| CTRI Number |
CTRI/2025/07/090957 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Home based care for kids with nephrotic syndrome (HOME-KIDS) |
|
Scientific Title of Study
|
Evaluation of effectiveness of home-based intervention model for kids with nephrotic syndrome HOME-KIDS trial |
| Trial Acronym |
HOME-KIDS trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavithrra S |
| Designation |
Postgraduate resident |
| Affiliation |
Government medical college and hospital Chandigarh |
| Address |
Department of Pediatrics Government medical college Chandigarh Dakshin Marg, Near Community Park Block B Sector 32 Chandigarh 160047
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9080474739 |
| Fax |
|
| Email |
satsupa15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidushi Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Pediatrics Government medical college Chandigarh Dakshin Marg, Near Community Park Block B Sector 32 Chandigarh 160047
Chandigarh
CHANDIGARH
160030
India |
| Phone |
09443202990 |
| Fax |
|
| Email |
vidushimahajan2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vidushi Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Pediatrics Government medical college Chandigarh Dakshin Marg, Near Community Park Block B Sector 32 Chandigarh 160047
Chandigarh
CHANDIGARH
160030
India |
| Phone |
09443202990 |
| Fax |
|
| Email |
vidushimahajan2003@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Chandi Path, Sector 32b, 32b, Sector 32, Chandigarh, India 160047 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Chandi Path, Sector 32b, 32b, Sector 32, Chandigarh, 160047, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Pavithrra S |
Government Medical College and Hospital, Chandigarh |
Department of Pediatrics Chandi Path, Sector 32b, 32b, Sector 32, Chandigarh, 160047, India
Chandigarh
CHANDIGARH |
09080474739
satsupa15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N04||Nephrotic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Home based intervention |
Structured daily monitoring using a nephrotic diary with regular urine dipsticks done twice per week and at time of suspected relapse, during infections, etc. in addition to routine care.
|
| Comparator Agent |
Routine Care |
Periodic 1-3 monthly clinic visits, Limited to 24-hour urine protein done at clinic visit and occasional urine dipsticks at home at time of suspected relapse, during infections, etc. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 to 18 years suffering from idiopathic nephrotic syndrome |
|
| ExclusionCriteria |
| Details |
Children on dialysis or end-stage renal disease
Secondary nephrotic syndrome IgA nephropathy MPGN HSP Nephritis Lupus Diabetes mellitus etc
Children with developmental delay
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study would be to determine the incidence of serious complications |
atleast 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no of hospital admission |
atleast 6 months |
| duration of hospital admissions |
atleast 6 months |
| days to report relapse |
atleast 6 months |
| time to remission |
atleast 6 months |
| growth and nutrition |
At every follow up visit |
| exercise levels |
At every follow up visit |
| absenteeism from school |
At every follow up visit |
| Quality of life |
At the end of follow up period, at least 6 months or longer post enrolment |
| Parental satisfaction in usage of nephrotic diary |
At the end of follow up period, at least 6 months |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
31/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is an open label randomized controlled trial to evaluate whether a structured home based intervention including a nephrotic diary and parental education can reduce complications and improve outcomes in children with idiopathic nephrotic syndrome. A total of 136 children aged 1 to 18 years will be randomized into two groups one receiving standard routine care as per IPNA guidelines and the other receiving the intervention at home. The primary outcome is the incidence of serious complications over a 6 month follow up period. Secondary outcomes include quality of life hospital admissions time to relapse detection and parental adherence. The study aims to determine whether empowering caregivers through education and structured home monitoring can improve clinical outcomes in pediatric nephrotic syndrome. |