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CTRI Number  CTRI/2021/02/031192 [Registered on: 10/02/2021] Trial Registered Prospectively
Last Modified On: 27/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Quality of life of people with hemophilia 
Scientific Title of Study   Quantitative and qualitative analysis of quality of life (QOL) of people with hemophilia in an Indian Setting 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreejith Govindan 
Designation  Associate Professor 
Affiliation  MAHE 
Address  Department of Microbiology Melaka Manipal Medical College,Manipal Manipal Academy of Higher Education (MAHE)

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  g.sreejith@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Sreejith Govindan 
Designation  Associate Professor 
Affiliation  MAHE 
Address  Department of Microbiology Melaka Manipal Medical College,Manipal Manipal Academy of Higher Education (MAHE)


KARNATAKA
576104
India 
Phone    
Fax    
Email  g.sreejith@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Sreejith Govindan 
Designation  Associate Professor 
Affiliation  MAHE 
Address  Department of Microbiology Melaka Manipal Medical College,Manipal Manipal Academy of Higher Education (MAHE)


KARNATAKA
576104
India 
Phone    
Fax    
Email  g.sreejith@manipal.edu  
 
Source of Monetary or Material Support  
Melaka Manipal Medical College, Manipal Academy of Higher Education, Manipal, 576104 
 
Primary Sponsor  
Name  World Federation of Hemophilia 
Address  1425, boul. René-Lévesque Ouest Bureau 1200 Montréal, Québec H3G 1T7 Canada 
Type of Sponsor  Other [non-profit organization] 
 
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 Sreejith Govindan  Manipal  Hemoiphilia Treatment Center, Opposite ENT OPD, 4th Floor, Kasturba Hospital, Manipal - 576104
Udupi
KARNATAKA 		 9980959353

g.sreejith@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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D66||Hereditary factor VIII deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient diagnosed with hemophilia A, B &C based on confirmatory factor assay will be
included.
 
 
ExclusionCriteria 
Details  Patient will be not included if family member of the child or / care taker / patient do not
give consent to participate in registry
Suspected cases without confirmed diagnosis will also be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
severity of hemophilia with the five domains that describe the
QOL through quantitative data analysis.
reasons and
complexities of their disease in-depth and will be able to assess the living environment of
the pwh in a holistic manner. 		 quality of life parameters will be assessed using questionnaires and structured interviews with all the participants twice during the study. This will be done during first year and later after one year. 
 
Secondary Outcome  
Outcome  TimePoints 
Perceptions about the quality of life of PwH  This data will be collected once during the study period. This activity will be done during the second year 
 
Target Sample Size   Total Sample Size="165"
Sample Size from India="165" 
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)   01/04/2021 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The Hemophilia Society, Manipal chapter is one of the 91 chapters in India affiliated to the Hemophilia Federation, India(HFI). HFI gathers basic data on hemophilia and other bleeding disorders through the chapters which forms the basis for the global survey data from India. There are also governmental registries in the state which collect basic data of person with hemophilia(pwh) visiting government hospitals and chapters. However, it all amounts to data on basic demographics, treatment and complications. Genetic analysis, functional outcomes and quality of life (QOL) in hemophilia are rarely studied and are not part of any registry other than WBDR. These are important for the prevention and progress in hemophilia care in a country. The data on the functional outcome and quality of life (QOL) is hence proposed to be collected. This study is also a preliminary study without genetic testing to identify discrepancies in clinical and laboratory severity which in turn can also alter the QOL In addition to the quantitative data on QOL, qualitative data will be collected which will help in understanding the living experiences of pwh. This will also help to look at measures to improve the functional outcome of pwh. 
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