| CTRI Number |
CTRI/2025/08/093275 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Training for Healthcare Professionals on reporting adverse events related to medical devices] |
| Study Design |
Other |
|
Public Title of Study
|
A study with healthcare professionals to improve how medical device safety is monitored in hospitals |
|
Scientific Title of Study
|
Evaluation and Optimization of Materiovigilance Activities in a Tertiary Care Teaching Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashutosh Vishwas Bhosale |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Pharmaceutical Sciences, Manipal |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7558418626 |
| Fax |
|
| Email |
ashutosh.mcopsmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences, Manipal |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448374166 |
| Fax |
|
| Email |
rajesh.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences, Manipal |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal
KARNATAKA
576104
India |
| Phone |
9448374166 |
| Fax |
|
| Email |
rajesh.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education, Manipal 576104, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivaprakash G |
Kasturba Medical College and Kasturba Hospital Manipal |
Department of Pharmacology, Room number 1, Kasturba Medical College, Manipal Academy of Higher Education, Manipal Karnataka 576104
Udupi
KARNATAKA |
9449553742
shiva.g@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C10||Malignant neoplasm of oropharynx, (2) ICD-10 Condition: I70||Atherosclerosis, (3) ICD-10 Condition: M20-M25||Other joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational Intervention |
To develop and validate a Video-Based Training Module (VBTM) as an educational intervention to enhance knowledge and adverse event (AE) reporting practices among healthcare professionals (HCPs) in a tertiary care setting. A prospective interventional study will be conducted over six months at Kasturba Hospital Manipal involving physicians nurses pharmacists and allied technicians who previously participated in the qualitative and quantitative assessments (Phase-1). Informed consent will be obtained from all participants prior to enrollment. Ethical clearance from the Institutional Ethics Committee will be obtained before giving the intervention.
A pilot sample of HCPs will be selected to review and validate the educational video for clarity content and audibility using a Likert scale. Validation will be performed by an expert panel including internal academic faculty and external members from the Indian Pharmacopoeia Commission Ghaziabad. The VBTM will be developed under expert guidance and structured into three modules-
(1) Introduction Aim Scope and Objectives of Materiovigilance
(2) Reporting Training – How Where What and When to Report an AE and
(3) Significance of Materiovigilance.
Printed pamphlets will also be distributed as supplementary educational materials.
The total training duration will be approximately 35 minutes including an orientation (5 minutes) introduction and scope of materiovigilance (10 minutes) AE reporting training (15 minutes) and explanation of reporting significance (5 minutes). Additionally one educational pamphlet will be provided to each participant to reinforce the video content. Once validated the VBTM will be implemented among the same HCPs involved in earlier phases of the study. The principal investigator will provide participants with an orientation and timeline to complete the training. Reminders will be sent via email or SMS to ensure timely completion. Each participant will be expected to view the modules and review the pamphlet content.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
For Observational Study
1. Patients who have experienced an Adverse Event
2. Patients greater than 18 year both genders who are willing to participate will be included in the study
For Interventional Study
1. Pharmacists Physicians nurses and Allied Technicians with a registered OR completed degree, who provide written informed consent will be eligible to participate in the study.
2. We will include the HCP with at least 1 year of experience.
|
|
| ExclusionCriteria |
| Details |
For Observational Study
1. Patients who are unwilling to sign the Informed Consent and unwilling to participate in the study will be excluded.
2. Patients who are terminally ill or in a coma will be excluded.
For Interventional Study
1. The HCPs who are not willing to participate in the study.
2. Pharmacists, medical practitioners nurses and Allied Technicians having less than 1 year of experience are ineligible to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. This study will collect and analyze data & estimate the incidence rate of medical device-related adverse events based on risk-based classification.
2. The implementation of video-based training modules (VBTM) is expected to boost the knowledge, attitudes, and practices (KAP) regarding materiovigilance among healthcare professionals. This will help to create awareness in the healthcare professionals on the significance of materiovigilance. |
1. This study will collect and analyze data & estimate the incidence rate of medical device-related adverse events based on risk-based classification is an observational study conducted for 3 Year data will be collected daily by visiting the department.
2. The implementation of video-based training modules (VBTM) is expected to boost the knowledge, attitudes, and practices (KAP) regarding materiovigilance among healthcare professionals. This is an interventional study which will be conducted in Three phases.
Phase I: Pre-Interventional Phase: Gap Analysis by using a mixed-method approach (conducting qualitative and quantitative surveys) qualitative survey 6 months data collection), followed by quantitative survey for 6 months data collection.
Phase II: Interventional Phase: Development of video-based interventional training modules for healthcare professionals. (6 months for preparing video and validation)
Phase III: Post-interventional Phase: Assessment of the impact of the video-based training modules using a mixed-method approach (qualitative and quantitative surveys). (Qualitative survey for 6 months data collection) (Quantitative Survey for 6 months data collection)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="789"
Sample Size from India="789"
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)
|
01/09/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is a three year prospective mixed methods study that aims to evaluate and optimize materiovigilance activities in a tertiary care teaching hospital. The project is divided into two parts: a prospective observational study on patients experiencing adverse events related to medical devices and a prospective interventional study assessing healthcare professionals knowledge attitude and practice using mixed method approach. The study will explore usage patterns and estimate the incidence of medical device-related adverse events. It will also assess healthcare professionals’ knowledge, attitudes, and practices (KAP) regarding materiovigilance using qualitative and quantitative surveys. To enhance knowledge and reporting practices, the project involves developing and validating video-based training modules for healthcare professionals. The effectiveness of video-based interventions will be assessed by comparing pre and post training outcomes. Recruitment will be stratified across departments and professional categories to ensure appropriate sample representation. Validated tools such as the Medical Device Adverse Event Reporting Form WHO UMC causality scales, and Common Terminology Criteria for Adverse Events will be utilized. Thematic analysis will be employed for qualitative data while quantitative analysis will use SPSS. Expected outcomes include improved awareness and reporting of device related adverse events, enhanced patient safety and evidence based recommendations for better regulatory frameworks. This study addresses a major research gap in India following the Medical Device Rules 2017 and represents the first comprehensive mixed methods assessment of materiovigilance among healthcare professionals in the Indian context. |