- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04353804
Rückkehr zu alltäglichen Aufgaben mithilfe von Rehabilitationsnetzwerken-III (RETURN-III) (RETURN-III)
Rückkehr zu alltäglichen Aufgaben unter Verwendung von Rehabilitation Networks-III Randomisierte klinische Pilotstudie (RETURN-III Pilot RCT)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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].
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Tennessee
-
Nashville, Tennessee, Vereinigte Staaten, 37212
- Vanderbilt University Medical Center
-
Nashville, Tennessee, Vereinigte Staaten, 37212-2637
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Computerized Cognitive Rehabilitation
Computerized Cognitive Rehabilitation |
Treatment Arm: Computerized Cognitive Rehabilitation |
|
Aktiver Komparator: Active Control computer games
Active Control computer games |
Active Control computer games |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Global Cognitive Composite Score
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Disabilities in Instrumental Activities in Daily Living (IADLs)
Zeitfenster: 3 and 12 months
|
Measured by Functional Assessment Questionnaire (FAQ) |
3 and 12 months
|
|
Global Cognitive Composite Score
Zeitfenster: 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
Zeitfenster: 3 and 12 months
|
Evaluation of processing speed and executive function |
3 and 12 months
|
|
Cognitive Self Report Questionnaire (CSRQ)
Zeitfenster: 3 and 12 months
|
Self-perceived recent cognition |
3 and 12 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: E. Wesley Ely, MD MPH, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
- Hauptermittler: Mayur B Patel, MD MPH, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- D2992-R
- 1506673-1 (Andere Kennung: TVHS IRB)
- I01RX002992-01A2 (US NIH Stipendium/Vertrag)
- 230960 (Andere Kennung: VUMC IRB)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The investigators will share data de-identified after study publication in accordance to clinical trial best practices and complying with federal guidelines for research.
IPD-Sharing-Zeitrahmen
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.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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