Phase II Multi-Site Randomized Controlled Trial Testing Integrated Kidney Palliative Care Compared With Usual Chronic Kidney Disease Care (Kidney RISE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
研究概览
简要总结
The purpose of study is to investigate whether adding palliative care to usual chronic kidney disease (CKD) care improves symptoms and quality of life for people with CKD. The primary objectives are to 1) determine efficacy of Kidney Palliative Care (KPC) integrated with CKD care on symptom burden compared with usual CKD care, 2) identify clinical and demographic factors associated with differential responses to KPC, and 3) characterize participant and provider experiences with kidney care and factors influencing implementation.
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
- Single (Outcomes Assessor)
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
- •Receive care at nephrology clinics or dialysis centers associated with each site.
- •Have CKD stage IV, V (eGFR < 30 mL/min/1.73m2), or be receiving chronic dialysis
- •Speak Spanish or English, and report at IPOS-Renal score of ≥ 3 on a screening survey.
- •Willing to be randomized to either study arm and to comply with the study procedures for the assigned group.
排除标准
- •Unable to provide informed consent
- •Has received palliative care (inpatient or outpatient) in the last six months.
- •Enrolled in hospice
- •Has any urgent palliative care needs (i.e. severe pain, emotional distress) identified upon screening. Research staff will be trained to recognize these needs.
- •Non-English and Non-Spanish speakers to correspond with the populations most impacted by CKD in the US.
- •Pregnant individuals.
结局指标
主要结局
Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
时间窗: Baseline, Week 12
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
时间窗: Baseline, Week 24
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
次要结局
- Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey(Baseline, Week 12)
- Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey(Baseline, Week 24)
- Number of participants with advance care planning(Week 12)
- Number of participants with advance care planning(Week 24)
- Change in Patient Activation Measure-13 (PAM-13) scores(Baseline, Week 12)
- Change in Patient Activation Measure-13 (PAM-13) scores(Baseline, Week 24)
- Change in General Anxiety Disorder-7 (GAD-7) scores(Baseline, Week 12)
- Change in General Anxiety Disorder-7 (GAD-7) scores(Baseline, Week 24)