| CTRI Number |
CTRI/2023/10/058342 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of a mobile phone application to improve drug compliance in children with epilepsy. |
|
Scientific Title of Study
|
The feasibility & efficacy of a mobile phone application in improving medication adherence and seizure control in children with drug resistant epilepsy in a tertiary care hospital - A Pilot Randomised Controlled Trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Paras Tewari |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Pediatrics, Third floor, Academic block, AIIMS Jodhpur, 342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
7425991291 |
| Fax |
|
| Email |
parastewari12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lokesh Saini |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Pediatrics, Academic Block, Medical College Complex, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9968859725 |
| Fax |
|
| Email |
drlokeshsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Paras Tewari |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Pediatrics, Third Floor, Academic Block, Medical College building, AIIMS Jodhpur, 342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
7425991291 |
| Fax |
|
| Email |
parastewari12@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Jodhpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
All India Institute Of Medical Sciences, Basni Industrial Area Phase II, Jodhpur, 342005 |
| Type of Sponsor |
Government 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 |
| Dr Paras Tewari |
AIIMS, Jodhpur |
Department Of Pediatrics, Second Floor, AIIMS Jodhpur.
Jodhpur
RAJASTHAN |
7425991291
parastewari12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No use of any mobile phone application to ensure drug adherence |
The participants will not receive any mobile phone application to keep a track of their medication |
| Intervention |
Use of a mobile phone application |
Use of a customisable mobile phone application to be used on a daily basis by the guardians of the patient |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with Drug Resistant Epilepsy |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The feasibility & efficacy of a mobile phone application in improving medication adherence in children with drug-resistant epilepsy as assessed by the Morisky Green & Levine Adherence Scale (MGLS) and pill count method |
0 month
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The utility & efficacy of a mobile phone application in reduction of seizures burden in children with drug resistant epilepsy as assessed by the Early Childhood Epilepsy Severity Score |
0 month
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
20/10/2023 |
| 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="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
|
This trial is being conducted to compare the efficacy of a mobile phone application in improving drug compliance in patients with drug resistant epilepsy as compared to standard recall based drug delivery. It has been seen that the most common cause of breakthrough seizures has been non compliance and missing drug doses. We are going to be using a mobile phone Application by the name of epilepto which implements multiple alarms, calendars and reminders to ensure proper drug compliance. |