| CTRI Number |
CTRI/2018/02/012106 [Registered on: 23/02/2018] Trial Registered Prospectively |
| Last Modified On: |
12/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Knowledge, Attitude and the Practice of Pharmacovigilance among the healthcare professionals |
|
Scientific Title of Study
|
Knowledge, Attitude, and the Practice (KAP) of Pharmacovigilance among the healthcare professionals in a tertiary care hospital in Rajasthan, India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surjit Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Deaprtment of Pharmacology
AIIMS Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996895 |
| Fax |
|
| Email |
sehmby_ss@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surjit Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Deaprtment of Pharmacology
AIIMS Jodhpur
Rajasthan
RAJASTHAN
342005
India |
| Phone |
8003996895 |
| Fax |
|
| Email |
sehmby_ss@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surjit Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Deaprtment of Pharmacology
AIIMS Jodhpur
Rajasthan
RAJASTHAN
342005
India |
| Phone |
8003996895 |
| Fax |
|
| Email |
sehmby_ss@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur
Basni -2, AIIMS Jodhpur
Rajasthan - 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Basni Industrial Area -2
AIIMS Jodhpur
Rajasthan |
| 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 Surjit Singh |
All India Institute of Medical Sciences Jodhpur |
C- 291, Department of Pharmacology
AIIMS Jodhpur
Rajasthan - 342005
Jodhpur
RAJASTHAN |
8003996895
sehmby_ss@yahoo.com |
|
|
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 |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
None |
None |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Doctors working in Clinical and Nonclinical departments of AIIMS, Jodhpur
2. Doctors willing to give written informed consent.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in All India institute of medical Sciences, Jodhpur (Rajasthan), a tertiary care teaching hospital. |
Single point recording at the time of enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the causation of underreporting of adverse drug reactions (ADRs) as it needs to be well-assessed in India. |
Single time point recording at the time of enrolment |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/03/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Methodology
A cross-sectional study will be carried out using a pretested questionnaire. The questionnaire will be designed to assess the KAP regarding pharmacovigilance. The healthcare professionals (doctors, nurses, and pharmacists) working in the AIIMS, Jodhpur (Rajasthan) during the study period will be included. Only those who gave their consent to participate were included in the study. Face Validity of the questionnaire has been confirmed by sending it to 10 experts in the field of medicine and modifying the questionnaire as per their suggestions and comments. Care will be taken to protect the confidentiality and anonymity of participants. Data analysis was done using Statistical Package for Social Sciences (SPSS) version 21.
Inclusion Criteria:
1. Doctors working in Clinical and Nonclinical departments of AIIMS, Jodhpur
2. Doctors willing to give written informed consent.
Exclusion Criteria: None
Design: Cross sectional study and survey.
Study group: Clinical, Non Clinical and Para Clinical Doctors in Tertiary care hospital.
Evaluation: Responses of the doctors will be recorded and analysed. Confidentiality and anonymity of the participants will be maintained as no personal information will be recorded on the questionnaire. After the responses are recoded, comparison will be done with regard to knowledge, attitude and practice of pharmacovigilance among consultant and residents and also among doctors of clinical and non-clinical doctors.
Statistical Analysis
Information from the returned pretested questionnaire will be coded and entered into Statistical Package for Social Sciences (SPSS) software version 21. Spearman’s correlation will be used to determine any relationship between training of pharmacovigilance and reporting ADR. |