| CTRI Number |
CTRI/2022/01/039628 [Registered on: 21/01/2022] Trial Registered Prospectively |
| Last Modified On: |
09/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Educational intervention] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Educational intervention for antibiotic awareness among school children |
|
Scientific Title of Study
|
Effectiveness of an educational intervention in promoting antibiotic awareness among 8th – 10th grade school children in Kerala |
| Trial Acronym |
STAR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Venkitachalam Ramanarayanan |
| Designation |
Assistant Professor |
| Affiliation |
Amrita School of Dentistry |
| Address |
Amrita School of Dentistry,
Amrita Vishwa Vidyapeetham,
Amrita Institute of Medical Sciences Campus,
Ponekkara, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9895741775 |
| Fax |
|
| Email |
venkitr2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parvathy Balachandran |
| Designation |
Resident |
| Affiliation |
Amrita School of Dentistry |
| Address |
Amrita School of Dentistry,
Amrita Vishwa Vidyapeetham,
Amrita Institute of Medical Sciences Campus,
Ponekkara, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
08129153947 |
| Fax |
|
| Email |
parvathysree7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parvathy Balachandran |
| Designation |
Resident |
| Affiliation |
Amrita School of Dentistry |
| Address |
Amrita School of Dentistry,
Amrita Vishwa Vidyapeetham,
Amrita Institute of Medical Sciences Campus,
Ponekkara, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
08129153947 |
| Fax |
|
| Email |
parvathysree7@gmail.com |
|
|
Source of Monetary or Material Support
|
| This study has been funded under the Student Project Scheme2021 by the Kerala State Council for Science, Technology and Environment |
|
|
Primary Sponsor
|
| Name |
Amrita School of Dentistry |
| Address |
Amrita School of Dentistry,
Amrita Institute of Medical Sciences campus,
Ponekkara, Kochi - 682041. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Parvathy Balachandran |
KTJM High School |
Edamattom, Edamattom P.O., Pala, Kottayam 686578
Kottayam
KERALA |
8129153947
parvathysree7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Amrita Institute of Medical Science |
Approved |
| Permission letter from School |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Educational intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational intervention |
The study involves an educational intervention for antibiotic awareness that will be undertaken among consenting school children from 8 th - 10th grade. The intervention will be delivered in three sessions over a period of 5 months (at baseline after pre-test, after 3 months and 5 months). |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All students (8th to 10th grade) enrolled in the selected school |
|
| ExclusionCriteria |
| Details |
1. Students who are unwilling to be a part of the study
2. Students whose parents do not give consent are also excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Knowledge, Attitude, and Behaviour (KAB) scores |
Baseline and after 5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "148"
Final Enrollment numbers achieved (India)="148" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/01/2022 |
| Date of Study Completion (India) |
26/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [venkitr2006@gmail.com].
- For how long will this data be available start date provided 01-09-2022 and end date provided 31-08-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This quasi-experimental study was designed to assess the effectiveness of a training program on the knowledge, attitude and behavior of antimicrobial resistance determinants among high school students (8th-10th grades) in Kerala. The primary outcome measured will be Knowledge Attitude and Behavior (KAB) scores of the study participants. Steps of the study are as follows:
1. Enrolment of the study population 2. Baseline assessment using KAB questionnaire 3. Intervention (educational module) delivered through three sessions including reinforcement at 3rd and 5th months 4. Follow-up assessment using KAB questionnaire after five months 5. Analysis
|