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CTRI Number  CTRI/2025/10/096285 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational intervention]  
Study Design  Single Arm Study 
Public Title of Study   Health education for mothers of children with Nephrotic Syndrome (Kidney disease to improve their understanding and Home care Practices. 
Scientific Title of Study   Effectiveness Of Health Education On Knowledge And Practices Among Mothers Of Children With Nephrotic Syndrome 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Somashekhar Sangappa Akalad 
Designation  Ph D Scholar 
Affiliation  KLE Academic of Higher education  
Address  KLE ACADEMIC OF HIGHER EDUCATION, BELGAUM INSTITUTE OF MEDICAL SCIENCES BELAGAVI.AMBEDKAR ROAD NEHRU NAGAR BELAGAVI
KLE ACADEMIC OF HIGHER EDUCATION, BELGAUM INSTITUTE OF MEDICAL SCIENCES BELAGAVI.AMBEDKAR ROAD NEHRU NAGAR BELAGAVI.
Belgaum
KARNATAKA
590010
India 
Phone  9008864268  
Fax    
Email  somuakalad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gavishiddayya Salimath 
Designation  Professor and Head, 
Affiliation  KLE Academic Of Higher Eduaction Belagavi 
Address  Department of Paediatric Nursing KLE Institute Of Nursing Science Belagavi KLE Institute Of Nursing Science Belagavi Belgaum KARNATAKA 590010 India
JNMC Campus, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA
590010
India 
Phone  9480033476  
Fax    
Email  gavisalimath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr.Somashekhar Sangappa Akalad 
Designation  Ph.D Scholar 
Affiliation  KLE Academic of Higher Education Belagavi 
Address  KLE academic of higher education Neharu Nagar Belagavi Belgaum Institute Of Medical Science Belgaum. Ambedkar Road Neharu Nagar Belagavi.
Department of Paediatric Nursing KLE Institute of Nursing Sciences,JNMC Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  9008864268  
Fax    
Email  somuakalad@gmail.com  
 
Source of Monetary or Material Support  
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE. AT-P B ROAD ,VIDYANAGAR TALUK-HUBBALLI DIST-DHARWAD STATE-KARNATAKA COUNTRY-INDIA PIN CODE-580021 
 
Primary Sponsor  
Name  Somashekhar Sangappa Akalad 
Address  Ph.D Scholar KLE Academic Higher Education and Research, Neharu Nagar Belagavi State-Karnataka Country-India Pin Code-590010  
Type of Sponsor  Other [Self] 
 
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 Vinod Ratageri  Karnataka Medical College And Research Institute I  Pediatric Ward Ward Number 103 and 104 Tq Hubballi
Dharwad
KARNATAKA 		 9448278480

kimspaed@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nephrotic syndrome  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Health Education sessions for Mothers of children with Nephrotic syndrome   Pre -Test will be conducted before the intervention and Intervention will be given in the form of Health education. Post-Test will be carried out immediately after intervention and after 3 months using same validated tool to evaluate the effectiveness of intervention 
Comparator Agent  Not applicable-Single arm Pre test Post Test interventional study  This study involves only one group of participants (Mothers of children with nephrotic syndrome).There is no separate control or comparator group.outcomes will be compared within the same group before and after intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Mothers of children diagnosed with nephrotic syndrome .
2. Mothers who have not participated in previous studies.
3. Mothers of children admitted in the hospital .
 
 
ExclusionCriteria 
Details  1. Mothers of children diagnosed with nephrotic syndrome , particularly those who are critically ill.
2. The mothers who are suffering from mental illness
3.The mothers who are not willing to participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Knowledge and care practices of mothers of children with Nephrotic syndrome measured by a structured questionnaire before and after the health education intervention  Baseline (Pre test), Immediately after intervention and 3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Knowledge and practice scores at a later follow up 3 months after intervention to see if improvements are maintained  3 month post intervention for retention and satisfaction assessment 
 
Target Sample Size   Total Sample Size="87"
Sample Size from India="87" 
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)   05/11/2025 
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="4"
Months="0"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 - Any purpose.

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

  6. For how long will this data be available start date provided 10-11-2025 and end date provided 10-11-2045?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This is a one group pre test Post test study designed to evaluate the effectiveness of health education on improving knowledge and care giving practices among mothers of children with nephrotic syndrome.Mothers will be selected based on inclusion and exclusion criteria from a pediatric hospital.A Pre test will be conducted, followed by a structured health education session focusing on the nature of illness,its causes,sign and symptoms,diagnosis,treatment,home care practices and prevention of complication.Knowledge and Practices will be assessed using a structured knowledge questionnaire and Likert scale before and after the intervention.The study aims to determine whether health education can lead to significant improvements in mothers understanding and care giving behaviour. A post test will be conducted after three months using the same tools.

 
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