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
|
|
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
|
|
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 |
|
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. |