The ACCELERATE Pilot Trial
Advancing Cognition and Cognitive Reserve Before ELective Surgery to Enhance Cognitive Recovery And TrajEctories (ACCELERATE)Trial: a Pilot Multicenter Randomized Trial
調査の概要
詳細な説明
Background: Delirium, a fluctuating, acute disturbance in attention and awareness, develops in 15-50% of older adults after major surgery. Promising, early stage evidence suggests that cognitive prehabilitation could decrease the absolute risk of postoperative delirium by 10% or more. However, multicenter trials that feasibly optimize cognitive prehabilitation adherence amongst populations most likely to benefit from the intervention are required to advance cognitive prehabilitation toward routine practice.
Overarching Aim: The ACCELERATE Pilot Trial will estimate whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol.
Methods:
Design, setting and participants: The ACCELERATE Pilot trial is prospective single-arm interventional pilot trial.
People >/= 60 years old with Clinical Frailty Scale (CFS) score >/= 4 having inpatient abdominal, orthopedic, spine, thoracic, pelvic, head-and-neck, and vascular surgery with expected time to surgery >/= 4 weeks will be included.
Intervention: Our intervention is a home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching.
Outcomes and sample size: Primary outcome is intervention adherence. Secondary outcomes are monthly recruitment and fidelity to delirium assessment. Our pilot sample size of n=103 is designed to provide 80% power at a 5% level of significance to test whether the proportion of adherent patients exceeds our feasibility target of 75%.
Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected outcomes: The ACCELERATE Pilot Trial will derive robust estimates of intervention adherence when supported by structured coaching, as well as trial protocol feasibility. If the pilot trial is feasible, we will proceed with the full ACCELERATE Trial, which will be powered to estimate the effectiveness of cognitive prehabilitation in reducing delirium along with partner-prioritized secondary outcomes.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Emily Hladkowicz, PhD
- 電話番号：18629 613-798-5555
- メール：emhladkowicz@toh.ca
研究連絡先のバックアップ
- 名前：Leandra Amado, MD
- 電話番号：613-798-5555
- メール：lamado@toh.ca
研究場所
-
-
Ontario
-
Ottawa、Ontario、カナダ、K1H 8L6
- The Ottawa Hospital
-
コンタクト：
- Emily Hladkowicz, PhD
- 電話番号：18629 613-798-5555
- メール：emhladkowicz@toh.ca
-
主任研究者：
- Leandra Amado, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age >/= 60 years
- Planned, inpatient, surgical procedures: abdominal, orthopedic, spine, thoracic, pelvic, ENT, and vascular
- Clinical Frailty Scale (CFS) score >/= 4
- Expected time to surgery >/= 4 weeks
- Cognitive capacity to independently consent for surgery
Exclusion Criteria:
- Cardiac and intracranial neurosurgery procedures
- Visual impairment
- Lack of English fluency
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention (cognitive prehabilitation)
Home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching.
|
home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching.
|
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 |
|---|---|---|
|
Intervention adherence
時間枠：From baseline until surgery; intervention duration varies by participant and continues through the preoperative period (minimum of 4 weeks pre-surgery)
|
≥75% of intervention participants completing >/=10 hrs of cognitive prehabilitation
|
From baseline until surgery; intervention duration varies by participant and continues through the preoperative period (minimum of 4 weeks pre-surgery)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Monthly recruitment
時間枠：1 month
|
≥4 participants per center per month (a 40% recruitment rate; full trial would require 36 months to complete)
|
1 month
|
|
Primary outcome ascertainment
時間枠：Delirium will be assessed at the following timepoints after surgery: 1 hour after emergence, and twice daily on postop days 1, 2 and 3 at 08:00 and 20:00; 7 total
|
≥ 90% of participants with ≥ 6 complete in-hospital delirium assessments
|
Delirium will be assessed at the following timepoints after surgery: 1 hour after emergence, and twice daily on postop days 1, 2 and 3 at 08:00 and 20:00; 7 total
|
協力者と研究者
捜査官
- 主任研究者：Leandra Amado, MD、The Ottawa Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
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
その他の研究ID番号
- REB TBD
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 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
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