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CTRI Number  CTRI/2024/03/064664 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 25/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Adapting and validating diabetes quality of life questionnaire in hindi: A cultural perspective from India 
Scientific Title of Study   Cross-cultural adaptation, translation and psychometric evaluation of the diabetes quality of life questionnaire in hindi, India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B-319, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida,

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandan Kumar 
Designation  Professor 
Affiliation  Galgotias University 
Address  Room No B-319, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida,

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7773923831  
Fax    
Email  chandankumar@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B-319, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida,

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell, Galgotias University 
 
Primary Sponsor  
Name  Galgotias University 
Address  Room No A315,Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Yamuna Expy, opposite Buddha International circuit, Greater Noida Uttar Pradesh 203201 
Type of Sponsor  Research institution 
 
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 Mohammad Sidiq  Galgotias University  Plot No 2, Sector 17A, Opposite Gautam Buddha International Circuit, Yamuna expressway
Gautam Buddha Nagar
UTTAR PRADESH 		 6006204628

sidufatima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Ethics Commitee, Galgotias Univerity  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not Applicable  NIL 
Comparator Agent  Not Applicable  Nill 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals diagnosed with diabetes residing in Hindi-speaking regions of India.
2. Fluent in Hindi language.
3. Willingness to participate in the study and provide informed consent.
4. Stable physical and mental health status.

 
 
ExclusionCriteria 
Details  1. Individuals with cognitive impairments affecting their ability to comprehend and respond to the questionnaire.
2. Non-Hindi speakers or those with limited proficiency in the Hindi language.
3. Patients with severe comorbidities or complications that may significantly impact their quality of life assessment.
4. Participants currently undergoing major treatment changes or interventions for diabetes.
5. Unwillingness or inability to commit to the study requirements, including follow-up assessments and data collection. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SF 36 for Quality of life
Diabetes Quality of Life questionnaire Hindi version
 		 Basline
48 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="225" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/03/2024 
Date of Study Completion (India) 10/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sidufatima@gmail.com].

  6. For how long will this data be available start date provided 30-04-2024 and end date provided 25-03-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary  
The study involves the cross-cultural adaptation, translation, and validation of the Diabetes Quality of Life Questionnaire (DQOL) in Hindi for use in India. Recognizing the importance of cultural relevance in healthcare assessments, the researchers aim to ensure that the DQOL effectively captures the unique experiences and perspectives of individuals with diabetes in the Indian context. The adaptation process will involve linguistic translation and cultural adaptation to maintain the questionnaire’s conceptual equivalence while accounting for linguistic and cultural differences as described by Beaton Guidelines 2000.

A rigorous validation process will be employed to assess the psychometric properties and reliability of the translated questionnaire. This includes testing the questionnaire on a sample of individuals with diabetes in Hindi-speaking regions of India and analyzing the results to ensure the instrument’s validity and reliability. The study aims to contribute to the field of health research by providing a culturally adapted and validated tool for assessing the quality of life in individuals with diabetes in Hindi-speaking populations, facilitating more accurate and culturally sensitive healthcare evaluations in the context of diabetes management in India.
 
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