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Идёт набор NCT06364358

Interactive Computer-adaptive Chronic Kidney Disease Education Program

Без фазы С лечением Chronic Kidney Diseases Hypertension

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: Computerized CKD Education, Usual Hospital Care.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Diseases, Hypertension. Базовые параметры: 18 лет — 70 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
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Официальное название

A Pilot to Develop and Test an Interactive Computer-adaptive Chronic Kidney Disease Education Program for Hospitalized African American Patients (I-C-CKD)

Обзор

The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC

Подробное описание

The goal of this pilot clinical trial is to evaluate a culturally tailored adaptive computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The investigator's first hypothesis is that computerized adaptive education (CAE) will be more effective than standard of care in improving knowledge about self-care for advanced CKD and renal replacement therapy (RRT) options (Primary Outcome). The primary outcome is knowledge about CKD and knowledge about RRT. The study team will measure this using the Kidney Disease Knowledge Survey (KiKs). The investigator's second hypothesis is that CAE will increase patients' intent to participate in CKD self-care (to take diabetes and/or hypertension meds, see a nephrologist, and make additional lifestyle changes like smoking cessation, exercise, low-salt diet) compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey and measure patient activation through the Patient Activation Measure (PAM). Similarly, the investigator hypothesizes that CAE will increase patients' intent to obtain non-catheter access prior to dialysis initiation, to initiate self-care dialysis (peritoneal (PD) or home hemodialysis (HHD), and/or have transplant evaluation compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey. The investigator's final hypothesis is that CAE will increase patients' action at 30 days post-discharge in participating in CKD self-care and CKD health-seeking behavior compared to standard of care controls.

Вмешательства

  • Поведенческое Computerized CKD Education
    The intervention is a culturally tailored computer-based adaptive program (developed during this intervention) to educate patients about kidney disease and renal replacement therapy options.
  • Поведенческое Usual Hospital Care
    Computer based patient education materials about general healthy lifestyle that will include information about the importance of a healthy diet, physical activity and medical adherence

Первичные конечные точки

  • Change in CKD Knowledge baseline to post patient education intervention [Срок оценки: Baseline and 1 day post-intervention]
  • Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention [Срок оценки: Baseline and 1 day post-intervention]
  • Change in ESKD Treatment Preferences from baseline to 1 day post-intervention [Срок оценки: Baseline and 1 day post-intervention]
Вторичные конечные точки (3)
  • Change in Patient Activation Measure from Baseline to 30 days Post-intervention [Срок оценки: Baseline, 1 day post-intervention, and 30 day follow-up]
  • Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up) [Срок оценки: Baseline, 1 day post-intervention and 30 day follow-up]
  • CKD Self-Management from baseline to 30 day post-intervention [Срок оценки: Baseline and 30 day follow-up]

Критерии участия

Критерии включения

  • African-American inpatients
  • Ages 18-70
  • estimated glomerular filtration rate (eGFR)<45
  • Enrolled in the Hospitalist Project

Критерии исключения

  • Does not self-identify as African American
  • Not able to consent
  • Unable to speak English
  • eGFR <45 due to acute kidney injury
  • In Intensive Care Unit
  • has had a transplant
  • currently on dialysis

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
Организация здравоохранения

Центры проведения

США · 1 центр
  • University of Chicago Medical Center — Chicago

Публикации

  • King A, Omoniyi T, Zasadzinski L, Gaspard C, Gorman D, Saunders M. Interactive Computer-Adaptive Chronic Kidney Disease (I-C-CKD) Education for Hospitalized African American Patients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 17;14:e66846. doi: 10.2196/66846. PMID 40245387

Идентификаторы

NCT: NCT06364358 · IRB23-0385 · 5R21DK121262

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗