The PROAKTIVE Trial
PRO-Active Rehabilitation Prior to Kidney Transplantation to ImproVe Patient-centered Recovery Evaluation
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Many Canadians are waiting for a kidney transplant, using this wait time to improve health before surgery could mean better outcomes. Proactive rehabilitation (pro-hab) is an approach where people are supported to exercise, improve their diet, and have emotional support before surgery, and during their recovery at home.
Overarching Aim: The PROAKTIVE Pilot Trial will test an approach where people are supported to exercise, improve diet, and receive emotional support at home before and after kidney transplant surgery to understand the ideal process and benefits.
Methods:
Design, setting and participants: The PROAKTIVE Pilot trial is a single arm, prospective trial design where eligible participants are enrolled into the pro-hab program.
People >/= 18 years old who will undergo kidney transplant surgery will be included.
Intervention: The intervention will be a multimodal pro-hab program delivered for at least 4 weeks prior to transplant and for 18 weeks after discharge from transplant. The program will be supported virtually using an established, non-commercial platform available on computer, tablet or smartphone.
Outcomes and sample size: The outcomes are: enrollment, program adherence, patient-reported outcome follow-up. The sample size for this stage will be 45, which will provide 80% power to rule out <75% adherence (5% significance) based on our past experience achieving 90% adherence in related populations.
Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected outcomes: The PROAKTIVE Pilot Trial will develop, evaluate and implement a multimodal proactive rehabilitation (pro-hab) program that effectively improves patient-centered recovery and resource use for patient waiting for, and recovering after, kidney transplantation.
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: Daniel McIsaac, MD
- Número de teléfono: 14169 613-798-5555
- Correo electrónico: dmcisaac@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
-
Investigador principal:
- Daniel McIsaac, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥18 years
- Scheduled, or on the pathway, for kidney transplant surgery
- Expected surgery date between at least 4 weeks from enrollment
- Access to internet-enabled device
- Email address
Exclusion Criteria:
- Inability to read and communicate in English
- Cognitive impairment preventing ability to provide informed consent independently
- No telephone/cell phone
Any of the following cardiovascular conditions:
- Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
- Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
- Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's HeartWalk program)
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 |
|---|---|
|
Experimental: Intervention (Pro-hab)
The intervention is a multimodal pro-hab program delivered for at least 4 weeks prior to transplant and for 18 weeks after discharge from transplant surgery.
The program will be supported virtually using an established, non-commercial platform available on computer, tablet or smartphone.
|
Multimodal pro-hab program delivered for at least 4 weeks prior to transplant and for 18 weeks after discharge from transplant, including exercise, breathing, nutrition, and psychosocial support.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Enrollment
Periodo de tiempo: One month
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>40% of eligible participants enroll (4/month) would allow us to complete a fully powered (n=312) patient trial in 24 months.
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One month
|
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Adequate pro-hab program adherence
Periodo de tiempo: A minimum of 4 weeks before surgery and 18 weeks after discharged from surgery
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>75% adherence is required to meaningfully benefit from multimodal health-promotion interventions.
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A minimum of 4 weeks before surgery and 18 weeks after discharged from surgery
|
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Adequate patient-reported outcome follow up
Periodo de tiempo: One year
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>90% complete outcome ascertainment ensures a low risk of bias trial in terms of non-missing data
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One year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Daniel McIsaac, 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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