NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Community health worker intervention, Standard Care (in control arm).
- Кому может быть актуально
- Состояния в реестре: Kidney Diseases, Chronic Kidney Diseases. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Navigate Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities Among Individuals With Kidney Disease
Обзор
The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for individuals with CKD. The investigators hypothesize that the multilevel NAVIGATE-Kidney program intervention will reduce the rate of central venous catheter use at KRT start (primary outcome), increase the rate of optimal KRT starts (secondary outcome), increase patient activation, and reduce decisional conflict (patient-centered outcomes) for individuals with advanced CKD. The project will have four (4) aims.
Подробное описание
The overarching goal of this project is to reduce kidney health disparities faced by individuals with advanced kidney disease. The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for individuals with kidney failure receiving maintenance hemodialysis. The investigators now aim to test NAVIGATE-Kidney among individuals with advanced CKD stage 4. The investigators hypothesize that compared to standard care, the multilevel NAVIGATE-Kidney intervention will reduce the composite endpoint, defined as (1) time to transition to KRT and central venous catheter use or (2) death (primary outcome), increase the rate of optimal KRT starts and optimal KRT process measures (secondary clinical outcomes), increase patient activation, reduce social challenges, and reduce decisional conflict (patient-centered outcomes) for individuals with advanced CKD stage 4/5 (eGFR 15-29 mL/min/1.73m2). The investigators will also evaluate Navigate-Kidney implementation outcomes using the PRISM (Practical Robust Implementation and Sustainable Model) science framework and conduct an economic evaluation to inform policy change.
Вмешательства
- Поведенческое Community health worker intervention
Community health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management. - Поведенческое Standard Care (in control arm)
Participants receive standard care
Первичные конечные точки
- Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death [Срок оценки: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)]
Вторичные конечные точки (10)
- Rate of Central Venous Catheter (CVC) use at onset of Kidney Replacement Therapy (KRT) or Death [Срок оценки: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)]
- Rate of Participants with Optimal Kidney Replacement Therapy (KRT) Start [Срок оценки: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)]
- Time to First Optimal Kidney Replacement Therapy (KRT) Process Measure Milestone [Срок оценки: From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)]
- Change in Estimated Glomerular Filtration Rate eGFR [Срок оценки: Screening until End of Study or Death, whichever occurs first (up to 5 years)]
- Change in Decisional Conflict Scale (DCS) scores [Срок оценки: Baseline, Month 6, Month 12, Month 24]
- Change in Patient Activation (PAM-13) scores [Срок оценки: Baseline, Month 6, Month 12, Month 24]
- Change in Quality of Life, as measured by Patient-Reported Outcomes Measurement Information Systems' (PROMIS) Global Health Scale scores [Срок оценки: Baseline, Month 6, Month 12, Month 24]
- Change in Social Determinants of Health, as measured by AHC-HRSN Responses [Срок оценки: Baseline, Month 6, Month 12, Month 24]
- Change in KRT knowledge as measured by the Rotterdam Renal Replacement Knowledge Test (R3K-T, 30 items) [Срок оценки: Baseline, Month 6, Month 12, Month 24]
- Change in Medical Mistrust, as measured by the Medical Mistrust Index (MMI) [Срок оценки: Baseline, Month 6, Month 12, Month 24]
Критерии участия
Критерии включения
- Adults ≥ 18 years of age,
- Adults who are not pregnant,
- Adults who are not incarcerated,
- Adults who have advanced kidney disease with an eGFR of 15-29 mL/min/1.73m2). No other measures are used to identify eligible patients.
Критерии исключения
- Previous kidney transplant
- Previous surgery for dialysis such as an arteriovenous fistula, arteriovenous graft, or peritoneal dialysis catheter placement
- On chronic dialysis
- Conservative management or primary goal is palliation
- Incarcerated
- Pregnant\*
- Under 18 years of age
- Moderate to severe dementia
- Deaf persons
- Lacking health insurance\*\*
- Investigator Discretion: Individuals who, in the judgment of the Site PI (or designee), are deemed unsuitable for participation due to behavioral or logistical circumstances that could compromise study integrity or the safety of the participant or staff.
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
- Двойное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 2 центра
- Denver Health and Hospital Authority — Denver
- University of New Mexico Health Science Center — Albuquerque
Идентификаторы
NCT: NCT06810622 · 23-2014