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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Emily Hladkowicz, PhD
- Número de teléfono: 18629 613-798-5555
- Correo electrónico: emhladkowicz@toh.ca
Copia de seguridad de contactos de estudio
- Nombre: Leandra Amado, MD
- Número de teléfono: 613-798-5555
- Correo electrónico: lamado@toh.ca
Ubicaciones de estudio
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- The Ottawa Hospital
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Contacto:
- Emily Hladkowicz, PhD
- Número de teléfono: 18629 613-798-5555
- Correo electrónico: emhladkowicz@toh.ca
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Investigador principal:
- Leandra Amado, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intervention adherence
Periodo de tiempo: From baseline until surgery; intervention duration varies by participant and continues through the preoperative period (minimum of 4 weeks pre-surgery)
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≥75% of intervention participants completing >/=10 hrs of cognitive prehabilitation
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From baseline until surgery; intervention duration varies by participant and continues through the preoperative period (minimum of 4 weeks pre-surgery)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Monthly recruitment
Periodo de tiempo: 1 month
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≥4 participants per center per month (a 40% recruitment rate; full trial would require 36 months to complete)
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1 month
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Primary outcome ascertainment
Periodo de tiempo: 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
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≥ 90% of participants with ≥ 6 complete in-hospital delirium assessments
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Leandra Amado, MD, The Ottawa Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
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
- REB TBD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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