| CTRI Number |
CTRI/2025/11/096798 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Health Education intervention in truck drivers to improve their health seeking behaviour |
|
Scientific Title of Study
|
Effectiveness of a Health education Intervention in Improving
health seeking behaviour, awareness and health outcomes
regarding refractive error, Diabetes and Hypertension among
truck drivers in Jodhpur 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 |
Dr Pranshu Agarwal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Community and Family Medicine, AIIMS, Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
9098626040 |
| Fax |
|
| Email |
pranshu14.agarwal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Akhil Dhanesh Goel |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
C 214, Department of Community and Family Medicine, AIIMS, Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
9643158274 |
| Fax |
|
| Email |
doc.akhilgoel.aiims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pranshu Agarwal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Community and Family Medicine, AIIMS, Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
9098626040 |
| Fax |
|
| Email |
pranshu14.agarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Basni Industrial Area Phase-2, Jodhpur, Rajasthan, India 342005 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Pranshu Agarwal |
AIIMS Jodhpur |
Department of Community and Family Medicine, AIIMS, Jodhpur Jodhpur RAJASTHAN |
9098626040
pranshu14.agarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hypertension, Type 2 Diabetes Mellitus and Refractive error
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education session |
Health education session to improve the health seeking behaviour regarding diabetes, hypertension and refractive error among truck drivers
It will be given for 30 minutes using IEC material at initial stage, then on follow up after 6 months |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Truck Drivers both female and male
Aged - 18 to 75 years
Truck driver in Jodhpur district |
|
| ExclusionCriteria |
| Details |
Truck drivers who refuse to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in health seeking behavior among truck drivers in Jodhpur |
baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="517" Sample Size from India="517"
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)
|
17/11/2025 |
| 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="6" 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
|
Visual disorders Diabetes and Hypertension are major health disorders in Truck drivers due to
their sedentary lifestyle and inability to get screened for the same at appropriate intervals.
Driving has become a visually intensive task. There has been a steep increase in road traffic
accidents in last decades in developing nations such as India This might be due to many reasons
but impaired visual function can be one of the major causes of mishaps According to the World
Health Organisation 2023 road traffic injuries are expected to become the seventh leading
cause of deaths globally by 2030 with low and middle income countries disproportionately
affected accounting for 93 percent of road traffic related injury mortality
Truck drivers health is one of the most neglected
part, often overlooked with poor working environment and medical care available A lot of truck
drivers are suffering from visual disorders Diabetes and Hypertension but are never screened and
also are not aware of these underling diseases To make them self aware and seek help health
education intervention should be done |