| CTRI Number |
CTRI/2025/09/095464 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving influenza management practices |
|
Scientific Title of Study
|
Improving Influenza Management and Prevention Practices among Physicians and vaccine uptake in high-risk groups at selected cities of India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aftab Ahmad |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Room No 13 Centre for Community Medicine All India Institute of Medical Sciences Ansari Nagar E South DELHI 110029 India |
| Phone |
9471391789 |
| Fax |
|
| Email |
aftab.ind@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Anand Krishnan |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Room No 13 Centre for Community Medicine All India Institute of Medical Sciences Ansari Nagar E South DELHI 110029 India |
| Phone |
9811500667 |
| Fax |
|
| Email |
anand.drk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anand Krishnan |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Room No 13 Centre for Community Medicine All India Institute of Medical Sciences Ansari Nagar E
DELHI 110029 India |
| Phone |
9811500667 |
| Fax |
|
| Email |
anand.drk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Community Medicine All India Institute of Medical Sciences, New Delhi, India - 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Anand Krishnan |
| Address |
Professor of Centre for Community Medicine All India Institute of Medical Sciences New Delhi India 110029 |
| Type of Sponsor |
Other [Individual Sponsor Guide] |
|
|
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 Aftab Ahmad |
All india Institute of Medical Sciences |
Room No 13 Centre for Community Medicine All India Institute of Medical Sciences Ansari Nagar (E) South DELHI |
9471391789
aftab.ind@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee All India Institute of Medical Sciences New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Physicians involved in influenza management |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational Intervention |
Self Directed Learning Intervention which would be in the form of a 2 hour online training for physicians |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Physicians working in the departments of General Medicine, Pulmonology / TB Chest Department, Pediatrics Department, Obstetrics and Gynecology department and Geriatrics department in the selected hospital
2. The minimum qualification of the physician should be MBBS.
|
|
| ExclusionCriteria |
| Details |
Physicians of alternative systems of medicine like AYUSH. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adherence to diagnostic guidelines (e.g., use of RT-PCR for SARI patients), therapeutic practices (e.g., prescription of antivirals for influenza-confirmed SARI cases), and vaccination practices (e.g., recommending and administering influenza vaccines to high-risk groups). |
Pre intervention, post intervention and 6 months post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of physicians from each department who undertake the intervention – This will provide insights into the acceptance and uptake of the educational module across different specialties.
2. Percent increase in knowledge and practice across three domains—diagnostics, therapeutics, and prevention – This will be evaluated using the difference in pre-test and post-test scores, which will be embedded within the training program. Improvements in these scores will reflect the intervention’s success in enhancing physicians’ understanding of influenza management.
|
Pre intervention, post intervention and 6 months post intervention |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
15/10/2026 |
| 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="1" Months="6" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aftab.ind@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2031?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A quasi-experimental pre-post intervention design will be employed in the same four cities. Physicians from the institutions involved in Objective 1 will be invited to participate in a self-directed educational intervention comprising six video modules (total ~2 hours) aligned with MoHFW guidelines. The modules will cover transmission, diagnosis, treatment, and prevention of influenza, and will be hosted online. Pre- and post-test assessments will be embedded within the platform, followed by a repeat survey at 6 months. Uptake and changes in knowledge and practices will be analyzed using generalized linear models with mixed effects, with stratified and sensitivity analyses for robustness. Per-protocol and intention-to-treat analyses will assess intervention impact. |