Living with Lupus Nephritis: Evaluating Quality of Life in Patients on Immunosuppressive Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome of this study is the Mean overall Quality of Life (QoL) score as measured by the
研究概览
简要总结
This is a prospective, cross-sectional observational study designed to assess the quality of life (QoL) in patients with biopsy-proven lupus nephritis (LN) who have completed at least six months of maintenance immunosuppressive therapy. Using validated instruments (LupusQoL and EQ-5D-5L), the study evaluates overall and domain-specific QoL and explores associations with disease class, remission status, steroid burden, treatment type, and clinical markers. The study aims to generate patient-centered insights to inform individualized care and integration of QoL assessment in routine LN management.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 8.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed as SLE by SLICC/ACR criteria and biopsy-proven lupus nephritis (Class III/IV/V combinations).
- •Has completed induction immunosuppressive regimen for at least 6 months and is on maintenance therapy for LN.
- •Able to provide informed consent.
排除标准
- •Patients with overlap syndromes, post-kidney transplant ESKD on dialysis, and patients not on immunosuppressive drugs for LN.
- •Severe psychiatric illness interfering with questionnaire completion.
- •Recent hospital admission, serious infection, cancer, or an acute illness in the past 4 weeks.
结局指标
主要结局
The primary outcome of this study is the Mean overall Quality of Life (QoL) score as measured by the
时间窗: 6 months
LupusQoL and EQ-5D-5L instruments in patients with lupus nephritis who are on maintenance
时间窗: 6 months
immunosuppression.
时间窗: 6 months
次要结局
- Domain-specific QoL scores from LupusQoL.(Comparison of QoL scores between different LN classes (e.g., Class III, IV, V combinations) and disease)
研究者
Prajna Angeline D Souza
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal.