| CTRI Number |
CTRI/2025/09/095112 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Training Hospital Cleaning Staff to Reduce Infections and Antibiotic Resistance |
|
Scientific Title of Study
|
Strengthening Infection Prevention & Control (IPC) through Housekeeping &
Support Staff: A Mixed methods Approach in Healthcare Settings |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Vishu Kumar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine, KMC Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
07043898200 |
| Fax |
|
| Email |
kumar.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Kirthinatha Ballala |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine, KMC Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844270050 |
| Fax |
|
| Email |
kirthinath.ballala@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kirthinatha Ballala |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine, KMC Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844270050 |
| Fax |
|
| Email |
kirthinath.ballala@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal
Tiger Circle Road
Madhav Nagar Eshwar Nagar Manipal Karnataka 576104
India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr Nikhil Vishu Kumar |
Kasturba Hospital Manipal |
Udupi Hebri Rd Madhav Nagar, Manipal
Near
Kasturba Medical College
Manipal
Udupi
Karnataka
576104
India
Udupi
KARNATAKA |
7043898200
kumar.kmcmpl2024@learner.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 - 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable healthy housekeeping staff evaluated for infection prevention and control knowledge and practices |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Practice/No Additional Training |
Housekeeping staff continue routine duties under existing infection prevention and control protocols without exposure to the structured IPC training program during the study phase, for a maximum period of 12 months. KAP Assessment is conducted at the same time points as the intervention group for comparative analysis. |
| Intervention |
Structured IPC Training Program for Housekeeping Staff |
Co-designed structured infection prevention and control (IPC) training modules delivered to housekeeping staff over a maximum period of 12 months, including interactive lectures, video demonstrations, simulation exercises, and role-plays. The program focuses on essential IPC knowledge, hand hygiene, biomedical waste management, surface cleaning protocols, and safe equipment handling. Effectiveness is assessed via pre- and post-intervention knowledge, attitude, and practice (KAP) surveys. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Housekeeping staff employed in the hospital for at least six months
Basic literacy (able to read and write)
Provided informed consent |
|
| ExclusionCriteria |
| Details |
Unwillingness to participate
Less than six months of employment
Unable to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of the change in knowledge, attitude, and practice (KAP) scores related to infection prevention and control (IPC) among housekeeping staff, as measured by validated questionnaires before and after the structured training intervention. |
Baseline (pre-intervention)
Immediately post-intervention
1 to 3 months post-intervention follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perceptions and feedback on IPC training effectiveness and barriers from qualitative interviews and focus group discussions |
Baseline (pre-intervention)
Immediately post-intervention
1 to 3 months post-intervention follow-up |
|
|
Target Sample Size
|
Total Sample Size="277"
Sample Size from India="277"
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)
|
01/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This mixed methods study aims to strengthen infection prevention and control practices among housekeeping and support staff in a tertiary care hospital in India The project evaluates baseline IPC knowledge attitudes and practices KAP explores perceptions of healthcare professionals regarding the housekeeping role and co designs a multimodal IPC training intervention tailored to housekeeping staff The intervention includes structured training modules delivered via lectures videos simulations and role plays Effectiveness will be assessed through pre and post intervention KAP surveys qualitative interviews and observation of IPC practices with both intervention and control groups evaluated The study addresses critical gaps in IPC training for frontline support staff who play a pivotal role in controlling healthcare associated infections and antimicrobial resistance in resource constrained settings Findings will inform scalable and context sensitive IPC strategies for similar low and middle income healthcare environments |