| CTRI Number |
CTRI/2025/05/087380 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can educating parents or caregivers improve the health and medication routine of children with nephrotic syndrome? |
|
Scientific Title of Study
|
Impact of Caregiver Empowerment Module on the Quality of Life and Medication Adherence in the Children with Idiopathic Nephrotic Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JYOTI SHUKLA |
| Designation |
Nursing Officer |
| Affiliation |
Kalawati Saran Children Hospital |
| Address |
Nephrology ward
Kalawati Saran Children Hospital
Bangla Sahib Marg
New Delhi
Central
DELHI
110001
India |
| Phone |
9868047765 |
| Fax |
|
| Email |
jyoti_shukla1984@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijeet Saha |
| Designation |
Director Professor |
| Affiliation |
LHMC and KSCH |
| Address |
Division of Paediatric Nephrology
Department of Pediatrics, LHMC and KSCH,New Delhi
Central
DELHI
110001
India |
| Phone |
9711007064 |
| Fax |
|
| Email |
drabhijeetsaha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnita Gupta |
| Designation |
Professor |
| Affiliation |
Chitkara University |
| Address |
Chitkara School of Health Science
Chitkara University
Patiala
PUNJAB
140401
India |
| Phone |
9876054823 |
| Fax |
|
| Email |
anita.gupta@chitkara.edu.in |
|
|
Source of Monetary or Material Support
|
| Kalawati Saran Children Hospital |
|
|
Primary Sponsor
|
| Name |
Jyoti shukla |
| Address |
Kalawati Saran Children Hospital
New Delhi |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAbhijeet Saha |
Kalawati saran Children Hospital |
Nephrology OPD
Kalawati saran Children Hospital
Bangla Sahib Marg
New Delhi
Central
DELHI |
9711007064
drabhijeetsaha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Lady Hardinge Medical College and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caregiver Empowerment Module |
A structured educational intervention (Caregiver Empowerment Module) delivered in four sessions over 2 months for caregivers of children with nephrotic syndrome. It includes a printed booklet covering illness, treatment, complications, medication and dietary adherence, urine dipstick testing, early relapse identification, and use of a medication diary. Sessions will be supported by PowerPoint presentations, demonstrations, and discussions. Fortnightly telephonic follow-up continues for six months to reinforce knowledge and caregiver support. |
| Comparator Agent |
routine care |
Caregivers in the control group receive routine care provided by the hospital for children with nephrotic syndrome. No additional educational sessions or materials are given. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with SSNS including Frequently Relapsing Nephrotic Syndrome (FRNS), Infrequent Relapsing Nephrotic syndrome (IFRNS), Steroid Dependence Nephrotic Syndrome (SDNS) and their primary caregivers
those who can understand hindi or english language |
|
| ExclusionCriteria |
| Details |
Children with Steroid resistant Nephrotic Syndrome (SRNS), congenital Nephrotic syndrome, Secondary Nephrotic syndrome and their caregivers |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in quality of life of children with idiopathic nephrotic syndrome (INS), measured using a pediatric quality of life questionnaire.
2. Change in medication adherence in children with idiopathic Nephrotic Syndrome, assessed using Morisky Medication Adherence Scale |
3 months and 6 months after completion of Caregiver Empowerment Module |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the knowledge and practice scores of the caregivers of the children with nephrotic syndrome |
3 months and 6 months after completion of Caregiver Empowerment module |
| correlation between medication adherence and Quality of Life in children with nephrotic syndrome |
3 months and 6 months after completion of Caregiver Empowerment module |
| Association of quality of life and medication adherence with selected demographic and clinical variables. |
3 months and 6 months after completion of the Caregiver Empowerment Module |
| Time to first relapse after enrollment during the study period. |
continously monitored for 6 months following completion of caregiver Empowerment Module |
Time of initiation of Prednisolone therapy at
60 mg/m²/day following relapse during study period |
continously monitored for 6 months following completion of caregiver Empowerment Module |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
03/06/2025 |
| 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="10"
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 - NO
|
|
Brief Summary
|
The randomized controlled trial aims to evaluate the impact of the Caregiver Empowerment Module on the quality of life and medication adherence among children (aged 2–12 years) diagnosed with steroid-sensitive nephrotic syndrome (SSNS), including frequently relapsing, infrequently relapsing, and steroid-dependent cases. The intervention group caregivers will receive a structured educational module comprising a booklet, PowerPoint presentations, demonstrations, and discussions delivered in four sessions over 2 months, followed by fortnightly telephonic follow-up for six months. The module includes disease understanding, treatment adherence, urine dipstick monitoring, relapse identification, and diary maintenance. The control group will receive routine care. Outcomes will be assessed at baseline, 3 months, and 6 months. In addition to quality of life and medication adherence, secondary outcomes include caregiver knowledge and practice, time to first relapse, and time to initiation of prednisolone therapy after relapse. The study will also examine correlations and associations between adherence, quality of life, and selected demographic and clinical variables. |