CKD-aP: Diagnosis and Treatment Through a Multidisciplinary Approach - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change from baseline to 6 months in the pruritus intensity-related item of the Kidney Disease Quality of Life - Short Form (KDQOL-SF) questionnaire.
研究概览
简要总结
This is a single-center, pilot, randomized, open-label, non-profit interventional study designed to evaluate the impact of a multidisciplinary approach on chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing chronic extracorporeal hemodialysis.
Twenty adult, clinically stable hemodialysis patients with moderate to severe uremic pruritus will be enrolled and randomized to receive either standard of care alone or standard of care plus a structured psychological intervention. The primary objective is to assess the change in pruritus-related quality of life after 6 months, measured by the KDQOL-SF questionnaire. Secondary objectives include evaluation of pruritus severity, quality of life, sleep quality, psychological distress, patient engagement, clinical and biochemical parameters, and exploration of patients' psychological experience over time.
The study aims to provide preliminary evidence on the effectiveness of integrating psychological support into the management of CKD-associated pruritus in the hemodialysis population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •KDQOL-SF™ 1.3 score ≥ 3 (corresponding to the presence of the symptom in the last 4 weeks, rated as "moderately bothered")
- •On chronic hemodialysis for at least 3 months and clinically stable
- •Signed informed consent for participation in the study
排除标准
- •Refusal to provide informed consent
- •Age < 18 years
- •KDQOL-SF™ 1.3 score < 3
- •Pruritus secondary to dermatologic diseases, autoimmune diseases with skin involvement (e.g. SLE, scleroderma, vasculitis, etc.), hepatobiliary diseases causing cholestatic jaundice, malignancies, or uncontrolled endocrine disorders
- •Active substance abuse
- •Severe mental illness or severe cognitive impairment (e.g. active psychosis, dementia, etc.)
研究组 & 干预措施
Control
standard of care alone
Intervention
standard of care plus a structured psychological intervention
干预措施: Structured psychological intervention (Other)
结局指标
主要结局
Change from baseline to 6 months in the pruritus intensity-related item of the Kidney Disease Quality of Life - Short Form (KDQOL-SF) questionnaire.
时间窗: 6 months
Change from baseline to 6 months in the pruritus intensity-related item of the Kidney Disease Quality of Life - Short Form (KDQOL-SF) questionnaire. This item assesses how bothersome pruritus is, on a scale ranging from 1 (not bothered at all) to 5 (extremely bothered).
次要结局
未报告次要终点
研究者
Federico Alberici
Prof.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia