| CTRI Number |
CTRI/2012/01/002327 [Registered on: 09/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
28/06/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Capacity building for Tobacco CEssation in India and Indonesia |
|
Scientific Title of Study
|
Capacity building for Tobacco Cessation in India and Indonesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KR Thankappan |
| Designation |
Professor |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Professor and Head
Achutha Menon Centre for Health Science Studies
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India 695011
Thiruvananthapuram
KERALA
695011
India |
| Phone |
471-2524231 |
| Fax |
471-2446433 |
| Email |
kavumpurathu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KR Thankappan |
| Designation |
Professor |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Professor and Head
Achutha Menon Centre for Health Science Studies
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India 695011
Thiruvananthapuram
KERALA
695011
India |
| Phone |
471-2524231 |
| Fax |
471-2446433 |
| Email |
kavumpurathu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KR Thankappan |
| Designation |
Professor |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Professor and Head
Achutha Menon Centre for Health Science Studies
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India 695011
Thiruvananthapuram
KERALA
695011
India |
| Phone |
471-2524231 |
| Fax |
471-2446433 |
| Email |
kavumpurathu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Fogarty International Center
National Institutes of Health
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220 USA |
|
|
Primary Sponsor
|
| Name |
Sree Chitra Tirunal Institute for Medical Science and Technology |
| Address |
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, India- 695 011
Tel: 91-471-2524400,
Fax: 91-471-2446433/2553469
kavumpurathu@yahoo.com
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof K R Thankappan |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram Kerala India 695 011
Thiruvananthapuram
KERALA |
0471-2524231
471-2446433
kavumpurathu@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Health Ministry Screening Committee, Government of India |
Approved |
| Institute Ethics Committee of Sree Chitra Tirunal Institute for Medical Science and Technology, Trivandrum |
Approved |
| Institute Ethics Committee, Sree Chitra Tirunal institute for medical science and technology, trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tobacco using diabetic patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Smoking cessation advice by physician and quit tobacco booklet |
Given smoking diabetes specific cessation advice by a physician and quit tobacco booklets. |
| Intervention |
Smoking cessation advice by physician, quit tobacco booklet and counseling by a trained non-physician |
Given smoking diabetes specific cessation advice by a physician, quit tobacco booklets and additional counseling session by a trained non-physician health
professional. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Male Diabetic smokers |
|
| ExclusionCriteria |
| Details |
females
Non-smokers
Cannot come for follow ups
refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Quit Rate (seven day smoking abstinence)validated by salivary cotinine test |
at 6 months, one year, two year , three year four year, five year |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| quit attempt and harm reduction |
at six months, one year, two year, three year, four year, five year |
|
Target Sample Size
Modification(s)
|
Total Sample Size="224"
Sample Size from India="224"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
30/06/2012 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="7"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
BMC Public Health, 2013
K.R. Thankappan, G.K. Mini, Meenu Hariharan, P.S. Sarma, G. Vijayakumar, Mark Nichter, Smoking Cessation Among Diabetes Patients: One Year Follow-Up Results of a Randomized Controlled Trial in Kerala, India. Diabetes. July 2013 62:A1-A98; doi:10.2337/db13-1-387.
BMC Public Health. 2013 Jan 18;13:47. doi: 10.1186/1471-2458-13-47.
Smoking cessation among diabetes patients: results of a pilot randomized controlled trial in Kerala, India.
Thankappan KR, Mini GK, Daivadanam M, Vijayakumar G, Sarma PS, Nichter M. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Capapcity building for toabcco cessation in India and Indonesia project is a multicountry project covering India and Indonesia. But the present trial is conducted in India only Background:The Indian State of Kerala has he highest rate of adult type-2 diabetes in South Asia(21%). A previous study carried out in 2008 of 444 diabetes patients found that a significant proportion (59%) of diabetes patients were tobacco users prior to the diagonosis and more than half of these ever routine users continued to use tobacco. The objective of the present study is to document the effectiveness of both a strong doctor’s cessation message and cessation counseling delivered by a no-doctor health professional. The patients will be followed up one at one month, three month and at six months with counseling for the intervention group and doctor’s advice for the control group. The yearly follow up up to five years will be without doctor’s advice and counseling. Method: All the male diabetic patients who attended a referral diabetic clinic located in South Kerala was screened for smoking. 224 consecutive male diabetic patients, who smoked in the past month and willing to participate in the study were randomized into intervention-1 and intervention-2 group. Both groups were given smoking diabetes specific cessation advice by a doctor and quit tobacco booklets. The intervention-2 group received an additional counseling session by a trained non-physician health professional. Expected Outcome: Quit rate, quit attempt, harm reduction. Quit rate will be validated by salivary cotinine test |