- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04353804
Regreso a las tareas cotidianas utilizando redes de rehabilitación-III (RETURN-III) (RETURN-III)
Regreso a las tareas cotidianas utilizando Rehabilitation Networks-III Ensayo clínico aleatorizado piloto (ECA piloto RETURN-III)
Millions of patients survive care in medical and surgical Intensive Care Units (ICUs) every year, only to suffer from a new or accelerated dementia-like process, called post-ICU long-term cognitive impairment (ICU-LTCI). ICU-LTCI causes considerable problems with personal relationships, return to work, and everyday tasks, such as managing medicines and money. No treatment for these patients is currently available. Technology using computerized cognitive rehabilitation could improve ICU-LTCI by harnessing the healing potential of the brain (i.e., neuroplasticity). This intervention is scalable, portable, and economical. The investigators will evaluate the effectiveness of computerized cognitive rehabilitation in a randomized controlled trial of 160 ICU survivors. The investigators hypothesize that this intervention could improve cognition. This research has high potential to influence rehabilitation strategies for Veteran and civilian ICU survivors.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Over a lifetime, an average American will be admitted to an intensive care unit (ICU) twice, will spend nearly a week in an ICU during their last six months of life, and will have a one in five chance of an ICU-related death. Of those millions who annually survive critical illness, ICU survivorship is marked by an inability to manage medication, handle finances, live independently, and maintain employment due to post-ICU long-term cognitive impairment (ICU-LTCI).
Data from the investigators' group and others show that 50% of ICU survivors suffer from ICU-LTCI. The investigators' Veterans Affairs (VA) Merit Award funded research, "Measuring the Incidence and determining risk factors for Neuropsychological Dysfunction in ICU Survivors" (MIND-ICU) study, helped define the epidemiology of this persistent and progressive chronic brain dysfunction that affects both executive function and memory domains of cognition. Among survivors from medical and surgical ICUs, 40% have impairments rivaling moderate traumatic brain injury, and 30% have impairments similar to mild-moderate Alzheimer's disease. The MIND-ICU study indicates that the number of Veterans who develop ICU-LTCI is as high as the number of new traumatic brain injury diagnoses among all Active Duty, National Guard, and Reserves of the Army, Navy, Air Force and Marine Corps. For a public health problem of this magnitude, there is a driving unmet need to find solutions for ICU-LTCI.
The investigators' pilot randomized "Returning to Everyday Tasks Utilizing Rehabilitation Networks-I" (RETURN-I) Study showed that a 12-week cognitive rehabilitation intervention (vs. controls) improved executive dysfunction. Next, the investigators transformed this non-computerized, resource-intensive strategy into a novel, efficient, and scalable Computerized Cognitive Rehabilitation (CCR) method. This plasticity-based adaptive CCR was applied to a case-series of ICU survivors which signaled improvements across multiple cognitive domains.
Building on nearly two decades of aging brain research with the VA-Tennessee Valley Geriatric Research, Education and Clinical Center (GRECC), the investigators now propose a Phase II randomized controlled trial (RCT) to investigate the efficacy of CCR for survivors with ICU-LTCI. The Returning to Everyday Tasks Utilizing Rehabilitation Networks-III Study (RETURN-III Study) will be the next logical data-driven approach to develop and offer innovative real-world solutions for civilians and Veterans surviving critical illness with disabling ICU-LTCI.
To test these hypotheses, the RETURN-III study will randomize medical and surgical ICU survivors to either intervention using CCR, or control of non-specific computer games. At three, and twelve months post-randomization, trained research personnel blinded to group assignment will use a validated battery to assess global cognition [primary outcome].
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37212
- Vanderbilt University Medical Center
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Nashville, Tennessee, Estados Unidos, 37212-2637
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults with a recent ICU stay (Medical or Surgical) requiring treatment for respiratory failure and/or shock (i.e., high-risk population)
- No longer requiring ICU-level care
Exclusion Criteria:
- History of pre-existing severe cognitive impairment (IQCODE>=3.8 or documentation in medical record)
- Unwilling to commit to participation in the intervention
- Under consideration for hospice
- Primary residence over 100 miles from enrolling site if the patient is unwilling to return to the enrolling site for follow-up
- Homeless without a secondary contact available
- Severe substance abuse or neuropsychiatric disorder of a severity that prevents independent living
- Active suicidal ideation
- Any past or present behavior that may be deemed a safety risk for follow-up
- Blind, deaf, or unable to understand/communicate in English
- Required ICU level care less than 24 hours
- Not capable of completing computer-based training
- Co-enrollment in another study
- Incarcerated
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Computerized Cognitive Rehabilitation
Computerized Cognitive Rehabilitation |
Treatment Arm: Computerized Cognitive Rehabilitation |
|
Comparador activo: Active Control computer games
Active Control computer games |
Active Control computer games |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Global Cognitive Composite Score
Periodo de tiempo: 3 months
|
Global Cognitive Composite Score derived from the composite score provided by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS, range 40-160). The higher the number, the better the outcome. |
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Disabilities in Instrumental Activities in Daily Living (IADLs)
Periodo de tiempo: 3 and 12 months
|
Measured by Functional Assessment Questionnaire (FAQ) |
3 and 12 months
|
|
Global Cognitive Composite Score
Periodo de tiempo: 12 months
|
Global Cognitive Composite Score derived from the composite score provided by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS, range 40-160). The higher the number, the better the outcome. |
12 months
|
|
Trail Making Test (TMT) Part B
Periodo de tiempo: 3 and 12 months
|
Evaluation of processing speed and executive function |
3 and 12 months
|
|
Cognitive Self Report Questionnaire (CSRQ)
Periodo de tiempo: 3 and 12 months
|
Self-perceived recent cognition |
3 and 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: E. Wesley Ely, MD MPH, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
- Investigador principal: Mayur B Patel, MD MPH, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- D2992-R
- 1506673-1 (Otro identificador: TVHS IRB)
- I01RX002992-01A2 (Subvención/contrato del NIH de EE. UU.)
- 230960 (Otro identificador: VUMC IRB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The investigators will share data de-identified after study publication in accordance to clinical trial best practices and complying with federal guidelines for research.
Marco de tiempo para compartir IPD
The investigators will share data de-identified >12 months after study publication in accordance to clinical trial best practices and complying with federal guidelines for research.
Criterios de acceso compartido de IPD
The investigators will share data de-identified after study publication in accordance to clinical trial best practices and complying with federal guidelines for research for an unlimited period of time.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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