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临床试验/NCT05167682
NCT05167682已完成不适用

Patient Empowerment for Major Surgery Preparation @ Home

University of Cologne1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Compliance of patients as feasibility of prehabilitation program

研究概览

简要总结

The PAPRIKA project is a feasibility study with duration of 10 months. The aim of the study is to recruit 25 patients over the age of 65 who will undergo tumor-related esophagectomy and will follow a prehabilitation program to prevent postoperative complications and improve patient-centric complications and patient-centered outcomes.

After determination of the oncologic treatment plan in the tumor board and functional assessment, patient will undergo an interdisciplinary assessment , which will be performed by the PAPRIKA team consisting of physiotherapists, internists/geriatricians, speech and occupational therapists, nutritionists and surgeons.

On the basis of this interdisciplinary assessment an individualized catalog of procedures will be created. Patient have to follow to this catalog of procedures until surgery. Procedures catalog contains behavioral changes, physical training, nutritional counseling, conditioning of pulmonary function and optimization of drug treatment of underlying diseases.

The individual treatments will be weekly reevaluated and if necessary the procedures will be adjusted by treatment teams.

The prehabilitation procedures will be communicated with the patient via a smartphone app, which is specially developed for the prehabilitation program. The implementation will be documented.

The primary aim of this study is to evaluate the compliance of the patients regarding to the prescribed procedures and the use of the smartphone app (feasibility).

As secondary aim postoperative outcome will be compared with the results of a historical cohort for quality control.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Planned operation in less than 4 weeks after enrollment
  • Urgent surgery indication
  • Patients with good to excellent general and nutritional condition (0 points in the pre-screening of the modified NRS OR 1 point in the pre-screening and <2 points in the main screening).
  • Patients deemed by the PAPRIKA team to be physically or mentally incapable of completing the exercise program.

结局指标

主要结局

Compliance of patients as feasibility of prehabilitation program

时间窗: 90 days after surgery

Percentage of patients will be assessed, who have successfully completed all study visits and have installed and used the smart phone app at least once

次要结局

  • Postoperative outcome(90 days after surgery)

研究者

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

Prof. Dr. Paul Brinkkoetter

Prof. MD, Consultant in Nephrology

University Hospital of Cologne

研究点 (1)

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