CTRI/2025/10/095844 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On:
03/10/2025
Post Graduate Thesis
Yes
Type of Trial
Observational
Type of Study
Cross Sectional Study
Study Design
Other
Public Title of Study
Awareness on cardiac problems among drivers
Scientific Title of Study
A descriptive study to assess the awareness on immediate response to out of hospital cardiac emergencies readiness and barriers to seek prompt treatment during cardiac emergencies among drivers in selected areas of Udupi district
Trial Acronym
nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Anvika T Maindan
Designation
M Sc Nursing
Affiliation
Manipal College of Nursing
Address
4th floor Room Number 400
Department of Community Health Nursing Manipal College of Nursing Manipal Academy of Higher Education Manipal 576104 Udupi Karnataka
Udupi KARNATAKA 576104 India
Phone
9880876393
Fax
Email
ananyaanvika@gmail.com
Details of Contact Person Scientific Query
Name
Dr Ansuya
Designation
Associate Professor
Affiliation
Manipal College of Nursing
Address
4th floor Room number 400
Department of Community Health Nursing
Manipal College of Nursing Manipal Academy of Higher Education Manipal 576104 Udupi Karnataka
Udupi KARNATAKA 576104 India
Phone
9535894558
Fax
Email
ansuya.bengre@manipal.edu
Details of Contact Person Public Query
Name
Mrs Shobha
Designation
Lecturer
Affiliation
Manipal College of Nursing
Address
6th floor Room number 600
Department of Obstetrical and Gynecological Nursing
Manipal College of Nursing Manipal Academy of Higher Education Manipal 576104 Udupi Karnataka
Udupi KARNATAKA 576104 India
Phone
8453320474
Fax
Email
shobha.nvr@manipal.edu
Source of Monetary or Material Support
Manipal College of Nursing
Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104
Primary Sponsor
Name
Anvika T Maindan
Address
M Sc Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal 576104 Udupi Karnataka
Type of Sponsor
Other [Self]
Details of Secondary Sponsor
Name
Address
nil
nil
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ansuya
Manipal College of Nursing Manipal Academy of Higher Education
4th floor Room Number 400
Department of Community Health Nursing
Manipal College of Nursing Manipal Academy Of Higher Education Manipal 576104 Udupi Karnataka India Udupi KARNATAKA
9535894558
ansuya.bengre@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 2 Student Research
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy
Intervention / Comparator Agent
Type
Name
Details
Intervention
Nil
Nil
Inclusion Criteria
Age From
20.00 Year(s)
Age To
60.00 Year(s)
Gender
Male
Details
The men drivers who operate a bus or auto in the selected areas of Udupi district
Drivers who are interested and willing to participate in the study
Drivers above age group of 20years and below age group of 60year
ExclusionCriteria
Details
Drivers who are unable to read and write in Kannada
Drivers who are not available during the time of data collection
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The study aims to assess the awareness on immediate response to out of hospital cardiac emergencies and to identify the barriers that may prevent them from seeking medical treatment By recognizing their awareness readiness and challenges to get timely medical help the study aims to reduces the treatment delays and improve the health status The result of this study gives an understanding of the awareness and the challenges of drivers which may help in developing intervention
1 year
Secondary Outcome
Outcome
TimePoints
nil
nil
Target Sample Size
Total Sample Size="428" Sample Size from India="428" 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)
01/11/2025
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="1" 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
A descriptive study to
assess the awareness on immediate response to out of hospital cardiac
emergencies, readiness and barriers to seek prompt treatment during cardiac
emergencies among drivers in selected areas of Udupi district