| CTRI Number |
CTRI/2024/01/061735 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
13/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Video based educational intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of video to increase the
knowledge and practice of reconstitution and storage of oral antibiotic suspensions among parents: A video based educational intervention |
|
Scientific Title of Study
|
Use of video to enhance knowledge and practice of reconstitution and storage of oral antibiotic suspensions among parents: A video based educational intervention |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Disha |
| Designation |
Student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
C/O Dr.Sahana D Acharya
Associate Professor
Department of Pharmacology
Kasturba Medical College, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
Dishaacharya7204@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sahana D Acharya |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Associate Professor
Department of Pharmacology
Kasturba Medical College, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448150876 |
| Fax |
|
| Email |
sahana.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sahana D Acharya |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Associate Professor
Department of Pharmacology
Kasturba Medical College, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448150876 |
| Fax |
|
| Email |
sahana.acharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Hospital, Mangalore |
|
|
Primary Sponsor
|
| Name |
Disha |
| Address |
Kasturba Medical College,
Light house hill road,
Hampankatta, Mangalore |
| 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 |
| DrSahana D Acharya |
Regional Advanced Paediatric care centre |
Paediatric ward,
Regional Advanced Paediatric care centre (RAPCC), government Wenlock Hospital, Hampankatta, Mangalore 575001
Dakshina Kannada
KARNATAKA |
9448150876
sahana.acharya@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Katurba Medical College Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy parent
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Standard, oral instruction for reconstitution will be given by the PI to all control group participants. No video will be shown to them. |
| Intervention |
Video based educational intervention |
The educational video of duration one minute on reconstitution & storage for the purpose of present study which will have stepwise demonstration with oral instructions regarding reconstitution and storage of the powder into suspension will be made in Kannada language by the paediatrician and reviewed by another. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Mothers of children 0-6 years who can communicate in Kannada language, mothers with educational level of Secondary school (10th standard) or below will be included. |
|
| ExclusionCriteria |
| Details |
Caregivers other than mother, mothers of children more than 6 years, mothers who cannot communicate in Kannada language, mothers with educational level above level of Secondary school (10th standard) will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge and practice of reconstitution, storage in mothers during the study |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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 3 |
|
Date of First Enrollment (India)
|
25/01/2024 |
| 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
|
Oral antibiotics for children are manufactured in powdered form and reconstituted into suspension before use. Parents knowledge & practice of reconstitution and storage of oral antibiotic suspensions plays a major role in adherence to atibiotic regimen prescribed to the child. In most mothers with limited education, it is difficult to understand the instructions merely from reading the packaging inserts present in the medication bottle. Educational video may help in this settings to improve administration of medication in children. |