Impact of Caregiver Empowerment Module on the Quality of Life and Medication Adherence in the Children with Idiopathic Nephrotic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- 1. Change in quality of life of children with idiopathic nephrotic syndrome (INS), measured using a pediatric quality of life questionnaire.
研究概览
简要总结
The randomized controlled trial aims to evaluate the impact of the Caregiver Empowerment Module on the quality of life and medication adherence among children (aged 2–12 years) diagnosed with steroid-sensitive nephrotic syndrome (SSNS), including frequently relapsing, infrequently relapsing, and steroid-dependent cases. The intervention group caregivers will receive a structured educational module comprising a booklet, PowerPoint presentations, demonstrations, and discussions delivered in four sessions over 2 months, followed by fortnightly telephonic follow-up for six months. The module includes disease understanding, treatment adherence, urine dipstick monitoring, relapse identification, and diary maintenance. The control group will receive routine care. Outcomes will be assessed at baseline, 3 months, and 6 months. In addition to quality of life and medication adherence, secondary outcomes include caregiver knowledge and practice, time to first relapse, and time to initiation of prednisolone therapy after relapse. The study will also examine correlations and associations between adherence, quality of life, and selected demographic and clinical variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with SSNS including Frequently Relapsing Nephrotic Syndrome (FRNS), Infrequent Relapsing Nephrotic syndrome (IFRNS), Steroid Dependence Nephrotic Syndrome (SDNS) and their primary caregivers those who can understand hindi or english language.
排除标准
- •Children with Steroid resistant Nephrotic Syndrome (SRNS), congenital Nephrotic syndrome, Secondary Nephrotic syndrome and their caregivers.
结局指标
主要结局
1. Change in quality of life of children with idiopathic nephrotic syndrome (INS), measured using a pediatric quality of life questionnaire.
时间窗: 3 months and 6 months after completion of Caregiver Empowerment Module
2. Change in medication adherence in children with idiopathic Nephrotic Syndrome, assessed using Morisky Medication Adherence Scale
时间窗: 3 months and 6 months after completion of Caregiver Empowerment Module
次要结局
- Change in the knowledge and practice scores of the caregivers of the children with nephrotic syndrome(3 months and 6 months after completion of Caregiver Empowerment module)
- correlation between medication adherence and Quality of Life in children with nephrotic syndrome(3 months and 6 months after completion of Caregiver Empowerment module)
- Association of quality of life and medication adherence with selected demographic and clinical variables.(3 months and 6 months after completion of the Caregiver Empowerment Module)
- Time to first relapse after enrollment during the study period.(continously monitored for 6 months following completion of caregiver Empowerment Module)
- Time of initiation of Prednisolone therapy at(60 mg/m²/day following relapse during study period)