| CTRI Number |
CTRI/2024/10/074610 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Healthcare Professionals Perspectives and experiences on the Use of Digital Health Information for Therapeutics in India |
|
Scientific Title of Study
|
Ethical perspectives and attitudes on the use of electronic health information resources in therapeutics by health care professionals in 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 |
Dr R Siddhanth |
| Designation |
Juniour Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Manipal University Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7799664565 |
| Fax |
|
| Email |
r.sid97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Siddhanth |
| Designation |
Juniour Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Pharmacology Kasturba Medical College Manipal University Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7799664565 |
| Fax |
|
| Email |
r.sid97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeffrey Pradeep Raj |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Division of Clinical Pharmacology, Department of Pharmacology Kasturba Medical College Manipal University Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095464464 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Manipal University MAHE,
Madhav Nagar
Manipal
Udupi District
Karnataka
India
PIN:576104
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, MAHE, Manipal |
| Address |
Kasturba Medical College, MAHE, Manipal University Madhav Nagar, Manipal Karnataka India 576104 |
| 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 R Siddhanth |
Kasturba Medical College |
Department of Pharmacology.
Ground floor, Physiology and Pharmacology building.
Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal, India
PIN:576104
Udupi
KARNATAKA |
7799664565
r.sid97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College & Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
Not applicable. |
| Comparator Agent |
nil |
Not applicable. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All health care professionals the age of 18 years and above working in India (Doctors, Nursing, Dentistry, and others like technicians, therapists, dieticians etc). |
|
| ExclusionCriteria |
| Details |
Incompletely filled survey forms.Those who fail to answer the trap question correctly.The trap question would be a repeat of one of the previous questions. Any discordance in the answer option chosen will be considered as failed |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perspectives and experiences of health workers with the ethical aspects of electronic resources. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Baseline |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1800"
Sample Size from India="1800"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Electronic health resources in Indian hospitals are valuable tools for enhancing patient care and clinical decision-making. These include electronic health records (EHRs), which simplify patient data management, and clinical decision support systems (CDSS) that offer evidence-based recommendations for diagnostics and treatment. Online databases like PubMed also help doctors stay updated on medical research. Despite their benefits, these tools pose risks to patient privacy and data security, including breaches from insecure messaging apps and inadequate consent protocols. Indian hospitals must adopt strong security measures, educate staff, and implement clear consent procedures to protect sensitive health data. Legal frameworks are needed to regulate electronic health systems in India. Standardized security protocols, such as encryption and access controls, are crucial to prevent data breaches, while usability standards ensure healthcare professionals can efficiently use these systems. |