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CTRI Number  CTRI/2026/04/108523 [Registered on: 16/04/2026] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Hindi Version of a Heart Failure Quality of Life Questionnaire for Patients at AIIMS, New Delhi 
Scientific Title of Study   A Methodological study to translate and culturally adapt the chronic heart failure health-related quality of life questionnaire into Hindi, and to evaluate its psychometric properties among patients at AIIMS, New Delhi. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mona Gyadi 
Designation  Msc Nursing 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  PORTA CABIN, COLLEGE OF NURSING AIIMS NEW DELHI.

South
DELHI
110029
India 
Phone  9870116439  
Fax    
Email  gyadimona@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSmita Das  
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  2nd floor near old OT Block COLLEGE OF NURSING AIIMS NEW DELHI

South
DELHI
110029
India 
Phone  9871755975  
Fax    
Email  smitadas307@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mona Gyadi 
Designation  Msc Nursing 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  2nd floor near old OT Block COLLEGE OF NURSING AIIMS NEW DELHI

South
DELHI
110029
India 
Phone  9870116439  
Fax    
Email  gyadimona@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  self sponsored 
Address  pota cabin 2 college of Nursing AIIMS ,New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
Mona Gyadi  AIIMS ,NEW DELHI  Cardiology/Heart Failure OPD and inpatient wards at AIIMS, New Delhi.
South
DELHI 		 09870116439

gyadimona@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe for Post Graduate Research, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I50||Heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)clinically diagnosed CHF (any NYHA class), stable for at least 2 weeks (no acute decompensation)
2)Adults age more than 18 years
3)able to read or understand Hindi& communicate in Hindi.
 
 
ExclusionCriteria 
Details  1)Patient having cognitive impairment
severe hearing or communication barriers, acute critical illness
2)Unwilling to participate in the study
3)Patient having acute Decompensated Heart Failure
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To translate and culturally adapt the chronic heart failure health related quality of life questionnaire into Hindi.
2) To evaluate the reliability and validity of the Hindi version of Questionnaire among the patients with chronic Heart failure.
 		 single time point  
 
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)   15/06/2026 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 30-11-2027 and end date provided 19-07-2032?
    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 - nil
Brief Summary   Chronic heart failure (CHF) significantly affects patients’ physical, psychological, and social well-being, leading to poor health-related quality of life (HRQoL). Routine assessment of HRQoL is essential for comprehensive CHF management; however, most available questionnaires are developed in Western contexts and may not be culturally appropriate for Hindi-speaking patients in India. This methodological study aims to translate and culturally adapt the Chronic Heart Failure Health-Related Quality of Life Questionnaire (CHFQOLQ-20) into Hindi and evaluate its psychometric properties among patients attending AIIMS, New Delhi. A quantitative cross-sectional design will be used. The translation process will follow standardized guidelines, including forward and backward translation, expert review, and pretesting. Psychometric evaluation will include content validity, internal consistency, test–retest reliability, and construct validity. The study is expected to produce a reliable and culturally appropriate Hindi HRQoL tool for clinical and research use in chronic heart failure care. 
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