| CTRI Number |
CTRI/2024/08/072796 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [change in quality of life of patients if an evidence based checklist is used in follow up care] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of an evidence based checklist in follow up care of epilepsy patients and its effect on quality of life. |
|
Scientific Title of Study
|
Comparing outcomes of epilepsy patient follow-up care with and without a checklist – A randomised control 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 |
Dr. Vaibhav Bhandari |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
7th floor, Department of neurology, Cardiothoracic and Neuroscience Centre, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9930265650 |
| Fax |
|
| Email |
drvaibhavb96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Bhushan Singh |
| Designation |
professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of neurology, Cardiothoracic and Neuroscience Centre, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8929042755 |
| Fax |
|
| Email |
mbsneuro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Bhushan Singh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of neurology, Cardiothoracic and Neuroscience Centre, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8929042755 |
| Fax |
|
| Email |
mbsneuro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurology, Cardiothoracic and Neuroscience Centre, All India Institute of Medical Sciences, New Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Vaibhav Bhandari |
| Address |
Department of Neurology, Cardiothoracic and Neuroscience Centre, All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Other [self sponsership] |
|
|
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 vaibhav bhandari |
All India Institute of Medical Sciences New Delhi |
department of neurology, cardiothoracic and neuroscience centre,All India Institute of Medical Sciences New Delhi
South
DELHI |
9930265650
drvaibhavb96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee for post graduate research , all india institute of medical sciences, ansari nagar , new delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evidence based checklist |
A tool used in wholesome care of epilepsy patient follow up.
It will be used at the time of registering patient into trial. It will be used once only at the time of registering patient. Quality of life will be checked at baseline and after 1 year by QOLIE-31 scale. |
| Comparator Agent |
regular follow up in opd |
There will be no tool/checklist used in this arm. Patient will be followed up similarly like intervention arm and quality of life will be assessed by QOLIE-31 at baseline and at the end of 1 year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
a. People with epilepsy more than or equal to 18 years coming to neurology OPD, AIIMS, Delhi
b. Follow up more than 1 year in AIIMS OPD, all subtypes of epilepsy and seizure as defined by ILAE
c. Provide consent |
|
| ExclusionCriteria |
| Details |
a. Less than 18 years of age
b. Refusal to consent
c. Newly diagnosed epilepsy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of change in quality of life by QOLIE-31 scale. |
Assessment will be done at baseline, before using checklist and after 1 year of follow up. QOLIE 31 after 1 year will be compared from baseline as well as from control arm. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of change in seizure frequency from baseline as well as comparison from control arm after using checklist.
• Assessment of change in seizure severity by National Hospital Seizure Severity Score (NHS3) from baseline as well as comparison from control arm after using checklist.
• Assessment of early identification & treatment of adverse drug reaction by subscale score of QOLIE-31
• Assessment of early identification of cognitive function by subscale score of QOLIE-31. |
all points mentioned above will be checked at baseline & after 1 year of follow up. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In our study, we are going to use evidence-based checklist and outcome will be measured by 5 domains of COME-ILAE on follow up in a randomized control trial. This study will help in validation and observing outcome in form of improvement in quality of life primarily by use of evidence-based checklist. |