| CTRI Number |
CTRI/2026/02/104619 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Game based cognitive training on Memory, Psychological well-being, Satisfaction with Aging, and Quality of Life Among Elderly Individuals. |
|
Scientific Title of Study
|
Effectiveness of Gamified Cognitive Enhancement Therapy on Cognitive Function Psychological Wellbeing Satisfaction with Aging and Quality of life Among Elderly Individuals |
| Trial Acronym |
GCET Elderly Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V N NANDHAKUMAR V NAVANEETHABALAKRISHNAN |
| Designation |
Professor and Head Department of Mental Health Nursing |
| Affiliation |
Al Shifa college of Nursing |
| Address |
lemon valley
AngadiPuram
perinthalmanna
Malappuram
679321
Department of Mental Health Nursing
lemon valley
Angadipuram perinthalmanna Malappuram
679321
Malappuram
KERALA
679321
India |
| Phone |
08086698504 |
| Fax |
04933224298 |
| Email |
vnnandhareddy1982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sara Sapharina |
| Designation |
Associate Professor Department of Psychiatric Nursing |
| Affiliation |
Sri Ramchandra College of Nursing |
| Address |
Sri Ramachandra College of Nursing
SRIHER DU
Porur
Chennai
Sri Ramachandra College of Nursing
SRIHER DU
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9894279745 |
| Fax |
04424767008 |
| Email |
sarajohn.g@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sara Sapharina G J |
| Designation |
Associate Professor Department of Psychiatric Nursing |
| Affiliation |
Sri Ramachandra Chandra College of Nursing |
| Address |
Sri Ramachandra Chandra College of Nursing
SRIHER DU
Porur
Chennai
Sri Ramachandra Chandra College of Nursing
SRIHER DU
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
08086698504 |
| Fax |
04424767008 |
| Email |
sarajohn.g@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| self funded by the investigator (PhD Scholar) infrastructure and institutional support are provided by AlShifa College of Nursing Perinthalmanna |
|
|
Primary Sponsor
|
| Name |
AlShifa College of Nursing |
| Address |
Department of Nursing
AlShifa College of Nursing
lemonvalley
Angadipuram
perinthalmanna
malappuram 679321 |
| Type of Sponsor |
Other [Private Nursing 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 V N Nandhakumar |
AlShifa Colege of Nursing |
Nursing Department
lemon valley
angadipuram perinthalmanna
Malappuram
KERALA |
04933228000
04933224298
alshifansg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee Alshifa college of Nursing perinthalmanna kerala India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild cognitive Decline associated with normal aging |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gamified Cognitive Enhancement Therapy |
Gamified Cognitive Enhancement Therapy is a structured cognitive training program consisting of memory exercises attention training executive function tasks and problem solving activities Each session will last approximately 45 to 60 minutes this will be conducted in a supervised group setting |
| Comparator Agent |
Routine cognitive Activities |
Participants in the comparator group will receive routine care and usual cognitive activities available at the institution |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.individual ale to read and understand malayalam
2.Mild cognitive impairment
3.Willing to Participate
4.Residing in selected community |
|
| ExclusionCriteria |
| Details |
1.Severe cognitive impairment
2.Unwilling to Participate
3.Hearing and Visual impairment
4.Neurological & Medical illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the Cognitive function as measured by Montreal Cognitive Assessment Score |
Baseline and eight weeks intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| psychological wellbeing satisfaction with aging and quality of life among elderly individuals |
outcomes will be measured at bsaeline and immediately post intervention |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
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 randomized controlled trial aims to evaluate the effectiveness of Gamified Cognitive Enhancement Therapy ( GCET ) on cognitive function psychological wellbeing satisfaction with aging and quality of life among elderly individuals A total of 120 participants will be randomly allocated into experimental and control groups The experimental group will receive structured gamified cognitive intervention while the control group will receive routine care Pre and post intervention assessments will be conducted using standardized tools to determine the effectiveness of the program |