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CTRI Number  CTRI/2017/07/009050 [Registered on: 17/07/2017] Trial Registered Retrospectively
Last Modified On: 17/07/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Mental illness awareness in Udupi taluka. 
Scientific Title of Study   Knowledge and attitudes towards Mental illness in Udupi Taluka, A community based study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monica 
Designation  Post Graduate Scholar 
Affiliation  Dept. of Public Health, Manipal University 
Address  Dept. of Public Health Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9050610099  
Fax    
Email  monicasindhu11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sameer Phadnis 
Designation  Associate Professor 
Affiliation  Dept. of Public Health, Manipal University 
Address  Dept. of Public Health Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901814768  
Fax    
Email  drphadnis78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Monica 
Designation  Post Graduate Scholar 
Affiliation  Dept. of Public Health, Manipal University 
Address  Dept. of Public Health Manipal University Manipal


KARNATAKA
576104
India 
Phone  9050610099  
Fax    
Email  monicasindhu11@gmail.com  
 
Source of Monetary or Material Support  
Dr Monica (self funded) PG scholar at Manipal University 
 
Primary Sponsor  
Name  Dept of Public Health Manipal University Manipal Karnataka 
Address  Dept. of Public Health Manipal University Manipal 
Type of Sponsor  Research institution 
 
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 Monica  Hude, Kapu, Malpe, Parampali, Kemman,Shirva, Alevoor, etc.   Udupi Taluka (Urban and rural sites) Karnataka 576104
Udupi
KARNATAKA 
9050610099

monicasindhu11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comitttee, Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  This study is to know awareness about mental health 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Consenting adults will be included 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Awareness of mental health in adults in Udupi Taluk  10 April 2017 
 
Secondary Outcome  
Outcome  TimePoints 
Factors and type of stigma  June 2017 
 
Target Sample Size   Total Sample Size="212"
Sample Size from India="212" 
Final Enrollment numbers achieved (Total)= "212"
Final Enrollment numbers achieved (India)="212" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2017 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/03/2017 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study is mixed method conducted in Udupi Taluk, Udupi, Karnataka. The study aimed to assess the awareness, attitude of people and perception of health care providers related to mental health problems in the community and identify the determinants. The questionnaire and vignettes used were compiled from validated source questionnaire from one of study and to collect data using interview method (quantitative) and for qualitative interviews with stakeholders (audio recording) conducted. 
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