| CTRI Number |
CTRI/2024/10/075561 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding What Makes Older People in India Choose to Get a Pneumonia Vaccine and How Much They Are Willing to Pay – An Online Survey |
|
Scientific Title of Study
|
Prediction of factors influencing the elderly population of India in accepting any Pneumococcal vaccination and their willingness to pay – an online discrete choice experiment study |
| 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 Jeffrey Pradeep Raj |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Division of Clinical Pharamcology
Department of Pharmacology
Ground Floor Physiology Pharmacology Buidling
Kasturba Medical College, Manipal, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7904286189 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeffrey Pradeep Raj |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Division of Clinical Pharamcology
Department of Pharmacology
Ground Floor Physiology Pharmacology Buidling
Kasturba Medical College, Manipal, Madhav Nagar, Manipal
KARNATAKA
576104
India |
| Phone |
7904286189 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeffrey Pradeep Raj |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Division of Clinical Pharamcology
Department of Pharmacology
Ground Floor Physiology Pharmacology Buidling
Kasturba Medical College, Manipal, Madhav Nagar, Manipal
KARNATAKA
576104
India |
| Phone |
7904286189 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Madhav Nagar, Manipal - 576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College, Manipal, Madhav Nagar, Manipal - 576104, Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
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 Jeffrey Pradeep Raj |
Kasturba Medical College Manipal |
Division of Clinical Pharamcology
Department of Pharmacology
Ground Floor Physiology Pharmacology Buidling
Kasturba Medical College, Manipal, Madhav Nagar, Manipal
Udupi
KARNATAKA |
7904286189
jpraj.m07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All consenting elderly of any biological sex, age 60 years and above
2. A citizen of India who has been residing in India.
3. Have not stayed outside of India for more than 3 months in the last 6 months |
|
| ExclusionCriteria |
| Details |
1. Incompletely filled survey forms
2. Those who are unable to fill the form due to language or technical barriers
3. 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
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preferred charactersitics of pneumococcal vaccine |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vaccine hesitancy |
At Baseline |
| Willingness to pay |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "2000"
Final Enrollment numbers achieved (India)="2000" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
20/12/2024 |
| 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)
Modification(s)
|
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
|
This study aims to identify the key factors that influence elderly people in India to accept pneumococcal vaccination and assess their willingness to pay for it. The study will use an online cross-sectional survey, focusing on citizens aged 60 and above. Participants will be asked to compare hypothetical vaccine options based on attributes such as effectiveness, duration of protection, side effects, and cost. Key procedures include: - An ethics committee’s approval before starting.
- Written electronic consent from participants.
- The survey will present participants with six pairs of hypothetical vaccines, each having randomized combinations of attributes.
- Participants will be asked to select their preferred vaccine in each scenario or choose "no vaccine."
The study will also include a trap question to ensure participant attentiveness. Data will be collected through digital platforms like WhatsApp, Facebook, and emails, with an anticipated sample size of around 2,000 participants. The survey is expected to take around 10 minutes, and the responses will help understand what factors make older adults in India more likely to accept or reject the pneumococcal vaccine and their willingness to pay for these vaccines |