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CTRI Number  CTRI/2025/03/082138 [Registered on: 11/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Tamil version of Diabetes quality of life questionnaire 
Scientific Title of Study   Cross cultural adaptation, translation, and psychometric analysis of Diabetes quality of life questionnaire(Diabetes QoL-Q) in Tamil language, 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  T.S.Veeragoudhaman 
Designation  Dean 
Affiliation  SRM College of Physiotherapy,Faculty of Medicine and Health Sciences,SRM Institute of Science and technology 
Address  Room No: PT 01,Dean Office,V Floor,SRM College of Physiotherapy,SRM Medical College building,SRM Institute of Science and Technology, Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9500375408  
Fax    
Email  veera5vikashini@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vinitha Arasu 
Designation  Physiotherapist 
Affiliation  SRM Institute of Science and technology 
Address  Room No:PT 22,SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur

Kancheepuram
TAMIL NADU
603 203
India 
Phone  8637488187  
Fax    
Email  vinithabks@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vinitha Arasu 
Designation  Physiotherapist 
Affiliation  SRM Institute of Science and technology 
Address  Room No:PT 22,SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur

Kancheepuram
TAMIL NADU
603 203
India 
Phone  8637488187  
Fax    
Email  vinithabks@gmail.com  
 
Source of Monetary or Material Support  
SRM College of Physiotehrapy,SRM Institute of science and technology,Kattankulathur,Tamil Nadu,India -603203 
 
Primary Sponsor  
Name  Prof.T.S.Veeragoudhaman 
Address  Dean Office, V Floor, SRM College of Physiotherapy,SRM Medical College Building, SRM Institute of Science and Technology, Kattankulathur -603 203 
Type of Sponsor  Other [Self funded] 
 
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 
DrTSVeeragoudhaman  SRM Institute of science and technology  Room no:05,Ground floor, General medicine outpatient unit, SRM Medical College Hospital and Research Centre,SRM Institute of Science and Technology,Kattankulathur 603 203
Kancheepuram
TAMIL NADU 		 9500375408

veera5vikashini@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable as it is a observational study   Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Participants should be native Tamil speakers or individuals fluent in Tamil, adults aged 18 years and above, both type I and Type II diabetes, those who is willing to participate in the study. 
 
ExclusionCriteria 
Details  Individuals with cognitive impairment, hearing impairment, visual impairment, physically challenged individuals and pregnant mothers.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Self reported quality of life using Diabetes quality of life questionnaire  Baseline and 2 weeks test retest reliability 
 
Secondary Outcome  
Outcome  TimePoints 
Self reported general health measured by SF 36questionnaire  Baseline & 2 weeks test retest reliability 
 
Target Sample Size   Total Sample Size="322"
Sample Size from India="322" 
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)   01/05/2025 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

1. Introduction

The purpose of this protocol is to outline the steps involved in the cross-cultural adaptation, translation, and psychometric analysis of the Diabetes Quality of life questionnaire (Diabetes QoL-Q) in Tamil language. The Diabetes QoL-Q (46 items) is a health related quality of life questionnaire widely used among diabetes population, which has been translated into different languages. Adapting and translating the Diabetes QoL- Q into Tamil language will enable its use in Tamil -speaking populations, ensuring cultural appropriateness and validity. The researchers hope to capture the distinctive experiences and opinions of individuals with diabetes in India using culturally relevant healthcare assessments.

2. Cross-Cultural Adaptation Process

The cross-cultural adaptation process involves the following steps:

Step 1: Permission and Collaboration

Obtain permission from the original developers of the Diabetes QoL-Q to proceed with the adaptation process. Seek collaboration from experts in diabetes related research and Tamil language specialists.

Step 2: Translation

Engage bilingual translators proficient in English and Tamil to independently translate the original Diabetes QoL-Q into Tamil language. Aim for two or more independent translations to ensure multiple perspectives.

Step 3: Synthesis

Form a committee consisting of translators, experts, and a methodologist. Review the independent translations and compare them to identify discrepancies and areas of disagreement. Develop a consensus version of the translated Diabetes QoL-Q through discussion and consensus among the committee members.

Step 4: Back-Translation

Engage bilingual translators who are native English speakers and are fluent in Tamil. Provide them with the consensus version of the translated QoL-Q Diabetes and instruct them to independently back-translate it into English.

Step 5: Expert Committee Review

Convene the expert committee to review the back-translated English version in comparison to the original QoL- Q Diabetes. Identify any discrepancies and discuss potential cultural and linguistic differences.

Step 6: Pretesting

Administer the pre-final version of the translated Diabetes QoL-Q to a sample of the target population (Tamil-speaking individuals). Collect feedback on comprehension, cultural relevance, and clarity of the items. Modify the translated Diabetes QoL-Q based on the feedback received.


3. Psychometric Analysis

Once the adapted and translated Diabetes QoL- Q is finalized, it is important to assess its psychometric properties to ensure validity and reliability. This involves the following steps:

Step 1: Sampling

Determine the desired sample size based on statistical considerations. Aim for a representative sample of Tamil-speaking individuals across different age groups, genders, and both type I and type II diabetes patients.

Step 2: Data Collection

Administer the finalized Tamil version of the Diabetes QoL-Q to the selected sample. Collect demographic information and ensure standardized procedures for data collection to minimize bias.

Step 3: Reliability Analysis

Assess the internal consistency reliability of the Tamil Diabetes QoL-Q using statistical methods such as Cronbach’s alpha. This analysis measures the extent to which items in the Diabetes QoL-Q are interrelated.

Step 4: Construct Validity Analysis

Evaluate the construct validity of the Tamil Diabetes QoL-Q by assessing its correlation with other established diabetes related measures or clinical assessments. Use appropriate statistical techniques such as correlation coefficients or factor analysis.

Step 5: Test-Retest Reliability

Assess the test-retest reliability of the Tamil Diabetes QoL-Q by re-administering the questionnaire to a subsample of participants after a specified interval. Calculate the intra class correlation coefficient (ICC) to determine the degree of agreement between the two administrations.

Step 6: Cultural Adaptation Report

Prepare a comprehensive report summarizing the cross-cultural adaptation process, translation procedure, and psychometric analysis results. Include recommendations for the use of the Tamil Diabetes QoL-Q in research and clinical practice.


4. Conclusion

This protocol outlines the steps involved in the cross-cultural adaptation, translation, and psychometric analysis of the Diabetes Quality of life questionnaire (Diabetes QoL- Q) in Tamil. Adapting and validating the Diabetes QoL-Q in Tamil will enable its accurate assessment of quality of life and related to their treatment among Tamil-speaking individuals, contributing to more culturally sensitive research and healthcare practices.

 

 

 
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