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CTRI Number  CTRI/2021/05/033712 [Registered on: 20/05/2021] Trial Registered Prospectively
Last Modified On: 19/05/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Challenges faced by hemodialysis patients in times of COVID- 19 Pandemic  
Scientific Title of Study   Challenges Faced by Patients Undergoing Hemodialysis during COVID- 19 Pandemic: A Qualitative Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravindra Prabhu A  
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal 
Address  Room Number 15, Department of Nephrology, Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448107771  
Fax    
Email  ravindra.prabhu@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Ravindra Prabhu A  
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal 
Address  Room Number 15, Department of Nephrology, Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448107771  
Fax    
Email  ravindra.prabhu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ravindra Prabhu A  
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal 
Address  Room Number 15, Department of Nephrology, Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448107771  
Fax    
Email  ravindra.prabhu@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, MAHE, Manipal Pin code: 576104 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Kasturba Medical College Manipal Academy of Higher Education Madhav Nagar Manipal 
Type of Sponsor  Private medical college 
 
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 
Ravindra Prabhu A  Kasturba Hospital, Madhav Nagar, Manipal, Karnataka  Room Number 15, Department of Nephrology, Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA 		 9448107771

ravindra.prabhu@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, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients undergoing in-center hemodialysis  
 
ExclusionCriteria 
Details  Subjects undergoing peritoneal dialysis
Critically ill patients
Pregnant Women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Qualitative evaluation of hemodialysis patients experiences during COVID 19 pandemic. The outcomes will be presented as overall themes and subthemes   6 months  
 
Secondary Outcome  
Outcome  TimePoints 
NA  0 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   15/06/2021 
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="0"
Months="6"
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   This is a single centre qualitative research study using an in-depth interview guide. A trained interviewer bilingual in English and Kannada will conduct in- depth interviews till saturation with patients undergoing hemodialysis over a period of 6 months. The primary outcome measure will be experiences of patients on hemodialysis during COVID 19 pandemic. 
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