FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/07/026286 [Registered on: 01/07/2020] Trial Registered Prospectively
Last Modified On: 26/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Exploratory Survey 
Study Design  Other 
Public Title of Study   Factors affecting Infection control nurses 
Scientific Title of Study   Structure, Staffing and Factors affecting (SSF) Infection Control Nurses (ICNs): Hospital Based National Exploratory Survey 
Trial Acronym  SSF-ICN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anice George 
Designation  Dean 
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922443  
Fax    
Email  anice.george@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Shalini G Nayak 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  shalini.mcon@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Mr Anil Raj A 
Designation  Lecturer 
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  anil.raj@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council if Medical Research 
Address  Ansari Nagar, Post Box No. 4911 New Delhi- 110029 
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 
Precilla Noronha  Kasturba Hospital  In-charge, Infection Control Nurse Room. No. 9 Kasturba Hospital Manipal
Udupi
KARNATAKA 
08202922444

office.kh@manipal.edu 
 
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  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Infection Control Nurses from Government and Private hospital. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Structure, Staffing, Factors affecting Infection Control Nurses  one time 
 
Secondary Outcome  
Outcome  TimePoints 
Development of module for the infection Control Nursing Department   One Time 
 
Target Sample Size   Total Sample Size="197"
Sample Size from India="197" 
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)   01/07/2020 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Nurses play a vital role in advocating and implementing infection control practices and it certainly requires some educational expertise, support from management and organizational policies. Little research has been undertaken in this aspect and in India, there is a lack of published research on infection control nurses in terms of numbers, qualification, roles and responsibilities. There is a need for the study to identify the existing structure of infection control nurses, their special education and their roles and responsibilities. Further, information from the present study may help to develop the strategy, policy or educational module for the infection control nurses. The current study will be a hospital-based exploratory survey conducted in Karnataka state, which will be conducted in two phases; Phase 1-survey to explore the existing structure and staffing pattern of infection control department and to identify factors affecting with infection control practices. In phase 2 Delphi will be conducted infection control nurses to bring about strategies to improve the Hospital Infection Control Practices. Expected study outcomes are to bring about a infection control module for the environmental and organizational structure of infection control department, staff requirements, basic education, opportunities for professional advancements, and training sessions for the healthcare workers hindering and favouring factors for the infection control nurses to work efficiently in the healthcare settings. Delphi from phase 2 among selected infection control nurses will be to find out problems and solutions for all the concerns pertaining to the infection control nurses in order to bring about a common guideline to all the hospital infection control nurses. 

 
Close