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Идёт набор NCT05738330

Symptom Monitoring in Hemodialysis

Без фазы С лечением End Stage Kidney Disease

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: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD), Usual Care.
Кому может быть актуально
Состояния в реестре: End Stage Kidney Disease. Базовые параметры: от 18 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

Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis

Обзор

The SMaRRT-HD trial is a cluster randomized trial of symptom monitoring with supported clinician follow-up using the SMaRRT-HD electronic patient reported outcome measure (ePROM) system versus Usual Care. Approximately 2400 patients at up to 36 geographically and racially diverse US hemodialysis clinics will be enrolled. The primary trial hypothesis is that regular symptom patient reported outcome measure (PROM) administration with supported clinician follow-up in dialysis care will reduce suffering and improve outcomes by prompting treatment of unrecognized symptoms, and enhancing patient-care team communication. Clinics randomized to the SMaRRT-HD group will adopt the use of SMaRRT-HD for 12 months. SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a PROM and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a Health Related Quality of Life survey that includes questions about symptoms.

Вмешательства

  • Поведенческое Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)
    Dialysis clinics randomized to the SMaRRT-HD group will use the SMaRRT-HD system to capture patient-reported symptoms and support clinician follow-up. The online system includes the patient symptom ePROM surveys, clinician real-time email alerts, clinician guidances for symptom management, and patient-facing symptom reports as well as an administrative dashboard supporting management of trial participants at clinics using SMaRRT-HD. Designated clinic personnel (i.e., patient care technicians and
  • Поведенческое Usual Care
    Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a CMS-mandated Health-Related Quality of Life (HRQOL) survey that includes questions about symptoms.

Первичные конечные точки

  • Severity of dialysis-associated symptoms (Effectiveness) [Срок оценки: Baseline, 6 months, 12 months]
Вторичные конечные точки (12)
  • Health-related quality of life (Effectiveness) [Срок оценки: Baseline, 6 months, 12 months]
  • Post-dialysis recovery time (Effectiveness) [Срок оценки: Baseline, 6 months, 12 months]
  • Fatigue (Effectiveness) [Срок оценки: Baseline, 6 months, 12 months]
  • Pain interference (Effectiveness) [Срок оценки: Baseline, 6 months, 12 months]
  • Anxiety (Effectiveness) [Срок оценки: Baseline, 6 months, 12 months]
  • Depression (Effectiveness) [Срок оценки: Baseline, 6 months, 12 months]
  • Healthcare Engagement (Effectiveness) [Срок оценки: Baseline, 6 months, 12 months]
  • Hospitalizations (Effectiveness) [Срок оценки: Duration of active 12 month study participation plus 6 months; 18 months total]
  • Mortality (Effectiveness) [Срок оценки: Duration of active 12 month study participation plus 6 months; 18 months total]
  • Missed dialysis sessions (Effectiveness) [Срок оценки: Duration of active 12 month study participation]
  • Shortened dialysis sessions (Effectiveness) [Срок оценки: Duration of active 12 month study participation]
  • Penetration (Implementation) [Срок оценки: Duration of active 12 month study participation]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Treatment with hemodialysis at a participating dialysis clinic
  • English or Spanish speaking

Критерии исключения

  • Not willing to report their symptoms using the SMaRRT-HD platform
  • Not willing to share clinically acquired data with the research team
  • Underlying condition such as dementia that is anticipated to prevent comprehension of the trial information document (fact sheet)
  • Incarceration

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Fresenius Medical Care — Waltham

Публикации

  • Flythe JE, Picataggio CB, Bernardo L, Dalrymple LS, Kossmann RJ, DeWalt DA, Hanson LC, Wang V, Unruh ML, Hsu JY, Dember LM. Design and rationale of the SMaRRT-HD study: A pragmatic, randomized trial of symptom monitoring for individuals receiving maintenance hemodialysis. Contemp Clin Trials. 2025 Oct;157:108058. doi: 10.1016/j.cct.2025.108058. Epub 2025 Aug 30. PMID 40889553

Идентификаторы

NCT: NCT05738330 · 852661

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗