Evaluation of effectiveness of home-based intervention model for kids with nephrotic syndrome HOME-KIDS trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- The primary outcome of this study would be to determine the incidence of serious complications
研究概览
简要总结
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.
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
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 1 to 18 years suffering from idiopathic nephrotic syndrome.
排除标准
- •Children on dialysis or end-stage renal disease Secondary nephrotic syndrome IgA nephropathy MPGN HSP Nephritis Lupus Diabetes mellitus etc Children with developmental delay.
结局指标
主要结局
The primary outcome of this study would be to determine the incidence of serious complications
时间窗: atleast 6 months
次要结局
- 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)
研究者
Pavithrra S
Government medical college and hospital Chandigarh