| CTRI Number |
CTRI/2019/05/019088 [Registered on: 13/05/2019] Trial Registered Prospectively |
| Last Modified On: |
10/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Will telephonic counselling have any impact on changing behavior of tobacco users? An interventional study |
|
Scientific Title of Study
|
Effectiveness of very brief telephonic counselling on behavioural change in quitting tobacco – a parallel design randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma A |
| Designation |
Postgraduate |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Dept. of Community Medicine, 2nd Floor, Administrative block, Sri Devaraj Urs Medical College, Tamaka, Kolar - 563101
Dept. of Community Medicine, 2nd Floor, Administrative block, Sri Devaraj Urs Medical College, Tamaka, Kolar - 563101
Kolar
KARNATAKA
563101
India |
| Phone |
918892581625 |
| Fax |
|
| Email |
sushu.a9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Kamath B T |
| Designation |
Professor and Head |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Dept. of Community Medicine, 2nd Floor, Administrative block, Sri Devaraj Urs Medical College, Tamaka, Kolar - 563101
Dept. of Community Medicine, 2nd Floor, Administrative block, Sri Devaraj Urs Medical College, Tamaka, Kolar - 563101
Kolar
KARNATAKA
563101
India |
| Phone |
917760418793 |
| Fax |
|
| Email |
btpkamath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushma A |
| Designation |
Postgraduate |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Dept. of Community Medicine, 2nd Floor, Administrative block, Sri Devaraj Urs Medical College, Tamaka, Kolar - 563101
Dept. of Community Medicine, 2nd Floor, Administrative block, Sri Devaraj Urs Medical College, Tamaka, Kolar - 563101
Kolar
KARNATAKA
563101
India |
| Phone |
918892581625 |
| Fax |
|
| Email |
sushu.a9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sushma A
Postgraduate,
Dept. of Community Medicine, 2nd Floor, Administrative block, Sri Devaraj Urs Medical College, Tamaka, Kolar - 563101 |
|
|
Primary Sponsor
|
| Name |
Sushma A |
| Address |
D/O Anjanappa V, Ammerahalli Village, Maderahalli Post, Kolar Taluk, Kolar District |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Sushma A |
R L Jalappa Hospital and Research Centre |
Ground floor, screening OPD, Dept of Community Medicine, R L Jalappa Hospital and Research Centre, Tamaka, Kolar - 563101
Kolar
KARNATAKA |
8892581625
sushu.a9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Devaraj Urs Medical College, Kolar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group which do not receive very brief telephonic counselling |
Outcome assessment will be done at end of six months and will be compared to baseline assessment. |
| Intervention |
Group which receive very brief telephonic counselling |
Counselling will be provided by single investigator based on the level of motivation assessed at baseline. Three calls will be made monthly once for three consecutive months after baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient should be adult i.e., age ≥18 years.
2. Patient should be residing in Kolar district for at least last six months.
3. Availability of mobile/telephone at household (at least one member in the family who dines with the participant at least once a day)
|
|
| ExclusionCriteria |
| Details |
Patients with history of any cancer and/or mental illness. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in the behaviour to quit tobacco according to the trans-theoretical model |
Zero and Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number who quit tobacco at end of intervention |
six months |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
15/05/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
According to Global Adult Tobacco Survey 2 (GATS 2) survey
in India, prevalence of current tobacco use is found to be 28.6% among those aged
15 years and above and nearly 38.5% of smokers made an attempt to quit smoking
using various methods of quitting in the past 12 months. But few are successful
in the quitting. To support such
attempts at quitting the efforts need to be expanded.
Brief or very brief interventions/counselling can be
delivered in various modes, the most commonly used one being face-to-face counselling. This cannot
be used to address large numbers, for which telephonic counselling is a better
tool. The Cochrane review in 2013 has showed telephonic counselling to improve
quitting by around 27%. There was a mixed result in terms of dose response
i.e., number of calls needed to make the intervention more effective.
Telephone counselling may be a cost-effective way of
providing individual counselling. Telephone contact can be timed such that it
could maximize the level of support around a planned quit date, and counselling
can be scheduled in response to the needs of the participant. There is no study
from India which has independently assessed the effectiveness of telephonic
counselling in improving the quit rate. This study is intended to test the same
in settings of low and middle-income country like India and also generate
evidence to scalability under relevant national programs. OBJECTIVES OF STUDY: Among patients seeking care at screening
out-patient department (OPD) who are tobacco users at R L Jalappa Hospital and
Research Centre (RLJH&RC), Kolar. Primary
objective: To assess the effectiveness of monthly
individualized very brief telephonic counselling in changing the behaviour to
quit tobacco according to the trans-theoretical model. Secondary
objective(s): 1.
To
determine the proportion of individuals who are dependent on tobacco by using Fagerstrom Test for Nicotine Dependence (FTND) questionnaire. 2. To assess the level of
motivation to quit tobacco among those who are willing to quit by using
Richmond test for motivation. |