| CTRI Number |
CTRI/2018/03/012892 [Registered on: 27/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
due to increasing number of tobacco related illness like oral cancer, respiratory problems, heart problems day by day so there is a need to screen and give advice to patients on one to one basis which will help them quiting the use of tobacco products. |
|
Scientific Title of Study
|
A pre-experimental study to assess the effectiveness of “Brief Intervention†on tobacco use among patients on OST (Opioids Substitution Therapy) attending DDTC, PGIMER, Chandigarh. (2016-18)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himshikha |
| Designation |
M.Sc. Nursing student |
| Affiliation |
PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education,PGIMER, Chandigarh Chandigarh CHANDIGARH 160012 India
National Institute of Nursing Education,PGIMER, Chandigarh Chandigarh CHANDIGARH 160012 India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855751861 |
| Fax |
|
| Email |
vish_1234@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karobi Das |
| Designation |
Lecturer(Clinical Psychology) |
| Affiliation |
PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education,PGIMER, Chandigarh Chandigarh CHANDIGARH 160012 India.
National Institute of Nursing Education,PGIMER, Chandigarh Chandigarh CHANDIGARH 160012 India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876055366 |
| Fax |
|
| Email |
karobi20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renu Sharma |
| Designation |
Clinical Instructor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education,PGIMER, Chandigarh Chandigarh CHANDIGARH 160012 India
National Institute of Nursing Education,PGIMER, Chandigarh Chandigarh CHANDIGARH 160012 India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988330964 |
| Fax |
|
| Email |
rain_nsg@yahoo.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Himshikha |
| Address |
National Institute of Nursing Education,PGIMER, Chandigarh Chandigarh CHANDIGARH 160012 India
|
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Dr Karobi Dass |
lecturer, NINE, PGIMER,Chandigarh 9876055366,karobi20@gmail.com |
| Dr S K Mattoo |
Professor, Department of Psychiatry, PGIMER, Chandigarh. 7087009804 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Himshikha |
DDTC |
DDTC, near eye centre,
PGIMER, chandigarh
Chandigarh
CHANDIGARH |
9855751861
vish_1234@ymail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutionalEthics Committee (PGIMER, CHANDIGARH) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
40 tobacco users on OST attending DDTC,chandigarh, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief intervention |
counselling technique given by WHO used to initiate a change in risky or unhealthy behaviour such as tobacco use. it includes motivation yo quit tobacco, taking of responsibilities for health and providing menu of options. major elements are FRAMES- Feedback, Responsibility, Advice, Menu of options, Empathy,Self efficacy. |
| Comparator Agent |
same group |
same group without control group due to time inadequacy |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients on OST on tobacco use
willing to participate
willing to reinterviewed after3 months |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| tobacco cessation |
after 3 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| healthy lifestyle with out disability |
after 3 months |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/07/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/07/2017 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
tobacco use is the leading cause of deaths in India. quitting smoking is the single best thing that a person can do for their health. providing cessation interventions is proven to be the cost effective and is widely supported in scientific literature.brief intervention from the health professionals in 5 A’s steps can make significant difference in quitting tobacco. mean age of the study subjects were 30.12 with S.D. 10.63. there is 100% reduction in Fagerstorm scores among smokers ans smokeless patients after intervention. there is 71% reduction in ASSIST scores after intervention. three patients completely stopped tobacco after intervention. |