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

NCT06699446 | Recruiting

• 1 other identifier: 01VSF21036
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Quality of life of patient via questionnaire

  via questionnaire

  6 month

Study Arms (3)

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

Other: pre rehabilitation

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.

Other: pre rehabilitation

Interventions

pre rehabilitation OTHER

preoperative pre-rehabilitation (respiratory training, exercise therapy). Establish an individualized rehabilitation plan and postoperative communication via telephone or app

Intensified education on new media (mobile app); Intensified patient education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Medical School Hanover

Hanover, Lower Saxony, 30625, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Bastian Schmack, PD

CONTACT

0511-532-3452; Schmack.bastian@mh-hannover.de

Jasmin S Hanke, PD

CONTACT

hanke.jasmin@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: June 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)