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CTRI Number  CTRI/2024/01/061811 [Registered on: 24/01/2024] Trial Registered Prospectively
Last Modified On: 26/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes
Other (Specify) [Educational intervention]  
Study Design  Single Arm Study 
Public Title of Study   A training for caregivers of dialysis patients. 
Scientific Title of Study   Effectiveness of dialysis homecare training (D-HCT) on quality of life, caregiver burden and family well being among caregivers of hemodialysis patients in a tertiary care hospital of Southern India. 
Trial Acronym  D-HCT 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Punitha M 
Designation  Msc Nursing 
Affiliation  MCON, MAHE, Manipal 
Address  Department of Medical Surgical Nursing MCON MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  8940896227  
Fax    
Email  punithascsc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Anil Raj A 
Designation  Assistant Professor 
Affiliation  MCON, MAHE, Manipal 
Address  Department of Medical Surgical Nursing MCON MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  7411892986  
Fax    
Email  anil.raj@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Melita Sheilini 
Designation  Assistant Professor - Senior Grade 
Affiliation  MCON, MAHE, Manipal 
Address  Department of Medical Surgical Nursing MCON MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Source of Monetary or Material Support  
Manipal college of Nursing, MAHE Manipal, Udupi, Karnataka, India. 576104 
 
Primary Sponsor  
Name  Manipal College of Nursing 
Address  Department of Medical Surgical Nursing MCON MAHE Manipal 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shankar Prasad N  Dept of Nephrology  Room No 26, Dialysis Unit, Dept of Nephrology KH Manipal, Karnataka
Udupi
KARNATAKA 		 9739905443

shankarmmcmed@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  caregivers of hemodialysis patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NO comparator  Nil 
Intervention  Post dialysis Home Care Training  PART I/ OR SECTION ONE: HOW TO TAKE CARE OF POST DIALYSIS PATIENTS What is chronic kidney failure? What is hemodialysis and its Indications? What is Vascular access for hemodialysis? Home care of post-dialysis patients Care of fistula Dietary management Fluid restriction Exercise for the patient Early identification of complications Insurance schemes available PART II/ SECTION II CARE OF CAREGIVERS Stress management (caregiver) Educational interventional will be provided to the individual caregivers when they are waiting outside the dialysis room. it might take 30 - 45 minutes per participants. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  one caregiver per patient
18years of age and above, both male and female
able to speak / read Kannada or English
willing to participate in this study
on dialysis for more than 6months to five years 
 
ExclusionCriteria 
Details  Being a healthcare worker
Lack of cooperation by the caregiver
paid caregiver 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of life  At base line and 3 weeks the intervention a post test will be conducted 
 
Secondary Outcome  
Outcome  TimePoints 
care giver Burden and family well - being  At base line and 3 weeks the intervention a post test will be conducted 
 
Target Sample Size   Total Sample Size="113"
Sample Size from India="113" 
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   29/01/2024 
Date of Study Completion (India) 21/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="3" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [punithascsc@gmail.com].

  6. For how long will this data be available start date provided 28-02-2025 and end date provided 29-10-2025?
    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   Study will be conducted after obtaining appropriate permission in the dialysis unit of Kasturba Hospital Manipal. The participants will be explained about the study and their participation in the research. Samples are selected using a purposive sampling technique. The researcher has adopted Pre experimental one group pretest posttest research design. Caregivers of dialysis patients are the participants in the study. While patients are receiving dialysis, the caregivers would be available in the waiting area and the data will be collected during that timeThe data on demographic variables will be collected by administering demographic proforma . During the pretest the caregivers will be given WHOQOL – BREF 26 to assess their quality-of-life, Caregiver burden will be measured by Zarit Caregiver Burden scale and to determine the family well – being by caregivers using a structured self-reported family well – being questionnaire. Then the caregivers will be given dialysis home care training in the form of an interventional booklet. On subsequent visits for dialysis, the researcher will be doing the follow up of the intervention by means of a quiz to ensure compliance. After three weeks of gap from the intervention, the post-test will be conducted to assess the effectiveness of dialysis home care training on quality of life, caregiver burden and family well-being using the same data collection instruments. 
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