| CTRI Number |
CTRI/2019/11/021836 [Registered on: 01/11/2019] Trial Registered Prospectively |
| Last Modified On: |
31/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Knowledge, attitude and practice survey among doctors about adverse effects related to medical devices |
|
Scientific Title of Study
|
Knowledge, attitude and practice survey among health care professionals about materiovigilance in a tertiary care hospital in West Bengal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nafisha Yasmin |
| Designation |
Demonstrator |
| Affiliation |
Institute of Postgraduate Medical Education & Research, Kolkata |
| Address |
Department of Pharmacology 244 Acharya Jagadish Chandra Bose Road
Kolkata
WEST BENGAL
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830972292 |
| Fax |
|
| Email |
drnyasmin.sona@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nafisha Yasmin |
| Designation |
Demonstrator |
| Affiliation |
Institute of Postgraduate Medical Education & Research, Kolkata |
| Address |
Department of Pharmacology 244 Acharya Jagadish Chandra Bose Road
Kolkata
WEST BENGAL
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830972292 |
| Fax |
|
| Email |
drnyasmin.sona@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saikat Kumar Dalui |
| Designation |
Senior Resident |
| Affiliation |
Institute of Postgraduate Medical Education & Research, Kolkata |
| Address |
Department of Pharmacology 244 Acharya Jagadish Chandra Bose Road
Kolkata
WEST BENGAL
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830310314 |
| Fax |
|
| Email |
dr.saikatdalui2011zico@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Medical Education and Research |
| Address |
244 Acharya Jagadish Chandra Bose Road Kolkata 700020 |
| Type of Sponsor |
Government 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 |
| Dr Nafisha Yasmin |
Institute of Post Graduate Medical Education and Research |
Department of Pharmacology
Room number 1
Division: Pharmacology
Kolkata
WEST BENGAL |
9830972292
drnyasmin.sona@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
prevention of Adverse events due to medical devices |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
healthcare professionals of Cardiology, Cardio-thoracic-vascular surgery, Surgery, Urosurgery, Orthopaedics, Dental Surgery, Anaesthesiology, Intensive care unit, Intensive Coronary Care Unit |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To document the knowledge, attitude and practices (KAP) of health care professionals towards materiovigilance |
Single point of recording at the time of enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the barriers to implementing a fully functional materiovigilance program |
Single point recording at the time of enrolment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/11/2019 |
| 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="0"
Months="3"
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
|
This is a cross-sectional observational study intended to gather information about the knowledge, attitude and practices regarding materiovigilance among healthcare professionals in West Bengal. Reasons associated with non reporting will be evaluated. We will use a predesigned and pretested validated questionnaire in the study . |