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CTRI Number  CTRI/2025/08/092330 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Making changes to the Cognitive Reserve Index Questionnaire and checking if it works well for elderly people 
Scientific Title of Study   Adaptation And Validation Of Cognitive Reserve Index Questionnaire 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  Rithika M Salian 
Designation  Post graduate Student 
Affiliation  MCHP MAHE 
Address  Department of Speech and Hearing, MCHP, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7411131399  
Fax    
Email  rithika1.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Hari Prakash P 
Designation  Associate Professor 
Affiliation  MCHP MAHE 
Address  Dept. Of Speech & Hearing, MCHP, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  919886135522  
Fax    
Email  hari.prakash@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Hari Prakash P 
Designation  Associate Professor 
Affiliation  MCHP MAHE 
Address  Dept. Of Speech & Hearing, MCHP, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  919886135522  
Fax    
Email  hari.prakash@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, Manipal 576104 Karnataka India 
 
Primary Sponsor  
Name  Rithika M Salian 
Address  Department Of Speech & Hearing, MCHP, MAHE, Manipal 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hari Prakash P  Kasturba Hospital  Room No. 307, research lab, Department of Speech and Hearing, MAHE Manipal, 576104 Karnataka, India
Udupi
KARNATAKA 		 9886135522

hari.prakash@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  aged above 60 years 
Patients  (1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Individuals aged above 60 years.
Proficient in Kannada (who can read and write in Kannada language).
Individuals with or without hearing loss (based on self-reported measures)
 
 
ExclusionCriteria 
Details  Individuals diagnosed with severe neurological issues, cognitive decline (such as Alzheimers disease).
Individuals diagnosed with known psychological issues.
Individuals with Restricted physical activity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cognitive reserve index questionnaire—to assess cognitive reserve.
MoCA—To determine the convergent validity.
The global physical activity questionnaire—to assess the divergent validity
 		 once at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   18/08/2025 
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  

Phase 1: Adaptation of CRIQ into Indian English and Kannada

The Cognitive Reserve Index Questionnaire (CRIQ) will be adapted and translated into Indian English and Kannada, following Hall et al. (2018) guidelines. Permission to use and translate the questionnaire is obtained beforehand.

  1. Forward Translation: Two independent translators (fluent in the target language) will each translate the questionnaire. Their versions will be combined into one by another independent translator.

  2. Back Translation: A new bilingual translator will translate the combined version back into the original language. This version will be checked by another expert to ensure it matches the original.

  3. Committee Review: A panel of experts (including a psychologist, linguist, audiologists, and speech-language pathologist) will review the translations for accuracy, cultural relevance, and clarity. Problematic items will be discussed and, if needed, referred back to the original questionnaire developers.

  4. Content Validation: Five healthcare professionals will rate each item for relevance using a 5-point scale. A Content Validation Index will be calculated to measure the questionnaire’s clarity, cultural appropriateness, and relevance.

  5. Cognitive Debriefing: The translated questionnaire will be tested with five elderly individuals. They will explain each item in their own words to ensure they understand the content.

  6. Final Review: Results from the field test will be reviewed, and the questionnaire will be proofread and finalized. All documentation will be shared with the original questionnaire creator.

Phase 2: Validation with Elderly Population

The final questionnaire will be tested on elderly individuals from local communities, such as parks and community centers. Participants who meet the criteria will provide written consent. The investigator will then explain the questionnaire and scoring method before administering it.

 
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