Postoperative delirium in patients following cardiac surgery F05
Conditions
Interventions
Group 1: Intervention group with AKTIVER Heart intervention - Multimodal, non-pharmacological delirium prevention program with the following modules: 1. Optimization of the medical perioperative manag
2. Optimization of the psychological preparation
3. Orientation visits
4. Intensive mobilization
5. Activation visits
6. Meal support during eating
7. Relaxation and sleep
8. Support/company during medical examinations (AKTIVER Heart)
Group 2: Control group with education about the admission for cardiac surgery and postoperative delirium/prevention of postoperative deli
Sponsors
Klinik für Herz-, Thorax- und Gefäßchirurgie der Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged = 65 years undergoing elective cardiac surgery (with or without heart-lung machine, with or without sternotomy, surgery duration > 60 min) 2. Ability to provide an informed consent 3. Willingness to voluntarily participate in the study after informed consent with signed informed consent form 4. Sufficient knowledge of the German language to complete/answer the questionnaires
Exclusion criteria
Exclusion criteria: 1. Ability to sign informed consent form 2. Severe dementia; severe mental disorders (acute psychosis, severe depressive depressive episode, acute suicidal tendencies), acute delirium 3. Diagnosis of acute alcohol or drug abuse 4. Unstable angina pectoris, STEMI or NSTEMI within the last 2 weeks 5. Heart failure, NYHA IV 6. Severe refractory cardiac arrhythmias 7. Advanced (metastasized) oncological disease 8. Participation in another intervention study (participation in registry studies is permitted)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of the AKTIVER Heart intervention - this is assumed if 90% of patients in the AKTIVE Heart intervention group (N=36) have received preoperative information on perioperative procedures, postoperative delirium and preoperative somatic (optimization by the cardiac surgeons) and psychological preparation (approx. 10-14 days before the planned procedure) and postoperatively at least 1 module per day after extubation for a period of five postoperative days. 2. Acceptance of the AKTIVER Heart intervention - this is assumed if a mean value of acceptance of the intervention is rated by patients on a scale of 0-10 (0=not at all acceptable; 10=very acceptable) with an average of = 7.0. 3. Feasibility of the study design - this is assumed, if an average of 1 patient per week is randomized into the study (36 patients in 36 weeks, 24 in the intervention group, 12 in the control group - 2:1 randomization) and at least 75% of the randomized patients complete all assessments at the 3-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory analyses of group differences between the AKTIVER Heart and the TAU+ group in the following variables: Delirium incidence (3-D-CAM, CAM-ICU, 4-AT), delirium severity (CAM-S, DRS-R-98), cognition (MoCA, SMI), psychological variables and sleep (HADS, PSQI, IES-R), disease acceptance and treatment expectation (IPQ, TEX-Q), nutrition (MNA), frailty (CSHA frailty index), sarcopenia (SARC-F, hand strength measurement), length of stay in the ICU and normal unit. | — |
Countries
Germany
Contacts
Public ContactMonika Sadlonova
Klinik für Herz-, Thorax- und Gefäßchirurgie der Universitätsmedizin Göttingen
Outcome results
None listed