Clinical trial NCT06699446: The "Seamless" Patient:From Preoperative Preparation to Postoperative Rehabilitation
Official title: The "Seamless" Patient: From Preoperative Preparation to Postoperative Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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%.

Primary outcomes:
measure: Quality of life of patient via questionnaire
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hanover
state: Lower Saxony
Study officials:
References: