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
|
|
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
|
|
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.
|