リハビリネットワークを活用した日常生活への復帰-Ⅲ(RETURN-Ⅲ) (RETURN-III)
リハビリネットワークを活用した日常生活への復帰-Ⅲパイロット無作為化臨床試験(RETURN-Ⅲパイロット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.
調査の概要
状態
詳細な説明
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].
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Tennessee
-
Nashville、Tennessee、アメリカ、37212
- Vanderbilt University Medical Center
-
Nashville、Tennessee、アメリカ、37212-2637
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Computerized Cognitive Rehabilitation
Computerized Cognitive Rehabilitation |
Treatment Arm: Computerized Cognitive Rehabilitation |
|
アクティブコンパレータ:Active Control computer games
Active Control computer games |
Active Control computer games |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Global Cognitive Composite Score
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disabilities in Instrumental Activities in Daily Living (IADLs)
時間枠:3 and 12 months
|
Measured by Functional Assessment Questionnaire (FAQ) |
3 and 12 months
|
|
Global Cognitive Composite Score
時間枠: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
時間枠:3 and 12 months
|
Evaluation of processing speed and executive function |
3 and 12 months
|
|
Cognitive Self Report Questionnaire (CSRQ)
時間枠:3 and 12 months
|
Self-perceived recent cognition |
3 and 12 months
|
協力者と研究者
捜査官
- 主任研究者:E. Wesley Ely, MD MPH、Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
- 主任研究者:Mayur B Patel, MD MPH、Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- D2992-R
- 1506673-1 (その他の識別子:TVHS IRB)
- I01RX002992-01A2 (米国 NIH グラント/契約)
- 230960 (その他の識別子:VUMC IRB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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