| CTRI Number |
CTRI/2019/01/016991 [Registered on: 08/01/2019] Trial Registered Prospectively |
| Last Modified On: |
24/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study in the community to understand the number of people using tobacco and the various patterns of using among adults in East Khasi Hills District Meghalaya |
|
Scientific Title of Study
|
A community based study on the prevalence and patterns of tobacco use among adults in East Khasi Hills District Meghalaya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khamlin Warjri |
| Designation |
MPH PG 2nd year student |
| Affiliation |
Prasanna School of Public Health Manipal Academy of Higher Education |
| Address |
Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8837367691 |
| Fax |
|
| Email |
khamlinwarjri1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya Vyas |
| Designation |
Assistant Professor |
| Affiliation |
Prasanna School of Public Health Manipal Academy of Higher Education |
| Address |
Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7795409920 |
| Fax |
|
| Email |
navya.vyas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Khamlin Warjri |
| Designation |
MPH PG 2nd year student |
| Affiliation |
Prasanna School of Public Health Manipal Academy of Higher Education |
| Address |
Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8837367691 |
| Fax |
|
| Email |
khamlinwarjri1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health |
|
|
Primary Sponsor
|
| Name |
Prasanna School of Public Health Manipal Academy of Higher Education |
| Address |
Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi Karnataka |
| Type of Sponsor |
Research institution |
|
|
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 |
| Khamlin Warjri |
20 villages in East Khasi Hills District |
District Medical and Health Office, East Khasi Hills District, Meghalaya
East Khasi Hills
MEGHALAYA |
8837367691
khamlinwarjri1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To screen the use of tobacco among healthy volunteers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Any person age 18 years and above present in the house during data collection and those who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Under 18 years of age
Critically ill patients and bed ridden patients
People with psychiatric conditions and who are unable to comprehend.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimation of the prevalence and patterns of tobacco use among adults |
Last week of April |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Estimation of the prevalence and patterns of tobacco use among adults |
Last week of April |
|
|
Target Sample Size
|
Total Sample Size="383"
Sample Size from India="383"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="384" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2019 |
| Date of Study Completion (India) |
16/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will help to understand the prevalence and patterns of tobacco use in East Khasi Hills District, Meghalaya. Ethical clearance is taken form Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee for conducting the study. A total of 4 blocks from East Khasi Hills District, Meghalaya will be selected in the study using Simple Random Sampling Technique. Randomly 5 villages will be selected from each block covering a total of 20 villages. Households will be selected using Probability Proportionate to Size (PPS) based on the population of each village. Selection of the study participant will be according to the inclusion criteria. Detail information about the study and its purpose will be explained. Informed consent will taken from the study participants before conducting the study. Face to face Interview will be conducted using pre-designed structured and validated questionnaire |