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The ACCELERATE Pilot Trial

6 juli 2026 uppdaterad av: Ottawa Hospital Research Institute

Advancing Cognition and Cognitive Reserve Before ELective Surgery to Enhance Cognitive Recovery And TrajEctories (ACCELERATE)Trial: a Pilot Multicenter Randomized Trial

The Advancing Cognition and Cognitive reserve before ELective surgery to Enhance cognitive Recovery And TrajEctories (ACCELERATE) Pilot Trial estimates whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

103

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Leandra Amado, MD
  • Telefonnummer: 613-798-5555
  • E-post: lamado@toh.ca

Studieorter

  • Kanada
    • Ontario
      • Ottawa, Ontario, Kanada, K1H 8L6
        • The Ottawa Hospital
        • Kontakt:
        • Huvudutredare:
          • Leandra Amado, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intervention adherence
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Monthly recruitment
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ottawa Hospital Research Institute

Samarbetspartners

Canadian Anesthesiologists' Society
University of Ottawa Anesthesiology and Pain Medicine

Utredare

  • Huvudutredare: Leandra Amado, MD, The Ottawa Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2028

Avslutad studie (Beräknad)

1 september 2029

Studieregistreringsdatum

Först inskickad

25 maj 2026

Först inskickad som uppfyllde QC-kriterierna

15 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • REB TBD

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.

Tidsram för IPD-delning

Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.

Kriterier för IPD Sharing Access

Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.

IPD-delning som stöder informationstyp

  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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