Efficacy of nurse driven interventional package on quality of life and biochemical markers among CKD patients in Nephrology Deparatment at GRH Madurai
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Nephrology Department Government Rajaji Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in Quality of Life (QoL) scores
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in Quality of Life (QoL) scores
Time Frame: 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
change in biochemical Markers
Time Frame: 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 Outcomes
- 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)
Investigators
RAJALAKSHMI N
Madurai Medical College