Kidney RISE: Randomized Integrated Supportive CarE Trial

Официальное название

Phase II Multi-Site Randomized Controlled Trial Testing Integrated Kidney Palliative Care Compared With Usual Chronic Kidney Disease Care (Kidney RISE)

Обзор

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.

Вмешательства

• Поведенческое Kidney RISE
  Core components include assessment of symptoms (IPOS-Renal), illness understanding, goals of care, advance care planning, spiritual needs, and screening for health-related social needs (HRSNs) using the validated Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities (AHC) Survey. Plans will address symptom management with evidence-based algorithms, linkage to social or spiritual supports, and shared decision-making appropriate to CKD stage.

Первичные конечные точки

• Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores [Срок оценки: Baseline, Week 12]
• Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores [Срок оценки: Baseline, Week 24]

Вторичные конечные точки (8)

• Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey [Срок оценки: Baseline, Week 12]
• Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey [Срок оценки: Baseline, Week 24]
• Number of participants with advance care planning [Срок оценки: Week 12]
• Number of participants with advance care planning [Срок оценки: Week 24]
• Change in Patient Activation Measure-13 (PAM-13) scores [Срок оценки: Baseline, Week 12]
• Change in Patient Activation Measure-13 (PAM-13) scores [Срок оценки: Baseline, Week 24]
• Change in General Anxiety Disorder-7 (GAD-7) scores [Срок оценки: Baseline, Week 12]
• Change in General Anxiety Disorder-7 (GAD-7) scores [Срок оценки: Baseline, Week 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Emory University — Atlanta
• NYU Langone Health — New York

Идентификаторы

NCT: NCT07741357 · 26-00770

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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