| CTRI Number |
CTRI/2022/08/044785 [Registered on: 22/08/2022] Trial Registered Prospectively |
| Last Modified On: |
05/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of an educational video on young aged adults cognitive health beliefs |
|
Scientific Title of Study
|
Efficacy of an educational video on beliefs of young aged adults about cognitive health |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Shetty |
| Designation |
Post graduate student |
| Affiliation |
Kasturba Medical College , Mangalore |
| Address |
Department of Audiology and Speech Language Pathology, 5th floor, Kasturba Medical College hospital, Attavar, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9632074831 |
| Fax |
|
| Email |
shreyashetty9812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gagan Bajaj |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College , Mangalore |
| Address |
Department of Audiology and Speech Language Pathology, 5th floor, Kasturba Medical College hospital, Attavar, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8368038336 |
| Fax |
|
| Email |
gagan.bajaj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gagan Bajaj |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College , Mangalore |
| Address |
Department of Audiology and Speech Language Pathology, 5th floor, Kasturba Medical College hospital, Attavar, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8368038336 |
| Fax |
|
| Email |
gagan.bajaj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Attavar 575001 |
|
|
Primary Sponsor
|
| Name |
Shreya Shetty |
| Address |
Department of Audiology and Speech Language Pathology, Kasturba Medical College hospital, Attavar, Mangalore 575001 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Shreya Shetty |
Kasturba Medical College, Attavar |
Department of Audiology and Speech Language Pathology, 5th floor, Kasturba Medical College hospital, Attavar, Mangalore 575001
Dakshina Kannada
KARNATAKA |
9632074831
shreyashetty9812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy aging adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active control group |
Non-educational video will be shown once for a duration of 30 mins |
| Intervention |
Educational intervention |
Educational video will be shown once for a duration of 30 mins |
| Comparator Agent |
Passive control group |
No video |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1) College going young-aged (18-25years), according to MIT Young Adult Development Program
2) Minimum qualification of 12th grade with English as the medium of instruction
3) Young-aged adults from non-health background
4) Normal or corrected vision and/or hearing
|
|
| ExclusionCriteria |
| Details |
1) History or complaints of any neurological disorder
2) History or complaints of any psychiatric or psychological disorder
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in knowledge and attitude of participants towards cognitive health |
Baseline, 1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in practices of participants towards cognitive health |
1 month |
|
|
Target Sample Size
|
Total Sample Size="261"
Sample Size from India="261"
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)
|
01/09/2022 |
| 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="23"
Months="2"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a randomized control trial, to assess the efficacy of the developed educational video on beliefs of young aged adults about cognitive health. The study will be done on 261 young aged adults . The primary outcome measure will be to examine the efficacy of the developed video in changing the knowledge and attitude of young aged adults towards cognitive health immediately after educational intervention. The secondary outcome measure will be to examine the efficacy of developed video in changing cognitive practices of young aged adults at 1 month after the educational intervention. |