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Идёт набор NCT06410144

Chronic Kidney Disease-Education (CKD-EDU)

Без фазы С лечением Chronic Kidney Diseases

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: Program A, Program B.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Diseases. Базовые параметры: от 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

Improving Kidney Therapy Decision-Making for Older People With Advanced Chronic Kidney Disease (CKD)

Обзор

The investigators are conducting a study to see which program better helps older patients with kidney disease choose their treatment. Investigators are also investigating if either program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults. Half of the participants will receive Program A, while the other half will receive Program B. Investigators will compare the two groups to see which participants feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits and hospital admissions. Participants in Program A will receive information from the National Kidney Foundation and meet with a kidney therapy educator. Participants in Program B will get information about kidney disease treatment and meet with a decision-support specialist who's an expert in decision-making.

Подробное описание

Older adults ≥75 years represent the fastest-growing population to initiate dialysis in the US; despite the life-altering effects of dialysis on quality of life, dialysis is often presented as a default without considering patient preferences, prognosis, and alternative options such as conservative kidney management. This study will test the first palliative care intervention for older patients with advanced chronic kidney disease to improve the kidney therapy decision-making process. This research not only has the potential to help thousands of older patients with advanced chronic kidney disease who often have unanswered questions, unmet information needs, and restricted opportunities to share personal treatment preferences with their nephrologists but also has the possibility of creating new models of collaborative care by integrating palliative care into routine nephrology care.

Вмешательства

  • Поведенческое Program A
    Subjects in the Control group will receive 1) National Kidney Foundation information, and 2) support from a kidney therapy educator.
  • Поведенческое Program B
    Subjects in the intervention group will receive 1) a video and paper decision aid, and 2) coaching from a decision support specialist. The visits will be aimed at supporting patients with kidney therapy decision-making.

Первичные конечные точки

  • Changes in Kidney Therapy Decision-Making Process using the Decisional Conflict Scale at 12 weeks [Срок оценки: Baseline, 4-6 weeks, and 12 weeks]
Вторичные конечные точки (3)
  • Changes in patients' well-being at 6 months using the Burden of Kidney Disease Subscale [Срок оценки: Base line 6 months]
  • Changes in number of hospital admissions, intensive care admissions, and emergency room visits [Срок оценки: Baseline, 6 months]
  • Differences in end-of-life care between intervention and control arm [Срок оценки: Baseline to 6 months]

Критерии участия

Критерии включения

  • Age ≥ 75 years old
  • Has advanced kidney disease with kidney function less than 30%
  • Speaks English
  • Has not yet made a dialysis decision

Критерии исключения

  • Has already decided on dialysis or active medical care without dialysis.
  • Has already been seen by a Palliative Care (PC) clinician for kidney-related issues or is enrolled in hospice
  • Currently on dialysis
  • Unable to provide informed consent or complete verbally administered surveys due to health, sensory, or cognitive impairment.

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 · 5 центров
  • UR Medicine Nephrology - Strong West — Brockport
  • Nephrology Clinic - Thompson Professional Building — Canandaigua
  • Nephrology Clinic - St. James Medical Office Building — Hornell
  • Highland Hospital — Rochester
  • University of Rochester Medical Center — Rochester

Идентификаторы

NCT: NCT06410144 · STUDY00009330 · R01AG082891

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗