| CTRI Number |
CTRI/2020/06/025531 [Registered on: 02/06/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Which one is a better method of teaching-providing digital educational material or interacting through a virtual medium (video call or telephonically) to improve knowledge regarding epilepsy? |
Scientific Title of Study
Modification(s)
|
Impact of virtual interactive epilepsy education versus digital educational material in people with epilepsy and their caregivers: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raunak Sepat |
| Designation |
M. Sc. Nursing Student |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
College of Nursing, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8570925597 |
| Fax |
|
| Email |
raunaksepat58@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi P Sinha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9899607076 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi P Sinha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 4, Porta Cabin, 2nd Floor, College of Nursing, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9899607076 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Raunak Sepat |
| Address |
Room No. N-302, Medha Hostel, Hostel no. 15, Masjid Moth, AIIMS, New Delhi |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| Raunak Sepat |
AIIMS Hospital, New Delhi |
Neurology OPD, Neurosciences centre, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI |
1126594656
raunaksepat58@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Epilepsy |
| Patients |
(1) ICD-10 Condition: G40||Epilepsy and recurrent seizures, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Digital educational material |
Providing digital epilepsy educational material alone and the participants will be requested to go through it. (Control arm) |
| Intervention |
virtual interactive epilepsy education |
Providing digital epilepsy educational material along with a virtual interactive training session either through a video call or telephonically. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
People with epilepsy (PWE) who have been in the follow-up for at least 6 months
PWE aged more than 18 years.
Caregivers who are staying with PWE for at least 1 month and are directly involved in care.
Smart phone users
Able to understand Hindi or English
|
|
| ExclusionCriteria |
| Details |
Not using smart phones
Unwilling to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Knowledge regarding epilepsy including first aid management of seizures and medication compliance as assessed by a self developed structured questionnaire |
Pre intervention, immediate post intervention |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Breakthrough seizures
Quality of life |
1 month after intervention |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
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)
Modification(s)
|
25/09/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A study to assess the impact of virtual interactive epilepsy education in people with epilepsy and their caregivers is undertaken by the researcher which is a randomized controlled trial. Participants will be randomly assigned either to the control arm (receiving digital educational material) or the experimental arm (receiving digital educational material plus virtual interactive epilepsy education). A pre- test will be taken before the intervention by a self- developed structured questionnaire, virtually, either in google forms format or telephonically. The control group will then receive digital educational material and they will be requested to go through it. In the intervention arm, participants will be receiving digital educational material and a 10 minutes session on information regarding epilepsy through a video call or telephonically which will be delivered by the researcher. The participants will also be taught how to maintain a seizure diary. Post- test will be taken after the intervention in both the groups with the help of self-developed structured questionnaire, virtually, either in google forms format or telephonically. After 15 days, a telephonic reinforcement will be given regarding maintaining the seizure diary and to ask for any problems encountered during this period. A one month follow up, telephonically, will be done focussing on breakthrough seizures and quality of life which will be assessed with the help of seizure diary and quality of life scale (QOLIE-31). The comparison between the two interventions will be done to see the impact that each intervention is having. |