Efficacy of nurse driven interventional package on quality of life and biochemical markers among CKD patients in Nephrology Deparatment at GRH Madurai
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Quality of Life (QoL) scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Quality of Life (QoL) scores
时间窗: 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
时间窗: 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
次要结局
- 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)
研究者
RAJALAKSHMI N
Madurai Medical College