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临床试验/NCT06699446
NCT06699446招募中不适用

The "Seamless" Patient: From Preoperative Preparation to Postoperative Rehabilitation

Hannover Medical School1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年6月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Quality of life of patient via questionnaire

研究概览

简要总结

The "seamless" patient: from preoperative preparation to postoperative rehabilitation.

The effects of digital services for perioperative care of patients undergoing cardiac surgery will be investigated

详细描述

Intervention by randomization in: G1. "Standard of care" Previous postal call-in without additional communication or special follow-up G2: Intensified patient education via classical communication channels as well as provision of information material for outpatient, preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and telephone postoperative communication (postoperative for Patient-Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROM) analysis) with the surgical center. G3: Intensified education on new media (mobile app) with outpatient preoperative rehabilitation (respiratory training, exercise therapy). Creation of an individualized rehabilitation plan and postoperative, two-way communication via mobileapp.

This project combines the establishment of outpatient pre-rehabilitation with the additional benefit of interrogating patient-reported outcome (PROs) with individualized rehabilitation. Through the improved exchange of information and the resulting more intensive care of patients alone, we hope not only to improve the quality of life, but also to reduce postoperative mortality and morbidity. The use of new techniques with the establishment of a mobile-based app should provide a decisive advantage in the effectiveness of the measures in this regard. The integration of secure, direct, and always-available communication channels will both improve the flow of information and enhance patients' sense of security in an increasingly fast-moving healthcare system.

Hypotheses:

  • The intervention in G2 "classic forms of communication" does not significantly improve the primary and secondary endpoints compared to the control group G1.
  • The intervention in G3 "next level" communication via app leads to a significant improvement of the primary and secondary endpoints compared to control group G1.
  • The rate of exercise performance (in the prehabilitation and rehabilitation phases; % of days) is significantly higher in the G3 "next level" communication via app group compared to the G2 "classical forms of communication" group.
  • Intervention in G2 "classical forms of communication" and G3 "next level" communication via app leads to significant improvement in PREMs compared to control group G1.
  • The questionaires: EQ-VAS, PROMIS-10 and HSSI are equally suitable for mapping the health status of patients* in the postoperative course.
  • The feedback rate (completion of the query) on health status is significantly higher for the questionaires EQ-VAS compared to questionaire PROMIS-10, questionaire HSSI and questionaire MLHFQ.
  • In patients* who develop postoperative pericardial tamponade, pneumonia, or surgical access wound complication (bleeding/Dressler syndrome, infection/sepsis, wound dehiscence/infection, mechanical instability), Questionaire EQ-VAS scores drop significantly before diagnosis. The questionaire EQ-VAS is therefore suitable as a non-specific postoperative parameter for triggering early further diagnostics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •Patient is capable of giving consent;
  • •planned, elective cardiac surgery (coronary bypass surgery and heart valve surgery incl. combination surgery). The planned surgery can be performed with or without a heart-lung machine.
  • •Minimally invasive procedures may also be explicitly included in the study.

排除标准

  • •Emergency care;
  • •congenital heart defects;
  • •age less than 18 years;
  • •patient unable to give consent;
  • •patient unable to perform simple physical training;
  • •high-risk surgery with a calculated Euroscore II of more than 8%.

研究组 & 干预措施

Standard of care"

No Intervention

Previous postal call-in without additional communication or special follow-up

Intensified patient education

Other

via classical communication channels as well as provision of information material for outpatient, preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and telephone postoperative communication (postoperative for Patient-Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROM) analysis) with the surgical center

干预措施: pre rehabilitation (Other)

Intensified education on new media (mobile app)

Other

with outpatient preoperative rehabilitation (respiratory training, exercise therapy). Creation of an individualized rehabilitation plan and postoperative, two-way communication via mobileapp.

干预措施: pre rehabilitation (Other)

结局指标

主要结局

Quality of life of patient via questionnaire

时间窗: 6 month

via questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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