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CTRI Number  CTRI/2017/10/009985 [Registered on: 03/10/2017] Trial Registered Prospectively
Last Modified On: 16/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of brief advice on abstinence from smoking in patients with tuberculosis and non-communicable diseases  
Scientific Title of Study   Effectiveness of brief cessation advice on abstinence from tobacco smoking among patients with tuberculosis and non-communicable diseases (Hypertension, Diabetes) attending a secondary level hospital, Ballabgarh, Haryana 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh Kumar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 12 Centre for Community Medicine Old OT Block AIIMS, New Delhi

South
DELHI
110029
India 
Phone  01126593233  
Fax    
Email  drrakesh@hotmail.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakesh Kumar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 12 Centre for Community Medicine Old OT Block AIIMS, New Delhi

South
DELHI
110029
India 
Phone  01126593233  
Fax    
Email  drrakesh@hotmail.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Rakesh Kumar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 12 Centre for Community Medicine Old OT Block AIIMS, New Delhi

South
DELHI
110029
India 
Phone  01126593233  
Fax    
Email  drrakesh@hotmail.co.uk  
 
Source of Monetary or Material Support  
Intra-mural grant from All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Ansari Nagar 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakesh Kumar  Comprehensive Rural Health Services Project (CRHSP) Hospital, Ballabgarh  General OPD, CRHSP-AIIMS Hospital Ballabgarh District Fardabad, Haryana-121004
Faridabad
HARYANA 
0129-2241362

drrakesh@hotmail.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A15-A19||Tuberculosis, (2) ICD-10 Condition: I10-I16||Hypertensive diseases, (3) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief tobacco cessation advice  Brief tobacco cessation advice by physician on monthly basis for six months 
Comparator Agent  Routine care  provision of treatment as was being provided before 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adult patients with 18 years or more with one of three diagnosed condition; pulmonary tuberculosis, hypertension and diabetes and who smokes tobacco 
 
ExclusionCriteria 
Details  1. Patients who are not able to comprehend the questionnaire/intervention or not willing to give consent
2. patients with substance abuse disorder 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Abstinence from tobacco smoking  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment outcome in pulmonary tuberculosis patients  6 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/11/2017 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a randomized controlled trial which will be conducted at the Comprehensive Rural Health Services Project (CRHSP) hospital, Ballabgarh in Faridabad district of Haryana, India. This is a secondary level hospital and caters to more than three hundred thousand patients every year and has specialized non-communicable diseases clinic as well as is a Tuberculosis Unit under Revised National Tuberculosis Control Programme. A total of 650 subjects with tuberculosis and NCDs (hypertension or diabetes) each will be recruited consecutively from the outpatient department. All subjects will be administered a questionnaire to assess tobacco use and Fagerstrom test for nicotine dependence will be used to assess nicotine dependence among those who smoke. 100 smokers each from the tuberculosis group and the NCD group will be recruited in the trial. They will be randomly assigned separately to either intervention or control arm. Intervention will include brief tobacco cessation advice administered at monthly interval for six months by the physician in the outpatient clinic. Control arm will consist of routine care. Primary outcome will be abstinence from tobacco use at six month as measured by carbon monoxide exhalation  measured using breath analyzer. Self-reported abstention from tobacco use will also be assessed and its correlation with exhaled carbon monoxide will be assessed. Proportion of subjects in both groups who attain abstinence from tobacco use will be measured and chi-square test will be used to assess the significance of difference in proportion of subjects who attained abstinence from tobacco smoking in both groups. Secondary outcome for tuberculosis patients will include treatment outcomes (time to sputum conversion, default, success, death). Qualitative methods will also be used to assess the challenges in integrating brief tobacco advice in routine health care delivery.

 
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