| CTRI Number |
CTRI/2010/091/000221 [Registered on: 14/05/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Cluster Randomized Trial |
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Public Title of Study
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A clinical trial to study the effects of group intervention and self help materials among tobacco users in rural Tamilnadu. |
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Scientific Title of Study
|
Community based group intervention for tobacco cessation in rural Tamilnadu: A Cluster randomized trial.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 273 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M.Santhosh Kumar |
| Designation |
|
| Affiliation |
|
| Address |
Achutha Menon Centre for Health Science Studies
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
08089393594 |
| Fax |
91-471-2446433 |
| Email |
sanmph09@sctimst.ac.in |
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Details of Contact Person
Scientific Query
|
| Name |
M.Santhosh Kumar |
| Designation |
|
| Affiliation |
|
| Address |
Achutha Menon Centre for Health Science Studies
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
08089393594 |
| Fax |
91-471-2446433 |
| Email |
sanmph09@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
M.Santhosh Kumar |
| Designation |
|
| Affiliation |
|
| Address |
Achutha Menon Centre for Health Science Studies
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
08089393594 |
| Fax |
91-471-2446433 |
| Email |
sanmph09@sctimst.ac.in |
|
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
No sponsorship. This is part of MPH dissertation |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| M.Santhosh Kumar |
Acutha Menon Centre, SCTIMST |
Medical college,-695011
|
08089393594
91-471-2446433
sanmph09@sctimst.ac.in |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SCTIMST IEC |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
health education for tobacco cessation, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
group intervention |
The intervention will comprise of two sessions of health education delivered two months apart. Each session will last for 30 minutes. Each group will have 10 members. 20 particpants will be selected from a cluster. The intervention will be delivered by a physician. The invention will comprise of culturally appropriate health education messages for tobacco cessation |
| Comparator Agent |
Self help materials |
The self help materials will be used to create awarness about harmful effects of tobacco. The content of the material will include harmful effects of tobacco, health benefits of quitting tobacco and advice on how to stop tobacco use. |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1) Adult men between 20-40 years of age
2) Resident of the village
3) Current user of any forms of tobacco
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| ExclusionCriteria |
| Details |
1)Women tobacco users
2)Bedridden patients with debilitating illness
3)Individuals planning for migration in the next three months
4)Mentally challenged
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Self reported point prevalence abstinence (No tobacco use in the past 7 days). |
Two months after recieving the intervention |
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Secondary Outcome
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| Outcome |
TimePoints |
| Any attempt to quit tobacco which last more than 24 hours. Reduced tobacco consumption to more than 50% of initial use. |
Two months |
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Target Sample Size
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Total Sample Size="400"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/06/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Tobacco use is the leading most preventable cause of death. More than 70% of tobacco users in India live in rural areas. So there is an urgent need to develop evidence based interventions for tobacco cessation. This study is cluster randomized trial comparing the efficacy of group intervention and self help materials for tobacco cessation in 400 eligible participants recruited from 20 villages in Manaparai taluk, Thiruchirappalli, Tamilnadu. The primary outcome measure will be self reported point prevalence abstinence (No tobacco use in the past 7 days). The secondary outcomes will be any attempt to quit tobacco which last more than 24 hours and reduced tobacco consumption to more than 50% of initial use at two months after intervention. |