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CTRI Number  CTRI/2025/02/080768 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [supportive educational intervention ]  
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   SUPPORTIVE EDUCATIONAL INTERVENTION ON QUALITY OF LIFE (SEI QOL) OF PATIENTS UNDERGOING HEMODIALYSIS 
Scientific Title of Study   Effectiveness of supportive educational intervention on Quality of Life (SEI QOL) of patients undergoing hemodialysis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahadeva Prasad N S 
Designation  Ph D Scholar 
Affiliation  College of Nursing, Teerthanker Mahaveer University 
Address  College of Nursing Teerthanker Mahaveer University, Department of Mental Health Nursing Room no 10 Delhi Road NH9 Moradabad

Moradabad
UTTAR PRADESH
244001
India 
Phone  09606364956  
Fax    
Email  mahadevaprasad.scholar@tmu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  DrRamkumar Garg  
Designation  Professor 
Affiliation  College of Nursing, Teerthanker Mahaveer University 
Address  College of Nursing Teerthanker Mahaveer University, Department of Mental Health Nursing Room no 10 College of Nursing. Delhi Road NH9

Moradabad
UTTAR PRADESH
244001
India 
Phone  9355641979  
Fax    
Email  ram.nursing@tmu.ac.in  
 
Details of Contact Person
Public Query  
Name  DrRamkumar Garg  
Designation  Professor 
Affiliation  College of Nursing, Teerthanker Mahaveer University 
Address  College of Nursing Teerthanker Mahaveer University, Department of Mental Health Nursing Room no 10 College of Nursing. Delhi Road NH9

Moradabad
UTTAR PRADESH
244001
India 
Phone  9355641979  
Fax    
Email  ram.nursing@tmu.ac.in  
 
Source of Monetary or Material Support  
Clearmedi Radiant Hospital, Mysuru 
 
Primary Sponsor  
Name  Mahadeva Prasad N S 
Address  College of Nursing Teerthanker Mahaveer University, Department of Mental Health Nursing Room no 10 College of Nursing. Delhi Road NH9 College of Nursing Teerthanker Mahaveer University, Department of Mental Health Nursing Room no 10, Delhi Road NH9 Moradabad 
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 
Dr Rakesh  Clearmedi radiant hospital, Mysore  Clearmedi radiant hospital, 3, A1 Block 3rd stage Vijaya Nagar Mysore
Mysore
KARNATAKA 		 8197412404

office@cconmys.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Teerthanker Mahaveer University  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No treatment  No intervention for control group 
Intervention  Supportive education  Supportive education given by the researcher to the patient on the quality of life of patients on health status, emotional problems, pain management, disease management, social health etc.,  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with Chronic Kidney disease who are
Receiving Haemodialysis in hospitals on a care basis
Who are in the age group of 18 to 65 years
Both Male and Female patients
Who are not seriously ill to respond
Who is willing to participate
Who can understand English or Kannada
 
 
ExclusionCriteria 
Details  • Patients who are in the age group of less than 18 and more than 65
• Patients who are at end stage
• Those who participated in the pilot study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study is expected to demonstrate improved quality of life for patients undergoing hemodialysis through targeted educational interventions after 6 weeks of supportive educational intervention  This study is expected to demonstrate improved quality of life for patients undergoing hemodialysis through targeted educational interventions after 6 weeks of supportive educational intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Enhanced quality of life, self empowerment, psychosocial insights  3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/03/2025 
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="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Chronic kidney disease (CKD) is a common condition that significantly impacts mortality and morbidity. With many patients requiring hemodialysis as a life-sustaining treatment, there’s an urgent need to explore ways to improve their overall well-being and quality of life. Patients undergoing hemodialysis often report a diminished quality of life due to various factors, including physical limitations, fatigue, anxiety, depression, and social isolation. In brief, the study is likely to have significant implications for improving patient care, informing clinical practices, and fostering a greater understanding of the needs of patients undergoing hemodialysis. 
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