| CTRI Number |
CTRI/2024/06/068390 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assessing the effectiveness of A nurse-led home care package for care givers of children with Nephrotic Syndrome |
|
Scientific Title of Study
|
A quasi experimental study to assess the effectiveness of A nurse- led home care package for care givers of children with Nephrotic Syndrome on selected outcome variables attending Nephrology OPD at APC, PGIMER, Chandigarh, 2023-25 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aneeshlal S V |
| Designation |
MSc Nursing Student |
| Affiliation |
Department of Nursing, National Institute of Nursing Education, PGIEMR, Chandigarh |
| Address |
MSc Nursing (Pediatric Speciality), Department of Nursing, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8699498952 |
| Fax |
|
| Email |
s.v.aneeshlal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Rupinder Kaur |
| Designation |
Tutor |
| Affiliation |
Department of Nursing, National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Department of Nursing, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878033748 |
| Fax |
|
| Email |
kauramanjot40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aneeshlal S V |
| Designation |
MSc Nursing Student |
| Affiliation |
Department of Nursing, National Institute of Nursing Education, PGIEMR, Chandigarh |
| Address |
MSc Nursing (Pediatric Specialty), Department of Nursing, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8699498952 |
| Fax |
|
| Email |
s.v.aneeshlal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aneeshlal S V |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh -160012 |
| 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 |
| Aneeshlal S V |
Post Graduate Institute of Medical Education and Research, Chandigah |
Advance Pediatric Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
8699498952
s.v.aneeshlal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N049||Nephrotic syndrome with unspecified morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A nurse -led home care package for care givers of children with Nephrotic Syndrome |
Develop and implement the nurse - led home care package for care givers of children with nephrotic syndrome that involve a brief information about nephrotic syndrome, diet, psychological support and prevention of complications and safety measures. |
| Comparator Agent |
A nurse -led home care package for care givers of children with Nephrotic Syndrome |
Develop and implement the nurse - led home care package for care givers of children with nephrotic syndrome that involve a brief information about nephrotic syndrome, diet, psychological support and prevention of complications and safety measures. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with nephrotic syndrome and their caregivers willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Children diagnosed with nephrotic syndrome having other chronic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical variables includes urine protein value, weight, blood pressure, input and output, infection and adherence of medications and follow up |
Follow up after 1 month and 2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Psychological variables include depression, anxiety, stress and quality of life |
2 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="2"
Days="30" |
|
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
|
In this study, assessing the effectiveness of a nurse led home care package for care givers of children with Nephrotic Syndrome on selected outcome variables such as clinical variables include urine protein value, weight, blood pressure, input and output, infection, adherence of medication and follow up , diet and the psychological variables include depression, anxiety, stress and quality of life [QOL]. An interventional package that involves brief information about nephrotic syndrome, common problems of nephrotic syndrome and prevention of complications and safety measures. |