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
|
|
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
|
|
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. |