| CTRI Number |
CTRI/2021/05/033786 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
14/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
School Based Interventions on Prevention and Control of Malaria |
|
Scientific Title of Study
|
School Based Interventions to Enhance Community Behaviour on Prevention and Control of Malaria in an Urban Community in Tamil Nadu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roja Chokkara |
| Designation |
Ph.D Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing
Division of Full time Ph.D scholars
Reg No: U02N190608
Faculty of Nursing
Sri Ramachandra Institute of Higher education and research Porur
Chennai
Department of Community Health Nursing
Division of Full time Ph.D Scholars
Reg No:U02N190608
Faculty of Nursing
Sri Ramachandra Institute of Higher education and research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
08106262138 |
| Fax |
|
| Email |
chokkararoja@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrASeetha Lakshmi |
| Designation |
Reader and Head |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Nursing Foundation
Division of Faculty of Nursing
Sri Ramachandra Institute of Higher education and research
Porur
Chennai
Department of Nursing Foundation
Division of Faculty of Nursing
Sri Ramachandra Institute of Higher education and research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9940420846 |
| Fax |
|
| Email |
seethalakshmi.a@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Roja Chokkara |
| Designation |
Ph.D Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Nursing Foundation
Division of Faculty of Nursing
Reg No U02N190608
Sri Ramachandra Institute of Higher education and research
Porur
Chennai
Department of Nursing Foundation
Division of Faculty of Nursing
Reg No U02N190608
Sri Ramachandra Institute of Higher education and research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
08106262138 |
| Fax |
|
| Email |
chokkararoja@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research (DU) and Chennai Girls Higher Secondary School and Chennai Higher Secondary School |
|
|
Primary Sponsor
|
| Name |
Shri NPV Ramaswamy Udayar Research fellow |
| Address |
Prof.S.P.Thyagarajan,
Professor of Eminence and Dean (Research), Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai-600116 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Ms Roja Chokkara |
Chennai Girls Higher Secondary School |
Buddha street, Ward 12, George Town, Royapuram zone-V
Chennai
TAMIL NADU |
8106262138
chokkararoja@sriramachandra.edu.in |
| MsRoja Chokkara |
Chennai Higher Secondary School |
No-731, TH Road, Tondiar pet
Chennai
TAMIL NADU |
8106262138
chokkararoja@sriramachandra.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Sri Ramachandra Institute of Higher Education and Research (DU) |
Approved |
| Institutional Ethical Committee, Sri Ramachandra Institute of Higher Education and Research (DU) |
Approved |
| School permission letter |
No Objection Certificate |
| School Permission letter-2 |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Knowledge on Malaria and behaviour of community on malaria |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational Intervention |
Investigator create awareness in the school children through the use of Pamphlets, lectures, group discussion) on modes of transmission, signs and symptoms, preventive measures on malaria and follow-up of student parent communication for 3rd month, 6th month and post survey of knowledge regarding prevention and control of Malaria. |
| Comparator Agent |
No Educational Intervention |
Pamphlets, lectures and group discussion for first month and 3 month and then for 6th month. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in study
2. Studying X, XI and XII class
3. Aged between 14 to 17 years
4. Read and understand English and
Tamil.
|
|
| ExclusionCriteria |
| Details |
1.Unwilling parents/participants
2. Systemic/general illness
3. Unable to understand and
respond to the questions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in knowledge of school children on prevention and control of malaria
|
first month and 3 month (Reinforcement) and then 6 th month (Reinforcement) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No Secondary outcome |
0 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
02/08/2021 |
| 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="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
will publish the results after the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This trial is a school based malaria educational intervention study to assess the knowledge of school children on malaria and behaviour of community on malaria and dengue. with the educational intervention on malaria and dengue in school children reduce the prevalence of malaria and dengue.
Changes: Along with the Malaria, "Dengue" condition also added for this study and with the amendments to EC, received new EC approval letter on 7/04/2021. Remaining everything is same as registered in the trial |