| CTRI Number |
CTRI/2025/08/092787 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Evaluate the Effectiveness of a Nurse-Driven Interventional Package on Quality of Life and Biochemical Markers in Patients with Chronic Kidney Disease at GRH, Madurai |
|
Scientific Title of Study
|
Efficacy of nurse driven interventional package on quality of life and biochemical markers among CKD patients in Nephrology Deparatment at GRH Madurai |
| Trial Acronym |
(NDIP = Nurse-Driven Interventional Package) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJALAKSHMI N |
| Designation |
NURSING TUTOR |
| Affiliation |
Madurai Medical College |
| Address |
College of Nursing
Madurai Medical College
Madurai
Government Rajaji Hospital
Madurai Medical College
Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9789894089 |
| Fax |
|
| Email |
rajkodeemdu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.M.Kavitha |
| Designation |
Professor in Nursing |
| Affiliation |
Affiliated to Meenakshi Academy of higher education and research |
| Address |
Meenakshi College of Nursing
Chikkarayapuram
Mangadu
Chennai
Meenakshi Academy of Higher education and Research
vembuliamman koil street
k.k Nagar
Chennai
Chennai
TAMIL NADU
600069
India |
| Phone |
9025123844 |
| Fax |
NA |
| Email |
kavitham@mcon.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Rajalakshmi N |
| Designation |
Nursing Tutor |
| Affiliation |
college of Nursing Madurai Medical College Madurai |
| Address |
No.14 Grace Illam
Nagu Nagar second street
Bethaniyapuram
Madurai
Government Rajaji Hospital
Madurai Medical College
Madurai
Madurai
TAMIL NADU
625016
India |
| Phone |
9789894089 |
| Fax |
|
| Email |
rajkodeemdu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-sponsored by the Principal Investigator, Mrs. N. Rajalakshmi, Government Rajaji Hospital, Madurai Medical College, Madurai, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Nephrology Department Government Rajaji Hospital |
| Address |
Nephrology Department
Government Rajaji Hospital
Madurai Medical College
Madurai-20 |
| 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 |
| DrManorajan |
Government Rajaji Hospital |
NEPHROLOGY DEPARTMENT
GOVERNMENT RAJAJAI HOSPITAL
MADURAI MEDICAL COLLEGE
MADURAI
Madurai
TAMIL NADU |
8778694992
drmanorajan69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-Driven Interventional Package (NDIP) |
Nurse-Driven Interventional Package comprising dietary counselling, medication adherence guidance, psychosocial support, fluid management education, and individualized health education sessions, administered over 6 Months. |
| Comparator Agent |
Routine standard care |
The control group will receive routine standard care provided at the nephrology department of Government Rajaji Hospital, Madurai. This includes medical management, regular dialysis sessions (as per protocol), and basic nursing support as per institutional norms. No additional intervention or structured package will be provided to this group. The duration of standard care will be 6 months, similar to the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years and above
patients with stage1 to 4
Stable medical conditions for the past three months.
Ability to communicate effectively
Willingness to participate in intervention and follow up
Access to phone or mobile device for regular communication
Patients with history of malnutrition or poor dietary habits
|
|
| ExclusionCriteria |
| Details |
Patient with advance cancer and terminal illness
Active psychiatric illness
unstable cardiovascular disease
chronic liver disease
immunocompromised status
severe neurological disorders
Pregnant/lactating
undergoing renal transplant
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Quality of Life (QoL) scores
change in biochemical Markers |
mprovement in Quality of Life (KDQOL-36) Baseline, 3 months, and 6 months
Changes in biochemical parameters (Creatinine, GFR, BUN, Hemoglobin, Electrolytes) Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in biochemical markers (e.g., serum creatinine, hemoglobin, BUN, GFR, potassium, sodium) |
Measured at baseline and after 6 months |
| Adherence to nurse-driven interventional package (measured via checklist) |
Weekly during 4-week intervention |
| Changes in anthropometric indicators (BMI, MUAC, waist-hip ratio) |
Baseline and 6 months post-intervention |
| Participant satisfaction with the intervention |
At the end of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
21/08/2025 |
| 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="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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rajkodeemdu@gmail.com].
- For how long will this data be available start date provided 02-01-2026 and end date provided 02-01-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This is a randomized controlled trial designed to evaluate the effectiveness of a nurse-driven interventional package on improving the quality of life and biochemical markers in patients with chronic kidney disease (CKD) at the Nephrology Department, Government Rajaji Hospital, Madurai. The intervention consists of individualized dietary counseling based on renal nutritional guidelines, nutrition education, guided mindfulness relaxation, seated physical exercises, and Nutritional changes include personalized menu plans, sodium and protein modification, and fluid intake guidance. A total of 150 participants will be randomized into intervention and control groups. The impact on quality of life (measured using KDQOL-36) and key biochemical parameters (e.g., serum creatinine, hemoglobin, GFR) will be assessed over a 6-month follow-up period.
|