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Идёт набор NCT07496255

Virtual Reality Cognitive Intervention for Critically Ill Delirium Survivors (VR-Cog)

Без фазы С лечением Intensive Care Unit Delirium Intensive Care Acquired Cognitive Impairment Post Intensive Care Unit Syndrome Virtual Reality Cognitive Training

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: VR-based cognitive training program, VR-based attention control.
Кому может быть актуально
Состояния в реестре: Intensive Care Unit Delirium, Intensive Care Acquired Cognitive Impairment, Post Intensive Care Unit Syndrome, Virtual Reality Cognitive Training. Базовые параметры: от 50 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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Обзор

The purpose of this study is to measure the feasibility, acceptability of virtual reality (VR) brain games and estimate their effect on memory, attention, and mood for ICU survivors. The VR program will be used at home through a headset and hand controls.

Подробное описание

Acute respiratory failure (ARF) accounts for 2 million admissions to adult intensive care units (ICUs) in the United States annually, and up to 80% of older adults with ARF suffer delirium, a form of ICU-related acute brain dysfunction. Delirium doubles the risk for new cognitive impairment or dementia within 12 months of ICU discharge. In addition, delirium survivors frequently develop related mental health and quality of life impairments. Unfortunately, there are few effective or scalable interventions to improve cognitive outcomes for ICU survivors.

Primary Objective Aim 1: Measure the feasibility, acceptability, and adherence of VR-Cog in older adult ICU delirium survivors at risk for ICU-acquired MCI and ADRD.

Secondary Objective Aim 2: Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors.

Tertiary/Exploratory/Correlative Objectives Aim 3: Explore the effects of VR-Cog on mental health (depression and anxiety).

Вмешательства

  • Устройство VR-based cognitive training program
    VR-Cog features HomeTown Bound, a suite of 18 modules organized into four training categories: attention, processing speed, memory, and visuospatial.
  • Устройство VR-based attention control
    VR-AC consists of a library of 9 nature scenes (content provided by Nature Treks VR).

Первичные конечные точки

  • Measure the feasibility of VR-Cog in older adult ICU delirium survivors [Срок оценки: Feasibility will be measured at 4 weeks (the end of the intervention period)]
  • Measure the acceptability of VR-Cog in older adult ICU delirium survivors [Срок оценки: Acceptability will be measured at 4 weeks (the end of the intervention period)]
  • Measure the adherence to VR-Cog in older adult ICU delirium survivors [Срок оценки: Adherence will be measured at 4 weeks (the end of the intervention period)]
Вторичные конечные точки (3)
  • Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors. [Срок оценки: Measured at Baseline, 4 weeks (end of intervention period), 3-Month and 6-Month follow up]
  • Explore the effects of VR-Cog on depression [Срок оценки: Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.]
  • Explore the effects of VR-Cog on anxiety [Срок оценки: Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.]

Критерии участия

Критерии включения

  • Adults aged 50 years or older
  • English speaking
  • Admitted to the intensive care unit (ICU) with acute respiratory failure/invasive mechanical ventilation
  • Screening positive for delirium (using Richmond Agitation Sedation Scale and Confusion Assessment Method for the ICU)

Критерии исключения

  • Acute neurologic injury such as stroke, traumatic brain injury, brain mass, intracranial hemorrhage, seizures, or central nervous system infection
  • Chronic cognitive or physical function deficit preventing participation in study interventions or assessments (determined by chart diagnoses and direct participant interview)
  • Chronic cognitive impairment (including mild cognitive impairment or dementia) identified by chart diagnosis, prescription of anti-dementia medications, or Informant Questionnaire on Cognitive Decline in the Elderly Score (IQCODE) >3.3 obtained from family caregiver
  • Severe, uncorrected vision or hearing impairment preventing participation in intervention or outcomes assessments
  • Admitted with acute alcohol or drug intoxication or withdrawal
  • Severe, uncontrolled psychiatric disorder (bipolar disorder or schizophrenia)
  • History of severe vertigo, motion-induced sickness, headaches, light sensitivity, seizures, or prior intolerance of virtual reality (VR)
  • Receiving comfort care measures or not expected to survive the hospitalization
  • Prisoners or patients unable to provide consent
  • Not expected to be discharged home from the hospital, or living more than 50 miles from the nearest recruitment site, or homeless

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
Лечение

Центры проведения

США · 1 центр
  • IU Health Methodist Hospital — Indianapolis

Идентификаторы

NCT: NCT07496255 · 28520

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗