| CTRI Number |
CTRI/2021/05/033872 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
18/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Do school principals write good quality referral letters for students who need assessment for not performing well in school? |
|
Scientific Title of Study
|
An Audit of Quality of Referral Letters written by School Principals for Students having Poor School Performance |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Karande |
| Designation |
Professor of Pediatrics |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pediatrics
Seth GS Medical College and KEM Hospital
Department of Pediatrics
Seth GS Medical College and KEM Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9322934309 |
| Fax |
912224112871 |
| Email |
sunilkarande@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Karande |
| Designation |
Professor of Pediatrics |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pediatrics
Seth GS Medical College and KEM Hospital
Department of Pediatrics
Seth GS Medical College and KEM Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9322934309 |
| Fax |
912224112871 |
| Email |
sunilkarande@kem.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rajiv Darsi |
| Designation |
Postgraduate Student |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pediatrics
Seth GS Medical College and KEM Hospital
Department of Pediatrics
Seth GS Medical College and KEM Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9640540778 |
| Fax |
912224112871 |
| Email |
rajiv.darsi@gmail.com |
|
|
Source of Monetary or Material Support
|
| KEM Hospital
Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
KEM Hospital |
| Address |
Department of Pediatrics
Seth GS Medical College and KEM Hospital Parel Mumbai 400012 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Karande |
KEM Hospital |
Department of Pediatrics
Seth GS Medical College and KEM Hospital
Mumbai
MAHARASHTRA |
9322934309
sunilkarande@kem.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee III Seth GS Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All school children referred to Learning Disability clinic from January 2018 to January 2021 for assessment of poor school performance shall be included
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the lacunae in referral letters written by school principals for students having poor school performance using a validated check list |
At 18 months when the study is completed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the sociodemographic profile of students and types of schools who refer students with poor school performance |
At 18 months when the study is completed |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1069" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/06/2021 |
| Date of Study Completion (India) |
31/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The research study will be published after its completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is a retrospective descriptive study comprising of data already collected over a period of three years. Referral letters and Case Record forms of all school children referred to Learning Disability clinic from January 2018 to January 2021 for
assessment of poor school performance shall be analyzed. Content analysis of each Referral Letter will be done using validated check list to assess its quality. Concordance of referral letter with final diagnosis of poor school performance of each student will be assessed. |