| CTRI Number |
CTRI/2018/02/012130 [Registered on: 23/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of E Surveillance of Healthcare associated infection |
|
Scientific Title of Study
|
Implementation and evaluation of E- surveillance of Healthcare associated infection (HAIs) by Infection Control Competent Nurses (ICCN) working in selected hospitals of Udupi and Dakshina Kannada district, Karnataka |
| Trial Acronym |
HAI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Christabel |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing Manipal Manipal Academy of Higher Education,Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9739319382 |
| Fax |
08202922572 |
| Email |
soumya.christabel@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Christopher Sudhaker |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing, MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448252340 |
| Fax |
08202922572 |
| Email |
chris.sudhakar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Christopher Sudhaker |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing, MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448252340 |
| Fax |
08202922572 |
| Email |
chris.sudhakar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal college of Nursing, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal College of Nursing |
| Address |
Manipal College of Nursing Manipal,Madhav Nagar,Manipal,Udupi
District,Karnataka-576104 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Soumya Christabel |
Kasturba Hospital Manipal |
Dept. of Nursing, Kasturba Hospital
Madhav Nagar Manipal
Udupi KARNATAKA
Udupi
KARNATAKA
Udupi
KARNATAKA |
9739319382
08202922572
soumya.christabel@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine surveillance practice |
Routine surveillance by the infection control nurses will be continues |
| Intervention |
Training on E-Surveillance of HAI |
Training will be given to nurses about E- Surveillance by the investigator using lectures, simulated situations and actual situation. Training also includes demonstration and re-demonstration on E- Surveillance. These nurses are also taught how to train other nurses in the wards. |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Nurses working in selected hospitals of Udupi and DK District, Karnataka. |
|
| ExclusionCriteria |
| Details |
Those staff nurses not interested in study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nurse’s competency in collecting, analyzing and disseminating HAI surveillance data. |
During enrollment to the study and after 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving overall data of HAI and more time spent on infection prevention practices |
During enrollment to the study and after 3 months of introducing E- Surveillance |
|
|
Target Sample Size
|
Total Sample Size="850"
Sample Size from India="850"
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)
|
01/12/2017 |
| 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="4"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
One publication is done from the trial.
The state of healthcare associated infection (HAI) Surveillance in selected acute care hospitals of Dakshina kannada district, Karnataka. RGUHS Journal of Nursing Sciences, December 2013 vol 3 issue 2. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A survey was conducted among selected hospitals of Udupi and D K district. This mainly focused on existing practice of surveillance, methods used, capturing method, data dissemination, reporting of surveillance of data, the problem faced by the personnel surveillance and suggestions to improve the existing system. |