| CTRI Number |
CTRI/2024/09/073485 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cognitive Functions and Quality Of Life among Elderly Population |
|
Scientific Title of Study
|
Relationship between Metacognition, Cognitive Reserve and Quality Of Life in Elderly Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ancilla Thomas |
| Designation |
MSc Clinical Psychology Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, MAHE, Manipal, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9677806775 |
| Fax |
|
| Email |
ancilla.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyesh C |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, MAHE, Manipal, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9538752702 |
| Fax |
|
| Email |
c.priyesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishalee S |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, MAHE, Manipal, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9488615322 |
| Fax |
|
| Email |
vaishalee.s@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE, Manipal, Karnataka- 576104 India |
|
|
Primary Sponsor
|
| Name |
Ancilla Thomas |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, MAHE, Manipal, Karnataka- 576104 |
| 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 |
| Ancilla Thomas |
Kasturba Hospital, Manipal |
Department of Clinical
Psychology
Udupi
KARNATAKA |
9677806775
ancilla.mchpmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Participants need to have basis level of English proficiency |
|
| ExclusionCriteria |
| Details |
1. Individuals diagnosed with Nerurodegenerative disorders
2. Individuals diagnosed with psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify the relationship between Metacognition, Cognitive Reserve and Quality of Life in Elderly population. Using,
1. Cognitive Reserve Index questionnaire (CRIq)
2. The Metacognition self-assessment scale 18 (MSAS 18)
3. Control, Autonomy, Self-Realization and Pleasure (CASP-19) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cognitive Reserve and Metacognition as predictors of Quality of Life |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
14/09/2024 |
| 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="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
|
Aim of the study: To assess the level and nature of relationship between Metacognition, Cognitive Reserve and Quality of Life in Elderly population
Primary Objective: To identify the relationship between Metacognition, Cognitive Reserve and Quality of Life in Elderly population Secondary Objective: Cognitive Reserve and Metacognition as predictors of Quality of Life in Elderly population
The study duration is from March 2024 to March 2025.
|