number of patients counselled by their treating physician will be tracked throughout the study. 

 
Close