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CTRI Number  CTRI/2018/01/011336 [Registered on: 15/01/2018] Trial Registered Prospectively
Last Modified On: 20/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   accuracy of data, and role health professionals in data collection and reporting.  
Scientific Title of Study   Assessment of integrated disease surveillance programme reporting in Deoghar, Jharkhand 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Medhavi Manish 
Designation  Student of MPH 
Affiliation  Prasanna School of public health 
Address  Prasanna school of public health, Old Tapmi building, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8902463698  
Fax    
Email  medhavimanis@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navya Vyas 
Designation  assistant professor 
Affiliation  Prasanna School of public health 
Address  Prasanna school of public health, Old Tapmi building, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9538126121  
Fax    
Email  navya.vyas@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Medhavi Manish 
Designation  Student of MPH 
Affiliation  Prasanna School of public health 
Address  Prasanna school of public health, Old Tapmi building, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8902463698  
Fax    
Email  medhavimanis@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  self  
Address  Medhavi Manish, prasanna school of public health, manipal university, manipal 
Type of Sponsor  Other [self funded] 
 
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 
Medhavi Manish  District surveillance unit, District hospital, SDH, CHCs, PHCs & Subcentres  district surveillance unit,Deoghar, Jharkhand
Deoghar
JHARKHAND 
8902463698

medhavimanis@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  no participant will be interviewed only observation of data of last 3 years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  3.00 Year(s)
Gender  Both 
Details  public health sector:- health facilities have a data record of last 3 years (2015, 2016 & 2017)
private health sector:- hospital/clinics/laboratories which are registered with their respective regulatory bodies 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
accuracy of data in IDSP  January 2018- June 2018 
 
Secondary Outcome  
Outcome  TimePoints 
role of health professional at each level & flow of information in IDSP  January 2018- June 2018 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2018 
Date of Study Completion (India) 28/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Thesis will be submitted to the Prasanna school of public health, manipal university 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Deoghar district has District surveillance unit, 1 District hospital, 1 Sub-divisional hospital, 8 Community health centers (CHCs), 4 Primary Health centers (PHCs/APHCs), 181 subcenters & 20 private clinic/ hospital & laboratories all the health facilities are included in the study except subcenters. 2 subcenters from each PHC/CHC will be selected using simple random sampling (i.e. 16 subcenters).
total of 51 health facilities will be included in the study and the data of last 3 years (2015, 2016 & 20170 will be observed from the reports (S, P & L FORM) and registers of various section of health facilities. data recorded in the register of various section of health facilities and data reported to district surveillance unit will be cross-checked with the records of district surveillance unit, the role of the health professional at each level and flow of information from each reporting unit to DSU will be observed. private health facilities are not reporting the cases so no data will be collected from them but it will be included in the study
 
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