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CTRI Number  CTRI/2020/01/022776 [Registered on: 15/01/2020] Trial Registered Prospectively
Last Modified On: 21/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on the Healthcare behaviour and the money spent on health from their pocket among small scale manufacturing workers,Chennai .  
Scientific Title of Study   Assessment of Healthcare seeking behaviour and out of pocket expenditure among Small Scale Manufacturing workers Ambattur,Chennai . 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meril Mariam Joy 
Designation  Post Graduate Student  
Affiliation  Department of Health policy,Prasanna school of public health 
Address  Department of Health Policy , Prasanna School Of Public Health , Manipal Academy of Higher Education .

Udupi
KARNATAKA
576104
India 
Phone  9952042586  
Fax    
Email  meriljoy2014@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shah Houssain  
Designation  Associate Professor  
Affiliation  Department of Health policy,Prasanna school of public health 
Address  Department of Health Policy , Prasanna School Of Public Health , Manipal Academy of Higher Education .

Udupi
KARNATAKA
576104
India 
Phone  08202923157  
Fax    
Email  shah.hossain@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shah Houssain  
Designation  Associate Professor  
Affiliation  Department of Health policy,Prasanna school of public health 
Address  Department of Health Policy , Prasanna School Of Public Health , Manipal Academy of Higher Education .

Udupi
KARNATAKA
576104
India 
Phone  08202923157  
Fax    
Email  shah.hossain@manipal.edu  
 
Source of Monetary or Material Support  
Not Applicable  
 
Primary Sponsor  
Name  Department of health policy Prasanna school of public health  
Address  Department of Health Policy , Prasanna School Of Public Health , Manipal Academy of Higher Education . 
Type of Sponsor  Research institution and hospital 
 
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 
Meril Joy   Sri Balaji Castings Private Limited   Department of manufacturing NO 26-B/14 North phase ,SIDCO industrial estate ambattur chennai
Thiruvallur
TAMIL NADU 
9952042586

meriljoy2014@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  General Health  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Workers who seek healthcare and had out of
pocket expenditure on health in the last year.
2.Workers who worked for a minimum of 1 year in
that particular industry.
3.Workers aged 18 -60 years of age. 
 
ExclusionCriteria 
Details  1. Workers who did not have any out of pocket
expenditure on health in the last year
2. Workers who are not willing to participate  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To understand the healthcare seeking behaviour and the out of pocket expenditure among small scale manufacturing workers   Mid April  
 
Secondary Outcome  
Outcome  TimePoints 
To understand the healthcare seeking behaviour and the out of pocket expenditure among small scale manufacturing workers   Mid August  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "230"
Final Enrollment numbers achieved (India)="230" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/01/2020 
Date of Study Completion (India) 16/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 16/03/2020 
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   NIL  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary    The purpose of this study is to look into the Health care-seeking behavior and out of pocket expenditure among the small scale manufacturing workers in Chennai, small scale companies is the total economic growth in Chennai and now how these companies have come down and how much burden it has caused on the workers and how they are managing the catastrophic expenditure with limited money from their job. A total enumeration of the participants working in  Sri Balaji casting Pvt ltd and Bhagavati industries is taken as sample size and look into their healthcare-seeking behavior and out of the pocket expenditure.  
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