| CTRI Number |
CTRI/2025/06/088495 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [KAP public health] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Health Education on Arboviral Diseases in Urban Bengaluru: a Quasi-Experimental Study |
|
Scientific Title of Study
|
Effectiveness of Health Education on Arboviral Diseases in Urban Bengaluru:a Quasi-Experimental 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 |
Sneha Singh |
| Designation |
MPH student |
| Affiliation |
MS Ramaiah university of Applied sciences |
| Address |
Ramaiah University of applied sciences Gnanagangothri campus FLAHS block MSR Nagara Bengaluru karnataka India
Ramaiah University of applied sciences Gnanagangothri campus FLAHS block MSR Nagara Bengaluru karnataka India
Bangalore
KARNATAKA
560054
India |
| Phone |
7483261701 |
| Fax |
|
| Email |
snehasinghg30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sneha Singh |
| Designation |
MPH student |
| Affiliation |
MS Ramaiah university of Applied sciences |
| Address |
Ramaiah University of applied sciences Gnanagangothri campus FLAHS block MSR Nagara Bengaluru karnataka India
Ramaiah University of applied sciences Gnanagangothri campus FLAHS block MSR Nagara Bengaluru karnataka India
Bangalore
KARNATAKA
560054
India |
| Phone |
7483261701 |
| Fax |
|
| Email |
snehasinghg30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Singh |
| Designation |
MPH student |
| Affiliation |
MS Ramaiah university of Applied sciences |
| Address |
Ramaiah University of applied sciences Gnanagangothri campus FLAHS block MSR Nagara Bengaluru karnataka India
Ramaiah University of applied sciences Gnanagangothri campus FLAHS block MSR Nagara Bengaluru karnataka India
Bangalore
KARNATAKA
56004
India |
| Phone |
7483261701 |
| Fax |
|
| Email |
snehasinghg30@gmail.com |
|
|
Source of Monetary or Material Support
|
| conducted in NEW Manjula Public School Bengaluru 560073 karnataka India and GJC school Bengaluru 560064 India with provided infrastructures Classroom |
|
|
Primary Sponsor
|
| Name |
Sneha Singh |
| Address |
Shri ranganatha kripa nagamma layout kadadkatte bhadravathi 577229 |
| Type of Sponsor |
Other [myself] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Denny John |
GJC |
yelahanka old town
Bangalore
KARNATAKA |
7483261701
dennyjohn.ah.ls@msruas.ac.in |
| Dr Denny John |
New manjula public school |
gruhalakshmi layout nelgedernahalli bengaluru
Bangalore
KARNATAKA |
7483261701
dennyjohn.ah.ls@msruas.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The University Ethics Committee for Human trials of MS Ramaiah University of Applied Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents who has children of age group 12-15 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
health education |
health education includes preventive and protective measures for arboviral diseases introduction,recognition of symptoms, effective strategies and measures to prevent dengue and malaria interventioon duration will be for 3 weeks and will be conducted once a week for 3 weeks |
| Comparator Agent |
no education |
parents will not be provided with any kind of health education and will be carrying on their usual activities baseline and end line data will be collected baseline in the 1 st weeek and endline in the 3rd week |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
parents whose children age group is 12-15 years
parents who provide informed consent |
|
| ExclusionCriteria |
| Details |
parents who have already participated in past research similar to this
parents who dont give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is an improvement in the knowledge, attitudes, and practices (KAP) regarding arboviral diseases such as dengue and malaria among parents of adolescents aged 12–15 years in urban Bengaluru |
4 week and 8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Outcome include eenhancing the quality of life of families by reducing the risk of arboviral diseases through the adoption of preventive measures & improved health awareness. |
4 week & 8 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/06/2025 |
| 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="0"
Months="1"
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
|
The primary purpose of this protocol is to evaluate the effectiveness of a health education intervention in improving knowledge, attitudes, and practices (KAP) regarding arboviral diseases and enhancing health-related quality of life (HRQoL) among participants. By employing a structured educational approach, the study aims to assess whether the intervention leads to significant improvements in disease awareness, preventive behaviors, and self-reported well-being as measured by the EQ-5D-5L instrument Null hypothesis The health education intervention will not result in significant changes in KAP scores or HRQoL among participants.Alternate hypothesis The health education intervention will lead to significant improvements in KAP scores and HRQoL, as measured by pre- and post-intervention assessments.
The statistical analysis, including paired t-tests and independent t-tests, will determine whether the observed changes in KAP and HRQoL are statistically significant, thus evaluating the effectiveness of the intervention. |