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CTRI Number  CTRI/2024/02/062352 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 02/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Mixed methods before- after quasi-experimental study.]  
Study Design  Other 
Public Title of Study   Epilepsy Smart Schools in India 
Scientific Title of Study   Tele-school health led Epilepsy Smart Schools in India: An Implementation Initiative with Mixed Methods Assessment (Tele_ESSI). 
Trial Acronym  Tele_ESSI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sulena  
Designation  Professor 
Affiliation  Guru Gobind Singh Medical College and Hospital 
Address  Division of Neurology Guru Gobind Singh Medical College and Hospita Sadiq Road

Faridkot
PUNJAB
151203
India 
Phone  7087907025  
Fax    
Email  sulenasingh@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Sulena  
Designation  Professor 
Affiliation  Guru Gobind Singh Medical College and Hospital 
Address  Division of Neurology Guru Gobind Singh Medical College and Hospita Sadiq Road


PUNJAB
151203
India 
Phone  7087907025  
Fax    
Email  sulenasingh@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Sulena  
Designation  Professor 
Affiliation  Guru Gobind Singh Medical College and Hospital 
Address  Division of Neurology Guru Gobind Singh Medical College and Hospita Sadiq Road


PUNJAB
151203
India 
Phone  7087907025  
Fax    
Email  sulenasingh@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi 
 
Primary Sponsor  
Name  Director General , Indian Council of Medical Research 
Address  Indian Council of Medical Research, New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shikha Jain  All India Institute of Medical Sciences  Plot No. 2, Sector - 20, MIHAN
Nagpur
MAHARASHTRA 		 7024134309

dr.shikhajain@aiimsnagpur.edu.in 
Dr Gagandeep Singh  Dayananad Medical College and Hospital  Second Floor, Neurology Office, Department of Neurology
Ludhiana
PUNJAB 		 9815500720

g.singh@ucl.ac.uk 
Dr Marami Das  Gauhati Medical CollegE  1ST Floor, Neurology Faculty Block, Cardiothoracic & Neuroscience Centre.
Kamrup
ASSAM 		 9954742007

moromi13das@yahoo.co.in 
Dr Sulena  Guru Gobind Singh Medical College and Hospital  Room no.11, OPD Block, Division of Neurology
Faridkot
PUNJAB 		 7087907025

sulenasingh@yahoo.co.in 
Dr Jitendra Kumar Sahu  Postgraduate Institute of Medical Education & Research  Room 5108, 5A, Advanced Pediatric Center
Chandigarh
CHANDIGARH 		 6239341620

jsh2003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
GURU GOBING SINGH MEDICAL COLLEGE,FARIDKOT ,PUNJAB  Approved 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
INSTITUTITIONAL ETHICS COMMITTEE  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary Health Care Providers, School Teachers, Supporting staff and Authorities and Parents of Children with Epilepsy. 
Patients  (1) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes, (2) ICD-10 Condition: G400||Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, (3) ICD-10 Condition: G402||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, (4) ICD-10 Condition: G40A||Absence epileptic syndrome, (5) ICD-10 Condition: G40B||Juvenile myoclonic epilepsy [impulsive petit mal], (6) ICD-10 Condition: G404||Other generalized epilepsy and epileptic syndromes, (7) ICD-10 Condition: G409||Epilepsy, unspecified, (8) ICD-10 Condition: G401||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, (9) ICD-10 Condition: G405||Epileptic seizures related to external causes, (10) ICD-10 Condition: G408||Other epilepsy and recurrent seizures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil This is a Quasi-experimental before and after study. So, there is no comparator agent. 
Intervention  Tele-school health led Epilepsy Smart Schools in India (Tele_ESSI).  Tele-school health led Epilepsy Smart Schools in India (Tele_ESSI) for one year (12 months). 
 
Inclusion Criteria  
Age From  24.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  School children of India in government schools  
 
ExclusionCriteria 
Details  School children of India not studying in government schools  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Health Outcomes :
i. Occurrence and incidence of epileptic seizures during school hours.
ii. Seizure Control and Quality of Life
iii. Number of Injuries and accidents related to seizures.
iv. Improved management of comorbidities
2. Education-related
i. Scholastic Performance of children with epilepsy in schools.
ii. School dropout rate.
3. Acceptability
i. Improvement in Knowledge, Attitude and Practices of stakeholders.
ii. Cost-effectiveness of the intervention model.
 		 12 months after the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. To document the occurrence and incidence of epileptic seizures during school hours.
2. To assess the feasibility, acceptability and adoptability of the school-based tele-intervention among school personnel, primary health care providers and parents of children with epilepsy.
3. To assess baseline Knowledge, Attitude and Practices (KAP) regarding epilepsy among school personnel, primary health care providers and parents of children with epilepsy.
4. To determine the impact of the intervention on KAP and a range of outcomes (Seizure control, adherence, quality of life, injuries and accidents, educational outcomes) for children with epilepsy.
5. To determine the cost implications of the initiative.
 		 24 and 36 months  
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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 4 
Date of First Enrollment (India)   10/02/2024 
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="3"
Months="0"
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  


       Study design: Mixed methods before- after quasi-experimental study.

        The research protocol will be undertaken in two stages:

Stage 1 with an observational design to estimate the occurrence and incidence of epileptic seizures during school hours through tele-school health initiatives in three nationwide districts.

Stage 2 with a hybrid interventional-implementation design comprising a school-based, before-after quasi-experimental study of Tele-school health-led Epilepsy Smart Schools in India (Tele_ESSI) Model to improve coverage and management of epilepsy in the schools in three nationwide districts.

 
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