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临床试验/NCT04295668
NCT04295668Unknown不适用

PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Postoperative complications

研究概览

简要总结

PAPRIKA establishes a technologically enabled and personalized prehabilitation and follow-up after surgical intervention program for patients undergoing elective major surgery Program creates close collaboration between the medical environment and the patients empowering them to co-create their own care.

It is at the first stage aimed to high-risk patients undergoing major surgery. Better condition before the surgery is proved to reduce the perioperative complications and to improve patients' health-related quality of life while cutting the associated costs. The concept integrates short-term (average 4 weeks) preoperative interventions including endurance training, promotion of physical activity and nutritional and psychological support. Interventions are planned both at community and at hospital reducing unnecessary interactions between patients and tertiary care.

PAPRIKA tackles three major drivers: i) human perspective ii) organizational challenges and iii) technical aspects. The project is based on previous experience on prehabilitation and the already refined service using design thinking methodologies. It will be also based on the proven reduction of associated costs for the healthcare system.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Age > 70 years old and/or American Society of Anesthesiologist (ASA) index 3-4 and/or highly aggressive surgery or solid organ transplantation.

排除标准

  • Non-elective surgery; metastatic disease.

结局指标

主要结局

Postoperative complications

时间窗: Duration of the initial hospitalization for surgery

Number of postoperative complications during the initial hospitalization for surgery

Severity of postoperative complications

时间窗: Duration of the initial hospitalization for surgery

Severity of postoperative complications during the initial hospitalization for surgery using the Clavien-Dindo classification

Hospital length of stay

时间窗: Duration of the initial hospitalization for surgery

Number of days of hospital length of stay during the initial hospitalization for surgery

次要结局

  • Hospital readmissions at 30 days(From initial hospital discharge to 30 days follow-up)
  • Emergency room visits at 30 days(From initial hospital discharge to 30 days follow-up)
  • Surgical reinterventions at 30 days(From initial hospital discharge to 30 days follow-up)
  • Mortality at 30 days(From initial hospital discharge to 30 days follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anael Barberan-Garcia

Principal investigator

Hospital Clinic of Barcelona

研究点 (1)

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