| CTRI Number |
CTRI/2024/04/065980 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of tobacco cessation intervention given by nurse |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness nurse led tobacco cessation interventions among patients attending OPD at AIIMS New Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yumnam Surbala Devi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
AIIMS, College of Nursing, New Delhi, Ansari Nagar East, New Delhi
South
DELHI
110049
India |
| Phone |
9953559853 |
| Fax |
|
| Email |
surshaikhom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yumnam Surbala Devi |
| Designation |
Associate professor |
| Affiliation |
AIIMS New Delhi |
| Address |
College of Nursing, AIIMS, New Delhi
South
DELHI
110049
India |
| Phone |
9953559853 |
| Fax |
|
| Email |
surshaikhom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yumnam Surbala Devi |
| Designation |
Associate professor |
| Affiliation |
AIIMS New Delhi |
| Address |
College of Nursing, AIIMS, Ansari Nagar East, New Delhi
South
DELHI
110049
India |
| Phone |
9953559853 |
| Fax |
|
| Email |
surshaikhom@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
College Of Nursing AIIMS New Delhi |
| Address |
AIIMS New Delhi, Ansari Nagar East, New Delhi |
| Type of Sponsor |
Other [Government medical institiute, research institute 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 |
| Dr Yumnam Surbala Devi |
AIIMS New Delhi |
Room no 212, Medicine OPD, New RAK OPD
South
DELHI |
9953559853
surshaikhom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS New Delhi Institutional Ethical Committee for Post Graduate Research for Basic Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Care as usual |
patients in control group will be provided with care as usual followed in OPD |
| Intervention |
Nurse led tobacco cessation |
Psychoeducation about tobacco and its forms, harmful effects of tobacco, benefits of quitting tobacco and brief intervention based on 5A and 5R approach by WHO to help patients quit.
Time duration of 15-20 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients ≥18 years of age
Patients who are using smokeless form of tobacco for at least last 6 months.
Patients who are attending outpatient Medicine Department of AIIMS, New Delhi
WHO-ASSIST score of more than 3+.
Patients having ability to understand Hindi or English.
Patients who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patients who are using tobacco in any form other than smokeless tobacco.
Patients who are very sick.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Self-reported continuous abstinence from smokeless tobacco at 1 month follow up (dichotomous) using Timeline Follow back (TLFB) method |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Self-reported 7 day point prevalence abstinence at 1 month follow up
Reduction in smokeless tobacco use using a dichotomous measure (50% or more reduction in smokeless tobacco) using Timeline Follow back (TLFB) method
Stage of change at 1 month follow-up as measured by Readiness to Change Questionnaire.
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
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)
|
01/05/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
To assess nurse led tobacco cessation intervention among patients using smokeless tobacco. Patients in intervention group will be provided with psychoeducation about tobacco, its form, harmful effects of tobacco and benefit of quitting tobacco and brief intervention to help the patients to quit which will be compared with patients in the control group receiving care as usual |