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CTRI Number  CTRI/2024/02/062514 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Establishing the psychometric properties of the Fall-related Knowledge, Attitude and Practices Questionnaire for older adults 
Scientific Title of Study   Establishing the psychometric properties of the Fall-related Knowledge, Attitude and Practices Questionnaire for older adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sebestina Anita Dsouza 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education
N1, Department of Occupational Therapy, Kasturba Hospital, Manipal, 576104
Udupi
KARNATAKA
576104
India 
Phone  09448152143  
Fax    
Email  sebestina.dsouza@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Sebestina Anita Dsouza 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education
N1, Department of Occupational Therapy, Kasturba Hospital, Manipal, 576104
Udupi
KARNATAKA
576104
India 
Phone  09448152143  
Fax    
Email  sebestina.dsouza@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Sebestina Anita Dsouza 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education
N1, Department of Occupational Therapy, Kasturba Hospital, Manipal, 576104
Udupi
KARNATAKA
576104
India 
Phone  09448152143  
Fax    
Email  sebestina.dsouza@manipal.edu  
 
Source of Monetary or Material Support  
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi 
 
Primary Sponsor  
Name  Dr Sebestina Anita Dsouza 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi 
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 Sebestina Anita Dsouza  Kasturba Hospital  Department of Occupational Therapy, N1
Udupi
KARNATAKA 		 9448152143

sebestina.dsouza@manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  older adults aged 60 years and above 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Individuals aged 60 years and above
2. Education level- 10th grade and above
3. Can ambulate with or without a mobility aid
4. Able to read and understand English or Kannada language. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fall-related Knowledge, Attitudes and Practices  0, 15-21 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   16/02/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  
The study aims to establish the psychometric properties of the Fall-related Knowledge, Attitude, and Practice Questionnaire (Fall- KAP). The objectives are to 1. To determine the construct validity of the Fall- KAP questionnaire
2. To determine the reliability (test-retest and internal consistency) of the Fall- KAP questionnaire. 3. To compare regional variations in fall-related knowledge, attitudes and practices among older adults in India. 
Convenience sampling will be used to recruit participants at the approved study sites (Udupi, Mangalore, Bangalore, Cochin, Chennai, Mumbai, Goa). Individuals willing to participate will be explained about the study, PIS will be given, and written informed consent will be obtained. The data will be gathered via paper-based or online questionnaire The Fall-KAP questionnaire (online and paper-based) takes approximately 20 minutes. The participants will be given sufficient time to complete the questionnaire. The questionnaire will be re-administered to some participants (n=81) after 15 - 21 days for test-retest reliability. The present study will also include the Fall-KAP questionnaire and demographic data of participants from an ongoing study (IEC:416/2021). The data analysis will be done on meeting the sample size.
 
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