| CTRI Number |
CTRI/2025/11/098054 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Organ Donation Engagement Initiatives on cognizance, attitude, willingness and decision making factors |
|
Scientific Title of Study
|
Impact of Organ Donation Engagement Initiatives on cognizance, attitude, willingness and decision making factors to register as donors among urban and rural adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Frank JC |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Community Health Nursing
Teerthanker Mahaveer College of Nursing
Moradabad
Teerthanker Mahaveer College of Nursing
Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9596975708 |
| Fax |
|
| Email |
frank.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Vashist |
| Designation |
Professor Cum HOD Mental Health Nursing |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Mental Health Nursing Department, Room No.210, Teerthanker Mahaveer College of Nursing
Moradabad
Teerthanker Mahaveer College of Nursing
Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9915650484 |
| Fax |
|
| Email |
suman.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Frank JC |
| Designation |
Ph D Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Community Health Nursing Department
Teerthanker Mahaveer College of Nursing
Moradabad
Teerthanker Mahaveer College of Nursing
Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9596975708 |
| Fax |
|
| Email |
frank.scholar@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Frank JC |
| Address |
PhD Scholar Teerthanker Mahaveer College of Nursing
Moradabad 244001
Moradabad |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Frank JC |
Block Bhalwal |
Ranjan
Bhalwal
Jammu
JAMMU & KASHMIR |
9596975708
jc.franklinnurse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE TEERTHANKER MAHAVEER DENTAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Organ donation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Control group will not receive any intervention during the study period. However, the educational intervention will be given after the conclusion of the scheduled sessions. |
| Intervention |
Intervention Organ Donation Intervention Initiatives |
In this study, it refers to the activities designed to raise awareness, educate the public, and encourage participation in organ donation. These initiatives aim to influence knowledge, attitudes, and willingness to organ donation and can be implemented through awareness education and street plays. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults (18 years and above)
Capable of giving informed consent
Willing to take part in study
|
|
| ExclusionCriteria |
| Details |
Individuals with prior formal education or training on organ donation
Those who refuse participation
Those who registered for Organ donation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved cognizance, attitude and willingness to donate organs |
15 days and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in cognizance |
15 and 30 days |
| Improvement in attitude |
15 and 30 days |
| Improved willingness to donate organs |
15 and 30 days |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Current
investigation aims to assess impact of organ donation engagement initiatives on
cognizance, attitude, willingness, and decision making factors related to organ
donor registration among urban and rural populations in Jammu and Kashmir.
The findings will provide evidence based insights into the effectiveness of
structured awareness programs in increasing organ donor pledges.
|