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Набор скоро начнётся NCT07696624

The PROAKTIVE Trial

Без фазы С лечением Kidney Transplant; Complications Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pro-hab program.
Кому может быть актуально
Состояния в реестре: Kidney Transplant; Complications, Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

PRO-Active Rehabilitation Prior to Kidney Transplantation to ImproVe Patient-centered Recovery Evaluation

Обзор

The PRO-Active rehabilitation prior to Kidney Transplantation to ImproVe patient-centered recovery Evaluation trial tests 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.

Подробное описание

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.

Вмешательства

  • Поведенческое Pro-hab program
    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.

Первичные конечные точки

  • Enrollment [Срок оценки: One month]
  • Adequate pro-hab program adherence [Срок оценки: A minimum of 4 weeks before surgery and 18 weeks after discharged from surgery]
  • Adequate patient-reported outcome follow up [Срок оценки: One year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • The Ottawa Hospital — Ottawa

Идентификаторы

NCT: NCT07696624 · REB # TBD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗